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An award cialis trial from the Health Resources and how to buy cialis online Services Administration will increase underrepresented minorities in medicine and support student work in areas of mental health, opioid addiction and primary care in rural areas. Written by Kevin StorrMedia contact. Adam PopeAn how to buy cialis online award from the Health Resources and Services Administration will increase underrepresented minorities in medicine and support student work in areas of mental health, opioid addiction and primary care in rural areas.(Photography. Andrea Mabry and Lexi Coon)The Health Resources and Services Administration has awarded a $1,492,465 grant to the University of Alabama at Birmingham Physician Assistant Studies program to expand mental health training for students, increase the number of underrepresented minorities in medicine and extend clinical care to more underserved patient populations.In Alabama, 62 of the 67 counties fall under the federal definition of Health Professional Shortage Areas. More than one-third of recent UAB physician assistant graduates work in medically underserved areas, but everyone recognizes that number needs to rise even more.

€œI grew up in a rural county in Alabama, and I have seen firsthand the devastating impact on a community when health how to buy cialis online care options continue to disappear,” said Kathy Nugent, Ph.D., chair of Department of Clinical and Diagnostic Sciences and director of the UAB Harbert Institute of Innovation and Entrepreneurship. €œI am excited that our PA students are being given more opportunities to reverse this disturbing trend and deliver more care to those in the most need.”The HRSA grant is part of the program’s “PA Training Enhancement Initiative” and goes through 2026. It will enhance student training in opioid and other substance use disorders by delivering a specialized addiction medicine elective rotation that will be offered to five UAB PA students. In addition, this new elective rotation will also be how to buy cialis online offered to five physician assistant students from other PA programs across the nation, on an annual basis for the next five years. €œThe substance use disorder — especially opioid addiction — is a cialis in the United States,” said Wei Li, Ph.D., the grant’s principal investigator and an associate professor in the UAB PA program.

€œThis grant how to buy cialis online will help us prepare PA students from our program, as well as other programs, in fighting this cialis. Physician assistant students from other PA programs are welcome to apply for an opportunity to complete an elective in our newly developed addiction medicine rotation, with corresponding expenses being covered by this grant as a scholarship.” As part of the new initiatives, the HRSA grant will provide the UAB PA program an opportunity to enhance their behavioral medicine didactic curriculum. New curriculum — including training in the courses Mental Health First Aid, Applied Suicide Intervention Skills Training, and Screening, Brief Intervention and Referral to Treatment — will be added to further develop student skills in recognizing and treating patients in the area of mental health.The National Alliance on Mental Health reports one in five U.S. Adults experiences mental illness how to buy cialis online. Considering the average primary care facility sees 20 patients per day, the physician assistant could encounter around four people experiencing mental illness daily.

The erectile dysfunction treatment cialis has had a profound impact on the lives of many Americans across the country, especially regarding their mental and emotional health. “Unfortunately, how to buy cialis online there are not enough psychiatrists or psychologists to screen, evaluate, treat and manage this growing population of patients,” said M. Tosi Gilford, M.D., PA-C, the grant’s co-investigator and director of the UAB Physician Assistant Studies program. €œUltimately, the burden of care will lie heavily on clinicians practicing in primary care and in the setting of urgent care and emergency medicine how to buy cialis online. €œTo ensure our students are prepared to meet the needs of these patients in a competent and compassionate manner, we are proud to be given an opportunity to expand our didactic and clinical training to equip students with the tools needed to assist in identifying, treating and counseling patients with mental illness.

And decrease the stigma of mental illness, in an effort to improve the cognitive, behavioral and emotional well-being of the patient population in which they will ultimately serve,” Gilford said. Recent diversity efforts how to buy cialis online from the Physician Assistant Studies program have resulted in a double-digit increase over the past two years in the number of students underrepresented in medicine accepted to their incoming cohorts. The HRSA grant will support an expansion of the recruiting and retention efforts of these students, to surpass the national average for physician assistant programs. Furthermore, the UAB PA program will intensify their efforts to facilitate the education of U.S. Military veterans to honor their service and the history of the how to buy cialis online program.

UAB PA is the second-oldest program in the nation and was founded by military veterans in 1968.This is the second HRSA grant for the UAB Physician Assistant Studies program, which is housed in the School of Health Professions. In 2004, the program was awarded a grant to conduct risk how to buy cialis online assessments for sexually transmitted diseases and HIV. That grant resulted in the development of curriculum on recognizing risk behaviors in patients, and the training was also offered to visiting PA students from other programs across the country.Start Preamble Start Printed Page 42608 Centers for Medicare &. Medicaid Services (CMS), HHS. Final rule how to buy cialis online.

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rule also updates and clarifies the IPF teaching policy with respect to IPF hospital closures and displaced residents and finalizes a technical change to one of the 2016-based IPF market basket price proxies. In addition, this final rule finalizes proposals on quality measures and reporting requirements under how to buy cialis online the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program. We note that this final rule does not finalize two proposals to remove quality measures. The changes finalized in this rule for the IPFQR Program are effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2021 through how to buy cialis online September 30, 2022 (FY 2022).

These regulations are effective on October 1, 2021. Start Further Info   The IPF Payment Policy mailbox at IPFPaymentPolicy@cms.hhs.gov for general information. Mollie Knight (410) 786-7948 or Eric Laib (410) 786-9759, for information regarding the market basket update or the labor related how to buy cialis online share. Nick Brock (410) 786-5148 or Theresa Bean (410) 786-2287, for information regarding the regulatory impact analysis. Lauren Lowenstein, (410) 786-4507, for information regarding the inpatient psychiatric facilities quality reporting program.

End Further Info End Preamble Start Supplemental Information Availability of Certain Tables Exclusively Through the Internet on the CMS Website Addendum how to buy cialis online A to this final rule summarizes the FY 2022 IPF PPS payment rates, outlier threshold, cost of living adjustment factors (COLA) for Alaska and Hawaii, national and upper limit cost-to-charge ratios, and adjustment factors. In addition, the B Addenda to this final rule shows the complete listing of ICD-10 Clinical Modification (CM) and Procedure Coding System (PCS) codes, the FY 2022 IPF PPS comorbidity adjustment, and electroconvulsive therapy (ECT) procedure codes. The A and B Addenda are available online at. Https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. Tables setting forth the FY 2022 Wage Index for Urban Areas Based on Core-Based Statistical Area (CBSA) Labor Market Areas and the FY 2022 Wage Index Based on CBSA Labor Market Areas for Rural Areas are available exclusively through the internet, on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​IPFPPS/​WageIndex.html.

I. Executive Summary A. Purpose This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs) for discharges occurring during FY 2022 beginning October 1, 2021 through September 30, 2022. This rule also updates and clarifies the IPF teaching policy with respect to IPF hospital closures and displaced residents and finalizes a technical change to one of the 2016-based IPF market basket price proxies. In addition, the final rule finalizes proposals to adopt quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program.

B. Summary of the Major Provisions 1. Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) For the IPF PPS, we are finalizing our proposal to— Update IPF PPS teaching policy with respect to IPF hospital closures and displaced residents. Replace one of the price proxies currently used for the For-profit Interest cost category in the 2016-based IPF market basket with a similar price proxy. Adjust the 2016-based IPF market basket update (2.7 percent) for economy-wide productivity (0.7 percentage point) as required by section 1886(s)(2)(A)(i) of the Social Security Act (the Act), resulting in a final IPF payment rate update of 2.0 percent for FY 2022.

Make technical rate setting changes. The IPF PPS payment rates will be adjusted annually for inflation, as well as statutory and other policy factors. This final rule updates. ++ The IPF PPS Federal per diem base rate from $815.22 to $832.94. ++ The IPF PPS Federal per diem base rate for providers who failed to report quality data to $816.61.

++ The Electroconvulsive therapy (ECT) payment per treatment from $350.97 to $358.60. ++ The ECT payment per treatment for providers who failed to report quality data to $351.57. ++ The labor-related share from 77.3 percent to 77.2 percent. ++ The wage index budget-neutrality factor from 0.9989 to 1.0017. ++ The fixed dollar loss threshold amount from $14,630 to $14,470 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF PPS payments.

2. Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program In this final rule, we are. Adopting voluntary patient-level data reporting for chart-abstracted measures for data submitted for the FY 2023 payment determination and mandatory patient-level data reporting for chart-abstracted measures for the FY 2024 payment determination and subsequent years. Revising our regulations at 42 CFR 412.434(b)(3) by replacing the term “QualityNet system administrator” with “QualityNet security official”. Adopting the erectile dysfunction disease 2019 (erectile dysfunction treatment) Vaccination Coverage Among Health Care Personnel (HCP) measure for the FY 2023 payment determination and subsequent years.

Adopting the Follow-up After Psychiatric Hospitalization (FAPH) measure for the FY 2024 payment determination and subsequent years. And Removing the following two measures for FY 2024 payment determination and subsequent years. ++ Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure and ++ Follow-up After Hospitalization for Mental Illness (FUH) measure. Not finalizing our proposals to remove the following two measures for Start Printed Page 42609FY 2024 payment determination and subsequent years. ++ Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention Provided (SUB-2/2a) measure.

And ++ Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) measure. C. Summary of Impacts II. Background A. Overview of the Legislative Requirements of the IPF PPS Section 124 of the Medicare, Medicaid, and State Children's Health Insurance Program Balanced Budget Refinement Act of 1999 (BBRA) (Pub.

L. 106-113) required the establishment and implementation of an IPF PPS. Specifically, section 124 of the BBRA mandated that the Secretary of the Department of Health and Human Services (the Secretary) develop a per diem Prospective Payment System (PPS) for inpatient hospital services furnished in psychiatric hospitals and excluded psychiatric units including an adequate patient classification system that reflects the differences in patient resource use and costs among psychiatric hospitals and excluded psychiatric units. €œExcluded psychiatric unit” means a psychiatric unit of an acute care hospital or of a Critical Access Hospital (CAH), which is excluded from payment under the Inpatient Prospective Payment System (IPPS) or CAH payment system, respectively. These excluded psychiatric units will be paid under the IPF PPS.

Section 405(g)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) extended the IPF PPS to psychiatric distinct part units of CAHs. Sections 3401(f) and 10322 of the Patient Protection and Affordable Care Act (Pub. L.

111-148) as amended by section 10319(e) of that Act and by section 1105(d) of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (hereafter referred to jointly as “the Affordable Care Act”) added subsection (s) to section 1886 of the Act. Section 1886(s)(1) of the Act titled “Reference to Establishment and Implementation of System,” refers to section 124 of the BBRA, which relates to the establishment of the IPF PPS. Section 1886(s)(2)(A)(i) of the Act requires the application of the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act to the IPF PPS for the rate year (RY) beginning in 2012 (that is, a RY that coincides with a FY) and each subsequent RY.

Section 1886(s)(2)(A)(ii) of the Act required the application of an “other adjustment” that reduced any update to an IPF PPS base rate by a percentage point amount specified in section 1886(s)(3) of the Act for the RY beginning in 2010 through the RY beginning in 2019. As noted in the FY 2020 IPF PPS final rule, for the RY beginning in 2019, section 1886(s)(3)(E) of the Act required that the other adjustment reduction be equal to 0.75 percentage point. This was the final year the statute required the application of this adjustment. Because FY 2021, was a RY beginning in 2020, FY 2021 was the first-year section 1886(s)(2)(A)(ii) did not apply since its enactment. Sections 1886(s)(4)(A) through (D) of the Act require that for RY 2014 and each subsequent RY, IPFs that fail to report required quality data with respect to such a RY will have their annual update to a standard Federal rate for discharges reduced by 2.0 percentage points.

This may result in an annual update being less than 0.0 for a RY, and may result in payment rates for the upcoming RY being less than such payment rates for the preceding RY. Any reduction for failure to report required quality data will apply only to the RY involved, and the Secretary will not take into account such reduction in computing the payment amount for a subsequent RY. More information about the specifics of the current Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program is available in the FY 2020 IPF PPS and Quality Reporting Updates for Fiscal Year Beginning October 1, 2019 final rule (84 FR 38459 through 38468). To implement and periodically update these provisions, we have published various proposed and final rules and notices in the Federal Register. For more information regarding these documents, see the Center for Medicare &.

Medicaid (CMS) website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​index.html?. €‹redirect=​/​InpatientPsychFacilPPS/​. B. Overview of the IPF PPS The November 2004 IPF PPS final rule (69 FR 66922) established the IPF PPS, as required by section 124 of the BBRA and codified at 42 CFR part 412, subpart N. The November 2004 IPF PPS final rule set forth the Federal per diem base rate for the implementation year (the 18-month period from January 1, 2005 through June 30, 2006), and provided payment for the inpatient operating and capital costs to IPFs for covered psychiatric services they furnish (that is, routine, ancillary, and capital costs, but not costs of approved educational activities, bad debts, and Start Printed Page 42610other services or items that are outside the scope of the IPF PPS).

Covered psychiatric services include services for which benefits are provided under the fee-for-service Part A (Hospital Insurance Program) of the Medicare program. The IPF PPS established the Federal per diem base rate for each patient day in an IPF derived from the national average daily routine operating, ancillary, and capital costs in IPFs in FY 2002. The average per diem cost was updated to the midpoint of the first year under the IPF PPS, standardized to account for the overall positive effects of the IPF PPS payment adjustments, and adjusted for budget-neutrality. The Federal per diem payment under the IPF PPS is comprised of the Federal per diem base rate described previously and certain patient- and facility-level payment adjustments for characteristics that were found in the regression analysis to be associated with statistically significant per diem cost differences with statistical significance defined as p less than 0.05. A complete discussion of the regression analysis that established the IPF PPS adjustment factors can be found in the November 2004 IPF PPS final rule (69 FR 66933 through 66936).

The patient-level adjustments include age, Diagnosis-Related Group (DRG) assignment, and comorbidities. Additionally, there are adjustments to reflect higher per diem costs at the beginning of a patient's IPF stay and lower costs for later days of the stay. Facility-level adjustments include adjustments for the IPF's wage index, rural location, teaching status, a cost-of-living adjustment for IPFs located in Alaska and Hawaii, and an adjustment for the presence of a qualifying emergency department (ED). The IPF PPS provides additional payment policies for outlier cases, interrupted stays, and a per treatment payment for patients who undergo electroconvulsive therapy (ECT). During the IPF PPS mandatory 3-year transition period, stop-loss payments were also provided.

However, since the transition ended as of January 1, 2008, these payments are no longer available. C. Annual Requirements for Updating the IPF PPS Section 124 of the BBRA did not specify an annual rate update strategy for the IPF PPS and was broadly written to give the Secretary discretion in establishing an update methodology. Therefore, in the November 2004 IPF PPS final rule, we implemented the IPF PPS using the following update strategy. Calculate the final Federal per diem base rate to be budget-neutral for the 18-month period of January 1, 2005 through June 30, 2006.

Use a July 1 through June 30 annual update cycle. Allow the IPF PPS first update to be effective for discharges on or after July 1, 2006 through June 30, 2007. In November 2004, we implemented the IPF PPS in a final rule that published on November 15, 2004 in the Federal Register (69 FR 66922). In developing the IPF PPS, and to ensure that the IPF PPS can account adequately for each IPF's case-mix, we performed an extensive regression analysis of the relationship between the per diem costs and certain patient and facility characteristics to determine those characteristics associated with statistically significant cost differences on a per diem basis. That regression analysis is described in detail in our November 28, 2003 IPF proposed rule (68 FR 66923.

66928 through 66933) and our November 15, 2004 IPF final rule (69 FR 66933 through 66960). For characteristics with statistically significant cost differences, we used the regression coefficients of those variables to determine the size of the corresponding payment adjustments. In the November 15, 2004 final rule, we explained the reasons for delaying an update to the adjustment factors, derived from the regression analysis, including waiting until we have IPF PPS data that yields as much information as possible regarding the patient-level characteristics of the population that each IPF serves. We indicated that we did not intend to update the regression analysis and the patient-level and facility-level adjustments until we complete that analysis. Until that analysis is complete, we stated our intention to publish a notice in the Federal Register each spring to update the IPF PPS (69 FR 66966).

On May 6, 2011, we published a final rule in the Federal Register titled, “Inpatient Psychiatric Facilities Prospective Payment System—Update for Rate Year Beginning July 1, 2011 (RY 2012)” (76 FR 26432), which changed the payment rate update period to a RY that coincides with a FY update. Therefore, final rules are now published in the Federal Register in the summer to be effective on October 1. When proposing changes in IPF payment policy, a proposed rule would be issued in the spring, and the final rule in the summer to be effective on October 1. For a detailed list of updates to the IPF PPS, we refer readers to our regulations at 42 CFR 412.428. The most recent IPF PPS annual update was published in a final rule on August 4, 2020 in the Federal Register titled, “Medicare Program.

FY 2021 Inpatient Psychiatric Facilities Prospective Payment System and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)” (85 FR 47042), which updated the IPF PPS payment rates for FY 2021. That final rule updated the IPF PPS Federal per diem base rates that were published in the FY 2020 IPF PPS Rate Update final rule (84 FR 38424) in accordance with our established policies. III. Provisions of the FY 2022 IPF PPS Final Rule and Responses to Comments A. Final Update to the FY 2021 Market Basket for the IPF PPS 1.

Background Originally, the input price index that was used to develop the IPF PPS was the “Excluded Hospital with Capital” market basket. This market basket was based on 1997 Medicare cost reports for Medicare participating inpatient rehabilitation facilities (IRFs), IPFs, long-term care hospitals (LTCHs), cancer hospitals, and children's hospitals. Although “market basket” technically describes the mix of goods and services used in providing health care at a given point in time, this term is also commonly used to denote the input price index (that is, cost category weights and price proxies) derived from that market basket. Accordingly, the term market basket as used in this document, refers to an input price index. Since the IPF PPS inception, the market basket used to update IPF PPS payments has been rebased and revised to reflect more recent data on IPF cost structures.

We last rebased and revised the IPF market basket in the FY 2020 IPF PPS rule, where we adopted a 2016-based IPF market basket, using Medicare cost report data for both Medicare participating freestanding psychiatric hospitals and psychiatric units. We refer readers to the FY 2020 IPF PPS final rule for a detailed discussion of the 2016-based IPF PPS market basket and its development (84 FR 38426 through 38447). References to the historical market baskets used to update IPF PPS payments are listed in the FY 2016 IPF PPS final rule (80 FR 46656). 2. Final FY 2022 IPF Market Basket Update For FY 2022 (that is, beginning October 1, 2021 and ending September 30, 2022), we proposed to update the IPF PPS payments by a market basket Start Printed Page 42611increase factor with a productivity adjustment as required by section 1886(s)(2)(A)(i) of the Act.

In the FY 2022 IPF proposed rule (86 FR 19483), we proposed to use the same methodology described in the FY 2021 IPF PPS final rule (85 FR 47045 through 47046), with one proposed modification to the 2016-based IPF market basket. For the price proxy for the For-profit Interest cost category of the 2016-based IPF market basket, we proposed to use the iBoxx AAA Corporate Bond Yield index instead of the Moody's AAA Corporate Bond Yield index. Effective for December 2020, the Moody's AAA Corporate Bond series is no longer available for use under license to IHS Global Inc. (IGI), the nationally recognized economic and financial forecasting firm with which we contract to forecast the components of the market baskets and multi-factor productivity (MFP). Since IGI is no longer licensed to use and publish the Moody's series, IGI was required to discontinue the publication of the associated historical data and forecasts of this series.

Therefore, IGI constructed a bond yield index (iBoxx) that closely replicates the Moody's corporate bond yield indices currently used in the market baskets. In the FY 2022 IPF PPS proposed rule, we stated that because the iBoxx AAA Corporate Bond Yield index captures the same technical concept as the current corporate bond proxy and tracks similarly to the current measure that is no longer available, we believed that the iBoxx AAA Corporate Bond Yield index is technically appropriate to use in the 2016-based IPF market basket. Based on IGI's fourth quarter 2020 forecast with historical data through the third quarter of 2020, the proposed 2016-based IPF market basket increase factor for FY 2022 was projected to be 2.3 percent. We also proposed that if more recent data became available after the publication of the proposed rule and before the publication of this final rule (for example, a more recent estimate of the market basket update or MFP), we would use such data, if appropriate, to determine the FY 2022 market basket update in this final rule. Section 1886(s)(2)(A)(i) of the Act requires that, after establishing the increase factor for a FY, the Secretary shall reduce such increase factor for FY 2012 and each subsequent FY, by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.

Section 1886(b)(3)(B)(xi)(II) of the Act sets forth the definition of this productivity adjustment. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide, private nonfarm business MFP (as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost reporting period, or other annual period) (the “productivity adjustment”). The U.S. Department of Labor's Bureau of Labor Statistics (BLS) publishes the official measure of private nonfarm business MFP. Please see http://www.bls.gov/​mfp for the BLS historical published MFP data.

A complete description of the MFP projection methodology is available on the CMS website at https://www.cms.gov/​Research-Statistics-Dataand-Systems/​Statistics-Trends-andReports/​MedicareProgramRatesStats/​MarketBasketResearch.html. We note that effective with FY 2022 and forward, CMS is changing the name of this adjustment to refer to it as the productivity adjustment rather than the MFP adjustment. We note that the adjustment relies on the same underlying data and methodology. This new terminology is more consistent with the statutory language described in section 1886(s)(2)(A)(i) of the Act. Using IGI's fourth quarter 2020 forecast, the productivity adjustment for FY 2022 was projected to be 0.2 percent.

We proposed to then reduce the proposed 2.3 percent IPF market basket update by the estimated productivity adjustment for FY 2022 of 0.2 percentage point. Therefore, the proposed FY 2022 IPF update was equal to 2.1 percent (2.3 percent market basket update reduced by the 0.2 percentage point productivity adjustment). Furthermore, we proposed that if more recent data became available after the publication of the proposed rule and before the publication of this final rule (for example, a more recent estimate of the market basket or MFP), we would use such data, if appropriate, to determine the FY 2022 market basket update and productivity adjustment in this final rule. Based on the more recent data available for this FY 2022 IPF final rule (that is, IGI's second quarter 2021 forecast of the 2016-based IPF market basket with historical data through the first quarter of 2021), we estimate that the IPF FY 2022 market basket update is 2.7 percent. The current estimate of the productivity adjustment for FY 2022 is 0.7 percentage point.

Therefore, the current estimate of the FY 2022 IPF increase factor is equal to 2.0 percent (2.7 percent market basket update reduced by 0.7 percentage point productivity adjustment). We invited public comment on our proposals for the FY 2022 market basket update and productivity adjustment. The following is a summary of the public comments received on the proposed FY 2022 market basket update and productivity adjustment and our responses. Comment. One commenter supported the update to the IPF payment rates of 2.1 percent.

Response. We thank the commenter for their support. Comment. One commenter stated that given the growing behavioral health and substance abuse crisis made worse by the erectile dysfunction treatment Public Health Emergency (PHE), that CMS should provide additional payment for IPFs in the future. Response.

We understand the commenter's concern. We acknowledge that the erectile dysfunction treatment PHE has amplified the growing need for behavioral health services in this country and remain committed to trying to find ways to mitigate its impact on IPFs. Our goal is to ensure that the IPF payment rates accurately reflect the best available data. For example, as discussed in section VI.C.3 of this final rule, in comparing and analyzing FY 2019 and FY 2020 claims, we determined that the erectile dysfunction treatment PHE appears to have significantly impacted the FY 2020 IPF claims such that the FY 2019 claims are the best available data to set the outlier fixed dollar loss threshold for FY 2022. Therefore, we deviated from our longstanding practice of using the most recent available year of claims, that is, FY 2020 claims, for estimating IPF PPS payments in FY 2022.

We will continue to analyze more recent available IPF claims data to better understand both the short- and long-term effects of the erectile dysfunction treatment PHE on the IPF PPS. Final Decision. After consideration of the comments we received, we are finalizing a FY 2022 IPF update equal to 2.0 percent based on the more recent data available. 3. Final FY 2022 IPF Labor-Related Share Due to variations in geographic wage levels and other labor-related costs, we believe that payment rates under the IPF PPS should continue to be adjusted by a geographic wage index, which would apply to the labor-related portion of the Federal per diem base rate (hereafter referred to as the labor-related share).

The labor-related share is determined by identifying the national average proportion of total costs that are related to, influenced by, or vary with the local labor market. We proposed to continue to classify a cost category as labor-related if the costs are labor-intensive and vary with the local labor market.Start Printed Page 42612 Based on our definition of the labor-related share and the cost categories in the 2016-based IPF market basket, we proposed to calculate the labor-related share for FY 2022 as the sum of the FY 2022 relative importance of Wages and Salaries. Employee Benefits. Professional Fees. Labor-related.

Administrative and Facilities Support Services. Installation, Maintenance, and Repair Services. All Other. Labor-related Services. And a portion of the Capital-Related relative importance from the 2016-based IPF market basket.

For more details regarding the methodology for determining specific cost categories for inclusion in the 2016-based IPF labor-related share, see the FY 2020 IPF PPS final rule (84 FR 38445 through 38447). The relative importance reflects the different rates of price change for these cost categories between the base year (FY 2016) and FY 2022. Based on IGI's fourth quarter 2020 forecast of the 2016-based IPF market basket, the sum of the FY 2022 relative importance for Wages and Salaries. Employee Benefits. Professional Fees.

Labor-related. Administrative and Facilities Support Services. Installation Maintenance &. Repair Services. And All Other.

Labor related Services was 74.0 percent. We proposed that the portion of Capital-Related costs that are influenced by the local labor market is 46 percent. Since the relative importance for Capital- Related costs was 6.7 percent of the 2016-based IPF market basket for FY 2022, we proposed to take 46 percent of 6.7 percent to determine the labor-related share of Capital-Related costs for FY 2022 of 3.1 percent. Therefore, we proposed a total labor-related share for FY 2022 of 77.1 percent (the sum of 74.0 percent for the labor-related share of operating costs and 3.1 percent for the labor-related share of Capital-Related costs). We also proposed that if more recent data became available after publication of the proposed rule and before the publication of this final rule (for example, a more recent estimate of the labor-related share), we would use such data, if appropriate, to determine the FY 2022 IPF labor-related share in the final rule.

Based on IGI's second quarter 2021 forecast of the 2016-based IPF market basket, the sum of the FY 2022 relative importance for Wages and Salaries. Employee Benefits. Professional Fees. Labor-related. Administrative and Facilities Support Services.

Installation Maintenance &. Repair Services. And All Other. Labor-related Services is 74.1 percent. Since the relative importance for Capital-Related costs is 6.7 percent of the 2016-based IPF market basket for FY 2022, we take 46 percent of 6.7 percent to determine the labor-related share of Capital-Related costs for FY 2022 of 3.1 percent.

Therefore, the current estimate of the total labor-related share for FY 2022 is equal to 77.2 percent (the sum of 74.1 percent for the labor-related share of operating costs and 3.1 percent for the labor-related share of Capital-Related costs). Table 1 shows the final FY 2022 labor-related share and the final FY 2021 labor-related share using the 2016-based IPF market basket relative importance. We invited public comments on the proposed labor-related share for FY 2022. Comment. Several commenters supported the decrease in the labor-related share from 77.3 percent in FY 2021 to 77.1 percent in FY 2022 noting that it will help any facility that has a wage index less than 1.0.

The commenters stated that, across this country there is a growing disparity between high-wage and low-wage states. Recognizing this disparity and slightly lowering the labor-related share provides some aid to hospitals in many rural and underserved communities. Response. We thank the commenter for their support. We agree with the commenters that the labor-related share should reflect the proportion of costs that are attributable to labor and vary geographically to account for differences in labor-related costs across geographic areas.

More recent data became available. Therefore, based on IGI's second quarter 2021 forecast with historical data through the first quarter 2021 the FY 2022 labor-related share for the final rule is 77.2 percent as shown in Table 1. After consideration of comments received, we are finalizing the use of the sum of the FY 2022 relative importance Start Printed Page 42613for the labor-related cost categories based on the most recent forecast (IGI's second quarter 2021 forecast) of the 2016-based IPF market basket labor-related share cost weights, as proposed. B. Final Updates to the IPF PPS Rates for FY Beginning October 1, 2021 The IPF PPS is based on a standardized Federal per diem base rate calculated from the IPF average per diem costs and adjusted for budget-neutrality in the implementation year.

The Federal per diem base rate is used as the standard payment per day under the IPF PPS and is adjusted by the patient-level and facility-level adjustments that are applicable to the IPF stay. A detailed explanation of how we calculated the average per diem cost appears in the November 2004 IPF PPS final rule (69 FR 66926). 1. Determining the Standardized Budget-Neutral Federal per Diem Base Rate Section 124(a)(1) of the BBRA required that we implement the IPF PPS in a budget-neutral manner. In other words, the amount of total payments under the IPF PPS, including any payment adjustments, must be projected to be equal to the amount of total payments that would have been made if the IPF PPS were not implemented.

Therefore, we calculated the budget-neutrality factor by setting the total estimated IPF PPS payments to be equal to the total estimated payments that would have been made under the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) (Pub. L. 97-248) methodology had the IPF PPS not been implemented. A step-by-step description of the methodology used to estimate payments under the TEFRA payment system appears in the November 2004 IPF PPS final rule (69 FR 66926). Under the IPF PPS methodology, we calculated the final Federal per diem base rate to be budget-neutral during the IPF PPS implementation period (that is, the 18-month period from January 1, 2005 through June 30, 2006) using a July 1 update cycle.

We updated the average cost per day to the midpoint of the IPF PPS implementation period (October 1, 2005), and this amount was used in the payment model to establish the budget-neutrality adjustment. Next, we standardized the IPF PPS Federal per diem base rate to account for the overall positive effects of the IPF PPS payment adjustment factors by dividing total estimated payments under the TEFRA payment system by estimated payments under the IPF PPS. In addition, information concerning this standardization can be found in the November 2004 IPF PPS final rule (69 FR 66932) and the RY 2006 IPF PPS final rule (71 FR 27045). We then reduced the standardized Federal per diem base rate to account for the outlier policy, the stop loss provision, and anticipated behavioral changes. A complete discussion of how we calculated each component of the budget-neutrality adjustment appears in the November 2004 IPF PPS final rule (69 FR 66932 through 66933) and in the RY 2007 IPF PPS final rule (71 FR 27044 through 27046).

The final standardized budget-neutral Federal per diem base rate established for cost reporting periods beginning on or after January 1, 2005 was calculated to be $575.95. The Federal per diem base rate has been updated in accordance with applicable statutory requirements and § 412.428 through publication of annual notices or proposed and final rules. A detailed discussion on the standardized budget-neutral Federal per diem base rate and the electroconvulsive therapy (ECT) payment per treatment appears in the FY 2014 IPF PPS update notice (78 FR 46738 through 46740). These documents are available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​index.html. IPFs must include a valid procedure code for ECT services provided to IPF beneficiaries in order to bill for ECT services, as described in our Medicare Claims Processing Manual, Chapter 3, Section 190.7.3 (available at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c03.pdf.) There were no changes to the ECT procedure codes used on IPF claims as a result of the final update to the ICD-10-PCS code set for FY 2022.

Addendum B to this final rule shows the ECT procedure codes for FY 2022 and is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. 2. Final Update of the Federal Per Diem Base Rate and Electroconvulsive Therapy Payment per Treatment The current (FY 2021) Federal per diem base rate is $815.22 and the ECT payment per treatment is $350.97. For the final FY 2022 Federal per diem base rate, we applied the payment rate update of 2.0 percent—that is, the 2016-based IPF market basket increase for FY 2022 of 2.7 percent less the productivity adjustment of 0.7 percentage point—and the wage index budget-neutrality factor of 1.0017 (as discussed in section III.D.1 of this final rule) to the FY 2021 Federal per diem base rate of $815.22, yielding a final Federal per diem base rate of $832.94 for FY 2022. Similarly, we applied the 2.0 percent payment rate update and the 1.0017 wage index budget-neutrality factor to the FY 2021 ECT payment per treatment of $350.97, yielding a final ECT payment per treatment of $358.60 for FY 2022.

Section 1886(s)(4)(A)(i) of the Act requires that for RY 2014 and each subsequent RY, in the case of an IPF that fails to report required quality data with respect to such RY, the Secretary will reduce any annual update to a standard Federal rate for discharges during the RY by 2.0 percentage points. Therefore, we are applying a 2.0 percentage point reduction to the Federal per diem base rate and the ECT payment per treatment as follows. For IPFs that fail requirements under the IPFQR Program, we applied a 0.0 percent payment rate update—that is, the IPF market basket increase for FY 2022 of 2.7 percent less the productivity adjustment of 0.7 percentage point for an update of 2.0 percent, and further reduced by 2 percentage points in accordance with section 1886(s)(4)(A)(i) of the Act—and the wage index budget-neutrality factor of 1.0017 to the FY 2021 Federal per diem base rate of $815.22, yielding a Federal per diem base rate of $816.61 for FY 2022. For IPFs that fail to meet requirements under the IPFQR Program, we applied the 0.0 percent annual payment rate update and the 1.0017 wage index budget-neutrality factor to the FY 2021 ECT payment per treatment of $350.97, yielding an ECT payment per treatment of $351.57 for FY 2022. C.

Final Updates to the IPF PPS Patient-Level Adjustment Factors 1. Overview of the IPF PPS Adjustment Factors The IPF PPS payment adjustments were derived from a regression analysis of 100 percent of the FY 2002 Medicare Provider and Analysis Review (MedPAR) data file, which contained 483,038 cases. For a more detailed description of the data file used for the regression analysis, see the November 2004 IPF PPS final rule (69 FR 66935 through 66936). We are finalizing our proposal to continue to use the existing regression-derived adjustment factors established in 2005 for FY 2022. However, we have used more recent claims data to simulate payments to finalize the outlier fixed dollar loss threshold amount and to assess the impact of the IPF PPS updates.Start Printed Page 42614 2.

IPF PPS Patient-Level Adjustments The IPF PPS includes payment adjustments for the following patient-level characteristics. Medicare Severity Diagnosis Related Groups (MS-DRGs) assignment of the patient's principal diagnosis, selected comorbidities, patient age, and the variable per diem adjustments. A. Final Update to MS-DRG Assignment We believe it is important to maintain for IPFs the same diagnostic coding and Diagnosis Related Group (DRG) classification used under the IPPS for providing psychiatric care. For this reason, when the IPF PPS was implemented for cost reporting periods beginning on or after January 1, 2005, we adopted the same diagnostic code set (ICD-9-CM) and DRG patient classification system (MS-DRGs) that were utilized at the time under the IPPS.

In the RY 2009 IPF PPS notice (73 FR 25709), we discussed CMS' effort to better recognize resource use and the severity of illness among patients. CMS adopted the new MS-DRGs for the IPPS in the FY 2008 IPPS final rule with comment period (72 FR 47130). In the RY 2009 IPF PPS notice (73 FR 25716), we provided a crosswalk to reflect changes that were made under the IPF PPS to adopt the new MS-DRGs. For a detailed description of the mapping changes from the original DRG adjustment categories to the current MS-DRG adjustment categories, we refer readers to the RY 2009 IPF PPS notice (73 FR 25714). The IPF PPS includes payment adjustments for designated psychiatric DRGs assigned to the claim based on the patient's principal diagnosis.

The DRG adjustment factors were expressed relative to the most frequently reported psychiatric DRG in FY 2002, that is, DRG 430 (psychoses). The coefficient values and adjustment factors were derived from the regression analysis discussed in detail in the November 28, 2003 IPF proposed rule (68 FR 66923. 66928 through 66933) and the November 15, 2004 IPF final rule (69 FR 66933 through 66960). Mapping the DRGs to the MS-DRGs resulted in the current 17 IPF MS-DRGs, instead of the original 15 DRGs, for which the IPF PPS provides an adjustment. For FY 2022, we did not propose any changes to the IPF MSDRG adjustment factors.

Therefore, we are finalizing our proposal to maintain the existing IPF MS-DRG adjustment factors. In the FY 2015 IPF PPS final rule published August 6, 2014 in the Federal Register titled, “Inpatient Psychiatric Facilities Prospective Payment System—Update for FY Beginning October 1, 2014 (FY 2015)” (79 FR 45945 through 45947), we finalized conversions of the ICD-9-CM-based MS-DRGs to ICD-10-CM/PCS-based MS-DRGs, which were implemented on October 1, 2015. Further information on the ICD-10-CM/PCS MS-DRG conversion project can be found on the CMS ICD-10-CM website at https://www.cms.gov/​Medicare/​Coding/​ICD10/​ICD-10-MS-DRG-Conversion-Project.html. For FY 2022, we are finalizing our proposal to continue to make the existing payment adjustment for psychiatric diagnoses that group to one of the existing 17 IPF MS-DRGs listed in Addendum A. Addendum A is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html.

Psychiatric principal diagnoses that do not group to one of the 17 designated MS-DRGs will still receive the Federal per diem base rate and all other applicable adjustments, but the payment will not include an MS-DRG adjustment. The diagnoses for each IPF MS-DRG will be updated as of October 1, 2021, using the final IPPS FY 2022 ICD-10-CM/PCS code sets. The FY 2022 IPPS/LTCH PPS final rule includes tables of the changes to the ICD-10-CM/PCS code sets, which underlie the FY 2022 IPF MS-DRGs. Both the FY 2022 IPPS final rule and the tables of final changes to the ICD-10-CM/PCS code sets, which underlie the FY 2022 MS-DRGs, are available on the CMS IPPS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​AcuteInpatientPPS/​index.html. Code First As discussed in the ICD-10-CM Official Guidelines for Coding and Reporting, certain conditions have both an underlying etiology and multiple body system manifestations due to the underlying etiology.

For such conditions, the ICD-10-CM has a coding convention that requires the underlying condition be sequenced first followed by the manifestation. Wherever such a combination exists, there is a “use additional code” note at the etiology code, and a “code first” note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes (etiology followed by manifestation). In accordance with the ICD-10-CM Official Guidelines for Coding and Reporting, when a primary (psychiatric) diagnosis code has a “code first” note, the provider will follow the instructions in the ICD-10-CM Tabular List. The submitted claim goes through the CMS processing system, which will identify the principal diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign a DRG code for adjustment.

The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment. For more information on the code first policy, we refer our readers to the November 2004 IPF PPS final rule (69 FR 66945) and see sections I.A.13 and I.B.7 of the FY 2020 ICD-10-CM Coding Guidelines, available at https://www.cdc.gov/​nchs/​data/​icd/​10cmguidelines-FY2020_​final.pdf. In the FY 2015 IPF PPS final rule, we provided a code first table for reference that highlights the same or similar manifestation codes where the code first instructions apply in ICD-10-CM that were present in ICD-9-CM (79 FR 46009). In FY 2018, FY 2019 and FY 2020, there were no changes to the final ICD-10-CM codes in the IPF Code First table. For FY 2021, there were 18 ICD-10-CM codes deleted from the final IPF Code First table.

For FY 2022 there are 18 codes finalized for deletion from the ICD-10-CM codes in the IPF Code First table. The final FY 2022 Code First table is shown in Addendum B on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. B. Final Payment for Comorbid Conditions The intent of the comorbidity adjustments is to recognize the increased costs associated with comorbid conditions by providing additional payments for certain existing medical or psychiatric conditions that are expensive to treat. In our RY 2012 IPF PPS final rule (76 FR 26451 through 26452), we explained that the IPF PPS includes 17 comorbidity categories and identified the new, revised, and deleted ICD-9-CM diagnosis codes that generate a comorbid condition payment adjustment under the IPF PPS for RY 2012 (76 FR 26451).

Comorbidities are specific patient conditions that are secondary to the patient's principal diagnosis and that require treatment during the stay. Diagnoses that relate to an earlier episode of care and have no bearing on the current hospital stay are excluded and must not be reported on IPF claims. Comorbid conditions must exist at the time of admission or develop subsequently, and affect the treatment received, length of stay (LOS), or both treatment and LOS.Start Printed Page 42615 For each claim, an IPF may receive only one comorbidity adjustment within a comorbidity category, but it may receive an adjustment for more than one comorbidity category. Current billing instructions for discharge claims, on or after October 1, 2015, require IPFs to enter the complete ICD-10-CM codes for up to 24 additional diagnoses if they co-exist at the time of admission, or develop subsequently and impact the treatment provided. The comorbidity adjustments were determined based on the regression analysis using the diagnoses reported by IPFs in FY 2002.

The principal diagnoses were used to establish the DRG adjustments and were not accounted for in establishing the comorbidity category adjustments, except where ICD-9-CM code first instructions applied. In a code first situation, the submitted claim goes through the CMS processing system, which will identify the principal diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign an MS-DRG code for adjustment. The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment. As noted previously, it is our policy to maintain the same diagnostic coding set for IPFs that is used under the IPPS for providing the same psychiatric care. The 17 comorbidity categories formerly defined using ICD-9-CM codes were converted to ICD-10-CM/PCS in our FY 2015 IPF PPS final rule (79 FR 45947 through 45955).

The goal for converting the comorbidity categories is referred to as replication, meaning that the payment adjustment for a given patient encounter is the same after ICD-10-CM implementation as it will be if the same record had been coded in ICD-9-CM and submitted prior to ICD-10-CM/PCS implementation on October 1, 2015. All conversion efforts were made with the intent of achieving this goal. For FY 2022, we are finalizing our proposal to continue to use the same comorbidity adjustment factors in effect in FY 2021, which are found in Addendum A, available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. We have updated the ICD-10-CM/PCS codes, which are associated with the existing IPF PPS comorbidity categories, based upon the final FY 2022 update to the ICD-10-CM/PCS code set. The final FY 2022 ICD-10-CM/PCS updates include.

8 ICD-10-CM diagnosis codes added to the Poisoning comorbidity category, 4 codes deleted, and 4 changes to Poisoning comorbidity long descriptions. 2 ICD-10-CM diagnosis codes added to the Developmental Disabilities comorbidity category and 1 code deleted. And 3 ICD-10-PCS codes added to the Oncology Procedures comorbidity category. These updates are detailed in Addenda B of this final rule, which are available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. In accordance with the policy established in the FY 2015 IPF PPS final rule (79 FR 45949 through 45952), we reviewed all new FY 2022 ICD-10-CM codes to remove codes that were site “unspecified” in terms of laterality from the FY 2022 ICD-10-CM/PCS codes in instances where more specific codes are available.

As we stated in the FY 2015 IPF PPS final rule, we believe that specific diagnosis codes that narrowly identify anatomical sites where disease, injury, or a condition exists should be used when coding patients' diagnoses whenever these codes are available. We finalized in the FY 2015 IPF PPS rule, that we would remove site “unspecified” codes from the IPF PPS ICD-10-CM/PCS codes in instances when laterality codes (site specified codes) are available, as the clinician should be able to identify a more specific diagnosis based on clinical assessment at the medical encounter. None of the finalized additions to the FY 2022 ICD-10-CM/PCS codes were site “unspecified” by laterality, therefore, we are not removing any of the new codes. Comment. A commenter requested that CMS add 13 ICD-10-CM codes for infectious diseases to the list of codes that qualify for the IPF PPS comorbidity adjustment.

Response. As noted previously, the intent of the comorbidity adjustments is to recognize the increased costs associated with comorbid conditions by providing additional payments for certain existing medical or psychiatric conditions that are expensive to treat. Also, the comorbidity adjustments were derived through a regression analysis, which also includes other IPF PPS adjustments (for example, the age adjustment). Our established policy is to annually update the ICD-10-CM/PCS codes, which are associated with the existing IPF PPS comorbidity categories. Adding or removing codes to the existing comorbidity categories that are not part of the annual coding update would occur as part of a larger IPF PPS refinement.

We did not propose to refine the IPF PPS in the FY 2022 IPF PPS proposed rule, and therefore, are not changing the policy in this final rule. However, we will consider the comment to potentially inform future refinements. C. Final Patient Age Adjustments As explained in the November 2004 IPF PPS final rule (69 FR 66922), we analyzed the impact of age on per diem cost by examining the age variable (range of ages) for payment adjustments. In general, we found that the cost per day increases with age.

The older age groups are costlier than the under 45 age group, the differences in per diem cost increase for each successive age group, and the differences are statistically significant. For FY 2022, we are finalizing our proposal to continue to use the patient age adjustments currently in effect in FY 2021, as shown in Addendum A of this rule (see https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html). D. Final Variable Per Diem Adjustments We explained in the November 2004 IPF PPS final rule (69 FR 66946) that the regression analysis indicated that per diem cost declines as the length of stay (LOS) increases. The variable per diem adjustments to the Federal per diem base rate account for ancillary and administrative costs that occur disproportionately in the first days after admission to an IPF.

As discussed in the November 2004 IPF PPS final rule, we used a regression analysis to estimate the average differences in per diem cost among stays of different lengths (69 FR 66947 through 66950). As a result of this analysis, we established variable per diem adjustments that begin on day 1 and decline gradually until day 21 of a patient's stay. For day 22 and thereafter, the variable per diem adjustment remains the same each day for the remainder of the stay. However, the adjustment applied to day 1 depends upon whether the IPF has a qualifying ED. If an IPF has a qualifying ED, it receives a 1.31 adjustment factor for day 1 of each stay.

If an IPF does not have a qualifying ED, it receives a 1.19 adjustment factor for day 1 of the stay. The ED adjustment is explained in more detail in section III.D.4 of this rule. For FY 2022, we are finalizing our proposal to continue to use the variable per diem adjustment factors currently in effect, as shown in Addendum A of this rule (available at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html). A complete discussion of the variable per diem adjustments appears in the November 2004 IPF PPS final rule (69 FR 66946).Start Printed Page 42616 D. Final Updates to the IPF PPS Facility-Level Adjustments The IPF PPS includes facility-level adjustments for the wage index, IPFs located in rural areas, teaching IPFs, cost of living adjustments for IPFs located in Alaska and Hawaii, and IPFs with a qualifying ED.

1. Wage Index Adjustment a. Background As discussed in the RY 2007 IPF PPS final rule (71 FR 27061), RY 2009 IPF PPS (73 FR 25719) and the RY 2010 IPF PPS notices (74 FR 20373), in order to provide an adjustment for geographic wage levels, the labor-related portion of an IPF's payment is adjusted using an appropriate wage index. Currently, an IPF's geographic wage index value is determined based on the actual location of the IPF in an urban or rural area, as defined in § 412.64(b)(1)(ii)(A) and (C). Due to the variation in costs and because of the differences in geographic wage levels, in the November 15, 2004 IPF PPS final rule, we required that payment rates under the IPF PPS be adjusted by a geographic wage index.

We proposed and finalized a policy to use the unadjusted, pre-floor, pre-reclassified IPPS hospital wage index to account for geographic differences in IPF labor costs. We implemented use of the pre-floor, pre-reclassified IPPS hospital wage data to compute the IPF wage index since there was not an IPF-specific wage index available. We believe that IPFs generally compete in the same labor market as IPPS hospitals so the pre-floor, pre-reclassified IPPS hospital wage data should be reflective of labor costs of IPFs. We believe this pre-floor, pre-reclassified IPPS hospital wage index to be the best available data to use as proxy for an IPF specific wage index. As discussed in the RY 2007 IPF PPS final rule (71 FR 27061 through 27067), under the IPF PPS, the wage index is calculated using the IPPS wage index for the labor market area in which the IPF is located, without considering geographic reclassifications, floors, and other adjustments made to the wage index under the IPPS.

For a complete description of these IPPS wage index adjustments, we refer readers to the FY 2019 IPPS/LTCH PPS final rule (83 FR 41362 through 41390). Our wage index policy at § 412.424(a)(2), requires us to use the best Medicare data available to estimate costs per day, including an appropriate wage index to adjust for wage differences. When the IPF PPS was implemented in the November 15, 2004 IPF PPS final rule, with an effective date of January 1, 2005, the pre-floor, pre-reclassified IPPS hospital wage index that was available at the time was the FY 2005 pre-floor, pre-reclassified IPPS hospital wage index. Historically, the IPF wage index for a given RY has used the pre-floor, pre-reclassified IPPS hospital wage index from the prior FY as its basis. This has been due in part to the pre-floor, pre-reclassified IPPS hospital wage index data that were available during the IPF rulemaking cycle, where an annual IPF notice or IPF final rule was usually published in early May.

This publication timeframe was relatively early compared to other Medicare payment rules because the IPF PPS follows a RY, which was defined in the implementation of the IPF PPS as the 12-month period from July 1 to June 30 (69 FR 66927). Therefore, the best available data at the time the IPF PPS was implemented was the pre-floor, pre-reclassified IPPS hospital wage index from the prior FY (for example, the RY 2006 IPF wage index was based on the FY 2005 pre-floor, pre-reclassified IPPS hospital wage index). In the RY 2012 IPF PPS final rule, we changed the reporting year timeframe for IPFs from a RY to the FY, which begins October 1 and ends September 30 (76 FR 26434 through 26435). In that FY 2012 IPF PPS final rule, we continued our established policy of using the pre-floor, pre-reclassified IPPS hospital wage index from the prior year (that is, from FY 2011) as the basis for the FY 2012 IPF wage index. This policy of basing a wage index on the prior year's pre-floor, pre-reclassified IPPS hospital wage index has been followed by other Medicare payment systems, such as hospice and inpatient rehabilitation facilities.

By continuing with our established policy, we remained consistent with other Medicare payment systems. In FY 2020, we finalized the IPF wage index methodology to align the IPF PPS wage index with the same wage data timeframe used by the IPPS for FY 2020 and subsequent years. Specifically, we finalized to use the pre-floor, pre-reclassified IPPS hospital wage index from the FY concurrent with the IPF FY as the basis for the IPF wage index. For example, the FY 2020 IPF wage index was based on the FY 2020 pre-floor, pre-reclassified IPPS hospital wage index rather than on the FY 2019 pre-floor, pre-reclassified IPPS hospital wage index. We explained in the FY 2020 proposed rule (84 FR 16973), that using the concurrent pre-floor, pre-reclassified IPPS hospital wage index will result in the most up-to-date wage data being the basis for the IPF wage index.

It will also result in more consistency and parity in the wage index methodology used by other Medicare payment systems. The Medicare SNF PPS already used the concurrent IPPS hospital wage index data as the basis for the SNF PPS wage index. Thus, the wage adjusted Medicare payments of various provider types will be based upon wage index data from the same timeframe. CMS proposed similar policies to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index data in other Medicare payment systems, such as hospice and inpatient rehabilitation facilities. For FY 2022, we proposed to continue to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index as the basis for the IPF wage index.

Comment. Several commenters expressed concerns with our proposal to continue using the concurrent pre-floor, pre-reclassified IPPS hospital wage index as the basis for the IPF wage index. Three commenters recommended CMS extend the transition for the reductions in payment for certain IPFs resulting from the wage index changes adopted in the FY 2021 IPF PPS final rule. Another commenter also recommended that CMS apply a non-budget neutral 5 percent cap on decreases to a hospital's wage index value to help mitigate wide annual swings that are beyond a hospital's ability to control. Response.

We did not propose to modify the transition policy that was finalized in the FY 2021 IPF PPS final rule. Therefore, we are not changing the previously adopted policy in this final rule. As we discussed in the FY 2021 IPF PPS final rule (85 FR 47058 through 47059), the transition policy caps the estimated reduction in an IPF's wage index to 5 percent in FY 2021, with no cap applied in FY 2022. We stated our belief that implementing updated wage index values along with the revised OMB delineations will result in wage index values being more representative of the actual costs of labor in a given area. As evidenced by the detailed economic analysis (85 FR 47065 through 47068), we estimated that implementing these wage index changes would have distributional effects, both positive and negative, among IPF providers.

We continue to believe that applying the 5-percent cap transition policy in year one provided an adequate safeguard against any significant payment reductions, has allowed for sufficient time to make operational changes for future FYs, and provided a reasonable balance between mitigating some short-term instability in IPF payments and improving the accuracy of the payment adjustment for differences in area wage levels.Start Printed Page 42617 We note that certain changes to wage index policy may significantly affect Medicare payments. These changes may arise from revisions to the OMB delineations of statistical areas resulting from the decennial census data, periodic updates to the OMB delineations in the years between the decennial censuses, or other wage index policy changes. While we consider how best to address these potential scenarios in a consistent and thoughtful manner, we reiterate that our policy principles with regard to the wage index include generally using the most current data and information available and providing that data and information, as well as any approaches to addressing any significant effects on Medicare payments resulting from these potential scenarios, in notice and comment rulemaking. Comment. Two commenters recommended that CMS incorporate a frontier state floor into the IPF wage index.

Another commenter requested that CMS implement policies to address the disparity in payments between rural and urban IPFs, similar to policies that have been adopted for IPPS hospitals. Response. We appreciate commenters' suggestions regarding opportunities to improve the accuracy of the IPF wage index. We did not propose the specific policies that commenters have suggested, but we will take them into consideration to potentially inform future rulemaking. Final Decision.

For FY 2022, we are finalizing the proposal to continue to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index as the basis for the IPF wage index. Since we did not propose any changes to the 2-year transition that was finalized in the FY 2021 IPF PPS final rule, there will be no cap applied to the reduction in the wage index for the second year (that is, FY 2022). We will apply the IPF wage index adjustment to the labor-related share of the national base rate and ECT payment per treatment. The labor-related share of the national rate and ECT payment per treatment will change from 77.3 percent in FY 2021 to 77.2 percent in FY 2022. This percentage reflects the labor-related share of the 2016-based IPF market basket for FY 2022 (see section III.A.4 of this rule).

B. Office of Management and Budget (OMB) Bulletins (i.) Background The wage index used for the IPF PPS is calculated using the unadjusted, pre-reclassified and pre-floor IPPS wage index data and is assigned to the IPF on the basis of the labor market area in which the IPF is geographically located. IPF labor market areas are delineated based on the Core-Based Statistical Area (CBSAs) established by the OMB. Generally, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses through OMB Bulletins.

These bulletins contain information regarding CBSA changes, including changes to CBSA numbers and titles. OMB bulletins may be accessed online at https://www.whitehouse.gov/​omb/​information-for-agencies/​bulletins/​. In accordance with our established methodology, the IPF PPS has historically adopted any CBSA changes that are published in the OMB bulletin that corresponds with the IPPS hospital wage index used to determine the IPF wage index and, when necessary and appropriate, has proposed and finalized transition policies for these changes. In the RY 2007 IPF PPS final rule (71 FR 27061 through 27067), we adopted the changes discussed in the OMB Bulletin No. 03-04 (June 6, 2003), which announced revised definitions for MSAs, and the creation of Micropolitan Statistical Areas and Combined Statistical Areas.

In adopting the OMB CBSA geographic designations in RY 2007, we did not provide a separate transition for the CBSA-based wage index since the IPF PPS was already in a transition period from TEFRA payments to PPS payments. In the RY 2009 IPF PPS notice, we incorporated the CBSA nomenclature changes published in the most recent OMB bulletin that applied to the IPPS hospital wage index used to determine the current IPF wage index and stated that we expected to continue to do the same for all the OMB CBSA nomenclature changes in future IPF PPS rules and notices, as necessary (73 FR 25721). Subsequently, CMS adopted the changes that were published in past OMB bulletins in the FY 2016 IPF PPS final rule (80 FR 46682 through 46689), the FY 2018 IPF PPS rate update (82 FR 36778 through 36779), the FY 2020 IPF PPS final rule (84 FR 38453 through 38454), and the FY 2021 IPF PPS final rule (85 FR 47051 through 47059). We direct readers to each of these rules for more information about the changes that were adopted and any associated transition policies. In part due to the scope of changes involved in adopting the CBSA delineations for FY 2021, we finalized a 2-year transition policy consistent with our past practice of using transition policies to help mitigate negative impacts on hospitals of certain wage index policy changes.

We applied a 5-percent cap on wage index decreases to all IPF providers that had any decrease in their wage indexes, regardless of the circumstance causing the decline, so that an IPF's final wage index for FY 2021 will not be less than 95 percent of its final wage index for FY 2020, regardless of whether the IPF was part of an updated CBSA. We refer readers to the FY 2021 IPF PPS final rule (85 FR 47058 through 47059) for a more detailed discussion about the wage index transition policy for FY 2021. On March 6, 2020 OMB issued OMB Bulletin 20-01 (available on the web at https://www.whitehouse.gov/​wp-content/​uploads/​2020/​03/​Bulletin-20-01.pdf). In considering whether to adopt this bulletin, we analyzed whether the changes in this bulletin would have a material impact on the IPF PPS wage index. This bulletin creates only one Micropolitan statistical area.

As discussed in further detail in section III.D.1.b.ii, since Micropolitan areas are considered rural for the IPF PPS wage index, this bulletin has no material impact on the IPF PPS wage index. That is, the constituent county of the new Micropolitan area was considered rural effective as of FY 2021 and would continue to be considered rural if we adopted OMB Bulletin 20-01. Therefore, we did not propose to adopt OMB Bulletin 20-01 in the FY 2022 IPF PPS proposed rule. (ii.) Micropolitan Statistical Areas OMB defines a “Micropolitan Statistical Area” as a CBSA associated with at least one urban cluster that has a population of at least 10,000, but less than 50,000 (75 FR 37252). We refer to these as Micropolitan Areas.

After extensive impact analysis, consistent with the treatment of these areas under the IPPS as discussed in the FY 2005 IPPS final rule (69 FR 49029 through 49032), we determined the best course of action would be to treat Micropolitan Areas as “rural” and include them in the calculation of each state's IPF PPS rural wage index. We refer the reader to the FY 2007 IPF PPS final rule (71 FR 27064 through 27065) for a complete discussion regarding treating Micropolitan Areas as rural. C. Final Adjustment for Rural Location In the November 2004 IPF PPS final rule, (69 FR 66954) we provided a 17 percent payment adjustment for IPFs located in a rural area. This adjustment was based on the regression analysis, which indicated that the per diem cost Start Printed Page 42618of rural facilities was 17 percent higher than that of urban facilities after accounting for the influence of the other variables included in the regression.

This 17 percent adjustment has been part of the IPF PPS each year since the inception of the IPF PPS. For FY 2022, we proposed to continue to apply a 17 percent payment adjustment for IPFs located in a rural area as defined at § 412.64(b)(1)(ii)(C) (see 69 FR 66954 for a complete discussion of the adjustment for rural locations). Comment. We received one comment in favor of the proposed extension of the 17 percent payment adjustment for rural IPFs. The commenter acknowledged CMS' efforts to avoid disparities in payments to facilities in rural and underserved communities.

Response. We appreciate this comment of support. Since the inception of the IPF PPS, we have applied a 17 percent adjustment for IPFs located in rural areas. As stated in the previous paragraph, this adjustment was derived from the results of our regression analysis and was incorporated into the payment system in order to ensure the accuracy of payments to rural IPFs. CMS continues to look for ways to ensure accuracy of payments to rural IPFs.

Final Decision. For FY 2022, we are finalizing our proposal to continue to apply a 17 percent payment adjustment for IPFs located in a rural area as defined at § 412.64(b)(1)(ii)(C). D. Final Budget Neutrality Adjustment Changes to the wage index are made in a budget-neutral manner so that updates do not increase expenditures. Therefore, for FY 2022, we are finalizing our proposal to continue to apply a budget-neutrality adjustment in accordance with our existing budget-neutrality policy.

This policy requires us to update the wage index in such a way that total estimated payments to IPFs for FY 2022 are the same with or without the changes (that is, in a budget-neutral manner) by applying a budget neutrality factor to the IPF PPS rates. We use the following steps to ensure that the rates reflect the FY 2022 update to the wage indexes (based on the FY 2018 hospital cost report data) and the labor-related share in a budget-neutral manner. Step 1. Simulate estimated IPF PPS payments, using the FY 2021 IPF wage index values (available on the CMS website) and labor-related share (as published in the FY 2021 IPF PPS final rule (85 FR 47043)). Step 2.

Simulate estimated IPF PPS payments using the final FY 2022 IPF wage index values (available on the CMS website) and final FY 2022 labor-related share (based on the latest available data as discussed previously). Step 3. Divide the amount calculated in step 1 by the amount calculated in step 2. The resulting quotient is the FY 2022 budget-neutral wage adjustment factor of 1.0017. Step 4.

Apply the FY 2022 budget-neutral wage adjustment factor from step 3 to the FY 2021 IPF PPS Federal per diem base rate after the application of the market basket update described in section III.A of this rule, to determine the FY 2022 IPF PPS Federal per diem base rate. 2. Final Teaching Adjustment a. Background In the November 2004 IPF PPS final rule, we implemented regulations at sect; 412.424(d)(1)(iii) to establish a facility-level adjustment for IPFs that are, or are part of, teaching hospitals. The teaching adjustment accounts for the higher indirect operating costs experienced by hospitals that participate in graduate medical education (GME) programs.

The payment adjustments are made based on the ratio of the number of full-time equivalent (FTE) interns and residents training in the IPF and the IPF's average daily census (ADC). Medicare makes direct GME payments (for direct costs such as resident and teaching physician salaries, and other direct teaching costs) to all teaching hospitals including those paid under a PPS, and those paid under the TEFRA rate-of-increase limits. These direct GME payments are made separately from payments for hospital operating costs and are not part of the IPF PPS. The direct GME payments do not address the estimated higher indirect operating costs teaching hospitals may face. The results of the regression analysis of FY 2002 IPF data established the basis for the payment adjustments included in the November 2004 IPF PPS final rule.

The results showed that the indirect teaching cost variable is significant in explaining the higher costs of IPFs that have teaching programs. We calculated the teaching adjustment based on the IPF's “teaching variable,” which is (1 + (the number of FTE residents training in the IPF/the IPF's ADC)). The teaching variable is then raised to the 0.5150 power to result in the teaching adjustment. This formula is subject to the limitations on the number of FTE residents, which are described in this section of this rule. We established the teaching adjustment in a manner that limited the incentives for IPFs to add FTE residents for the purpose of increasing their teaching adjustment.

We imposed a cap on the number of FTE residents that may be counted for purposes of calculating the teaching adjustment. The cap limits the number of FTE residents that teaching IPFs may count for the purpose of calculating the IPF PPS teaching adjustment, not the number of residents teaching institutions can hire or train. We calculated the number of FTE residents that trained in the IPF during a “base year” and used that FTE resident number as the cap. An IPF's FTE resident cap is ultimately determined based on the final settlement of the IPF's most recent cost report filed before November 15, 2004 (publication date of the IPF PPS final rule). A complete discussion of the temporary adjustment to the FTE cap to reflect residents due to hospital closure or residency program closure appears in the RY 2012 IPF PPS proposed rule (76 FR 5018 through 5020) and the RY 2012 IPF PPS final rule (76 FR 26453 through 26456).

In section III.D.2.b of this final rule, we discuss finalized updates to the IPF policy on temporary adjustment to the FTE cap. In the regression analysis, the logarithm of the teaching variable had a coefficient value of 0.5150. We converted this cost effect to a teaching payment adjustment by treating the regression coefficient as an exponent and raising the teaching variable to a power equal to the coefficient value. We note that the coefficient value of 0.5150 was based on the regression analysis holding all other components of the payment system constant. A complete discussion of how the teaching adjustment was calculated appears in the November 2004 IPF PPS final rule (69 FR 66954 through 66957) and the RY 2009 IPF PPS notice (73 FR 25721).

As with other adjustment factors derived through the regression analysis, we do not plan to rerun the teaching adjustment factors in the regression analysis until we more fully analyze IPF PPS data. Therefore, in this FY 2022 final rule, we are finalizing our proposal to continue to retain the coefficient value of 0.5150 for the teaching adjustment to the Federal per diem base rate. B. Final Update to IPF Teaching Policy on IPF Program Closures and Displaced Residents For FY 2022, we proposed to change the IPF policy regarding displaced residents from IPF closures and closures of IPF teaching programs. Specifically, we proposed to adopt conforming changes to the IPF PPS teaching policy Start Printed Page 42619to align with the policy changes that the IPPS finalized in the FY 2021 IPPS final rule (85 FR 58865 through 58870).

We believe that the IPF IME policy relating to hospital closure and displaced students is susceptible to the same vulnerabilities as IPPS GME policy. Hence, if an IPF with a large number of residents training in its residency program announces that it is closing, these residents will become displaced and will need to find alternative positions at other IPF hospitals or risk being unable to become Board-certified. Although we proposed to adopt a policy under the IPF PPS that is consistent with an applicable policy under the IPPS, the actual caps under the two payment systems may not be commingled. In other words, the resident cap applicable under the IPPS is separate from the resident cap applicable under the IPF PPS. Moreover, a provider cannot add its IPF resident cap to its IPPS resident cap in order to increase the number of residents it receives payment for under either payment system.

As stated in the November 2004 IPF PPS final rule (69 FR 66922), we implemented regulations at § 412.424(d)(1)(iii) to establish a facility-level adjustment for IPFs that are, or are part of, teaching hospitals. The facility-level adjustment we are providing for teaching hospitals under IPF PPS parallels the IME payments paid under the IPPS. Both payments are add on adjustments to the amount per case and both are based in part on the number of full-time equivalent (FTE) residents training at the facility. The regulation at 42 CFR 412.424(d)(1)(iii)(F) permits an IPF to temporarily adjust its FTE cap to reflect residents added because of another hospital or program's closure. We first implemented regulations regarding residents displaced by teaching hospital and program closures in the May 6, 2011 IPF PPS final rule (76 FR 26431).

In that final rule, we adopted the IPPS definition of “closure of a hospital” at 42 CFR 413.79(h)(1)(i) to apply to IPF closures as well, and to mean that the IPF terminates its Medicare provider agreement as specified in 42 CFR 489.52. In the proposed rule, we proposed to codify this definition, as well as, the definition of an IPF program closure, at § 412.402. Although not explicitly stated in regulatory text, our current policy is that a displaced resident is one that is physically present at the hospital training on the day prior to or the day of hospital or program closure. This longstanding policy derived from the fact that in the regulations text, there are requirements that the receiving hospital identifies the residents “who have come from the closed IPF” (§ 412.424(d)(1)(iii)(F)(1)(ii)) or identifies the residents “who have come from another IPF's closed program” (§ 412.424(d)(1)(iii)(F)(2)(i)), and that the IPF that closed its program identifies “the residents who were in training at the time of the program's closure” (§ 412.424(d)(1)(iii)(F)(2)(ii)). We considered the residents who were physically present at the IPF to be those residents who were “training at the time of the program's closure,” thereby granting them the status of “displaced residents.” Although we did not want to limit the “displaced residents” to only those physically present at the time of closure, it becomes much more administratively challenging for the following groups of residents at closing IPFs/programs to continue their training.

(1) Residents who leave the program after the closure is publicly announced to continue training at another IPF, but before the actual closure. (2) residents assigned to and training at planned rotations at other IPFs who will be unable to return to their rotations at the closing IPF or program. And (3) individuals (such as medical students or would-be fellows) who matched into resident programs at the closing IPF or program but have not yet started training at the closing IPF or program. Other groups of residents who, under current policy, are already considered “displaced residents” include—(1) residents who are physically training in the IPF on the day prior to or day of program or IPF closure. And (2) residents who would have been at the closing IPF or IPF program on the day prior to or of closure but were on approved leave at that time, and are unable to return to their training at the closing IPF or IPF program.

We proposed to amend the IPF policy with regard to closing teaching IPFs and closing residency programs to address the needs of residents attempting to find alternative IPFs in which to complete their training. Additionally, this proposal addresses the incentives of originating and receiving IPFs with regard to ensuring we appropriately account for their indirect teaching costs by way of an appropriate IPF teaching adjustment based on each program's resident FTEs. We proposed to change two aspects of the current IPF policy, which are discussed in the following section. First, rather than link the status of displaced residents, for the purpose of the receiving IPF's request to increase their FTE cap, to the resident's presence at the closing IPF or program on the day prior to or the day of program or IPF closure, we proposed that the ideal day will be the day that the closure was publicly announced, (for example, via a press release or a formal notice to the Accreditation Council on Graduate Medical Education (ACGME)). This will provide greater flexibility for the residents to transfer while the IPF operations or residency programs were winding down, rather than waiting until the last day of IPF or program operation.

This will address the needs of the first group of residents as previously described. Residents who leave the IPF program after the closure was publicly announced to continue training at another IPF, but before the day of actual closure. Second, by removing the link between the status of displaced residents and their presence at the closing IPF or program on the day prior to or the day of program or IPF closure, we proposed to also allow the second and third group of residents who are not physically at the closing IPF/closing program, but had intended to train at (or return to training at, in the case of residents on rotation) to be considered displaced residents. Thus, we proposed to revise our teaching policy with regard to which residents can be considered “displaced” for the purpose of the receiving IPF's request to increase their FTE cap in the situation where an IPF announces publicly that it is closing or that it is closing an IPF residency program(s). Specifically, we are adopting the definitions of “closure of a hospital”, “closure of a hospital residency training program”, and “displaced resident” as defined at 42 CFR 413.79(h) but with respect to IPFs and for the purposes of accounting for indirect teaching costs.

In addition, we proposed to change another detail of the IPF teaching policy specific to the requirements for the receiving IPF. To apply for the temporary increase in the FTE resident cap, the receiving IPF will have to submit a letter to its Medicare Administrative Contractor (MAC) within 60 days of beginning the training of the displaced residents. As established under existing regulation at § 412.424(d)(1)(iii)(F)(1)(ii) and § 412.424(d)(1)(iii)(F)(2)(i), this letter must identify the residents who have come from the closed IPF or program that have caused the receiving IPF to exceed its cap, and the receiving IPF must specify the length of time the adjustment is needed. Moreover, we want to propose clarifications on how the information will be delivered in this letter. Consistent with IPPS teaching policy, we proposed that the letter from the receiving IPF will have to include.

Start Printed Page 42620(1) The name of each displaced resident. (2) the last four digits of each displaced resident's social security number. (3) the IPF and program in which each resident was training previously. And (4) the amount of the cap increase needed for each resident (based on how much the receiving IPF is in excess of its cap and the length of time for which the adjustments are needed). We proposed to require the receiving hospital to only supply the last four digits of each displaced resident's social security number to reduce the amount of personally identifiable information (PII) included in these agreements.

We also clarified, as previously discussed in the May 6, 2011 IPF PPS final rule (76 FR 26455), the maximum number of FTE resident cap slots that could be transferred to all receiving IPFs is the number of FTE resident cap slots belonging to the IPF that has the closed program or that is closing. Therefore, if the originating IPF is training residents in excess of its cap, then being a displaced resident does not guarantee that a cap slot will be transferred along with that resident. Therefore, if there are more IPF displaced residents than available cap slots, the slots may be apportioned according to the closing IPF's discretion. The decision to transfer a cap slot if one is available will be voluntary and made at the sole discretion of the originating IPF. However, if the originating IPF decides to do so, then it will be the originating IPF's responsibility to determine how much of an available cap slot will go with a particular resident (if any).

We also note, as we previously discussed in the May 6, 2011 IPF PPS final rule (76 FR 25455), only to the extent a receiving IPF would exceed its FTE cap by training displaced residents would it be eligible for a temporary adjustment to its resident FTE cap. Displaced residents are factored into the receiving IPF's ratio of resident FTEs to the facility's average daily census. Comment. We received 3 comments on our proposed updates to IPF teaching policy. All commenters appreciate the alignment of IPF teaching policy with IPPS.

They believe it is important to protect medical education. Therefore, decreasing confusion and streamlining the process gives residents and program directors more time to find a new program or rotation site, which can only help the transfer process. Response. We thank these commenters for their support. Final Decision.

For FY 2022, we are finalizing the closure policy as proposed. Section 124 of the BBRA gives the Secretary broad discretion to determine the appropriate adjustment factors for the IPF PPS. We are finalizing our proposal to implement the policy regarding IPF resident caps and closures to remain consistent with the way that the IPPS teaching policy calculates FTE resident caps in the case of a receiving hospital that obtains a temporary IME and direct GME cap adjustment for assuming the training of displaced residents due to another hospital or residency program's closure. We are also finalizing our proposal that in the future, we will deviate from IPPS teaching policy as it pertains to counting displaced residents for the purposes of the IPF teaching adjustment only when it is necessary and appropriate for the IPF PPS. In addition, we are finalizing our proposal to amend the IPF policy with regard to closing teaching IPFs and closing residency programs to address the needs of residents attempting to find alternative IPFs in which to complete their training.

This proposal addresses the incentives of originating and receiving IPFs with regard to ensuring we appropriately account for their indirect teaching costs by way of an appropriate IPF teaching adjustment based on each program's resident FTEs. We are also finalizing our proposal to change two aspects of the current IPF policy, which are discussed in the following section. First, rather than link the status of displaced residents for the purpose of the receiving IPF's request to increase their FTE cap to the resident's presence at the closing IPF or program on the day prior to or the day of program or IPF closure, we are finalizing our proposal that the ideal day will be the day that the closure was publicly announced, (for example, via a press release or a formal notice to the Accreditation Council on Graduate Medical Education (ACGME)). This will provide greater flexibility for the residents to transfer while the IPF operations or residency programs were winding down, rather than waiting until the last day of IPF or program operation. This will address the needs of the first group of residents as previously described.

Residents who leave the IPF program after the closure was publicly announced to continue training at another IPF, but before the day of actual closure. Second, by removing the link between the status of displaced residents and their presence at the closing IPF or program on the day prior to or the day of program or IPF closure, we are finalizing to also allow the second and third group of residents who are not physically at the closing IPF/closing program, but had intended to train at (or return to training at, in the case of residents on rotation) to be considered a displaced resident. Thus, we are finalizing our proposal to revise our teaching policy with regard to which residents can be considered “displaced” for the purpose of the receiving IPF's request to increase their FTE cap in the situation where an IPF announces publicly that it is closing or that it is closing an IPF residency program(s). Specifically, we are adopting the definitions of “closure of a hospital”, “closure of a hospital residency training program”, and “displaced resident” as defined at 42 CFR 413.79(h) but with respect to IPFs and for the purposes of accounting for indirect teaching costs. In addition, we are finalizing our proposal to change another detail of the IPF teaching policy specific to the requirements for the receiving IPF.

To apply for the temporary increase in the FTE resident cap, the receiving IPF will have to submit a letter to its Medicare Administrative Contractor (MAC) within 60 days of beginning the training of the displaced residents. As established under existing regulation at § 412.424(d)(1)(iii)(F)(1)(ii) and § 412.424(d)(1)(iii)(F)(2)(i), this letter must identify the residents who have come from the closed IPF or program that have caused the receiving IPF to exceed its cap, and the receiving IPF must specify the length of time the adjustment is needed. Moreover, we are finalizing the clarifications on how the information will be delivered in this letter. Consistent with IPPS teaching policy, the letter from the receiving IPF will have to include. (1) The name of each displaced resident.

(2) the last four digits of each displaced resident's social security number. (3) the IPF and program in which each resident was training previously. And (4) the amount of the cap increase needed for each resident (based on how much the receiving IPF is in excess of its cap and the length of time for which the adjustments are needed). We are also finalizing our proposal to require the receiving hospital to only supply the last four digits of each displaced resident's social security number to reduce the amount of personally identifiable information (PII) included in these agreements. We are also finalizing the clarification that the maximum number of FTE resident cap slots that could be transferred to all receiving IPFs is the number of FTE resident cap slots belonging to the IPF that has the closed program or that is closing.

Therefore, if the originating IPF is training residents in excess of its cap, then being a displaced resident does not guarantee that a cap slot will be transferred along Start Printed Page 42621with that resident. Therefore, if there are more IPF displaced residents than available cap slots, the slots may be apportioned according to the closing IPF's discretion. The decision to transfer a cap slot if one is available will be voluntary and made at the sole discretion of the originating IPF. However, if the originating IPF decides to do so, then it will be the originating IPF's responsibility to determine how much of an available cap slot will go with a particular resident (if any). We also note that, as we previously discussed in the May 6, 2011 IPF PPS final rule (76 FR 25455), only to the extent a receiving IPF would exceed its FTE cap by training displaced residents would it be eligible for a temporary adjustment to its resident FTE cap.

Displaced residents are factored into the receiving IPF's ratio of resident FTEs to the facility's average daily census. 3. Final Cost of Living Adjustment for IPFs Located in Alaska and Hawaii The IPF PPS includes a payment adjustment for IPFs located in Alaska and Hawaii based upon the area in which the IPF is located. As we explained in the November 2004 IPF PPS final rule, the FY 2002 data demonstrated that IPFs in Alaska and Hawaii had per diem costs that were disproportionately higher than other IPFs. Other Medicare prospective payment systems (for example, the IPPS and LTCH PPS) adopted a COLA to account for the cost differential of care furnished in Alaska and Hawaii.

We analyzed the effect of applying a COLA to payments for IPFs located in Alaska and Hawaii. The results of our analysis demonstrated that a COLA for IPFs located in Alaska and Hawaii will improve payment equity for these facilities. As a result of this analysis, we provided a COLA in the November 2004 IPF PPS final rule. A COLA for IPFs located in Alaska and Hawaii is made by multiplying the non-labor-related portion of the Federal per diem base rate by the applicable COLA factor based on the COLA area in which the IPF is located. The COLA factors through 2009 were published by the Office of Personnel Management (OPM), and the OPM memo showing the 2009 COLA factors is available at https://www.chcoc.gov/​content/​nonforeign-area-retirement-equity-assurance-act.

We note that the COLA areas for Alaska are not defined by county as are the COLA areas for Hawaii. In 5 CFR 591.207, the OPM established the following COLA areas. City of Anchorage, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse. City of Fairbanks, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse. City of Juneau, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse.

Rest of the state of Alaska. As stated in the November 2004 IPF PPS final rule, we update the COLA factors according to updates established by the OPM. However, sections 1911 through 1919 of the Non-foreign Area Retirement Equity Assurance Act, as contained in subtitle B of title XIX of the National Defense Authorization Act (NDAA) for FY 2010 (Pub. L. 111-84, October 28, 2009), transitions the Alaska and Hawaii COLAs to locality pay.

Under section 1914 of NDAA, locality pay was phased in over a 3-year period beginning in January 2010, with COLA rates frozen as of the date of enactment, October 28, 2009, and then proportionately reduced to reflect the phase-in of locality pay. When we published the proposed COLA factors in the RY 2012 IPF PPS proposed rule (76 FR 4998), we inadvertently selected the FY 2010 COLA rates, which had been reduced to account for the phase-in of locality pay. We did not intend to propose the reduced COLA rates because that would have understated the adjustment. Since the 2009 COLA rates did not reflect the phase-in of locality pay, we finalized the FY 2009 COLA rates for RY 2010 through RY 2014. In the FY 2013 IPPS/LTCH final rule (77 FR 53700 through 53701), we established a new methodology to update the COLA factors for Alaska and Hawaii, and adopted this methodology for the IPF PPS in the FY 2015 IPF final rule (79 FR 45958 through 45960).

We adopted this new COLA methodology for the IPF PPS because IPFs are hospitals with a similar mix of commodities and services. We think it is appropriate to have a consistent policy approach with that of other hospitals in Alaska and Hawaii. Therefore, the IPF COLAs for FY 2015 through FY 2017 were the same as those applied under the IPPS in those years. As finalized in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53700 and 53701), the COLA updates are determined every 4 years, when the IPPS market basket labor-related share is updated. Because the labor-related share of the IPPS market basket was updated for FY 2018, the COLA factors were updated in FY 2018 IPPS/LTCH rulemaking (82 FR 38529).

As such, we also updated the IPF PPS COLA factors for FY 2018 (82 FR 36780 through 36782) to reflect the updated COLA factors finalized in the FY 2018 IPPS/LTCH rulemaking. For FY 2022, we are finalizing our proposal to update the COLA factors published by OPM for 2009 (as these are the last COLA factors OPM published prior to transitioning from COLAs to locality pay) using the methodology that we finalized in the FY 2013 IPPS/LTCH PPS final rule and adopted for the IPF PPS in the FY 2015 IPF final rule. Specifically, we are finalizing our proposal to update the 2009 OPM COLA factors by a comparison of the growth in the Consumer Price Indices (CPIs) for the areas of Urban Alaska and Urban Hawaii, relative to the growth in the CPI for the average U.S. City as published by the Bureau of Labor Statistics (BLS). We note that for the prior update to the COLA factors, we used the growth in the CPI for Anchorage and the CPI for Honolulu.

Beginning in 2018, these indexes were renamed to the CPI for Urban Alaska and the CPI for Urban Hawaii due to the BLS updating its sample to reflect the data from the 2010 Decennial Census on the distribution of the urban population (https://www.bls.gov/​regions/​west/​factsheet/​2018cpirevisionwest.pdf, accessed January 22, 2021). The CPI for Urban Alaska area covers Anchorage and Matanuska-Susitna Borough in the State of Alaska and the CPI for Urban Hawaii covers Honolulu in the State of Hawaii. BLS notes that the indexes are considered continuous over time, regardless of name or composition changes. Because BLS publishes CPI data for only Urban Alaska and Urban Hawaii, using the methodology we finalized in the FY 2013 IPPS/LTCH PPS final rule and adopted for the IPF PPS in the FY 2015 IPF final rule, we are finalizing our proposal to use the comparison of the growth in the overall CPI relative to the growth in the CPI for those areas to update the COLA factors for all areas in Alaska and Hawaii, respectively. We believe that the relative price differences between these urban areas and the U.S.

(as measured by the CPIs) are appropriate proxies for the relative price differences between the “other areas” of Alaska and Hawaii and the U.S. BLS publishes the CPI for All Items for Urban Alaska, Urban Hawaii, and for the average U.S. City. However, consistent with our methodology finalized in the FY 2013 IPPS/LTCH PPS final rule and adopted for the IPF PPS in the FY 2015 IPF final rule, we are finalizing our proposal to create reweighted CPIs for each of the respective areas to reflect the underlying Start Printed Page 42622composition of the IPPS market basket nonlabor-related share. The current composition of the CPI for All Items for all of the respective areas is approximately 40 percent commodities and 60 percent services.

However, the IPPS nonlabor-related share is comprised of a different mix of commodities and services. Therefore, we are finalizing our proposal to create reweighted indexes for Urban Alaska, Urban Hawaii, and the average U.S. City using the respective CPI commodities index and CPI services index and proposed shares of 57 percent commodities/43 percent. We created reweighted indexes using BLS data for 2009 through 2020—the most recent data available at the time of this final rulemaking. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38530), we created reweighted indexes based on the 2014-based IPPS market basket (which was adopted for the FY 2018 IPPS update) and BLS data for 2009 through 2016 (the most recent BLS data at the time of the FY 2018 IPPS/LTCH PPS rulemaking), and we updated the IPF PPS COLA factors accordingly for FY 2018.

We continue to believe this methodology is appropriate because we continue to make a COLA for hospitals located in Alaska and Hawaii by multiplying the nonlabor-related portion of the standardized amount by a COLA factor. We note that OPM's COLA factors were calculated with a statutorily mandated cap of 25 percent. As stated in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38530), under the COLA update methodology we finalized in the FY 2013 IPPS/LTCH PPS final rule, we exercised our discretionary authority to adjust payments to hospitals in Alaska and Hawaii by incorporating this cap. In applying this finalized methodology for updating the COLA factors, for FY 2022, we are finalizing our proposal to continue to use such a cap, as our policy is based on OPM's COLA factors (updated by the methodology described above). Applying this methodology, the COLA factors that we are finalizing our proposal to establish for FY 2022 to adjust the nonlabor-related portion of the standardized amount for IPFs located in Alaska and Hawaii are shown in Table 2.

For comparison purposes, we also are showing the COLA factors effective for FY 2018 through FY 2021. The final IPF PPS COLA factors for FY 2022 are also shown in Addendum A to this final rule, and is available at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. 4. Final Adjustment for IPFs with a Qualifying Emergency Department (ED) The IPF PPS includes a facility-level adjustment for IPFs with qualifying EDs. We provide an adjustment to the Federal per diem base rate to account for the costs associated with maintaining a full-service ED.

The adjustment is intended to account for ED costs incurred by a psychiatric hospital with a qualifying ED or an excluded psychiatric unit of an IPPS hospital or a CAH, for preadmission services otherwise payable under the Medicare Hospital Outpatient Prospective Payment System (OPPS), furnished to a beneficiary on the date of the beneficiary's admission to the hospital and during the day immediately preceding the date of admission to the IPF (see § 413.40(c)(2)), and the overhead cost of maintaining the ED. This payment is a facility-level adjustment that applies to all IPF admissions (with one exception which we described), regardless of whether a particular patient receives preadmission services in the hospital's ED. The ED adjustment is incorporated into the variable per diem adjustment for the first day of each stay for IPFs with a qualifying ED. Those IPFs with a qualifying ED receive an adjustment factor of 1.31 as the variable per diem adjustment for day 1 of each patient stay. If an IPF does not have a qualifying ED, it receives an adjustment factor of 1.19 as the variable per diem adjustment for day 1 of each patient stay.

The ED adjustment is made on every qualifying claim except as described in this section of the proposed rule. As specified in § 412.424(d)(1)(v)(B), the ED adjustment is not made when a patient is discharged from an IPPS hospital or CAH and admitted to the same IPPS hospital's or CAH's excluded psychiatric unit. We clarified in the November 2004 IPF PPS final rule (69 FR 66960) that an ED adjustment is not made in this case because the costs associated with ED services are reflected in the DRG payment to the IPPS hospital or through the reasonable cost payment made to the CAH. Therefore, when patients are discharged from an IPPS hospital or CAH and admitted to the same hospital's or CAH's excluded Start Printed Page 42623psychiatric unit, the IPF receives the 1.19 adjustment factor as the variable per diem adjustment for the first day of the patient's stay in the IPF. For FY 2022, we are finalizing our proposal to continue to retain the 1.31 adjustment factor for IPFs with qualifying EDs.

A complete discussion of the steps involved in the calculation of the ED adjustment factors are in the November 2004 IPF PPS final rule (69 FR 66959 through 66960) and the RY 2007 IPF PPS final rule (71 FR 27070 through 27072). F. Other Final Payment Adjustments and Policies 1. Outlier Payment Overview The IPF PPS includes an outlier adjustment to promote access to IPF care for those patients who require expensive care and to limit the financial risk of IPFs treating unusually costly patients. In the November 2004 IPF PPS final rule, we implemented regulations at § 412.424(d)(3)(i) to provide a per-case payment for IPF stays that are extraordinarily costly.

Providing additional payments to IPFs for extremely costly cases strongly improves the accuracy of the IPF PPS in determining resource costs at the patient and facility level. These additional payments reduce the financial losses that would otherwise be incurred in treating patients who require costlier care, and therefore, reduce the incentives for IPFs to under-serve these patients. We make outlier payments for discharges in which an IPF's estimated total cost for a case exceeds a fixed dollar loss threshold amount (multiplied by the IPF's facility-level adjustments) plus the Federal per diem payment amount for the case. In instances when the case qualifies for an outlier payment, we pay 80 percent of the difference between the estimated cost for the case and the adjusted threshold amount for days 1 through 9 of the stay (consistent with the median LOS for IPFs in FY 2002), and 60 percent of the difference for day 10 and thereafter. The adjusted threshold amount is equal to the outlier threshold amount adjusted for wage area, teaching status, rural area, and the COLA adjustment (if applicable), plus the amount of the Medicare IPF payment for the case.

We established the 80 percent and 60 percent loss sharing ratios because we were concerned that a single ratio established at 80 percent (like other Medicare PPSs) might provide an incentive under the IPF per diem payment system to increase LOS in order to receive additional payments. After establishing the loss sharing ratios, we determined the current fixed dollar loss threshold amount through payment simulations designed to compute a dollar loss beyond which payments are estimated to meet the 2 percent outlier spending target. Each year when we update the IPF PPS, we simulate payments using the latest available data to compute the fixed dollar loss threshold so that outlier payments represent 2 percent of total estimated IPF PPS payments. 2. Final Update to the Outlier Fixed Dollar Loss Threshold Amount In accordance with the update methodology described in § 412.428(d), we are finalizing our proposal to update the fixed dollar loss threshold amount used under the IPF PPS outlier policy.

Based on the regression analysis and payment simulations used to develop the IPF PPS, we established a 2 percent outlier policy, which strikes an appropriate balance between protecting IPFs from extraordinarily costly cases while ensuring the adequacy of the Federal per diem base rate for all other cases that are not outlier cases. Our longstanding methodology for updating the outlier fixed dollar loss threshold involves using the best available data, which is typically the most recent available data. For this final rulemaking, the most recent available data are the FY 2020 claims. However, during FY 2020, the U.S. Healthcare system undertook an unprecedented response to the PHE declared by the Health and Human Services Secretary on January 31, 2020 in response to the outbreak of respiratory disease caused by a novel (new) erectile dysfunction that has been named “SARS CoV 2” and the disease it causes, which has been named “erectile dysfunction disease 2019” (abbreviated “erectile dysfunction treatment”).

Therefore, as discussed in section VI.C.3 of the FY 2022 IPF PPS proposed rule (86 FR 19524 through 195266), we considered whether the most recent available year of claims, FY 2020, or the prior year, FY 2019, would be the best for estimating IPF PPS payments in FY 2021 and FY 2022. We compared the two years' claims distributions as well as the impact results, and based on that analysis determined that the FY 2019 claims appeared to be the best available data at this time. We refer the reader to section VI.C.3 of the FY 2022 IPF PPS proposed rule (86 FR 19524 through 195266 FR) for a detailed discussion of that analysis. Comment. We received 2 comments on our analysis of the FY 2019 and FY 2020 claims in determining the best available data for estimating IPF PPS payments in FY 2021 and FY 2022.

Both comments were supportive of our proposal to use the FY 2019 claims for this purpose. One of these commenters expressed appreciation for the proposed reduction in the outlier fixed dollar loss threshold. Another commenter agreed with our assessment that FY 2020 claims were heavily impacted by the intensity of the erectile dysfunction treatment cialis. Response. We appreciate these commenters' support.

Based on the revised impact analysis discussed in section VI.C.3 of this final rule, we continue to believe that the FY 2019 claims are the best available data for estimating FY 2021 and FY 2022 payments. Final Decision. We are finalizing as proposed to use the June 2020 update of the FY 2019 IPF claims for updating the outlier fixed dollar loss threshold. Based on an analysis of the June 2020 update of FY 2019 IPF claims and the FY 2021 rate increases, we believe it is necessary to update the fixed dollar loss threshold amount to maintain an outlier percentage that equals 2 percent of total estimated IPF PPS payments. We are finalizing our proposal to update the IPF outlier threshold amount for FY 2022 using FY 2019 claims data and the same methodology that we used to set the initial outlier threshold amount in the RY 2007 IPF PPS final rule (71 FR 27072 and 27073), which is also the same methodology that we used to update the outlier threshold amounts for years 2008 through 2021.

Based on an analysis of these updated data, we estimate that IPF outlier payments as a percentage of total estimated payments are approximately 1.9 percent in FY 2021. Therefore, we are finalizing our proposal to update the outlier threshold amount to $14,470 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF payments for FY 2022. This final update is a decrease from the FY 2021 threshold of $14,630. In contrast, using the FY 2020 claims to estimate payments, the final outlier fixed dollar loss threshold for FY 2022 would be $22,720, which would have been an increase from the FY 2021 threshold of $14,630. We refer the reader to section VI.C.3 of this final rule for a detailed discussion of the estimated impacts of the final update to the outlier fixed dollar loss threshold.

We note that our use of the FY 2019 claims to set the final outlier fixed dollar loss threshold for FY 2022 deviates from what has been our longstanding practice of using the most recent available year of claims, which is FY 2020 data. However, we are finalizing this policy in a way that remains otherwise consistent with the Start Printed Page 42624established outlier update methodology. As discussed in this section and in section VI.C.3 of this final rule, we are finalizing our proposal to update the outlier fixed dollar loss threshold based on FY 2019 IPF claims in order to maintain the appropriate outlier percentage in FY 2022. We are finalizing our proposal to deviate from our longstanding practice of using the most recent available year of claims only because, and to the extent that, the erectile dysfunction treatment PHE appears to have significantly impacted the FY 2020 IPF claims. As discussed in section VI.C.3 of this final rule, we have analyzed more recent available IPF claims data and continue to believe that using FY 2019 IPF claims is appropriate for the FY 2022 update.

We intend to continue to analyze further data in order to better understand both the short-term and long-term effects of the erectile dysfunction treatment PHE on IPFs. 3. Final Update to IPF Cost-to-Charge Ratio Ceilings Under the IPF PPS, an outlier payment is made if an IPF's cost for a stay exceeds a fixed dollar loss threshold amount plus the IPF PPS amount. In order to establish an IPF's cost for a particular case, we multiply the IPF's reported charges on the discharge bill by its overall cost-to-charge ratio (CCR). This approach to determining an IPF's cost is consistent with the approach used under the IPPS and other PPSs.

In the FY 2004 IPPS final rule (68 FR 34494), we implemented changes to the IPPS policy used to determine CCRs for IPPS hospitals, because we became aware that payment vulnerabilities resulted in inappropriate outlier payments. Under the IPPS, we established a statistical measure of accuracy for CCRs to ensure that aberrant CCR data did not result in inappropriate outlier payments. As we indicated in the November 2004 IPF PPS final rule (69 FR 66961), we believe that the IPF outlier policy is susceptible to the same payment vulnerabilities as the IPPS. Therefore, we adopted a method to ensure the statistical accuracy of CCRs under the IPF PPS. Specifically, we adopted the following procedure in the November 2004 IPF PPS final rule.

Calculated two national ceilings, one for IPFs located in rural areas and one for IPFs located in urban areas. Computed the ceilings by first calculating the national average and the standard deviation of the CCR for both urban and rural IPFs using the most recent CCRs entered in the most recent Provider Specific File (PSF) available. For FY 2022, we are finalizing our proposal to continue to follow this methodology. To determine the rural and urban ceilings, we multiplied each of the standard deviations by 3 and added the result to the appropriate national CCR average (either rural or urban). The upper threshold CCR for IPFs in FY 2022 is 2.0261 for rural IPFs, and 1.6879 for urban IPFs, based on CBSA-based geographic designations.

If an IPF's CCR is above the applicable ceiling, the ratio is considered statistically inaccurate, and we assign the appropriate national (either rural or urban) median CCR to the IPF. We apply the national median CCRs to the following situations. New IPFs that have not yet submitted their first Medicare cost report. We continue to use these national median CCRs until the facility's actual CCR can be computed using the first tentatively or final settled cost report. IPFs whose overall CCR is in excess of three standard deviations above the corresponding national geometric mean (that is, above the ceiling).

Other IPFs for which the MAC obtains inaccurate or incomplete data with which to calculate a CCR. We are finalizing our proposal to continue to update the FY 2022 national median and ceiling CCRs for urban and rural IPFs based on the CCRs entered in the latest available IPF PPS PSF. Specifically, for FY 2022, to be used in each of the three situations listed previously, using the most recent CCRs entered in the CY 2021 PSF, we provide an estimated national median CCR of 0.5720 for rural IPFs and a national median CCR of 0.4200 for urban IPFs. These calculations are based on the IPF's location (either urban or rural) using the CBSA-based geographic designations. A complete discussion regarding the national median CCRs appears in the November 2004 IPF PPS final rule (69 FR 66961 through 66964).

IV. Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program A. Background and Statutory Authority We refer readers to the FY 2019 IPF PPS final rule (83 FR 38589) for a discussion of the background and statutory authority [] of the IPFQR Program. B. Covered Entities In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53645), we established that the IPFQR Program's quality reporting requirements cover those psychiatric hospitals and psychiatric units paid under Medicare's IPF PPS (§ 412.404(b)).

Generally, psychiatric hospitals and psychiatric units within acute care and critical access hospitals that treat Medicare patients are paid under the IPF PPS. Consistent with previous regulations, we continue to use the terms “facility” or IPF to refer to both inpatient psychiatric hospitals and psychiatric units. This usage follows the terminology in our IPF PPS regulations at § 412.402. For more information on covered entities, we refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53645). C.

Previously Finalized Measures and Administrative Procedures The current IPFQR Program includes 14 measures. For more information on these measures, we refer readers to Table 5 of this final rule and the following final rules. The FY 2013 IPPS/LTCH PPS final rule (77 FR 53646 through 53652). The FY 2014 IPPS/LTCH PPS final rule (78 FR 50889 through 50897). The FY 2015 IPF PPS final rule (79 FR 45963 through 45975).

The FY 2016 IPF PPS final rule (80 FR 46695 through 46714). The FY 2017 IPPS/LTCH PPS final rule (81 FR 57238 through 57247). The FY 2019 IPF PPS final rule (83 FR 38590 through 38606). And The FY 2020 IPF PPS final rule (84 FR 38459 through 38467). For more information on previously adopted procedural requirements, we refer readers to the following rules.

The FY 2013 IPPS/LTCH PPS final rule (77 FR 53653 through 53660). The FY 2014 IPPS/LTCH PPS final rule (78 FR 50897 through 50903). The FY 2015 IPF PPS final rule (79 FR 45975 through 45978). The FY 2016 IPF PPS final rule (80 FR 46715 through 46719);Start Printed Page 42625 The FY 2017 IPPS/LTCH PPS final rule (81 FR 57248 through 57249). The FY 2018 IPPS/LTCH PPS final rule (82 FR 38471 through 38474).

The FY 2019 IPF PPS final rule (83 FR 38606 through 38608). And The FY 2020 IPF PPS final rule (84 FR 38467 through 38468). D. Closing the Health Equity Gap in CMS Quality Programs—Request for Information (RFI) Persistent inequities in health care outcomes exist in the U.S., including among Medicare patients. In recognition of persistent health disparities and the importance of closing the health equity gap, we requested information on revising several CMS programs to make reporting of health disparities based on social risk factors and race and ethnicity more comprehensive and actionable for facilities, providers, and patients.

The RFI that was included in the proposed rule is part of an ongoing effort across CMS to evaluate appropriate initiatives to reduce health disparities. Feedback will be used to inform the creation of a future, comprehensive, RFI focused on closing the health equity gap in CMS programs and policies. The RFI contained four parts. Background. This section provided information describing our commitment to health equity, and existing initiatives with an emphasis on reducing health disparities.

Current CMS Disparity Methods. This section described the methods, measures, and indicators of social risk currently used with the CMS Disparity Methods. Future potential stratification of quality measure results. This section described four potential future expansions of the CMS Disparity Methods, including (1) Stratification of Quality Measure Results—Dual Eligibility. (2) Stratification of Quality Measure Results—Race and Ethnicity.

(3) Improving Demographic Data Collection. And (4) Potential Creation of a Facility Equity Score to Synthesize Results Across Multiple Social Risk Factors. Solicitation of public comment. This section specified 12 requests for feedback on these topics. We reviewed feedback on these topics and note our intention for an additional RFI or rulemaking on this topic in the future.

1. Background Significant and persistent inequities in health care outcomes exist in the U.S. Belonging to a racial or ethnic minority group. Living with a disability. Being a member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community.

Living in a rural area. Or being near or below the poverty level, is often associated with worse health outcomes.[] Such disparities in health outcomes are the result of number of factors, but importantly for CMS programs, although not the sole determinant, poor access and provision of lower quality health care contribute to health disparities. For instance, numerous studies have shown that among Medicare beneficiaries, racial and ethnic minority individuals often receive lower quality of care, report lower experiences of care, and experience more frequent hospital readmissions and operative complications.[] Readmission rates for common conditions in the Hospital Readmissions Reduction Program are higher for Black Medicare beneficiaries and higher for Hispanic Medicare beneficiaries with Congestive Heart Failure and Acute Myocardial Infarction.[] Studies have also shown that African Americans are significantly more likely than white Americans to die prematurely from heart disease, and stroke.[] The erectile dysfunction treatment cialis has further illustrated many of these longstanding health inequities with higher rates of , hospitalization, and mortality among Black, Latino, and Indigenous and Native American persons relative to White persons.[] As noted by the Centers for Disease Control “long-standing systemic health and social inequities have put many people from racial and ethnic minority groups at increased risk of getting sick and dying from erectile dysfunction treatment.” [] One important strategy for addressing these important inequities is improving data collection to allow for better measurement and reporting on equity across our programs and policies. We are committed to achieving equity in health care outcomes for our beneficiaries by supporting providers in quality improvement activities to reduce health inequities, enabling them to make more informed decisions, and promoting provider accountability for health care disparities.[] For the purposes of this final rule, we are using a definition of equity established in Start Printed Page 42626Executive Order 13985, as “the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color. Members of religious minorities.

Lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons. Persons with disabilities. Persons who live in rural areas. And persons otherwise adversely affected by persistent poverty or inequality.” [] We note that this definition was recently established by the current administration, and provides a useful, common definition for equity across different areas of government, although numerous other definitions of equity exist. Our ongoing commitment to closing the equity gap in CMS quality programs is demonstrated by a portfolio of programs aimed at making information on the quality of health care providers and services, including disparities, more transparent to consumers and providers.

The CMS Equity Plan for Improving Quality in Medicare outlines a path to equity which aims to support Quality Improvement Networks and Quality Improvement Organizations (QIN-QIOs) in their efforts to engage with and assist providers that care for vulnerable populations. Federal, state, local, and tribal organizations. Providers. Researchers. Policymakers.

Beneficiaries and their families. And other stakeholders in activities to achieve health equity.[] The CMS Equity Plan for Improving Quality in Medicare focuses on three core priority areas which inform our policies and programs. (1) Increasing understanding and awareness of health disparities. (2) developing and disseminating solutions to achieve health equity. And (3) implementing sustainable actions to achieve health equity.[] The CMS Quality Strategy [] and Meaningful Measures Framework [] include elimination of racial and ethnic disparities as a central principle.

Our efforts aimed at closing the health equity gap to date have included providing transparency about health disparities, supporting providers with evidence-informed solutions to achieve health equity, and reporting to providers on gaps in quality through the following reports and programs. The CMS Mapping Medicare Disparities Tool, which is an interactive map that identifies areas of disparities and a starting point to understand and investigate geographical, racial and ethnic differences in health outcomes for Medicare patients.[] The Racial, Ethnic, and Gender Disparities in Health Care in Medicare Advantage Stratified Report, which highlights racial and ethnic differences in health care experiences and clinical care, compares quality of care for women and men, and looks at racial and ethnic differences in quality of care among women and men separately for Medicare Advantage plans.[] The Rural-Urban Disparities in Health Care in Medicare Report, which details rural-urban differences in health care experiences and clinical care.[] The Standardized Patient Assessment Data Elements for certain post-acute care Quality Reporting Programs, which now includes data reporting for race and ethnicity and preferred language, in addition to screening questions for social needs (84 FR 42536 through 42588). The CMS Innovation Center's Accountable Health Communities Model, which include standardized data collection of health-related social needs data. The Guide to Reducing Disparities which provides an overview of key issues related to disparities in readmissions and reviews sets of activities that can help hospital leaders reduce readmissions in diverse populations.[] The CMS Disparity Methods, which provide hospital-level confidential results stratified by dual eligibility for condition-specific readmission measures currently included in the Hospital Readmission Reduction Program (84 FR 42496 through 42500). These programs are informed by reports by the National Academies of Science, Engineering and Medicine (NASEM) [] and the Office of the Assistant Secretary for Planning and Evaluation (ASPE) [] which have examined the influence of social risk factors on several of our quality programs.

In this RFI, we addressed only the seventh initiative listed, the CMS Disparity Methods, which we have implemented for measures in the Hospital Readmissions Reduction Program and are considering in other programs, including the IPFQR Program. We discussed the implementation of these methods to date and present considerations for continuing to improve and expand these methods to provide providers and ultimately consumers with actionable information on disparities in health care quality to support efforts at closing the equity gap. 2. Current CMS Disparity Methods We first sought public comment on potential confidential and public reporting of IPFQR program measure data stratified by social risk factors in the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 20121). We initially focused on stratification by dual eligibility, which is consistent with recommendations from ASPE's First Report to Congress which was required by the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (Pub.

L. 113-185).[] This report found that in the context of value-based purchasing (VBP) programs, dual eligibility was among the most powerful predictors of poor health outcomes Start Printed Page 42627among those social risk factors that ASPE examined and tested. In the FY 2018 IPPS/LTCH PPS final rule we also solicited feedback on two potential methods for illuminating differences in outcomes rates among patient groups within a provider's patient population that would also allow for a comparison of those differences, or disparities, across providers for the Hospital IQR Program (82 FR 38403 through 38409). The first method (the Within-Hospital disparity method) promotes quality improvement by calculating differences in outcome rates among patient groups within a hospital while accounting for their clinical risk factors. This method also allows for a comparison of the magnitude of disparity across hospitals, permitting hospitals to assess how well they are closing disparity gaps compared to other hospitals.

The second methodological approach (the Across-Hospital method) is complementary and assesses hospitals' outcome rates for dual-eligible patients only, across hospitals, allowing for a comparison among hospitals on their performance caring for their patients with social risk factors. In the FY 2018 IPPS/LTCH PPS proposed rule under the IPFQR Program (82 FR 20121), we also specifically solicited feedback on which social risk factors provide the most valuable information to stakeholders. Overall, comments supported the use of dual eligibility as a proxy for social risk, although commenters also suggested investigation of additional social risk factors, and we continue to consider which risk factors provide the most valuable information to stakeholders. Concurrent with our comment solicitation on stratification in the IPFQR Program, we have considered methods for stratifying measure results for other quality reporting programs. For example, in the FY 2019 IPPS/LTCH PPS final rule (82 FR 41597 through 41601), we finalized plans to provide confidential hospital-specific reports (HSRs) containing stratified results of the Pneumonia Readmission (NQF #0506) and Pneumonia Mortality (NQF #0468) measures including both the Across-Hospital Disparity Method and the Within-Hospital Disparity Method (disparity methods), stratified by dual eligibility.

In the FY 2019 IPPS/LTCH PPS final rule (83 FR 41554 through 41556), we also removed six condition/procedure specific readmissions measures, including the Pneumonia Readmission measure (NQF #0506) and five mortality measures, including the Pneumonia Mortality measure (NQF #0468) (83 FR 41556 through 41558) from the Hospital IQR Program. However, the Pneumonia Readmission (NQF #0506) and the other condition/procedure readmissions measures remained in the Hospital Readmissions Reduction Program. In 2019, we provided hospitals with results of the Pneumonia Readmission measure (NQF#0506) stratified using dual eligibility. We provided this information in annual confidential HSRs for claims-based measures. We then, in the FY 2020 IPPS/LTCH PPS Final Rule (84 FR 42388 through 42390), finalized the proposal to provide confidential hospital specific reports (HSRs) containing data stratified by dual-eligible status for all six readmission measures included in the Hospital Readmission Reduction Program.

3. Potential Expansion of the CMS Disparity Methods We are committed to advancing health equity by improving data collection to better measure and analyze disparities across programs and policies.[] As we previously noted, we have been considering, among other things, expanding our efforts to provide stratified data for additional social risk factors and measures, optimizing the ease-of-use of the results, enhancing public transparency of equity results, and building towards provider accountability for health equity. We sought public comment on the potential stratification of quality measures in the IPFQR Program across two social risk factors. Dual eligibility and race/ethnicity. A.

Stratification of Quality Measure Results—Dual Eligibility As described previously in this section, landmark reports by the National Academies of Science, Engineering and Medicine (NASEM) [] and the Office of the Assistant Secretary for Planning and Evaluation (ASPE),[] which have examined the influence of social risk factors on several of our quality programs, have shown that in the context of value-based purchasing (VBP) programs, dual eligibility, as an indicator of social risk, is a powerful predictor of poor health outcomes. We noted that the patient population of IPFs has a higher percentage of dually eligible patients than the general Medicare population. Specifically, over half (56 percent) of Medicare patients in IPFs are dually eligible [] while approximately 20 percent of all Medicare patients are dually eligible.[] We are considering stratification of quality measure results in the IPFQR Program and are considering which measures would be most appropriate for stratification and if dual eligibility would be a meaningful social risk factor for stratification. For the IPFQR Program, we would consider disparity reporting using two disparity methods derived from the Within-Hospital and Across-Hospital methods, described in section IV.D.2 of this final rule. The first method (based on the Within-Facility disparity method) would aim to promote quality improvement by calculating differences in outcome rates between dual and non-dual eligible patient groups within a facility while accounting for their clinical risk factors.

This method would allow for a comparison of those differences, or disparities, across facilities, so facilities could assess how well they are closing disparity gaps compared to other facilities. The second approach (based on the Across-Facility method) would be complementary and assesses facilities' outcome rates for subgroups of patients, such as dual eligible patients, across facilities, allowing for a comparison among facilities on their performance caring for their patients with social risk factors. B. Stratification of Quality Measure Results—Race and Ethnicity The Administration's Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government directs agencies to assess potential barriers that underserved communities and individuals may face to enrollment in and access to benefits and services in Federal Programs. As summarized in section IV.D of this final rule, studies have shown that among Medicare beneficiaries, racial and ethnic minority persons often experience worse health outcomes, including more frequent hospital readmissions and operative Start Printed Page 42628complications.

An important part of identifying and addressing inequities in health care is improving data collection to allow us to better measure and report on equity across our programs and policies. We are considering stratification of quality measure results in the IPFQR Program by race and ethnicity and are considering which measures would be most appropriate for stratification. As outlined in the 1997 Office of Management and Budget (OMB) Revisions to the Standards for the Collection of Federal Data on Race and Ethnicity, the racial and ethnic categories, which may be used for reporting the disparity methods are considered to be social and cultural, not biological or genetic.[] The 1997 OMB Standard lists five minimum categories of race. (1) American Indian or Alaska Native. (2) Asian.

(3) Black or African American. (4) Native Hawaiian or Other Pacific Islander. (5) and White. In the OMB standards, Hispanic or Latino is the only ethnicity category included, and since race and ethnicity are two separate and distinct concepts, persons who report themselves as Hispanic or Latino can be of any race.[] Another example, the “Race &. Ethnicity—CDC” code system in Public Health Information Network (PHIN) Vocabulary Access and Distribution System (VADS) [] permits a much more granular structured recording of a patient's race and ethnicity with its inclusion of over 900 concepts for race and ethnicity.

The recording and exchange of patient race and ethnicity at such a granular level can facilitate the accurate identification and analysis of health disparities based on race and ethnicity. Further, the “Race &. Ethnicity—CDC” code system has a hierarchy that rolls up to the OMB minimum categories for race and ethnicity and, thus, supports aggregation and reporting using the OMB standard. ONC includes both the CDC and OMB standards in its criterion for certified health IT products.[] For race and ethnicity, a certified health IT product must be able to express both detailed races and ethnicities using any of the 900 plus concepts in the “Race &. Ethnicity—CDC” code system in the PHIN VADS, as well as aggregate each one of a patient's races and ethnicities to the categories in the OMB standard for race and ethnicity.

This approach can reduce burden on providers recording demographics using certified products. Self-reported race and ethnicity data remain the gold standard for classifying an individual according to race or ethnicity. However, CMS does not consistently collect self-reported race and ethnicity for the Medicare program, but instead gets the data from the Social Security Administration (SSA) and the data accuracy and comprehensiveness have proven challenging despite capabilities in the marketplace via certified health IT products. Historical inaccuracies in Federal data systems and limited collection classifications have contributed to the limited quality of race and ethnicity information in Medicare's administrative data systems.[] In recent decades, to address these data quality issues, we have undertaken numerous initiatives, including updating data taxonomies and conducting direct mailings to some beneficiaries to enable more comprehensive race and ethnic identification.[] Despite those efforts, studies reveal varying data accuracy in identification of racial and ethnic groups in Medicare administrative data, with higher sensitivity for correctly identifying White and Black individuals, and lower sensitivity for correctly identifying individuals of Hispanic ethnicity or of Asian/Pacific Islander and American Indian/Alaskan Native race.[] Incorrectly classified race or ethnicity may result in overestimation or underestimation in the quality of care received by certain groups of beneficiaries. We continue to work with Federal and private partners to better collect and leverage data on social risk to improve our understanding of how these factors can be better measured in order to close the health equity gap.

Among other things, we have developed an Inventory of Resources for Standardized Demographic and Language Data Collection [] and supported collection of specialized International Classification of Disease, 10th Revision, Clinical Modification (ICD-10-CM) codes for describing the socioeconomic, cultural, and environmental determinants of health, and sponsored several initiatives to statistically estimate race and ethnicity information when it is absent.[] The Office of the National Coordinator for Health Information Technology (ONC) included social, psychological, and behavioral standards in the 2015 Edition health information technology (IT) certification criteria (2015 Edition), providing interoperability standards (LOINC (Logical Observation Identifiers Names and Codes) and SNOMED CT (Systematized Nomenclature of Medicine—Clinical Terms)) for financial strain, education, social connection and isolation, and others. Additional stakeholder efforts underway to expand capabilities to capture additional social determinants of health data elements include the Gravity Project to identify and harmonize social risk factor data for interoperable electronic health information exchange for EHR fields, as well as proposals to expand the ICD-10 (International Classification of Diseases, Tenth Revision) Z codes, the alphanumeric codes used worldwide to represent diagnoses.[] While development of sustainable and consistent programs to collect data on social determinants of health can be considerable undertakings, we recognize that another method to identify better race and ethnicity data is needed in the short term to address the need for reporting on health equity. In working with our contractors, two algorithms have been developed to indirectly estimate the race and ethnicity of Medicare beneficiaries (as described further in the following paragraphs). We feel that using indirect estimation can Start Printed Page 42629help to overcome the current limitations of demographic information and enable timelier reporting of equity results until longer term collaborations to improve demographic data quality across the health care sector materialize. The use of indirectly estimated race and ethnicity for conducting stratified reporting does not place any additional collection or reporting burdens on facilities as these data are derived using existing administrative and census-linked data.

Indirect estimation relies on a statistical imputation method for inferring a missing variable or improving an imperfect administrative variable using a related set of information that is more readily available.[] Indirectly estimated data are most commonly used at the population level (such as the facility or health plan-level), where aggregated results form a more accurate description of the population than existing, imperfect data sets. These methods often estimate race and ethnicity using a combination of other data sources which are predictive of self-identified race and ethnicity, such as language preference, information about race and ethnicity in our administrative records, first and last names matched to validated lists of names correlated to specific national origin groups, and the racial and ethnic composition of the surrounding neighborhood. Indirect estimation has been used in other settings to support population-based equity measurement when self-identified data are not available.[] As described in section IV.D.2, we have previously supported the development of two such methods of indirect estimation of race and ethnicity of Medicare beneficiaries. One indirect estimation approach, developed by our contractor, uses Medicare administrative data, first name and surname matching, derived from the U.S. Census and other sources, with beneficiary language preference, state of residence, and the source of the race and ethnicity code in Medicare administrative data to reclassify some beneficiaries as Hispanic or Asian/Pacific Islander (API).[] In recent years, we have also worked with another contractor to develop a new approach, the Medicare Bayesian Improved Surname Geocoding (MBISG), which combines Medicare administrative data, first and surname matching, geocoded residential address linked to the 2010 U.S.

Census, and uses both Bayesian updating and multinomial logistic regression to estimate the probability of belonging to each of six racial/ethnic groups.[] The MBISG model is currently used to conduct the national, contract-level, stratified reporting of Medicare Part C &. D performance data for Medicare Advantage Plans by race and ethnicity.[] Validation testing reveals concordances with self-reported race and ethnicity of 0.96 through 0.99 for API, Black, Hispanic, and White beneficiaries for MBISG version 2.1.[] The algorithms under consideration are considerably less accurate for individuals who self-identify as American Indian/Alaskan Native or multiracial.[] Indirect estimation can be a statistically reliable approach for calculating population-level equity results for groups of individuals (such as the facility-level) and is not intended, nor being considered, as an approach for inferring the race and ethnicity of an individual. However, despite the high degree of statistical accuracy of the indirect estimation algorithms under consideration there remains the small risk of unintentionally introducing bias. For example, if the indirect estimation is not as accurate in correctly estimating race and ethnicity in certain geographies or populations it could lead to some bias in the method results. Such bias might result in slight overestimation or underestimation of the quality of care received by a given group.

We feel this amount of bias is considerably less than would be expected if stratified reporting was conducted using the race and ethnicity currently contained in our administrative data. Indirect estimation of race and ethnicity is envisioned as an intermediate step, filling the pressing need for more accurate demographic information for the purposes of exploring inequities in service delivery, while allowing newer approaches, as described in the next section, for improving demographic data collection to progress. We expressed interest in learning more about, and solicited comments about, the potential benefits and challenges associated with measuring facility equity using an imputation algorithm to enhance existing administrative data quality for race and ethnicity until self-reported information is sufficiently available. C. Improving Demographic Data Collection Stratified facility-level reporting using dual eligibility and indirectly estimated race and ethnicity would represent an important advance in our ability to provide equity reports to facilities.

However, self-reported race and ethnicity data remain the gold standard for classifying an individual according to race or ethnicity. The CMS Quality Strategy outlines our commitment to strengthening infrastructure and data systems by ensuring that standardized demographic information is collected to identify disparities in health care delivery outcomes.[] Collection and sharing of a standardized set of social, psychological, and behavioral data by facilities, including race and ethnicity, using electronic data definitions which permit nationwide, interoperable health information exchange, can significantly enhance the accuracy and robustness of our equity reporting.[] This could potentially include expansion to Start Printed Page 42630additional social risk factors, such as disability status, where accuracy of administrative data is currently limited. We are mindful that additional resources, including data collection and staff training may be necessary to ensure that conditions are created whereby all patients are comfortable answering all demographic questions, and that individual preferences for non-response are maintained. We are also interested in learning about and solicited comments on current data collection practices by facilities to capture demographic data elements (such as race, ethnicity, sex, sexual orientation and gender identity (SOGI), primary language, and disability status). Further, we are interested in potential challenges facing facility collection, at the time of admission, of a minimum set of demographic data elements in alignment with national data collection standards (such as the standards finalized by the Affordable Care Act) [] and standards for interoperable exchange (such as the U.S.

Core Data for Interoperability incorporated into certified health IT products as part of the 2015 Edition of health IT certification criteria).[] Advancing data interoperability through collection of a minimum set of demographic data collection, and incorporation of this demographic information into quality measure specifications, has the potential for improving the robustness of the disparity method results, potentially permitting reporting using more accurate, self-reported information, such as race and ethnicity, and expanding reporting to additional dimensions of equity, including stratified reporting by disability status. D. Potential Creation of a Facility Equity Score To Synthesize Results Across Multiple Social Risk Factors As we describe in section IV.D.3.a of this final rule, we are considering expanding the disparity methods to IPFs and to include two social risk factors (dual eligibility and race/ethnicity). This approach would improve the comprehensiveness of health equity information provided to facilities. Aggregated results from multiple measures and multiple social risk factors, from the CMS Disparity Methods, in the format of a summary score, can improve the usefulness of the equity results.

In working with our contractors, we recently developed an equity summary score for Medicare Advantage contract/plans, the Health Equity Summary Score (HESS), with application to stratified reporting using two social risk factors. Dual eligibility and race and as described in Incentivizing Excellent Care to At-Risk Groups with a Health Equity Summary Score.[] The HESS calculates standardized and combined performance scores blended across the two social risk factors. The HESS also combines results of the within-plan (similar to the Within-Facility method) and across-plan method (similar to the Across-Facility method) across multiple performance measures. We are considering building a “Facility Equity Score,” not yet developed, which would be modeled off the HESS but adapted to the context of risk-adjusted facility outcome measures and potentially other IPF quality measures. We envision that the Facility Equity Score would synthesize results for a range of measures and using multiple social risk factors, using measures and social risk factors, which would be reported to facilities as part of the CMS Disparity Methods.

We believe that creation of the Facility Equity Score has the potential to supplement the overall measure data already reported on the Care Compare or successor website, by providing easy to interpret information regarding disparities measured within individual facilities and across facilities nationally. A summary score would decrease burden by minimizing the number of measure results provided and providing an overall indicator of equity. The Facility Equity Score under consideration would potentially. Summarize facility performance across multiple social determinants of health (initially dual eligibility and indirectly estimated race and ethnicity). And Summarize facility performance across the two disparity methods (that is, the Within-Facility Disparity Method and the Across-Facility Disparity Method) and potentially for multiple measures.

Prior to any future public reporting, if we determine that a Facility Equity Score can be feasibly and accurately calculated, we would provide results of the Facility Equity Score, in confidential facility specific reports, which facilities and their QIN-QIOs would be able to download. Any potential future proposal to display the Facility Equity Score on the Care Compare or successor website would be made through future RFI or rulemaking. C. Solicitation of Public Comment We solicited public comments on the possibility of stratifying IPFQR Program measures by dual eligibility and race and ethnicity. We also solicited public comments on mechanisms of incorporating co-occurring disability status into such stratification as well.

We sought public comments on the application of the within-facility or across-facility disparities methods IPFQR Program measures if we were to stratify IPFQR Program measures. We also solicited comment on the possibility of facility collection of standardized demographic information for the purposes of potential future quality reporting and measure stratification. In addition, we solicited public comments on the potential design of a facility equity score for calculating results across multiple social risk factors and measures, including race and disability. Any data pertaining to these areas that are recommended for collection for measure reporting for a CMS program and any potential public disclosure on Care Compare or successor website would be addressed through a separate and future notice- and-comment rulemaking. We plan to continue working with ASPE, facilities, the public, and other key stakeholders on this important issue to identify policy solutions that achieve the goals of attaining health equity for all patients and minimizing unintended consequences.

We also noted our intention for additional RFIs or rulemaking on this topic in the future. Specifically, we solicited public comment on the following. Future Potential Stratification of Quality Measure Results The possible stratification of facility-specific reports for IPFQR program measure data by dual-eligibility status given that over half of the patient population in IPFs are dually eligible, including, which measures would be most appropriate for stratification. The potential future application of indirect estimation of race and ethnicity to permit stratification of measure data for reporting facility-level disparity results until more accurate forms of self-identified demographic information are available. Appropriate privacy safeguards with respect to data produced from the indirect estimation of race and ethnicity to ensure that such data are properly Start Printed Page 42631identified if/when they are shared with providers.

Ways to address the challenges of defining and collecting accurate and standardized self-identified demographic information, including information on race and ethnicity and disability, for the purposes of reporting, measure stratification and other data collection efforts relating to quality. Recommendations for other types of readily available data elements for measuring disadvantage and discrimination for the purposes of reporting, measure stratification and other data collection efforts relating to quality, in addition, or in combination with race and ethnicity. Recommendations for types of quality measures or measurement domains to prioritize for stratified reporting by dual eligibility, race and ethnicity, and disability. Examples of approaches, methods, research, and considerations or any combination of these for use of data-driven technologies that do not facilitate exacerbation of health inequities, recognizing that biases may occur in methodology or be encoded in datasets. We received comments on these topics.

Comments. Many commenters expressed support for the collection of data to support stratifying or otherwise measuring disparities in care related to dual-eligibility, race and ethnicity, and disability. Some commenters specifically supported the confidential reporting of stratified results to facilities. Several commenters urged CMS to expand data collection and measure stratification to include factors such as language preference, veteran status, health literacy, gender identity, and sexual orientation to provide a more comprehensive assessment of health equity. One commenter urged CMS to collect data on race and ethnicity specifically for patients suffering from psychiatric disorders, while another noted that for the IPF patient population risk factors, such as substance abuse, may be of more importance.

One commenter also provided examples of how their health system has successfully collected and begun to analyze patient-level demographic data. Another commenter referred to an existing effort by the National Committee for Quality Assurance to improve the collection of race and ethnicity data as a possible model for improving data collection. This commenter also supported the use of indirect estimation of race and ethnicity for Medicare beneficiaries, noting some concern about the lack of granularity, especially with respect to Native American and Asian populations. One commenter urged CMS to explore how to best identify social determinants of health using current claims data. While many commenters expressed support for stratification of claims-based measures, many commenters expressed concern that the existing chart-abstracted measures would face limitations when stratified and thus felt the burden of collecting stratification data for these measures significantly outweighed any potential benefit of doing so.

Specifically, commenters noted that stratifying the IPF patient population is more vulnerable to statistical concerns during the stratification process than other patient populations (for example, numbers of patients in one or more strata may be insufficient for reliable sampling and calculations) due to low patient volume in some facilities. One commenter suggested that for this and other reasons CMS should develop disparities reporting specifically for the IPF program rather than adopt an approach developed for a different program. A few commenters also questioned the value of stratification of these measures given the current high levels of performance by many IPFs. One commenter noted that stratified claims-based measures would exclude all privately insured care and thus be less useful. Several commenters stated that interoperability issues such as a lack of EHRs, particularly for IPFs that are smaller or not part of a large hospital or health system, further add to the burden of stratifying chart-abstracted measures and may contribute to bias in the data.

Several commenters also noted that stratification may be challenging due to differences in the patient population served by IPFs compared to other Medicare programs such as acute and long-term care hospitals, for example, age, proportion and reason for dual-eligibility (income versus disability), and substance abuse disorder prevalence. However, several commenters noted many of these same characteristics, as well as the mental and behavioral health needs of patients cared for by IPFs, are evidence of the need to improve data collection and measurement in IPFs. A commenter also recommended further analysis on the predictive power of social risk factors on mental and behavioral health patient outcomes compared to that of the diagnosis requiring treatment. Several commenters recommended CMS further address issues related to the potential stratification of data such as. Patient privacy and the collection and sharing of social risk factors from patient records or through indirect estimation, differing requirements for collection of race and ethnicity data, transparency regarding indirect estimation methods, and differing Medicaid eligibility requirements by state.

One commenter related these concerns to public reporting, suggesting support for confidential reporting until these issues are addressed. We appreciate all of the comments and interest in this topic. We believe that this input is very valuable in the continuing development of the CMS health equity quality measurement efforts. We will continue to take all concerns, comments, and suggestions into account for future development and expansion of our health equity quality measurement efforts. Improving Demographic Data Collection Experiences of users of certified health IT regarding local adoption of practices for collection of social, psychological, and behavioral data elements, the perceived value of using these data for improving decision-making and care delivery, and the potential challenges and benefits of collecting more granular, structured demographic information, such as the “Race &.

Ethnicity—CDC” code system. The possible collection of a minimum set of social, psychological, and behavioral data elements by hospitals at the time of admission using structured, interoperable data standards, for the purposes of reporting, measure stratification and other data collection efforts relating to quality. We received comments on these topics. Comments. We received mixed feedback regarding demographic data collection.

Many commenters supported the need for and use of such data, noting that structured, interoperable electronic health data are the gold standard. They also noted that many barriers exist to adopting electronic health information technology systems necessary for capture of these data, particularly in freestanding psychiatric facilities. A commenter stated that the commenter's organization cannot support demographic data collection due to the workload burden it would place on both the IPF and patients and their families. This commenter also noted that the likelihood of patients and families comfortably answering multiple sensitive demographic questions is low, especially upon admission. Another commenter expressed concerns with the current capabilities of the industry to collect these data, specifying a lack of standardization in screening and data collection and need for staff training.

Start Printed Page 42632Multiple commenters expressed concern about the patient and family's perception of the organization if given a data collection questionnaire upon admission, noting that they may think the organization is more focused on data collection rather than care. Other commenters noted the importance of closing the health equity gap through measurement of demographic characteristics. A commenter suggested that agencies leverage the role of nurses in identifying sociodemographic factors and barriers to health equity. Another commenter supported this method, noting that although this may add another step to data collection processes, it would be valuable in addressing health equity gaps. To reduce possible workload burden on organizations that are new to this process, a commenter recommended a staggered approach to data collection, suggesting CMS require providers and facilities to collect data on age and sex by the end of 2022, race and ethnicity by the end of 2023, etc., with the goal of at least 80 percent data completeness with 80 percent accuracy.

In addition, commenters suggested reducing burden by adopting standardized screening tools to collect this information, such as ICD-Z-codes, which in practice would allow patients to be referred to resources and initiatives when appropriate. Several commenters encouraged collection of comprehensive social determinants of health and demographic information in addition to race and ethnicity, such as disability, sexual orientation, and primary language. Several commenters provided feedback on the potential use of an indirect estimation algorithm when race and ethnicity are missing/incorrect, and emphasized the sensitivity of demographic information and recommended that CMS use caution when using estimates from the algorithm, including assessing for potential bias, reporting the results of indirect estimation alongside direct self-report at the organizational level for comparison, and establishing a timeline to transition to entirely directly collected data. Commenters also advised that CMS be transparent with beneficiaries and explain why data are being collected and the plans to use these data. A commenter noted that information technology infrastructure should be established in advance to ensure that this information is being used and exchanged appropriately.

We appreciate all of the comments and interest in this topic. We believe that this input is very valuable in the continuing development of the CMS health equity quality measurement efforts. We will continue to take all concerns, comments, and suggestions into account for future development and expansion of our health equity quality measurement efforts. Potential Creation of a Facility Equity Score To Synthesize Results Across Multiple Social Risk Factors The possible creation and confidential reporting of a Facility Equity Score to synthesize results across multiple social risk factors and disparity measures. Interventions facilities could institute to improve a low facility equity score and how improved demographic data could assist with these efforts.

We received comments on these topics. Comments. Commenters generally supported ongoing thoughtful investigation into best practices for measuring health equity. Many commenters expressed concerns about the potential Facility Equity Score. Commenters argued that the current approach used to generate the composite score may not lead to aggregate results, which would not be actionable for many facilities.

Commenters also raised concerns about risk adjustment, limitations in stratification variables, and the appropriateness of the current measure set. A commenter noted that although they support thoughtful efforts to categorize performance, the HESS has been established only as a “proof of concept” and will require considerable time and resources to produce a valid and actionable measure. The same commenter also noted that HESS scoring was only feasible for less than one-half of Medicare Advantage (MA) plans and as such, may not be practical for many smaller facilities, or facilities whose enrolled populations differ in social risk factor distribution patterns compared to typical MA plans. Commenters generally did not support use of the Facility Equity Score in public reporting or payment incentive programs, suggesting that it is imperative to first understand any unintended consequences prior to implementation. More specifically, several commenters gave the example of facilities failing to raise the quality of care for at-risk patients while appearing to achieve greater equity due to lower quality of care for patients that are not at risk.

A commenter stated the belief that CMS should begin their initiative to improve health equity by using structural health equity measures. Commenters also raised concerns about use of dual-eligibility as a social risk factor due to variations in state-level eligibility for Medicaid, making national comparisons, or benchmarking of facility scores unreliable. Additionally, commenters who expressed data reliability concerns recommended that CMS focus its resources on improving standardized data collection and reporting procedures for sociodemographic data before moving forward with a Facility Equity Score. We appreciate all of the comments and interest in this topic. We believe that this input is very valuable in the continuing development of the CMS health equity quality measurement efforts.

We will continue to take all concerns, comments, and suggestions into account for future development and expansion of our health equity quality measurement efforts. We also received comments on the general topic of health equity in the IPFQR Program. Comments. Many commenters expressed overall support of CMS' goals to advance health equity. There were some comments regarding the need to further extend and specify the definition of equity provided in the proposed rule.

Commenters also noted that equity initiatives should be based on existing disparities and population health goals, be mindful of the needs of the communities served, and work to bridge hospitals with post-acute and community-based providers. Several commenters encouraged CMS to be mindful about whether collection of additional quality measures and standardized patient assessment elements might increase provider burden. Several commenters noted support for consideration of a measure of organizational commitment to health equity, outlining how infrastructure supports delivery of equitable care. A commenter noted the importance of focusing programming on inequities in treatment-preventable illness. Another commenter noted that CMS may expand their view of equity beyond quality reporting to payment and coverage policies.

We appreciate all of the comments and interest in this topic. We believe that this input is very valuable in the continuing development of the CMS health equity quality measurement efforts. We will continue to take all concerns, comments, and suggestions into account for future development and expansion of our health equity quality measurement efforts. E. Measure Adoption We strive to put consumers and caregivers first, ensuring they are empowered to make decisions about their own healthcare along with their Start Printed Page 42633clinicians using information from data-driven insights that are increasingly aligned with meaningful quality measures.

We support technology that reduces burden and allows clinicians to focus on providing high-quality healthcare for their patients. We also support innovative approaches to improve quality, accessibility, and affordability of care while paying particular attention to improving clinicians' and beneficiaries' experiences when interacting with our programs. In combination with other efforts across the Department of Health and Human Services (HHS), we believe the IPFQR Program helps to incentivize facilities to improve healthcare quality and value while giving patients and providers the tools and information needed to make the best decisions for them. Consistent with these goals, our objective in selecting quality measures is to balance the need for information on the full spectrum of care delivery and the need to minimize the burden of data collection and reporting. We have primarily focused on measures that evaluate critical processes of care that have significant impact on patient outcomes and support CMS and HHS priorities for improved quality and efficiency of care provided by IPFs.

When possible, we also propose to incorporate measures that directly evaluate patient outcomes and experience. We refer readers to section VIII.F.4.a. Of the FY 2013 IPPS/LTCH PPS final rule (77 FR 53645 through 53646) for a detailed discussion of the considerations taken into account in selecting quality measures. 1. Measure Selection Process Before being proposed for inclusion in the IPFQR Program, measures are placed on a list of measures under consideration (MUC), which is published annually on behalf of CMS by the National Quality Forum (NQF).

Following publication on the MUC list, the Measure Applications Partnership (MAP), a multi-stakeholder group convened by the NQF, reviews the measures under consideration for the IPFQR Program, among other Federal programs, and provides input on those measures to the Secretary. We consider the input and recommendations provided by the MAP in selecting all measures for the IPFQR Program. In our evaluation of the IPFQR Program measure set, we identified two measures that we believe are appropriate for the IPFQR Program. 2. erectile dysfunction treatment Vaccination Coverage Among Health Care Personnel (HCP) [] Measure for the FY 2023 Payment Determination and Subsequent Years a.

Background On January 31, 2020, the Secretary declared a PHE for the U.S. In response to the global outbreak of erectile dysfunction, a novel (new) erectile dysfunction that causes a disease named “erectile dysfunction disease 2019” (erectile dysfunction treatment).[] erectile dysfunction treatment is a contagious respiratory illness [] that can cause serious illness and death. Older individuals and those with underlying medical conditions are considered to be at higher risk for more serious complications from erectile dysfunction treatment.[] As of April 2, 2021, the U.S. Had reported over 30 million cases of erectile dysfunction treatment and over 550,000 erectile dysfunction treatment deaths.[] Hospitals and health systems saw significant surges of erectile dysfunction treatment patients as community levels increased.[] From December 2, 2020 through January 30, 2021, more than 100,000 Americans were in the hospital with erectile dysfunction treatment at the same time.[] Evidence indicates that erectile dysfunction treatment primarily spreads when individuals are in close contact with one another.[] The cialis is typically transmitted through respiratory droplets or small particles created when someone who is infected with the cialis coughs, sneezes, sings, talks, or breathes.[] Thus, the CDC advises that s mainly occur through exposure to respiratory droplets when a person is in close contact with someone who has erectile dysfunction treatment.[] Experts believe that erectile dysfunction treatment spreads less commonly through contact with a contaminated surface (although that is not thought to be a common way that erectile dysfunction treatment spreads),[] and that in certain circumstances, can occur through airborne transmission.[] Subsequent to the publication of the proposed rule, the CDC confirmed that the three main ways that erectile dysfunction treatment is spread are. (1) Breathing in air when close to an infected person who is exhaling small droplets and particles that contain the cialis.

(2) Having these small droplets and particles that contain cialis land on the eyes, nose, or mouth, especially through splashes and sprays like a cough or sneeze. And (3) Touching eyes, nose, or mouth with hands that have the cialis on them.[] According to the CDC, those at greatest risk of are persons who have had prolonged, unprotected close contact (that is, within 6 feet for 15 minutes or longer) with an individual with confirmed erectile dysfunction , regardless of whether the individual has symptoms.[] Although personal protective equipment (PPE) and other -control precautions can reduce the likelihood of transmission in health care settings, erectile dysfunction treatment can spread between health care personnel (HCP) and patients, or from patient to patient given the close contact that may occur during the provision of care.[] The CDC has emphasized that health care settings, including long-term care Start Printed Page 42634settings, can be high-risk places for erectile dysfunction treatment exposure and transmission.[] Vaccination is a critical part of the nation's strategy to effectively counter the spread of erectile dysfunction treatment and ultimately help restore societal functioning.[] On December 11, 2020, FDA issued the first Emergency Use Authorization (EUA) for a erectile dysfunction treatment in the U.S.[] Subsequently, FDA issued EUAs for additional erectile dysfunction treatments.[] FDA determined that it was reasonable to conclude that the known and potential benefits of each treatment, when used as authorized to prevent erectile dysfunction treatment, outweighed its known and potential risks.[] As part of its national strategy to address erectile dysfunction treatment, the Biden Administration stated that it would work with states and the private sector to execute an aggressive vaccination strategy and has outlined a goal of administering 200 million shots in 100 days.[] Although the goal of the U.S. Government is to ensure that every American who wants to receive a erectile dysfunction treatment can receive one, Federal agencies recommended that early vaccination efforts focus on those critical to the PHE response, including HCP providing direct care to patients with erectile dysfunction treatment, and individuals at highest risk for developing severe illness from erectile dysfunction treatment.[] For example, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended that HCP should be among those individuals prioritized to receive the initial, limited supply of the erectile dysfunction treatment vaccination given the potential for transmission in health care settings and the need to preserve health care system capacity.[] Research suggests most states followed this recommendation,[] and HCP began receiving the treatment in mid-December of 2020.[] There are approximately 18 million healthcare workers in the U.S.[] As of April 3, 2021 the CDC reported that over 162 million doses of erectile dysfunction treatment had been administered, and approximately 60 million people had received a complete vaccination course as described in IV.E.b.i of this final rule.[] By July 15, 2021 the CDC reported that over 336,000,000 doses had been administered, and approximately 160,000,000 people had received a complete vaccination course.[] President Biden indicated on March 2, 2021 that the U.S. Is on track to have sufficient treatment supply for every adult by the end of May 2021.[] Subsequent to the publication of the IPF PPS proposed rule, on June 3, 2021, the White House confirmed that there was sufficient treatment supply for all Americans.[] We believe it is important to require that IPFs report HCP vaccination in their facilities in order to assess whether they are taking steps to protect health care workers and to help sustain the ability of IPFs to continue serving their communities throughout the PHE and beyond. Therefore, we proposed a new measure, erectile dysfunction treatment Vaccination Coverage Among HCP, beginning with the FY 2023 program year.

For that program year, IPFs would be required to report data on the measure for the fourth quarter of 2021 (October 1, 2021 through December 31, 2021). For more information about the reporting period, see section V.E.2.c of this final rule. The measure would assess the proportion of an IPF's health care workforce that has been vaccinated against erectile dysfunction treatment. Although at the time of the proposed rule, data to show the effectiveness of erectile dysfunction treatments to prevent asymptomatic or transmission of erectile dysfunction were limited, we stated our belief that IPFs should report the level of vaccination among their HCP as part of their efforts to assess and reduce the risk of transmission of erectile dysfunction treatment within their facilities. HCP vaccination can potentially reduce illness that leads to work absence and limit disruptions to care.[] Data from influenza vaccination demonstrates that provider uptake of the treatment is associated with that provider recommending vaccination to patients,[] and we believe HCP erectile dysfunction treatment vaccination in IPFs could similarly increase uptake among that patient population.

We also believe that publishing the HCP vaccination rates would be helpful to many patients, including those who are at high-risk for Start Printed Page 42635developing serious complications from erectile dysfunction treatment, as they choose facilities from which to seek treatment. Under CMS' Meaningful Measures Framework, the erectile dysfunction treatment measure addresses the quality priority of “Promote Effective Prevention and Treatment of Chronic Disease” through the Meaningful Measure Area of “Preventive Care.” b. Overview of Measure The erectile dysfunction treatment Vaccination Coverage Among HCP measure (“erectile dysfunction treatment HCP vaccination measure”) is a process measure developed by the CDC to track erectile dysfunction treatment vaccination coverage among HCP in facilities such as IPFs. (1). Measure Specifications The denominator is the number of HCP eligible to work in the IPF for at least 1 day during the reporting period, excluding persons with contraindications to erectile dysfunction treatment vaccination that are described by the CDC.[] The numerator is the cumulative number of HCP eligible to work in the IPF for at least 1 day during the reporting period and who received a completed vaccination course against erectile dysfunction treatment since the treatment was first available or on a repeated interval if revaccination on a regular basis is needed.[] Vaccination coverage for the purposes of this measure is defined as the estimated percentage of HCP eligible to work at the IPF for at least 1 day who received a completed vaccination course.

A completed vaccination course may require one or more doses depending on the EUA for the specific treatment used. The finalized specifications for this measure are available at https://www.cdc.gov/​nhsn/​nqf/​index.html. (2). Review by the Measure Applications Partnership The erectile dysfunction treatment HCP vaccination measure was included on the publicly available “List of Measures under Consideration for December 21, 2020,” [] a list of measures under consideration for use in various Medicare programs. When the Measure Applications Partnership (MAP) Hospital Workgroup convened on January 11, 2021, it reviewed the MUC List and the erectile dysfunction treatment HCP vaccination measure.

The MAP recognized that the proposed measure represents a promising effort to advance measurement for an evolving national cialis and that it would bring value to the IPFQR Program measure set by providing transparency about an important erectile dysfunction treatment intervention to help prevent s in HCP and patients.[] The MAP also stated that collecting information on erectile dysfunction treatment vaccination coverage among HCP and providing feedback to facilities would allow facilities to benchmark coverage rates and improve coverage in their IPF, and that reducing rates of erectile dysfunction treatment in HCP may reduce transmission among patients and reduce instances of staff shortages due to illness.[] In its preliminary recommendations, the MAP Hospital Workgroup did not support this measure for rulemaking, subject to potential for mitigation.[] To mitigate its concerns, the MAP believed that the measure needed well-documented evidence, finalized specifications, testing, and NQF endorsement prior to implementation.[] Subsequently, the MAP Coordinating Committee met on January 25, 2021, and reviewed the erectile dysfunction treatment Vaccination Coverage Among HCP measure. In the 2020-2021 MAP Final Recommendations, the MAP offered conditional support for rulemaking contingent on CMS bringing the measures back to MAP once the specifications are further refined.[] The MAP specifically stated, “the incomplete specifications require immediate mitigation and further development should continue.” [] The spreadsheet of final recommendations no longer cited concerns regarding evidence, testing, or NQF endorsement.[] In response to the MAP final recommendation request that CMS bring the measure back to the MAP once the specifications were further refined, CMS and the CDC met with MAP Coordinating committee on March 15th. Additional information was provided to address treatment availability, alignment of the erectile dysfunction treatment Vaccination Coverage Among HCP measure as closely as possible with the data collection for the Influenza HCP vaccination measure (NQF 0431), and clarification related to how HCP are defined. At this meeting, CMS and the CDC presented preliminary findings from the testing of the numerator of erectile dysfunction treatment Vaccination Coverage Among HCP, which was in process at that time. These preliminary findings showed numerator data should be feasible and reliable.

Testing of the numerator of the number of healthcare personnel vaccinated involves a comparison of the data collected through NHSN and independently reported through the Federal pharmacy partnership program for delivering vaccination to LTC facilities. These are two completely independent data collection systems. In initial analyses of the first month of vaccination, the number of healthcare workers vaccinated in approximately 1,200 facilities, which had data from both systems, the number of healthcare personnel vaccinated was highly correlated between these 2 systems with a correlation coefficient of nearly 90 percent in the second two weeks of reporting.[] The MAP further noted that the measure would add value to the program measure set by providing visibility into an important intervention to limit erectile dysfunction treatment s in healthcare personnel and the patients for whom they provide care.[] We value the recommendations of the MAP and considered these recommendations carefully. Section 1890A(a)(4) of the Act requires the Secretary to take into consideration input from multi-stakeholder groups in selecting certain quality and efficiency measures. While we value input from the MAP, we believe it is important to propose the measure as quickly as Start Printed Page 42636possible to address the urgency of the erectile dysfunction treatment PHE and its impact on vulnerable populations, including IPFs.

We continue to engage with the MAP to mitigate concerns and appreciate the MAP's conditional support for the measure. (3). NQF Endorsement Under section 1886(s)(4)(D)(i) of the Act, unless the exception of clause (ii) applies, measures selected for the quality reporting program must have been endorsed by the entity with a contract under section 1890(a) of the Act. The NQF currently holds this contract. Section 1886(s)(4)(D)(ii) of the Act provides an exception to the requirement for NQF endorsement of measures.

In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. This measure is not NQF endorsed and has not been submitted to NQF for endorsement consideration. The CDC, in collaboration with CMS, are planning to submit the measure for consideration in the NQF Fall 2021 measure cycle. Because this measure is not NQF-endorsed, we considered other available measures. We found no other feasible and practical measures on the topic of erectile dysfunction treatment vaccination among HCP, therefore, we believe the exception in Section 1186(s)(4)(D)(ii) of the Act applies.

C. Data Collection, Submission and Reporting Given the time-sensitive nature of this measure considering the PHE, in the FY 2022 IPF PPS proposed rule, we proposed that IPFs would be required to begin reporting data on the proposed erectile dysfunction treatment Vaccination Coverage Among HCP measure beginning October 1, 2021 for the FY 2023 IPFQR Program year (86 FR 19504). Thereafter, we proposed quarterly [] reporting periods. To report this measure, facilities would report erectile dysfunction treatment vaccination data to the NHSN for at least one week each month, beginning in October 2021 for the October 1, 2021 through December 31, 2021 reporting period affecting FY 2023 payment determination and continuing for each quarter in subsequent years. For more details on data submission, we refer readers to section V.J.2.a of this final rule.

We proposed that IPFs would report the measure through the CDC National Healthcare Safety Network (NHSN) web-based surveillance system.[] While the IPFQR Program does not currently require use of the NHSN web-based surveillance system, we have previously required use of this system. We refer readers to the FY 2015 IPF PPS final rule in which we adopted the Influenza Vaccination Coverage Among Healthcare Personnel (NQF #0431) measure for additional information on reporting through the NHSN web-based surveillance system (79 FR 45968 through 45970). IPFs would report erectile dysfunction treatment vaccination data in the NHSN Healthcare Personnel Safety (HPS) Component by reporting the number of HCP eligible to have worked at the IPF that week (denominator) and the number of those HCP who have received a completed vaccination course of a erectile dysfunction treatment vaccination (numerator). For additional information about the data reporting requirements, see IV.J.4. Of this final rule.

We invited public comment on our proposal to add a new measure, erectile dysfunction treatment Vaccination Coverage Among HCP, to the IPFQR Program for the FY 2023 payment determination and subsequent years. Comment. Some commenters supported the proposed erectile dysfunction treatment Vaccination Coverage Among Healthcare Personnel measure. One commenter observed that data on vaccination coverage are important for patients and for individuals seeking employment at IPFs. Several commenters noted the importance of treatments to reduce transmission, and one commenter specifically observed that vaccination is particularly important in settings such as IPFs because non-pharmaceutical interventions are challenging in such institutional settings.

Another commenter expressed the belief that the measure is methodologically sound. Response. We thank these commenters for their support. Comment. Many commenters expressed concern that using NHSN for reporting is too burdensome and disproportionately affects smaller and freestanding IPFs.

Some of these commenters further expressed that requiring reporting through NHSN is inconsistent with the removal of Influenza treatment Coverage among HCP measure because the rationale for removing the Influenza treatment Coverage among HCP measure was the high reporting burden associated with NHSN reporting. Response. We believe that there are many significant benefits to collecting and reporting data on erectile dysfunction treatment vaccination coverage among HCP that outweigh its burden. As discussed in our proposal to adopt this measure, HCP vaccination can potentially reduce illness that leads to work absence and limit disruptions to care (86 FR 19502). The CDC has emphasized that health care settings can be high-risk places for erectile dysfunction treatment exposure and transmission.[] In these settings, erectile dysfunction treatment can spread between health care personnel (HCP) and patients, or from patient to patient given the close contact that may occur during the provision of care.[] Subsequent to the publication of the IPF PPS proposed rule, the CDC updated its Science Brief on erectile dysfunction treatments and Vaccination and observed that the growing body of evidence indicates that people who are fully vaccinated with an mRNA treatment are less likely to have asymptomatic or to transmit erectile dysfunction to others.

The CDC further noted that the studies are continuing on the benefits of the Johnson &. Johnson/Janssen treatment.[] Therefore we believe that vaccination coverage among HCP will reduce the risk of contracting erectile dysfunction treatment for patients in IPFs, and that IPFs reporting this information can help patients identify IPFs where they may have lower risk of erectile dysfunction treatment exposure. Publishing the HCP vaccination rates will be helpful to many patients, including those who are at high-risk for developing serious complications from erectile dysfunction treatment, as they choose IPFs from which to seek treatment. While we agree with the commenters that there is some burden associated with reporting this measure (see Section (V)(A)(2)(c) of this final rule), we believe the benefits of data collection and Start Printed Page 42637reporting on erectile dysfunction treatment vaccination coverage among HCP are sufficient to outweigh this burden. In addition, commenters are correct in noting that when we removed the Influenza Vaccination Coverage Among Healthcare Personnel (NQF #0431) measure from the IPFQR Program in the FY 2019 IPF PPS final rule, we observed that reporting measure data through the NHSN is relatively more burdensome for IPFs than for acute care hospitals and that this may be especially true for independent or freestanding IPFs (83 FR 38593 through 38595).

However, in our analysis of facilities that did not receive full payment updates for FY 2018 and FY 2019 and the reasons these facilities did not receive full payment updates we observed that 98.24 percent and 99.05 percent of IPFs respectively, including small, independent, and freestanding IPFs, successfully reported data for the Influenza Vaccination Coverage Among Health Care Personnel (NQF #0431) measure prior to its removal from the IPFQR Program. For the reasons outlined above, the erectile dysfunction treatment cialis and associated PHE has had a much more significant effect on most aspects of society, including the ability of the healthcare system to operate smoothly, than influenza, making the benefits of the erectile dysfunction treatment Vaccination Among HCP measure greater than those of the Influenza Vaccination Coverage Among Health Care Personnel (NQF #0431) measure. Comment. Other commenters expressed concern that facilities face duplicative reporting requirements given that other agencies are requiring reporting through systems other than NHSN, such as the HHS TeleTracking site. A few of these commenters recommended that CMS use the TeleTracking site for data reporting and consumer information as opposed to adopting a quality measure.

Other commenters recommended that CMS sunset TeleTracking and use NHSN for reporting erectile dysfunction treatment vaccination coverage data. One commenter recommended that CMS collaborate with CDC to ensure minimal reporting burden. Response. We recognize that this measure may lead to duplicative reporting requirements if facilities voluntarily report erectile dysfunction treatment HCP vaccination information to data reporting systems other than NHSN, and we are collaborating with other HHS agencies, including the CDC, to ensure minimal reporting burden and to eliminate duplicative requirements to the extent feasible. Comment.

Some commenters expressed concern about the measure specifications leading to increased reporting burden. Several of these commenters expressed that the proposed quarterly reporting of three weeks of data (one week per month) is excessively burdensome. Other commenters expressed concern that the measure specifications are not aligned with the Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431), specifically noting that the erectile dysfunction treatment Vaccination Coverage Among HCP measure requires data elements (such as contraindications) that are not required for Influenza Vaccination Coverage Among Healthcare Personnel measure (NQF #0431). One commenter observed that including all staff (not just clinical staff or staff directly employed by the IPF) makes the measure unduly burdensome. Another commenter observed that tracking location is challenging in large organizations with staff that work across locations.

Response. We recognize commenters' concern regarding reporting burden associated with the specifications of this measure. We believe that, given the public health importance of vaccination in addressing the erectile dysfunction treatment PHE, the benefits of requiring reporting outweigh the burden. We believe that reporting these data on a frequent interval would increase their value by allowing the CDC to better track these important public health data while also being a valuable quality measure that supports consumer choice and IPF improvement initiatives. Because the CDC requests data reported on a monthly basis for one week per month, we believe this is an appropriate reporting frequency for our quality measure to ensure that IPFs do not have duplicative reporting requirements to meet the CDC's need for public health data and CMS' quality measure reporting requirements.

We further note that while we have sought to align this measure with the Influenza Vaccination Coverage Among HCP measure (NQF #0431), each measure addresses different public health initiatives and therefore complete alignment may not be possible. For example, because influenza vaccinations are provided during the influenza season (that is, October 1 through March 31) these measures have different reporting periods. Further, we note that while the Influenza Vaccination Coverage Among HCP measure (NQF #0431) does not have a denominator exclusion for HCP with contraindications to the influenza treatment, there is a numerator category for these HCP. Specifically, the numerator description is as follows. €œHCP in the denominator population who during the time from October 1 (or when the treatment became available) through March 31 of the following year.

. . . (b) were determined to have a medical contraindication/condition of severe allergic reaction to eggs or to other component(s) of the treatment, or a history of Guillain-Barre Syndrome within 6 weeks after a previous influenza vaccination. .

.” [] We believe that this numerator element requires the IPF to track HCP's contraindications to the influenza vaccination. Therefore, we disagree with the commenter's statement that the erectile dysfunction treatment Vaccination Coverage Among HCP measure is more burdensome than the Influenza Vaccination Coverage Among HCP measure due to requiring IPFs to track HCP's contraindications to the treatment. Finally, we note that CDC's guidance for entering data requires submission of HCP count at the IPF level [] and the measure requires reporting consistent with that guidance. We proposed the reporting schedule of monthly reporting of data from only one week a month to provide erectile dysfunction treatment vaccination coverage data on a more timely basis than annual influenza vaccination coverage (NQF #0431) while also reducing burden on facilities of weekly reporting which has been the reporting cycle for many erectile dysfunction treatment-related metrics during the cialis. As described in response to previous commenters, we believe that the public health benefits to having these data available are high, and that they therefore outweigh the burden of reporting for systems with multiple facilities or locations.

In summary, we recognize that there may be some elements of the measure specifications that increase burden for some IPFs, however given the impact that the erectile dysfunction treatment PHE has had on society and the healthcare system, we believe that the benefits outweigh this reporting burden. Comment. Some commenters expressed concern that having some vaccinations require two doses creates undue reporting burden for IPFs. One commenter recommended modelling this measure on the measure under consideration for patient vaccination coverage within the Merit-Based Incentive Payment System (MIPS) program which would require reporting based on receipt of one dose, as opposed to requiring reporting on receipt of a full course of the treatment. Some commenters Start Printed Page 42638expressed concern that because it can take up to 28 days for an individual to be fully vaccinated, requiring reporting for HCP who have worked only one day of the reporting period is burdensome or that this disparately affects facilities without access to the one-dose treatment.

Response. We believe that it is appropriate to require data on HCP who have received complete erectile dysfunction treatment vaccination courses, because an IPF has more long-term and regular contact with the HCP who work there than an ambulatory care provider, such as those being evaluated under the MIPS Program, has with their patient population. This gives the IPF more ability to track and encourage HCP to receive their complete vaccination course. We recognize that since a complete vaccination course could take up to 28 days, some IPFs may initially appear to have lower performance than others (based on having access to two dose vaccinations as opposed to one dose vaccination). However, we believe that with the reporting frequency these providers should show rapid improvement as their staff become fully vaccinated.

We note that given the highly infectious nature of the erectile dysfunction treatment cialis, we believe it is important to encourage all personnel within the IPF, regardless of patient contact, role, or employment type, to receive the erectile dysfunction treatment vaccination to prevent outbreaks within the IPF which may affect resource availability and have a negative impact on patient access to care. Comment. Some commenters recommended deferring measurement of treatment coverage among HCP until there is at least one treatment that has received full FDA approval (as opposed to an EUA). A few commenters expressed concern that the long-term effects of the treatments are unknown and that some HCP concerned about the risk of serious adverse events. One commenter further expressed concerns regarding the rapid development and EUA timelines.

A few commenters expressed concerns regarding HCP being unwilling to receive a treatment which has not received full FDA approval. Response. We support widespread vaccination coverage, and note that in issuing the EUAs for these treatments FDA has established that the known and potential benefits of these treatments outweigh the known and potential risks.[] Furthermore, as July 15, 2021, more than 336,000,000 doses have been administered in the United States.[] Although erectile dysfunction treatments are authorized for emergency use prevent erectile dysfunction treatment and serious health outcomes associated with erectile dysfunction treatment, including hospitalization and death,[] we understand that some HCP may be concerned about receiving the erectile dysfunction treatment prior to the treatment receiving full FDA approval. We also understand that some HCP may be concerned about long-term effects. We note that the erectile dysfunction treatment Vaccination Coverage Among HCP measure does not require HCP to receive the vaccination, nor does this measure reward or penalize IPFs for the rate of HCP who have received a erectile dysfunction treatment.

The erectile dysfunction treatment Vaccination Coverage Among HCP measure requires IPFs to collect and report erectile dysfunction treatment vaccination data that would support public health tracking and provide beneficiaries and their caregivers information to support informed decision making. Therefore, we believe that it is appropriate to collect and report these data as soon as possible. Comment. One commenter observed that there are interventions through which an IPF can promote vaccination coverage, such as by removing barriers to access (through means such as extended treatment clinic hours). This commenter recommended encouraging these interventions as opposed to promoting vaccination coverage among HCP by adopting the erectile dysfunction treatment Vaccination Coverage Among HCP measure.

Response. We agree with the commenter that there are interventions through which an IPF can increase vaccination coverage by reducing barriers to access. However, we believe that it is appropriate to propose this measure for the IPFQR Program to encourage such interventions by collecting data on vaccination coverage among HCP. We believe that vaccination is an important health intervention that can protect the health of vulnerable patients and the availability of the healthcare system (that is, limiting the number of HCP absent from work due to illness to ensure that patients have access to care). Comment.

Some commenters expressed the belief that it is inappropriate to use IPF payment policies to drive vaccination coverage among HCP. Some commenters expressed concern that this measure could lead facilities to mandate treatments for staff, with potential unintended consequences (specifically, staff quitting or legal risk for facilities for staff experiencing adverse events). One commenter expressed the belief that the tie to public reporting and potentially IPF payment is an indirect treatment mandate. Several commenters recommended CMS not consider this measure for pay-for-reporting because state laws regarding mandates vary and therefore could lead to inconsistent performance through no fault of facilities. One commenter expressed the belief that this measure was developed for public health tracking and is not appropriate for quality assessment.

Response. We note that this measure does not require vaccination coverage among HCP at IPFs. It requires IPFs to report of erectile dysfunction treatment vaccination rates. Therefore, we believe it is incorrect to characterize this measure as a “treatment mandate.” Furthermore, we note that the historical national average of providers who had received the influenza vaccination, as reported on the then Hospital Compare website was 85 percent, 80 percent, and 82 percent respectively for the FY 2017, FY 2018, and FY 2019 payment determinations prior to removal of the Influenza Vaccination Coverage among Healthcare Personnel measure from the IPFQR Program. We do not believe that this represents performance that would be consistent with a widespread “treatment mandate” and therefore we do not believe that a vaccination coverage among HCP measure, including the erectile dysfunction treatment Vaccination Coverage among HCP measure, inherently leads to “treatment mandates.” However, we believe that data regarding erectile dysfunction treatment vaccination coverage among HCP are important to empower patients to make health care decisions that are best for them.

Comment. Some commenters expressed concern that the measure does not fully account for potential reasons that HCP may not receive erectile dysfunction treatment vaccinations. One commenter recommended expanding the exclusions to the measure's calculation, specifically citing religious objections as an exclusion category. Another commenter observed that there is uncertainty about how effective treatments are for certain populations, such as those with underlying conditions.Start Printed Page 42639 Response. We recognize that there are many reasons, including religious objections or concerns regarding an individual provider's specific health status, which may lead individual HCP to decline vaccination.

The CDC's NHSN tool allows facilities to report on the number of HCP who were offered a vaccination but declined for reasons including religious or philosophical objections.[] We agree that there is uncertainty about effectiveness among certain patient populations, including those with underlying conditions. The CDC has found that there is evidence of reduced antibody response to or reduced immunogenicity of erectile dysfunction treatment mRNA treatment among some immunosuppressed people.[] However, we note that erectile dysfunction treatments may be administered to most people with underlying medical conditions.[] Therefore, we believe that individual HCP who may have underlying conditions that could affect treatment efficacy should make the decision of whether to receive the erectile dysfunction treatment vaccination in discussion with their individual care provider. We believe that vaccination coverage rates are meaningful data for beneficiaries to use in choosing an IPF which can also be used for public health tracking. Comment. One commenter expressed the concern that this may have an adverse impact on HCP as it is unclear whether in the future individual HCP will be required to pay for the vaccination themselves.

Response. We understand the commenter's concerns that individual HCP may potentially have to pay for the erectile dysfunction treatment in the future. In alignment with our pledge to put patients first in all our programs, we believe that it is important to empower patients to work with their doctors and make health care decisions that are best for them.[] This includes the belief that HCP should be empowered to work with their own healthcare providers to make the health care decisions that are best for them, based on the totality of their circumstances, including potential costs to receive the treatment and their increased risks of contracting erectile dysfunction treatment based on occupational exposure. Comment. Many commenters expressed concern that this measure should not be adopted until there is clarity around the impact of future boosters.

These commenters also noted that booster availability could have an impact on vaccination coverage among HCP. One commenter specifically expressed concern regarding past supply chain disruptions and observed that similar issues may affect booster availability in the future. Response. The erectile dysfunction treatment Vaccination Coverage among HCP measure is a measure of a completed vaccination course (as defined in section IV.E.2.b.(1) of the FY 2022 IPF PPS proposed rule (86 FR 19502 through 19503) and does not address booster shots. Currently, the need for erectile dysfunction treatment booster doses has not been established, and no additional doses are currently recommended for HCP.

However, we believe that the numerator is sufficiently broad to include potential future boosters as part of a “complete vaccination course” and therefore the measure is sufficiently specified to address boosters. We acknowledge the potential for supply chain disruptions or other factors that affect treatment availability, but we believe that the urgency of adopting the measure to address the current erectile dysfunction treatment PHE outweighs these potential concerns. Comment. Some commenters expressed that collecting the data to report this measure is challenging. These commenters observed that because, unlike influenza vaccinations, HCP have received erectile dysfunction treatment vaccinations from settings outside their places of employment, employers may still be attaining vaccination records from employees.

One commenter observed that the data for HCP is housed in separate systems from those typically used for quality reporting. Response. We recognize that some IPFs may still be obtaining vaccination records from their employees and other personnel that work within their facilities. However, most healthcare settings, including IPFs, have been reporting erectile dysfunction treatment data to Federal or state agencies for some time and therefore have established the appropriate workflows or other means to obtain these records from employees or other personnel that work within the IPF. Therefore, we believe that IPFs must have the means to obtain the data, either directly from HCP or from other systems in which these data are housed, and that it is appropriate to require IPFs to report these data.

Comment. Another commenter expressed concern that the shortened performance period for the first year may lead to incomplete data. One commenter recommended allowing voluntary reporting without publicly reporting data for the first performance year to account for potential data gaps. Response. Given that results would be calculated quarterly for this measure, facilities should show rapid progress as they obtain more complete data on vaccination coverage for their HCP.

While we understand the desire for a year of voluntary reporting to account for potential data gaps, we believe that the importance of providing patients and their caregivers with data on erectile dysfunction treatment Vaccination Coverage among HCP at individual IPFs in a timely manner outweighs this concern and should be accomplished as soon as practical. Comment. A few commenters expressed concern that due to the delay between data collection (which takes place during a quarter) and public reporting (which follows the reporting of the data collected during the quarter, the deadline for which is 4.5 months after the end of the quarter) the data would not be useful by the time they are publicly reported either because they are too old or because the trajectory of the cialis has changed. One commenter opposed public reporting until data has been reported for several years. Response.

We believe that it is important to make these data available as soon as possible. We agree with commenters that observe that there is a delay between data collection and public reporting for this measure, and note that such a delay exists for all measures in the IPFQR Program. However, we believe that the data will provide meaningful information to consumers in making healthcare decisions because the data will be able to reflect differences between IPFs in erectile dysfunction treatment vaccination coverage among HCP even if the data do not reflect the current vaccination rates and we believe it will benefit consumers to have these data available as early as possible. We proposed the shortened reporting period for the first performance period to make the erectile dysfunction treatment Vaccination among HCP measure data available as quickly as possible. Comment.

One commenter observed that the data would not provide consumers a complete picture of control procedures because treatments are only one tactic to prevent and control s. Another commenter observed that public reporting may lead to comparisons between facilities. An additional commenter recommended a validation process to ensure that consumers can rely on the data.Start Printed Page 42640 Response. While we recognize that the data may not fully represent all activities to prevent and control s, we believe that the data would be useful to consumers in choosing IPFs, including making comparisons between facilities. We note that we do not currently have a validation process for any measures in the IPFQR Program and refer readers to section IV.J.3 of this final rule where we discuss considerations for a validation program for the IPFQR Program.

Comment. Some commenters recommended deferring the measure until it has been fully tested and NQF endorsed. One commenter observed that the MAP reviewed the measure concept, not the full measure, and therefore it is premature to include it in the IPFQR Program without further review. Another commenter observed that such rapid measure adoption may set a precedent for future rapid measure adoption. Response.

We believe that given the current erectile dysfunction treatment PHE, it is important to adopt this measure as quickly as possible to allow tracking and reporting of erectile dysfunction treatment Vaccination Coverage Among HCP in IPFs. This tracking would provide consumers with important information. We refer readers to FY 2022 IPF PPS proposed rule where we discuss our consideration of NQF endorsed measures on the topic of erectile dysfunction treatment vaccination coverage among healthcare personnel for additional information (86 FR 19503 through 19504). We note that the MAP had the opportunity to review and provide feedback on the full measure in the March 15th meeting. The CDC, in collaboration with CMS, is planning to submit the measure for consideration in the NQF Fall 2021 measure cycle.

Finally, we evaluate all measures on a case-by-case basis and therefore the pace at which we propose to adopt one measure is dependent on the measure and the purpose for adopting it. Comment. One commenter requested clarification for the reporting frequency. Response. We recognize that the proposed required frequency for reporting, may have been unclear because we referred to “annual reporting” periods two times in the proposed rule.

Specifically, we referenced annual reporting periods in the first paragraph of section IV.E.2.c (86 FR 19504) and in our burden estimate for the measure (86 FR 19519). Our description of data submission under IV.J.2.a in which we stated that facilities would be required to report the vaccination data to the NHSN for at least one week each month and that if they reported more than one week, the most recent week's data would be used (86 FR 19513) is correct. In that section, we further noted that the CDC would calculate a single quarterly result for summarizing the data reported monthly. In summary, the measure would require monthly reporting of at least one week's data per month. This would be calculated into quarterly results.

We note that IPFs are required to report to NHSN sufficient data (that is, vaccination data for at least one week in each month per quarter) to calculate four quarterly results per year, except for the first performance period which depends on only one quarter of data (the vaccination data for at least one week in each month in Q1 of FY 2022). While IPFs can report data to the NHSN at any time, they must report by 4.5 months following the preceding quarter for the purposes of measure calculation. For the first performance period for this measure (that is Q1 of FY 2022), 4.5 months following the end of the quarter is May 15, 2022. Comment. One commenter requested clarification on which provider types are considered healthcare personnel.

Response. The provider types that are considered healthcare personnel, along with the specifications for this measure, are available at https://www.cdc.gov/​nhsn/​nqf/​index.html. The categories of HCP included in this measure are ancillary services employees. Nurse employees. Aide, assistant, and technician employees.

Therapist employees. Physician and licensed independent practitioner employees. And other HCP. For more detail about each of these categories we refer readers to the Table of Instructions for Completion of the Weekly Healthcare Personnel erectile dysfunction treatment Cumulative Vaccination Summary Form for Non-Long-Term Care Facilities available at https://www.cdc.gov/​nhsn/​forms/​instr/​57.220-toi-508.pdf. Comment.

One commenter observed that the definition of “location” for measure calculation is unclear. Response. CDC's guidance for entering data requires submission of HCP count at the IPF level, not at the location level within the IPF.[] After consideration of the public comments, we are finalizing the COVD-19 Vaccination Coverage Among Healthcare Personnel measure as proposed for the FY 2023 payment determination and subsequent years. 3. Follow-Up After Psychiatric Hospitalization (FAPH) Measure for the FY 2024 Payment Determination and Subsequent Years a.

Background We proposed one new measure, Follow-Up After Psychiatric Hospitalization (FAPH), for the FY 2024 payment determination and subsequent years. The FAPH measure would use Medicare fee-for-service (FFS) claims to determine the percentage of inpatient discharges from an inpatient psychiatric facility (IPF) stay with a principal diagnosis of select mental illness or substance use disorders (SUDs) for which the patient received a follow-up visit for treatment of mental illness or SUD. Two rates would be calculated for this measure. (1) The percentage of discharges for which the patient received follow-up within 7 days of discharge. And (2) the percentage of discharges for which the patient received follow-up within 30 days of discharge.

The FAPH measure is an expanded and enhanced version of the Follow-Up After Hospitalization for Mental Illness (FUH, NQF #0576) measure currently in the IPFQR Program. We proposed to adopt the FAPH measure and replace the FUH measure and refer readers to section IV.F.2.d of the FY 2022 IPF PPS proposed rule for our proposal to remove the FUH measure contingent on adoption of the FAPH measure (86 FR 19510). The FUH (NQF #0576) measure uses Medicare FFS claims to determine the percentage of inpatient discharges from an IPF stay with a principal diagnosis of select mental illness diagnoses for which the patient received a follow-up visit for treatment of mental illness, and it excludes patients with primary substance use diagnoses. During the 2017 comprehensive review of NQF #0576, the NQF Behavioral Health Standing Committee (BHSC) recommended expanding the measure population to include patients hospitalized for drug and alcohol disorders, because these patients also require follow-up care after they are discharged. In 2018, CMS began development of a measure to expand the IPFQR FUH population to include patients with principal SUD diagnoses to address the NQF BHSC recommendation and the CMS Meaningful Measures priority to promote treatment of SUDs.

The FAPH measure would expand the number of discharges in the denominator by about 35 percent over the current FUH measure by adding patients with SUD or dementia as principal diagnoses (including patients with any Start Printed Page 42641combination of SUD, dementia, or behavioral health disorders), populations that also benefit from timely follow-up care. Furthermore, compared to the criteria for provider type in the current FUH measure, the FAPH measure does not limit the provider type for the follow-up visit if it is billed with a diagnosis of mental illness or SUD. During the measure's testing, the most frequent provider types for the FAPH measure were family or general practice physicians, internal medicine physicians, nurse practitioners, and physician assistants. The technical expert panel (TEP) convened by our contractor agreed that these provider types should be credited by the measure for treating mental illness and SUD and confirmed that this is aligned with integrated care models that aim to treat the whole patient. The TEP further noted that in areas where there are shortages of mental health or SUD clinicians, other types of providers are often the only choice for follow-up treatment.

Allowing visits to these types of providers to count towards the numerator allows the measure to capture the rates of appropriate follow-up care more accurately in areas with provider shortages. Performance on the FAPH measure indicates that follow-up rates for patients hospitalized with mental illness or SUD are less than optimal and that room for improvement is ample. The clinical benefits of timely follow-up care after hospitalization, including reduced risk of readmission and improved adherence to medication, are well-documented in the published literature.[] Behavioral health patients in particular have a number of risk factors that underscore the need for timely follow-up and continuity of care. Behavioral health patients have higher baseline hospitalization rates, higher hospital readmission rates, and higher health care costs as compared with the general population of patients.[] Among patients with serious mental illness, 90 percent have comorbid clinical conditions such as hypertension, cardiovascular disease, hyperlipidemia, or diabetes.[] Among patients hospitalized for general medical conditions, those who also have a mental illness are 28 percent more likely to be readmitted within 30 days than their counterparts without a psychiatric comorbidity.[] The high prevalence of clinical comorbidities among behavioral health patients, combined with the compounding effect of mental illness on patients with general medical conditions, suggests that behavioral health patients are uniquely vulnerable and supports the intent of the measure to increase follow-up after hospitalization. In addition, clinical practice guidelines stress the importance of continuity of care between settings for patients with mental illness and SUD.

For the treatment of SUD patients, the 2010 guidelines of the American Psychiatric Association (APA) state. €œIt is important to intensify the monitoring for substance use during periods when the patient is at a high risk of relapsing, including during the early stages of treatment, times of transition to less intensive levels of care, and the first year after active treatment has ceased.” [] This statement is accompanied by a grade of [I], which indicates the highest level of APA endorsement. €œrecommended with substantial clinical evidence.” Evidence supports that outpatient follow-up care and interventions after hospital discharges are associated with a decreased risk of readmissions for patients with mental illness.[] IPFs can influence rates of follow-up care for patients hospitalized for mental illness or SUD. Three studies reported that with certain interventions—such as pre-discharge transition interviews, appointment reminder letters or reminder phone calls, meetings with outpatient clinicians before discharge, and meetings with inpatient staff familiar to patients at the first post-discharge appointment—facilities achieved 30-day follow-up rates of 88 percent or more.[] This is substantially higher than the national rate of about 52 percent observed in the current FUH measure for Medicare FFS discharges between July 1, 2016, and June 30, 2017.[] Medicare FFS data from July 1, 2016, to June 30, 2017, show the national 7-day follow-up rate to be 35.5 percent and the 30-day rate to be 61.0 percent. These data reveal wide variation in follow-up rates across facilities, with a 16.9 percent absolute difference between the 25th and 75th Start Printed Page 42642percentiles for the 7-day rate and a 17.4 percent absolute difference for the 30-day rate.

If all facilities achieved the benchmark follow-up rates for their Medicare FFS patients (as calculated using the AHRQ Achievable Benchmarks of Care method,) [] 53,841 additional discharges would have a 7-day follow-up visit, and 47,552 would have a 30-day follow-up visit.[] During the development process, we used the CMS Quality Measures Public Comment Page to ask for public comments on the measure.[] We accepted public comments from January 25, 2019, to February 13, 2019. During this period, we received comments from 29 organizations or individuals. Many commenters acknowledged the importance of developing a measure that assesses acute care providers for follow-up post-hospitalization. Some commenters expressed skepticism about the measure's appropriateness as a tool for evaluating the performance of discharging IPFs due to factors beyond the IPFs' control that can affect whether a patient receives timely post-discharge follow-up care. Ten stakeholders expressed support for the measure based on the expanded list of qualifying diagnoses in the denominator and the inclusion of more patients who could benefit from post-discharge follow-up visits.[] We reviewed the comments we received with the TEP, whose members shared similar feedback regarding the importance of follow-up for patients with both mental health diagnoses and substance use disorders, as well as concerns about the ability of IPFs to influence follow-up care.

We agree with commenters that some factors that influence follow-up are outside of an IPF's control. However, as described previously in this section, we believe that there are interventions (such as pre-discharge transition interviews, appointment reminder letters or reminder phone calls, meetings with outpatient clinicians before discharge, and meetings with inpatient staff familiar to patients at the first post-discharge appointment) that allow facilities to improve their follow-up adherence. We remain committed to monitoring follow-up to improve health outcomes and view this measure as an expansion of our ability to measure appropriate follow-up care established by FUH. B. Overview of Measure (1).

Measure Calculation The FAPH measure would be calculated by dividing the number of discharges that meet the numerator criteria by the number that meet the denominator criteria. Two rates are reported for this measure. The 7-day rate and the 30-day rate. (a) Numerator The first rate that would be reported for this measure includes discharges from an IPF that are followed by an outpatient visit for treatment of mental illness or SUD within 7 days. The second rate reported for this measure would include discharges from an IPF that are followed by an outpatient visit for treatment of mental illness or SUD within 30 days.

Outpatient visits are defined as outpatient visits, intensive outpatient encounters, or partial hospitalization and are defined by the Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), and Uniform Billing (UB) Revenue codes. Claims with codes for emergency room visits do not count toward the numerator. (b) Denominator The denominator includes discharges paid under the IPF prospective payment system during the performance period for Medicare FFS patients with a principal diagnosis of mental illness or SUD. Specifically, the measure includes IPF discharges for which the patient was. Discharged with a principal diagnosis of mental illness or SUD that would necessitate outpatient follow-up care, Alive at the time of discharge, Enrolled in Medicare Parts A and B during the month of the discharge date and at least one month after the discharge date to ensure that data are available to capture the index admission and follow-up visits, and Age 6 or older on the date of discharge, because follow-up treatment for mental illness or SUD might not always be recommended for younger children.

The denominator excludes IPF discharges for patients who. Were admitted or transferred to acute and non-acute inpatient facilities within the 30-day follow-up period, because admission or transfer to other institutions could prevent an outpatient follow-up visit from taking place, Were discharged against medical advice, because the IPF could have limited opportunity to complete treatment and prepare for discharge, Died during the 30-day follow-up period, or Use hospice services or elect to use a hospice benefit at any time during the measurement year regardless of when the services began, because hospice patients could require different follow-up services. The FAPH measure differs from FUH mostly in the expansion of the measure population to include SUD and other mental health diagnoses in the measure's denominator, but it includes some additional differences. The FAPH measure simplifies the exclusion of admission or transfer to acute or non-acute inpatient facilities within 30 days after discharge by aligning with the HEDIS® Inpatient Stay Value Set used in both the HEDIS® FUH and the HEDIS® Follow-Up After Emergency Department Visit for Alcohol and Other Drug Abuse or Dependence (FUA) measures to identify acute and non-acute inpatient stays. A discharge is excluded from the FAPH measure if it is followed by an admission or a transfer with one of the codes in the value set.

The FAPH measure uses Medicare UB Revenue codes (rather than inpatient discharge status code, which the FUH measure uses) to identify discharge or transfer to other health care institutions. This is to align better with the intent of the HEDIS® FUH and HEDIS® FUA measures. The FAPH measure allows mental illness or SUD diagnoses in any position on the follow-up visit claim to count toward the numerator and does not require that it be in the primary position as the FUH measure does. (2) Measure Reliability and Validity In 2019, CMS used the final measure specifications to complete reliability and validity testing, which revealed that the FAPH measure provides reliable and valid IPF-level rates of follow-up after psychiatric hospitalization. We evaluated measure reliability based on a signal-to-noise analysis,[] in which a score of 0.0 implies that all variation is attributed to measurement error (noise), and a score of 1.0 implies that all measure score variation is caused by a real difference in performance across IPFs.

Using that approach, we established a minimum denominator size of 40 discharges to attain an overall Start Printed Page 42643reliability score of 0.7 for both the 7-day and the 30-day rate. These analyses revealed that the measure can reliably distinguish differences in performance between IPFs with adequate denominator size. We evaluated the validity of the measure based on its correlation to two conceptually related measures in the IPFQR Program. The 30-Day All-Cause Unplanned Readmission After Psychiatric Discharge from an IPF (IPF Readmission) measure, and the Medication Continuation Following Inpatient Psychiatric Discharge (Medication Continuation) measure. We observed a weak negative correlation between FAPH and the IPF Readmission measure for both 7-day (—0.11) and 30-day (—0.18) measure rates.

This negative correlation is expected because a higher score is indicative of better quality of care for the FAPH, while a lower score is indicative of better quality of care for the IPF readmission measure (that is, a lower rate of unplanned readmissions). High rates of follow-up after visits after discharge and low rates of unplanned readmissions both indicate good care coordination during the discharge process. We observed a weak positive correlation between the 7-day FAPH measure rate and the Medication Continuation measure (0.32), and between the 30-day FAPH measure rate and the Medication Continuation measure (0.42). This result is expected because for both the FAPH and the Medication Continuation measures higher scores are indicative of better-quality care. Follow-up visits after discharge and continuation of medication after discharge both indicate good care coordination during the discharge process.

After reviewing these results and the proposed measure specifications, all 13 TEP members who were present agreed that the measure had face validity.[] (3) Review by the Measure Applications Partnership and NQF Under section 1890A(a)(2) of the Act, this measure was included in a publicly available document. €œList of Measures Under Consideration for December 1, 2019,” available at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​QualityMeasures/​Downloads/​Measures-under-Consideration-List-for-2018.pdf. On January 15, 2020, the MAP Coordinating Committee rated the measure as “Conditional Support for Rulemaking” contingent upon NQF endorsement. We submitted the measure to the NQF for endorsement in the spring 2020 cycle.

However, some members of the NQF Behavioral Health and Substance Use Standing Committee were concerned about the measure's exclusions for patients who died during the 30-day follow-up period or who were transferred. In addition, some members objected to combining persons with a diagnosis of SUD and those with a diagnosis for a mental health disorder into a single measure of follow-up care. Therefore, the NQF declined to endorse this measure. We noted that the exclusions for patients who died or who were admitted or transferred to an acute or non-acute inpatient facility during the 30-day follow up period align with the FUH measure currently in the IPFQR Program. Section 1886(s)(4)(D)(ii) of the Act authorizes the Secretary to specify a measure for the IPFQR Program that is not endorsed by NQF.

The exception to the requirement to specify an endorsed measure states that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization. The FAPH measure is not NQF endorsed. We have reviewed NQF-endorsed and other consensus-endorsed measures related to follow-up care and identified the FUH measure (NQF #0576) currently in the IPFQR Program and Continuity of Care after Inpatient or | Residential Treatment for SUD (NQF #3453), we believe that the FAPH measure is an improvement over the current FUH measure and over the Continuity of Care after Inpatient or Residential Treatment of Substance Use Disorder because we believe that it is important to ensure appropriate access to follow-up treatment for the largest patient population possible and the FAPH measure applies to a larger patient population than either of the measures we considered. Therefore, we proposed to adopt the FAPH measure described in this section for the FY 2024 payment determination and subsequent years. C.

Data Collection, Submission and Reporting FAPH uses Medicare FFS Part A and Part B claims that are received by Medicare for payment purposes. The measure links Medicare FFS claims submitted by IPFs and subsequent outpatient providers for Medicare FFS IPF discharges. Therefore, no additional data collection would be required from IPFs. For additional information on data submission for this measure, see section IV.J.2.b of this final rule. The performance period used to identify cases in the denominator is 12 months.

Data from this period and 30 days afterward are used to identify follow-up visits in the numerator. Consistent with other claims-based measures in the IPFQR Program, the performance period for this measure is July 1 through June 30. For example, for the FY 2024 payment determination, the performance period would include discharges between July 1, 2021 and June 30, 2022.[] We invited public comment on our proposal to add a new measure, Follow-Up After Psychiatric Hospitalization, to the IPFQR Program, beginning with the FY 2024 payment determination and subsequent years. We received the following comments on our proposal. Comment.

Many commenters supported the adoption of the FAPH measure. Some commenters expressed that the expanded cohort would improve the measure's value. Some commenters expressed that expanding the eligible provider types for the follow-up visit would improve care because of the shortage of psychiatrists. A few commenters observed that care transitions are important, and that outpatient follow-up serves to improve the value of the inpatient services provided. One commenter expressed that adoption of this measure is timely due to the increased behavioral health needs associated with the erectile dysfunction treatment cialis.

One commenter recommended using this measure at the health system level to better identify care coordination, access, and referral network adequacy. Response. We thank these commenters for their support. We agree that the expanded definitions would improve the measure's applicability and capture more follow-up visits. Regarding the commenter's Start Printed Page 42644recommendation on using this measure at the health system level, we believe the commenter is recommending adopting this measure to evaluate performance of regional or local health systems (such as those affiliated with large hospital networks).

We note that the IPFQR Program applies to Medicare participating freestanding psychiatric hospitals and psychiatric units and we believe that health systems that have IPFs that participate in the IPFQR Program would find this measure useful as they assess access and referral network adequacy within their systems. Comment. Some commenters observed that some follow-ups, especially for substance use disorders, may not be identifiable in claims. A few commenters specifically noted that some providers who often provide follow-ups are not covered by Medicare (for example, therapists) or that some follow-ups may be covered by other insurers. These commenters observed that this may lead the measure to undercount follow-ups provided.

A few of these commenters did not support measure adoption because of this undercount. However, one commenter that expressed this concern supported measure adoption because the commenter believes that burden reduction associated with claims reporting outweighs the potential undercounting. Response. We acknowledge that, like the Follow-Up After Hospitalization for Mental Illness (FUH, NQF #0576) measure that we proposed to replace with the FAPH measure, the FAPH measure would not be able to capture follow-up visits provided by professionals outside of Medicare, or if the patient uses another payer or self-pay to cover the patient's follow-up care, which could lead to an undercount. However, we believe that the data captured by the measure would be sufficient to inform consumers and to provide data for quality improvement initiatives.

Further, we agree with the commenter that the burden reduction associated with using claims-based measures outweighs the potential undercounting. Comment. Some commenters expressed concern that this measure may be difficult for some IPFs to perform well on due to factors outside of the IPF's control. One commenter observed that many rural hospitals lack community resources and therefore cannot refer patients to outpatient psychiatrists. Another commenter observed that some patients may be unwilling to see an outpatient psychiatrist.

Other commenters observed that this measure captures patient behavior, not provider actions. Some of these commenters observed that lack of transportation, access barriers, homelessness or other patient characteristics outside of the IPF's control may affect performance. Some of these commenters expressed preference for a process measure that tracks whether IPFs performed interventions to improve follow-up rates before or during discharge. Response. We recognize that there is regional variation in access to outpatient resources and that patients have varying comfort levels with different provider types.

However, we believe that this updated measure helps to address some of the commenters' concerns. Specifically, we note that this measure expands the definition of follow-up to include a wider range of outpatient providers, including family or general practice physicians, internal medicine physicians, nurse practitioners, and physician assistants. We agree with commenters that there are factors that influence follow-up that are outside of an IPF's control (including patient behavior, lack of transportation, access barriers, homelessness, among others). As described in the FY 2022 IPF PPS proposed rule (86 FR 19504 through 19505), there are interventions that allow facilities to improve their follow-up adherence. We believe it is incumbent upon facilities to identify potential barriers to follow-up adherence and apply appropriate interventions to improve adherence.

We believe that this measure is preferable to a process measure because it provides insight into the success of interventions by identifying follow-up rates. As discussed in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50894 through 50895) and the FY 2022 IPF PPS proposed rule in our proposal to adopt the FAPH measure (86 FR 19504 through 19507) we do not expect 100 percent of patients discharged from IPFs to receive follow-up care within 7 or 30 days of discharge because of factors both within and outside of the control of facilities such as availability of providers in the referral network. Comment. Some commenters opposed the FAPH measure because it is not NQF endorsed and because it was not fully supported by the MAP. A few commenters observed that the measure may undergo changes to achieve NQF endorsement which would create burden if the measure were in the program when these changes occurred.

Some commenters recommended delaying implementation until NQF's concerns are fully addressed. One commenter observed that the similar NQF-endorsed FUH measure is available and therefore CMS has not properly considered available consensus endorsed measures. Response. We appreciate the commenters' concerns about the FAPH measure's lack of NQF endorsement. As we stated in the proposed rule, after having given due consideration to similar measures, FUH measure (NQF #0576) and Continuity of Care after Inpatient or Residential Treatment for SUD (NQF #3453), we believe that the FAPH measure is an improvement over the FUH measure currently in the IPFQR Program (86 FR 19507).

The FAPH measure expands the number of discharges in the denominator by adding patients with SUD or dementia, populations that also benefit from timely follow-up care. We propose updates to the IPFQR program measure set on an annual basis through the rulemaking process. During the measure evaluation process, we carefully consider the potential burden to clinicians, health systems, and patients of any updates that are under consideration. The primary concerns of some NQF Behavioral Health and Substance Use Standing Committee members with the FAPH measure were exclusions for patients who died during the 30-day follow-up period or who were transferred. While we respect the NQF's concerns, we note that these same exclusions align with the exclusions in the Follow-Up After Hospitalization for Mental Illness (FUH, NQF #0576) measure which is already NQF endorsed, and which we adopted under the IPFQR Program in the FY 2014 IPPS/LTCH PPS final rule.

This measure has a very similar denominator (78 FR 50893 through 50895). The clinical expert work group and technical expert panel convened by our contractor supported these exclusions as being appropriate for both measures. After having given due consideration to similar measures, FUH measure (NQF #0576) and Continuity of Care after Inpatient or Residential Treatment for SUD (NQF #3453), we believe that the FAPH measure is an improvement over the FUH measure which is currently in the IPFQR Program, because it includes patients with SUD or dementia, populations that also benefit from timely follow-up care (86 FR 19504 through 19506). Comment. Some commenters recommended further research or testing.

Some commenters recommended that CMS continue to consider evidence supporting the expanded patient cohort. Response. We thank commenters for these recommendations and will Start Printed Page 42645continue to evaluate them as part of our measure monitoring and evaluation process. We believe that the evidence cited in our proposal, including the evidence supporting the APA grade of [I] applied to the 2010 guidelines for the treatment of SUD patients that state “It is important to intensify the monitoring for substance use during periods when the patient is at a high risk of relapsing, including during the early stages of treatment, times of transition to less intensive levels of care, and the first year after active treatment has ceased” [] is sufficient evidence to support measuring follow up after hospitalization for SUD. We note that because discharge from an IPF is a time of transition to less intensive levels of care these guidelines apply to discharge from an IPF and support the expanded patient cohort.

Comment. One commenter requested CMS specifically consider the impact of the physician self-referral law (commonly referred to as “the Stark Law”) on an IPF's ability to ensure necessary SUD follow-up care. Some commenters recommended that CMS evaluate additional risk adjustment for social risk factors. One commenter further expressed that this measure may not be a successful strategy for reducing readmissions. Another commenter recommended that CMS investigate whether FAPH is an appropriate replacement for the Alcohol &.

Other Drug Use Disorder Treatment Provided or Offered at Discharge and Alcohol &. Other Drug Use Disorder Treatment at Discharge (SUB-3/3a) measure. Response. Section 1877 of the Act, also known as the physician self-referral law. (1) Prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless an exception applies.

And (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. A financial relationship is an ownership or investment interest in the entity or a compensation arrangement with the entity.[] We believe that the comment regarding the physician self-referral law relates to compensation arrangements between IPFs (which qualify as hospitals, and “entities”, for purposes of the physician self-referral law) and physicians who provide post-discharge SUD follow-up care that may implicate the physician self-referral law. To the extent an IPF enters into a compensation arrangement with a physician who provides SUD follow-up care to patients discharged from the hospital, we note that there are exceptions to the physician self-referral law applicable to such compensation arrangements, including recently finalized exceptions for value-based arrangements. We will consider this measure for potential risk adjustment or stratification as we seek to close the equity gap as described in section IV.D of this final rule. We note that a reduction in readmissions is this measure's objective, though improved follow-up adherence may serve to reduce readmissions because of improved continuity of care.

Finally, we will evaluate whether the FAPH measure is an appropriate replacement for Alcohol &. Other Drug Use Disorder Treatment Provided or Offered at Discharge and Alcohol &. Other Drug Use Disorder Treatment at Discharge (SUB-3/3a). Comment. Some commenters requested clarification regarding visits that would be considered post-discharge follow-up.

Some commenters requested clarification regarding whether telehealth visits, specifically audio-only telehealth visits, would be considered follow-up for purposes of the measure. A few commenters requested clarification regarding whether visits implemented through collaborative agreements with mental health providers would be considered follow-ups. These commenters further observed that including these visits would incentivize community partnerships. One commenter requested clarification regarding whether a visit to any HCP (including physicians, clinics, etc.) would be considered follow-up for purposes of the measure. This commenter further requested clarification regarding whether specific diagnosis codes would be required to be present on the follow-up claim.

Response. Regarding the request for clarification about the eligibility of telehealth visits for FAPH measure, both in-person and telehealth outpatient visits are acceptable, including audio-only visits. The FAPH numerator defines qualifying outpatient visits as outpatient visits, intensive outpatient encounters or partial hospitalizations that occur within 7 or 30 days of discharge and are defined by the Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), and Uniform Billing (UB) Revenue codes, with or without the GT telehealth modifier. The CPT codes 99441, 99442, and 99443, which represent telephone E/M visits, are included in the list of codes to identify eligible outpatient visits. With respect to the request for clarification regarding collaborative agreements, the measure is agnostic to relationships between mental health providers, other providers, and health systems.

The codes used to identify outpatient visits for the FAPH measure are not limited to mental health providers. The outpatient visit may be any outpatient visit, intensive outpatient encounter or partial hospitalization that occurs within 7 or 30 days of discharge as defined in section IV.E.3.b.(1). This visit must be paired with a qualifying ICD-10-CM diagnosis of mental illness or substance use disorder used to define the denominator. Comment. One commenter observed that historical trending would no longer be available due to the transition from FUH to FAPH.

Response. We agree with the commenter that replacing FUH with FAPH would mean that historical trending would no longer be available. However, we believe that the benefits associated with the expanded patient population and the expanded provider types for follow-up appointments outweigh the loss of trend data. After consideration of the public comments, we are finalizing the FAPH measure as proposed for the FY 2024 payment determination and subsequent years. F.

Removal or Retention of IPFQR Program Measures 1. Background In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38463 through 38465), we adopted considerations for removing or retaining measures within the IPFQR Program and criteria for determining when a measure is “topped out.” In the FY 2019 IPF PPS final rule (83 FR 38591 through 38593), we adopted one additional measure removal factor. We did not propose any changes to these removal factors, topped-out criteria, or retention factors and refer readers to the FY 2018 IPPS/LTCH PPS final rule (82 FR 38463 through 38465) and the FY 2019 IPF PPS final rule (83 FR 38591 through 38593) for more information. We will continue to retain measures from each previous year's IPFQR Program measure set for subsequent years' measure sets, except when we specifically propose to remove or replace a measure. We will continue to use the notice-and-comment rulemaking Start Printed Page 42646process to propose measures for removal or replacement, as we described upon adopting these factors in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38464 through 38465).

In the FY 2022 IPF PPS proposed rule we described that in our continual evaluation of the IPFQR Program measure set under our Meaningful Measures Framework and according to our measure removal and retention factors, we identified four measures that we believed were appropriate to propose removing from the IPFQR Program for the FY 2024 payment determination and subsequent years (86 FR 19507). Our discussion of these measures follows. 2. Measures Proposed for Removal in the FY 2022 IPF PPS Proposed Rule a. Retention of the Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) Measure Beginning With FY 2024 Payment Determination We proposed to remove the Alcohol Use Brief Intervention Provided or Offered (SUB-2) and subset measure Alcohol Use Brief Intervention (SUB2a) collectively referred to as the SUB-2/2a measure from the IPFQR Program beginning with the FY 2024 payment determination under our measure removal Factor 8, “The costs associated with a measure outweigh the benefit of its continued use in the program.” We adopted the Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) measure in the FY 2016 IPF PPS final rule (80 FR 46699 through 46701) because we believe it is important to address the common comorbidity of alcohol use among IPF patients.

This measure requires facilities to chart-abstract measure data on a sample of IPF patient records, in accordance with established sampling policies (80 FR 46717 through 46719). We have previously stated our intent to move away from chart-abstracted measures to reduce information collection burden in this and other CMS quality programs (78 FR 50808. 79 FR 50242. 80 FR 49693). When we adopted the SUB-2/2a measure to the IPFQR Program, the benefits of this measure were high because IPF performance was not consistent.

Therefore, the measure provided a means of distinguishing IPF performance and incentivized facilities to improve rates of treatment for this common comorbidity. Between the FY 2018 payment determination (the first year that SUB-2/2a was included in the IPFQR Program measure set) and the FY 2019 payment determination, we saw substantial performance improvement on the SUB-2 measure (which is the portion of the SUB-2/2a measure that assesses whether the IPF provided or offered a brief intervention for alcohol use). However, for the FY 2019 and FY 2020 payment determinations, the rate of improvement has leveled off to consistently high performance, as indicated in Table 3. These data further show that at this time there is little room for improvement in the SUB 2 measure, and that the quality improvement benefits from the measure have greatly diminished. As stated in the proposed rule, we continue to believe that alcohol use is an important comorbidity to address in the IPF setting, and that brief interventions are a key component of addressing this comorbidity.

However, based on these data, we believe that most IPFs routinely offer alcohol use brief interventions, and that IPFs will continue to offer these interventions to patients, regardless of whether the SUB-2/2a measure is in the IPFQR Program measure set, because it has become an embedded part of their clinical workflows. In the proposed rule, we noted that while the measure does not meet our criteria for “topped-out” status because of the TCV higher than 0.1, we believe that this measure no longer meaningfully supports the program objectives of informing beneficiary choice and driving improvement in IPF interventions for alcohol use because it is no longer showing significant improvement in IPF performance (that is, in providing or offering alcohol use brief interventions). Furthermore, as we stated in the FY 2019 IPF PPS final rule, costs are multi-faceted and include not only the burden associated with reporting, but also the costs associated with implementing and maintaining the program (83 FR 38592). For example, it may be costly for health care providers to maintain general administrative knowledge to report this measure. Additionally, CMS must expend resources in maintaining information collection systems, analyzing reported data, and providing public reporting of the collected information.

Here, IPF information collection burden and related costs associated with reporting the SUB 2/2a measure to CMS are high because it is a chart-abstracted measure. Furthermore, CMS incurs costs associated with the program oversight of the measure for public display. As a result, we believe that the costs and burdens associated with this chart-abstracted measure outweigh the benefit of its continued use in the program. Therefore, we proposed to remove the Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) measure from the IPFQR Program beginning with the FY 2024 payment determination. We welcomed public comments on our proposal to remove the SUB-2/2a measure from the IPFQR Program.

We received the following comments on our proposal. Comment. Many commenters supported our proposal to remove the Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) measure. Some commenters agreed with our rationale that the costs of this measure outweigh the benefit of its continued use in the IPFQR Program. A few commenters recommended that CMS remove the measure immediately, rather than beginning with FY 2024 payment determination as proposed, to further reduce burden.

One commenter agreed Start Printed Page 42647that providers will continue these interventions after the measure has been removed. Another commenter also supported removal because the measure is no longer NQF endorsed and was not specified for this setting. Response. We thank the commenters for their support. While we continue to believe that the performance on the SUB-2/2a measure in recent years indicates that IPFs routinely offer alcohol use brief interventions, we recognize that we will not be able to monitor whether IPFs continue these interventions if we remove this measure.

We considered proposing to remove the measure sooner, but because data are currently being collected to report during CY 2022 to inform the FY 2023 payment determination, we proposed removing the measure following that payment determination, that is, for the FY 2024 payment determination. The commenter is correct that the measure is no longer NQF endorsed and is not specified for the IPF setting. However, we continue to believe that this measure is appropriate for the IPF setting. We reiterate that we proposed to remove this measure because of the belief that the costs of the measure outweigh its continued benefits in the IPFQR Program, not because it is no longer NQF endorsed nor because it was not specified for this setting. Comment.

One commenter supported removal of the SUB-2/2a measure, but recommended development of more meaningful measures than SUB-2/2a and the Alcohol &. Other Drug Use Disorder Treatment Provided or Offered at Discharge and Alcohol &. Other Drug Use Treatment at Discharge (SUB-3/3a) measure to address screening and intervention for substance use. Another commenter recommended that CMS consult with consumers to ascertain the benefits of measures in the IPFQR Program prior to proposing to remove any such measures, this commenter specifically recommended that CMS not finalize removal of the SUB-2/2a measure until fully considering input from consumers. Response.

We appreciate this commenter's input and are continually seeking to improve our measure set by developing more meaningful and less burdensome measures. As we evaluate areas appropriate for measure development, we will consider additional measures or measure concepts that more meaningfully address alcohol use disorder treatment for the IPF patient population. In response to the request that we consult with consumers to ascertain the benefits of the measure, we note that we evaluate input from all stakeholders, including consumers, patients, caregivers, and patient advocacy groups that we receive in response to our proposals to adopt or remove measures from the IPFQR Program. As part of this process, we have reviewed input from consumers regarding the benefits of the measure and considered this input in our analysis. Comment.

Some commenters expressed concern about removing the measure. A few of these commenters stated that not all facilities perform well on the measure and, therefore, there is still room for improvement. One commenter stated that the erectile dysfunction treatment cialis has led to increased alcohol use and expressed the belief that removing the measure now is poorly timed. Response. We note that we proposed to remove the measure because of the belief that the benefits of retaining it have lessened to the point that its costs outweigh those benefits, not because the measure is topped out.

We agree with commenters that not all facilities perform uniformly well on the Alcohol Use Disorder Brief Intervention Provided or Offered and Alcohol Use Disorder Brief Intervention Provided (SUB-2/2a) measure. We also agree that alcohol use has increased during the erectile dysfunction treatment cialis.[] In our literature review regarding this comment, we also identified evidence that individuals with mental health and substance use conditions may be at an increased risk of erectile dysfunction treatment complications and appropriate substance use disorder treatment may help mitigate these complications.[] To ensure that providers would continue to address alcohol use disorders among this patient population, we have maintained the Alcohol &. Other Drug Use Disorder Treatment Provided or Offered at Discharge and Alcohol &. Other Drug Use Treatment at Discharge (SUB-3/3a) measure. However, we note that a prominent model to ensure those with alcohol use disorder are identified and referred to treatment include both brief interventions and referrals.[] Given the increased need for alcohol use brief interventions due to the cialis, the current performance levels [] (for FY 2018 payment determination, the mean performance nationally was approximately 80 percent of patients who screened positive for alcohol use disorder were offered or provided a brief intervention), and the importance of providing alcohol use brief interventions to improve the efficacy of alcohol use treatment at discharge, we believe that the benefits of retaining the Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) measure are greater than we initially estimated in our proposal to remove this measure and that the measure should not be removed from the program at this time.

Comment. One commenter observed that this measure may be useful for future stratification based on race and ethnicity. Response. We agree with the commenter that this measure may be useful for future stratification based on race and ethnicity. While we do not believe it would be appropriate to retain this measure specifically for the purpose of potential future stratification, we agree that this potential is another benefit of the measure that we had not considered in our previous analysis of the benefits versus the costs of retaining the measure.

Comment. One commenter observed that there are benefits to retaining this measure because IPFs and health systems use performance data on this measure as part of quality improvement initiatives to reduce alcohol use and that removal may affect these programs. Response. We thank the commenter for this input. We note that IPFs are responsible for abstracting the data for this measure, so we believe that IPFs who use these data for their own quality improvement initiatives have access to these data regardless of whether the measure is in the IPFQR Program.

Start Printed Page 42648However, we recognize that such IPFs and health systems would not have access to publicly reported data regarding other IPFs and that these data may be useful for baselining. Therefore, we agree that such IPF level and systemic programs to reduce alcohol use is a benefit to retaining the measure that we had not evaluated in our proposal to remove this measure. Comment. One commenter observed that this measure is less burdensome than the newly proposed erectile dysfunction treatment vaccination measure and therefore the commenter believes that removing this measure because the costs, especially the information collection burden, outweigh benefits is inconsistent. Response.

We evaluate measures on a case-by-case basis looking at the overall benefits of the measure versus the overall costs of the measure. Therefore, measures are not evaluated based on whether they are more or less burdensome than other measures. However, we now believe that the benefits of retaining this measure are greater than we had considered in our proposal to remove the measure from the IPFQR Program measure set. After consideration of the public comments, we now believe that the benefits of retaining this measure, which include the potential for IPFs to continue improving performance on this measure, the importance of substance use interventions due to increased substance use during the erectile dysfunction treatment cialis, and this measure's potential influence on other quality improvement activities related to substance use are greater than we had considered in our proposal to remove the measure from the IPFQR Program measure set. Accordingly, we are not finalizing our proposal to remove the Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) measure beginning with the FY 2024 payment determination.

That is, we are retaining the Alcohol Use Disorder Brief Intervention Provided or Offered and Alcohol Use Disorder Brief Intervention Provided (SUB-2/2a) measure in the IPFQR Program measure set. After consideration of the public comments, we are not finalizing our proposal to remove the Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) measure beginning with the FY 2024 payment determination. That is, we are retaining the Alcohol Use Disorder Brief Intervention Provided or Offered and Alcohol Use Disorder Brief Intervention Provided (SUB-2/2a) measure in the IPFQR Program measure set. B. Retention of the Tobacco Use Treatment Provided or Offered and Tobacco Treatment (TOB-2/2a) Measure Beginning With FY 2024 Payment Determination [] We proposed to remove the Tobacco Use Treatment Provided or Offered (TOB-2) and Treatment (TOB-2a), collectively referred to as the TOB-2/2a measure from the IPFQR Program beginning with the FY 2024 payment determination under our measure removal Factor 8, “The costs associated with a measure outweigh the benefit of its continued use in the program.” We adopted the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) measure in the FY 2015 IPF PPS final rule (79 FR 45971 through 45972) because we believe it is important to address the common comorbidity of tobacco use among IPF patients.

Like SUB-2/2a described in the previous subsection, this measure requires facilities to chart-abstract measure data on a sample of IPF patient records, in accordance with established sampling policies (80 FR 46717 through 46719). When we introduced the TOB-2/2a measure to the IPFQR Program, the benefits of this measure were high, because IPF performance was not consistent and therefore the measure provided a means of distinguishing IPF performance and incentivized facilities to improve rates of treatment for this common comorbidity. Between the FY 2017 payment determination (the first year that TOB-2/2a was included in the IPFQR Program's measure set) and the FY 2019 payment determination we saw substantial performance improvement on TOB-2. However, between the FY 2019 and FY 2020 payment determinations, that improvement has leveled off to consistently high performance, as indicated in Table 4. These data further show that currently there is little room for improvement in the TOB-2 measure, and that the quality improvement benefits from the measure have greatly diminished.

We continue to believe that tobacco use is an important comorbidity to address in the IPF setting, and that brief interventions are a key component of addressing this comorbidity. However, based on these data, we stated in the proposed rule that we believe that most IPFs routinely offer tobacco use brief interventions, and that IPFs will continue to offer these interventions to patients, regardless of whether the TOB-2/2a measure is in the IPFQR Program measure set, because it has become an embedded part of their clinical workflows. While the measure does not meet our criteria for “topped-out” status because of the TCV higher than 0.1, we believe that this measure no longer meaningfully supports the program objectives of informing beneficiary choice and driving improvement in IPF interventions for tobacco use because it is no longer showing significant improvement in IPF performance (that is, in providing or offering tobacco use brief interventions). Furthermore, as we Start Printed Page 42649stated in the FY 2019 IPF PPS final rule, costs are multi-faceted and include not only the burden associated with reporting, but also the costs associated with implementing and maintaining the program (83 FR 38592). For example, it may be costly for health care providers to maintain general administrative knowledge to report this measure.

Additionally, CMS must expend resources in maintaining information collection systems, analyzing reported data, and providing public reporting of the collected information. Here, IPF information collection burden and related costs associated with reporting this measure to CMS are high because the measure is a chart-abstracted measure. Furthermore, CMS incurs costs associated with the program oversight of the measure for public display. As a result, we believe that the costs and burdens associated with this chart-abstracted measure outweigh the benefit of its continued use in the program. Therefore, we proposed to remove the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) measure from the IPFQR Program beginning with the FY 2024 payment determination.

We welcomed public comments on our proposal to remove the TOB-2/2a measure from the IPFQR Program. We received the following comments on our proposal. Comment. Many commenters supported our proposal to remove the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) measure. Some of these commenters agreed with our rationale that the costs of this measure outweigh the benefits of its continued use in the IPFQR Program.

Several commenters recommended removing the measure immediately, rather than beginning with FY 2024 payment determination as proposed, to further reduce burden. One commenter agreed that providers will continue offering this intervention even if it is not being measured. Another commenter further expressed that removal is appropriate because the measure is no longer NQF endorsed and is not specified for this setting. Response. We thank the commenters for their support.

We considered proposing to remove the measure sooner, but because data are currently being collected to report during CY 2022 to inform the FY 2023 payment determination, we proposed to remove the measure following that payment determination, that is, for the FY 2024 payment determination. While we continue to believe that the performance on the TOB-2/2a measure in recent years indicates that IPFs routinely offer tobacco use cessation interventions during the inpatient stay, we recognize that we will not be able to monitor whether IPFs continue these interventions if we remove this measure. The commenter is correct that the measure is no longer NQF endorsed and is not specified for the IPF setting. We reiterate that we proposed to remove this measure because of the belief that the costs of the measure outweigh its continued benefits in the IPFQR Program not because it is no longer NQF endorsed nor because it was not specified for this setting and we continue to believe that this measure is appropriate for the IPF setting. Comment.

One commenter expressed the belief that progress in electronic reporting systems leads to lower burden for reporting this measure. This commenter expressed the belief that this reduced burden should factor into the consideration of whether costs outweigh benefits and recommended that CMS retain this measure. Response. We thank the commenter for this feedback. However, we note that because this is a chart-abstracted measure, we do not believe access to electronic reporting systems will significantly impact the burden of collecting and reporting this measure for most IPFs.

Comment. One commenter supported removal of the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment Provided (TOB-2/2a) measure, but recommended development of more meaningful measures than TOB-2/2a and Tobacco Use Treatment Provided or Offered at Discharge and Tobacco Use Treatment Provided at Discharge (TOB-3/3a) to address screening and intervention for tobacco use. One commenter recommended that CMS seek consumer input on the benefit of measures before proposing to remove them. Response. We appreciate this commenter's input and are continually seeking to improve our measure set by developing more meaningful and less burdensome measures.

As we evaluate areas appropriate for measure development, we will consider additional measures or measure concepts that more meaningfully address tobacco use treatment for the IPF patient population. In response to the request that we consult with consumers to ascertain the benefits of the measure, we note that we evaluate input from all stakeholders, including consumers, patients, caregivers, and patient advocacy groups that we receive in response to our proposals to adopt or remove measures from the IPFQR Program. As part of this process, we have reviewed input from consumers regarding the benefits of the measure and considered this input in our analysis. Comment. Some commenters expressed concern about removing the TOB-2/2a measure from the IPFQR Program measure set.

Some of these commenters expressed that there continues to be significant room for improvement in providing interventions. One commenter specifically observed that the measure is not topped out. A few commenters observed that the proposed removal is poorly timed due to the increase in tobacco use during the erectile dysfunction treatment cialis. Another commenter cited evidence supporting the benefit of brief interventions as part of a comprehensive program to address topped out. We agree with commenters that not all facilities perform uniformly well on the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment Provided (TOB-2/2a) measure.

We also agree with the commenter's observation that tobacco use has increased during the erectile dysfunction treatment cialis.[] In our literature review, we also identified evidence that individuals who use tobacco may be at an increased risk of erectile dysfunction treatment complications and tobacco use treatment may help mitigate these complications.[] To ensure that providers would continue to address tobacco use among this patient population, we maintained the Tobacco Use Treatment Provided or Offered at Discharge and Tobacco Use Treatment Provided at Discharge (TOB-3/3a). However, we agree with the commenter who expressed that these interventions are most effective as part of a comprehensive tobacco treatment program. Given the increased need for tobacco use interventions due to the erectile dysfunction treatment cialis, that this measure is not topped out and there is room for improvement across facilities,[] and the importance of providing tobacco use treatment during the inpatient stay to improve the efficacy of tobacco use treatment at discharge, we believe that the benefits of retaining the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment Provided (TOB-2/2a) measure are greater than we Start Printed Page 42650estimated in our proposal to remove this measure and that the measure should not be removed from the program at this time. Comment. Many commenters opposed removal of the measure because of the clinical importance of treating tobacco use in the IPF patient population.

Many of these commenters observed that tobacco use is undertreated. Some of these commenters referenced CDC data stating that only 48.9 percent of mental health treatment facilities reported screening patients for tobacco use. Some commenters pointed to this statistic and expressed concern that without measures related to tobacco use treatment this care may no longer be provided in IPFs. These commenters observed that tobacco use is nearly three times more prevalent in people with serious psychological distress than in those without. Some of these commenters observed that this discrepancy contributes to a shorter life expectancy for patients with mental illness who smoke.

These commenters expressed the belief that the potential to increase patient life expectancy and quality of life outweighs the costs of reporting the measure. A few of these commenters observed there are high costs associated with treating tobacco associated illness and that these costs could be significantly reduced by increased screening, intervention, and treatment. Some commenters stated that the 2020 Surgeon General's report specifically stated that tobacco dependence treatment is applicable to the behavioral health setting. One commenter observed that brief interventions are part of the “Treating Tobacco Use and Dependence Clinical Practice Guidelines.” One commenter stated that behavioral health patients often have limited interaction with the healthcare system and therefore the commenter believes that it is important to use these interactions to drive health behaviors. Response.

We agree with commenters that providing or offering tobacco use brief intervention within the IPF setting is a valuable intervention because of the prevalence of this comorbidity within this patient population and because of the ability of this intervention to facilitate quitting tobacco use. We further agree that brief interventions are part of clinical guidelines and are appropriate to provide to patients receiving care for behavioral health conditions. We note that the tobacco screening statistics cited by commenters refer to all behavioral health and substance use treatment facilities, whereas the IPFQR Program only requires reporting on treatment provided by IPFs that receive Medicare payment under the IPF PPS, therefore the statistics cited by commenters do not directly reflect care provided by IPFs.[] However, we acknowledge that the low performance on tobacco use screening in the behavioral health setting does indicate that tobacco screening and treatment performance may lapse in the IPF setting without measures to address this topic, and that the inpatient setting may be a uniquely opportune setting for providing tobacco cessation interventions to some patients due to limited access to or utilization of the healthcare system. We also agree with commenters that providing tobacco use brief interventions has the potential to increase patient life expectancy and quality of life while reducing healthcare costs associated with treating tobacco associated illness. Given the importance of tobacco use interventions in extending life expectancy and improving quality of life, the concern regarding potential reduction in performance if measures are removed (as demonstrated by CDC data that show that the provision of brief intervention for tobacco use cessation is not the current standard of care across behavioral health settings as only 48.9 percent of mental health treatment facilities report screening patients for tobacco use), and the room for improvement in the current performance levels, we believe that the benefits of retaining the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment Provided (TOB-2/2a) measure are greater than we estimated in our proposal to remove this measure and that the measure should not be removed from the program at this time.

Comment. One commenter observed that there are health equity concerns regarding tobacco use and recommended that CMS retain this measure for future stratification based on race and ethnicity. Response. We agree with the commenter that this measure may be useful for future stratification based on race and ethnicity. While we do not believe it would be appropriate to retain this measure specifically for the purpose of potential future stratification, we agree that this potential is another benefit of the measure that we had not considered in our previous analysis of the benefits versus the costs of retaining the measure.

Comment. One commenter observed that there are benefits to retaining this measure because IPFs and health systems use performance data on this measure as part of quality improvement initiatives to reduce tobacco use and that measure removal may affect those programs. Response. We thank the commenter for this feedback. We note that IPFs are responsible for abstracting the data for this measure, so we believe that IPFs who use these data for their own quality improvement initiatives have access to these data regardless of whether the measure is in the IPFQR Program.

However, we recognize that such IPFs and health systems would not have access to publicly reported data regarding other IPFs and that these data may be useful for baselining. Therefore, we agree that such IPF level and systemic programs to reduce tobacco use is a benefit to retaining the measure that we had not evaluated in our proposal to remove this measure. Comment. Many commenters expressed the belief that without this measure IPFs would not continue to provide tobacco use brief interventions. Some commenters expressed concern that removing this measure would reduce providers' incentive to offer brief interventions.

These commenters further observed that it would be difficult to determine whether IPFs continue to offer this intervention as the ability to track that depends on the continued collection of this measure. Some commenters further expressed concern that CMS policies drive the behavior of other payers and without this measure the healthcare system may lose focus on tobacco treatment for patients with behavioral health disorders. Response. We understand commenters' concern regarding the potential for IPFs and other payers to no longer focus on tobacco treatment without the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) quality measure in the IPFQR Program and we agree that ensuring continuing focus on tobacco use treatment in this setting is a benefit of retaining this measure in the IPFQR program. Additionally, we agree that tracking whether IPFs continue to offer this intervention is a benefit of retaining the measure in the IPFQR program measure set.

Comment. One commenter observed that the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) measure is not as burdensome as the newly proposed erectile dysfunction treatment vaccination measure and therefore the commenter believes that removing this measure because the costs, especially the information Start Printed Page 42651collection burden, outweigh benefits is inconsistent. Response. We evaluate measures on a case-by-case basis looking at the overall benefits of the measure versus the overall costs of the measure. Therefore, measures are not evaluated based on whether they are more or less burdensome than other measures.

However, we now believe that the benefits of retaining this measure are greater than we had considered in our proposal to remove the measure from the IPFQR Program measure set. After consideration of the public comments, we now believe that the benefits of retaining this measure, which include the potential for IPFs to continue improving performance on this measure, the importance of tobacco use interventions due to increased tobacco use during the erectile dysfunction treatment cialis, and this measure's potential influence on other quality improvement activities related to tobacco use, are greater than we had considered in our proposal to remove the measure from the IPFQR Program measure set. Accordingly, we are not finalizing our proposal to remove the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) measure beginning with the FY 2024 payment determination. That is, we are retaining the Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a) measure in the IPFQR Program measure set. C.

Removal of the Timely Transmission of Transition Record (Discharges From an Inpatient Facility to Home/Self Care or Any Other Site of Care) Measure Beginning With FY 2024 Payment Determination We proposed to remove the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure from the IPFQR Program beginning with the FY 2024 payment determination under our measure removal Factor 8, “The costs associated with a measure outweigh the benefit of its continued use in the program.” We adopted the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure in the FY 2016 IPF PPS final rule (80 FR 46706 through 46709) because more timely communication of vital information regarding the inpatient hospitalization results in better care, reduction of systemic medical errors, and improved patient outcomes. The Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure builds on the Transition Record with Specified Elements Received by Discharged Patients (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure, which requires facilities to provide a discharge record with 11 specified elements to patients at discharge. We continue to believe that the 11 elements required by the Transition Record with Specified Elements measure provide meaningful information about the quality of care provided by IPFs, and we therefore did not propose to remove that measure from the IPFQR Program. However, we believe that the benefits of requiring facilities to transmit the discharge record with 11 specified elements to the next level care provided within 24 hours, as required by the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure, have been reduced. Reporting this measure requires facilities to chart-abstract measure data on a sample of IPF patient records, in accordance with established sampling policies (80 FR 46717 through 46719).

On May 1, 2020, we updated the Conditions of Participation (CoPs) for IPFs participating in the Medicare program in the Medicare and Medicaid Programs. Patient Protection and Affordable Care Act. Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally Facilitated Exchanges, and Health Care Providers final rule (85 FR 25588). In the May 1, 2020 update to the CoPs, we adopted a requirement for psychiatric hospitals that possess EHR or other administrative systems with the technical capacity to generate information for electronic patient event notifications to send electronic patient event notifications of a patient's admission, discharge, transfer to another health care facility or to another community provider, or combination of patient events at the time of a patient's discharge or transfer. Because these updated CoP requirements overlap with, but are not the same as, the requirements for the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure (which requires transmission of a discharge record with 11 specified elements to the next level care provider within 24 hours of the patient's discharge rather that requiring notification regarding the patient's inpatient stay to be transmitted at discharge), we believe that the adoption of these updated CoPs increases the costs of the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure while decreasing its benefit.

Specifically, we believe that the costs of this measure are increased because facilities to which the new CoPs apply (that is, facilities that possess EHR or other administrative systems with the technical capacity to generate information for electronic patient event notifications as defined in the CoP) could bear increased cost if they separately implement the patient event notifications meeting both the criteria for the updated CoPs and the capacity to share a transition record that meets the requirements of our measure. We noted that the updated CoPs do not include the level of detail regarding data to be transferred at discharge that our Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure requires. While the set of information in the CoP notification policy is a minimal set of information, we believe that it would continue to be appropriate for providers to transmit the transition record that they will continue to be providing to patients under our Transition Record Received by Discharged Patients (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure, we further note that the CoPs referenced in the proposed rule are not an exhaustive list of data transfer requirements. We believe the different requirements regarding both timeliness of notification and contents of notification could lead some providers to send two separate discharge notifications to meet the separate requirements. Further, we believe that the benefits of the measure are reduced because all facilities to which the new CoPs apply will be sending patient discharge information to the next level of care provider as required by the CoPs.

Therefore, the benefits of this measure are reduced because it is less likely to ensure that these facilities provide patient discharge information to the next level care provider, and it is less likely to provide information to help consumers differentiate quality between facilities. While these updated CoPs do not directly address transmission of patient event notifications for facilities that do not possess EHR systems with the capacity to generate information for electronic patient event notifications, Start Printed Page 42652such facilities should continue to transmit data using their existing infrastructure and timelines. Because we believe that the costs are now increased and the benefits are now reduced, we believe that the costs and burdens associated with this chart-abstracted measure outweigh the benefit of its continued use in the IPFQR Program. Therefore, we proposed to remove the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure from the IPFQR Program beginning with the FY 2024 payment determination. We welcomed public comments on our proposal to remove the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure from the IPFQR Program.

We received the following comments on our proposal. Comment. Many commenters supported the removal of the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure. One commenter recommended immediate removal to further reduce burden. Another commenter expressed that this measure was not developed for IPFs and has been difficult to report because the specifications are not appropriate for the setting.

Another commenter further noted that the measure is no longer NQF endorsed. Response. We thank the commenters for their support. We considered removing the measure sooner, but because data are currently being collected to report during CY 2022 to inform the FY 2023 payment determination, we decided to propose removing the measure following that payment determination, therefore we proposed removal for the FY 2024 payment determination. The commenter is correct that the measure is no longer NQF endorsed and is not specified for the IPF setting.

However we continue to believe that this measure is appropriate for the setting. We reiterate that removal of the measure is because we believe that the costs of the measure outweigh its continued benefits in the IPFQR Program. Comment. Some commenters observed that the updated CoPs will not apply to many IPFs, especially freestanding IPFs that are not part of larger healthcare facilities, because IPFs were excluded from Meaningful Use incentives and therefore often do not have electronic data systems capable of meeting the standards in the updated CoPs. Response.

We acknowledge that there are a large number of IPFs that do not possess EHR systems with the technical capacity to generate information for electronic patient event notifications of a patient's admission, discharge, or transfer to another health care facility or to another community provider, or combination of patient events at the time of a patient's discharge or transfer. However, for those IPFs that can meet these requirements, we believe that retaining the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure could be burdensome depending on how facilities implement new requirements. Therefore, while for some IPFs the benefits may outweigh the costs, overall, for the IPFQR Program we believe the costs now outweigh the benefits. We reiterate that for IPFs that do not possess EHR systems with the capacity to generate information for patient event notifications as defined in the CoP regulations set forth at 42 CFR 482.24(d), such facilities should continue to transmit data using their existing infrastructure and timelines. Comment.

A few commenters recommended that CMS retain the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure. Some of these commenters believe that the measure's benefits are more significant than the burden. One commenter recommended that CMS seek consumer input on benefits prior to proposing measures for removal. Response. We reiterate that we do not believe that the benefits of transmitting the transition record within 24 hours of discharge are reduced, or are lower than the costs of reporting.

We believe that given the updates to the CoPs which overlap with this measure the benefits of retaining the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure are no longer sufficient to justify retention. We used the notice and comment rulemaking process to solicit input on measure benefits from all stakeholders, including consumers. After consideration of the public comments, we are finalizing our proposal to remove the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure beginning with the FY 2024 payment determination. D. Removal of the Follow-Up After Hospitalization for Mental Illness (FUH, NQF #0576) Beginning With FY 2024 Payment Determination In the FY 2022 IPF PPS proposed rule we stated that if we finalize adoption of the Follow-Up After Psychiatric Hospitalization measure described in section IV.E.3, we believed that our current measure removal Factor 3 would apply to the existing Follow-Up After Hospitalization for Mental Illness (FUH, NQF #0576) measure (86 FR 19510).

Measure removal Factor 3 applies when a “measure can be replaced by a more broadly applicable measure (across settings or populations) or a measure that is more proximal in time to desired patient outcomes for the particular topics.” We adopted removal factor 3 in the FY 2017 IPPS/LTCH PPS final rule (82 FR 38463 through 38465). The FAPH measure expands the patient population from patients with mental illness to also include patients with primary SUD diagnoses while addressing the same important aspect of care transitions. Because this FAPH measure uses the same methodology to address the same element of care for a broader patient population than the FUH measure, we believe that it is more broadly applicable across populations. Therefore, we proposed to remove the FUH measure under measure removal Factor 3 only if we finalized our proposal to adopt of the FAPH measure. We noted that if we did not adopt the FAPH measure, we would retain the FUH measure because we believe this measure addresses an important clinical topic.

We welcomed public comments on our proposal to remove FUH if we were to adopt FAPH. We received the following comments on our proposal. Comment. Many commenters supported removal of this measure. Some commenters specifically noted that FAPH is more broadly applicable and therefore preferable.

Response. We thank these commenters for their support. Comment. One commenter does not support either the FUH measure or the FAPH measure due to the belief that measures of follow-up after hospitalization are not appropriate for the IPFQR Program and recommended removing the FUH measure but not adopting the FAPH measure. Response.

For the reasons set forth in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50894 through 50895) and the FY 2022 IPF PPS proposed rule in our proposal to adopt the FAPH measure (86 FR 19504 through 19507), we believe that a measure of follow-after Start Printed Page 42653hospitalization is an important concept for the inpatient psychiatric setting. Therefore, we do not believe it would be appropriate to remove the FUH measure without adopting the FAPH measure. Comment. One commenter observed that the FUH measure is an NQF-endorsed measure, while the NQF declined to endorse the FAPH measure. This commenter recommended retaining the FUH measure because it is endorsed.

Response. The commenter is correct that the FUH measure is NQF endorsed and that the NQF declined to endorse the FAPH measure. However, as discussed in the FY 2022 IPF PPS proposed rule, the FUH measure does not apply to as broad a patient population, nor does it allow for follow-up care to be provided by as many provider types (86 FR 19507). Further, for the reasons we discussed in the FY 2022 IPF PPS proposed rule, we believe the exception under section 1886(s)(4)(D)(ii) of the Act applies (86 FR 19507). Because the FAPH measure is a more broadly applicable measure we believe it is appropriate for adoption into the IPFQR Program.

After consideration of the public comments, we are finalizing our proposal to remove Follow-Up After Hospitalization for Mental Illness (FUH, NQF #0576) measure beginning with the FY 2024 payment determination. G. Summary of IPFQR Program Measures 1. IPFQR Program Measures for the FY 2023 Payment Determination and Subsequent Years There are 14 previously finalized measures for the FY 2023 payment determination and subsequent years. In this final rule, we are adopting one measure for the FY 2023 payment determination and subsequent years.

The 15 measures which will be in the program are shown in Table 5. 2. IPFQR Program Measures for the FY 2024 Payment Determination and Subsequent Years There are 14 previously finalized measures for the FY 2024 payment determination and subsequent years. In this final rule, we are adopting one measure for the FY 2023 payment determination and subsequent years. Additionally, we are finalizing our proposal to remove one measure and replace one measure for the FY 2024 payment determination and subsequent years.

We are not finalizing our proposals to remove two measures for the FY 2024 payment determination and subsequent years. The 14 measures which will be in the program for FY 2024 payment determination and subsequent years are shown in Table 6. Start Printed Page 42654 H. Considerations for Future Measure Topics As we have previously indicated, we seek to develop a comprehensive set of quality measures to be available for widespread use for informed decision-making and quality improvement in the IPF setting (79 FR 45974 through 45975). Therefore, through future rulemaking, we intend to propose new measures for development or adoption that will help further our goals of achieving better healthcare and improved health for individuals who obtain inpatient psychiatric services through the widespread dissemination and use of quality information.

In 2017, we introduced the Meaningful Measures Framework as a tool to foster operational efficiencies and reduce costs including collection and reporting burden while producing quality measurement that is more focused on meaningful outcomes (83 FR 38591). As we continue to evolve the Meaningful Measures Framework, we have stated that we intend to better address health care priorities and gaps, emphasize digital quality measurement, and promote patient perspectives.[] As we work to align the IPFQR Program's measure set with these priorities, we have identified the following areas that we believe are important to stakeholders, but which are not covered in the current IPFQR Program measure set. Patient Experience of Care, Functional Outcomes Measurement, and digital measures. As described in the following subsections, we sought public comment on each of these topics and other future measure considerations which stakeholders believe are important. We received the following public comment on measure considerations which stakeholders believe are important.

Comments. Many commenters suggested measure areas that they believe are important for IPFs. These areas were. (1) Suicide evaluation and reduction. (2) patient experience.

(3) patient improvement. (4) clinical processes that impact significant numbers of patients in important clinical domains. (5) patient and workforce safety. (6) caregiver engagement. (7) safety culture.

(8) workforce engagement, (9) immunization status. (10) measures that more rigorously capture data on tobacco and substance use interventions. And (11) discharge planning measures. Some commenters recommended developing improved discharge planning measures. One commenter recommended that CMS ensure that the role of nurse practitioners is included in measures.

One commenter recommend that CMS engage with patients and their caregivers to identify topics they find important. Another commenter recommended that CMS seek industry input on measure considerations. Response. We thank these commenters for this input. We will consider these recommendations as we seek to develop a more comprehensive measure set for the IPFQR Program.

1. Patient Experience of Care Data Collection Instrument When we finalized removal of the Assessment of Patient Experience of Start Printed Page 42655Care attestation measure in the FY 2019 IPF PPS final rule (83 FR 38596) we stated that we believed we had collected sufficient information to inform development of a patient experience of care measure that would capture data on the results of such a survey. In the FY 2020 IPF PPS proposed rule (84 FR 16986 through 16987), we solicited input on how providers had implemented the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey in their facilities. We also sought public comment on other potential surveys that commenters believed would be appropriate to adopt for the IPFQR Program. We received many comments on this subject, and many of these comments expressed that there is not one survey used predominantly across IPFs (84 FR 38467).

Additional commenters expressed concerns that the HCAHPS survey may not be appropriate for the IPF setting because it does not include some of the unique aspects of inpatient psychiatric care including, group therapy, non-physician providers, and involuntary admissions. While we did not solicit public comment on this issue in the FY 2021 IPF PPS proposed rule, we received many comments addressing this issue (85 FR 47043). We continue to seek to identify a minimally burdensome patient experience of care instrument that would be appropriate for the IPF setting. Therefore, in the FY 2022 IPF PPS proposed rule (86 FR 19511 through 19512) we sought public comment on instruments currently in use in the IPF setting, input on whether the HCAHPS survey may be appropriate for this setting, and information on how facilities that currently use the HCAHPS survey have addressed challenges with using this survey within this setting (that is, concerns regarding unique aspects of inpatient psychiatric care). We received the following comments in response to our request.

Comment. Many commenters expressed support for development of a uniform patient experience of care measure because this is a gap in the IPFQR measure set. Many commenters expressed that there is currently no patient experience of care measure in the IPFQR Program and expressed the belief that such a survey could improve provider accountability, show respect for patients, and drive quality improvement. Some commenters observed that patients should be given the opportunity to share their experiences regardless of diagnosis. One commenter observed that evaluations of patient experience of care can be a driver of health equity.

Many commenters shared personal or family experiences in IPFs and indicated that being able to share such experiences in a formal survey would allow patients and caregivers to have a voice, provide valuable feedback, feel respected, provide information for quality improvements, and inform other potential patients. One commenter observed that allowing proxies would be valuable. Some commenters observed that not collecting patient experience of care data leads to the perception that patients' opinions are not valid and expressed the concern that this message may further objectify and traumatize a vulnerable patient population in a stressful and potentially stigmatizing situation (that is, psychiatric hospitalization). Other commenters expressed that not collecting such data normalizes poor treatment of psychiatric patients. Some commenters observed that patients with psychiatric illness are not less likely to be competent to express their experience of care than patients with other acute care needs.

Many commenters recommended that CMS identify a minimum set of items to include in surveys, as opposed to requiring a specific survey. These commenters observed that the net promoter score (NPS) used by the National Health Service in the UK may be a good model to consider. Some commenters observed that many facilities have designed their own surveys tailored to their patient populations (for example, pediatric patients, involuntarily admitted, etc.) and that it would be preferable for these facilities to add questions to meet a minimum set rather than to replace their surveys. Many commenters expressed that they do not support HCAHPS for the IPF setting. These commenters expressed that (1) the HCAHPS was developed for patients with non-psych primary diagnoses and not for behavioral health diagnoses therefore the questions on HCAHPS do not address patients' top concerns regarding IPF care.

(2) the survey protocols which allow for administration of the survey up to 6 weeks post-discharge may negatively impact completion rates due to the transient nature of the patient population. (3) the protocols do not have a web-interface for survey administration nor email or text survey invites. And (4) HCAHPS does not account for involuntary admissions. Some commenters also expressed concern that HCAHPS is not validated, nor has it been through psychometric testing in this setting. Some commenters observed the HCAHPS survey is due for a redesign and observed that CMS could potentially address concerns with the HCAHPS survey as part of the intended redesign.

Other commenters recommended that CMS develop a survey unique to this setting that addresses aspects of care specific to the setting (such as group therapy, treatment by therapists, involuntary admission, medication treatment, consistency of treatment). One commenter recommended that CMS collaborate with AHRQ in survey design and development. Some commenters recommended that CMS ensure proper risk adjustment because patient characteristic can affect patient experience. Some commenters observed that the questions on HCAHPS apply to IPF patients and recommended that CMS test HCAHPS for this setting. A few of these commenters observed that using the same measure across settings would improve behavioral health parity, facility comparison, and reduce burden for facilities that are distinct part units in acute care hospitals that use HCAHPS.

A few commenters expressed concern that excluding psychiatric patients from HCAHPS is discrimination based on a disability which, because of the benefits derived from patient experience surveys, denies patients with psychiatric diagnoses equal treatment. Other commenters observed that minimizing burden is not a factor in establishing patient experience of care measures in other settings and that therefore it should not be a consideration in this setting. Some commenters observed that CMS has requested and received input on this subject for several years and requested a specific plan of action. A few commenters recommended that CMS collaborate with IPFs to determine how to assess patients' experience of care, several commenters recommended that CMS establish a technical expert panel (TEP) with IPF members. One commenter recommended that CMS reintroduce the attestation measure until a solution for assessing patient experience of care is identified.

Response. We thank these commenters for their input. We agree that Patient Experience of Care is a gap in the current IPFQR Program measure set and we agree with commenters that adoption of such a measure would be a meaningful step towards ensuring that patients have a voice regarding the care they receive. We appreciate the input from patients and their caregivers explaining how meaningful such a measure would be for these stakeholders. We intend to use the feedback provided here and in past requests to identify the most appropriate Start Printed Page 42656path forward towards adopting such a measure as soon as possible.

2. Functional Outcomes Instrument for Use in a Patient Reported Outcomes Measure When we introduced the Meaningful Measures Framework, we stated that we wanted to focus on meaningful outcomes (83 FR 38591). As we have assessed the IPFQR Program measure set against the Meaningful Measures Framework, we have identified functional outcomes as a potential gap area in the IPFQR Program's measure set. Therefore, we are evaluating whether a patient reported outcomes measure that assesses functional outcomes, such as global functioning, interpersonal problems, psychotic symptoms, alcohol or drug use, emotional lability, and self-harm, would be an appropriate measure to include in the IPFQR program measure set. If we were to develop such a measure, we would develop a measure that compares a patient's responses to a standardized functional outcomes assessment instrument at admission with the patient's results on the same assessment instrument at discharge.

We sought public comment on the value of such a measure in the IPFQR program measure set, what would be an appropriate functional outcome assessment instrument to use in the potential development of such a measure, and any additional topics or concepts stakeholders believe would be appropriate for patient reported outcomes measures. We received the following comments in response to our request. Comment. Many commenters supported the concept of a functional outcomes measure and recommended preceding development of such a measure with an attestation measure which asks IPFs whether they use an assessment, and if so which one. Some commenters expressed concern regarding outcome measures in this setting.

One commenter specifically observed that short lengths of stay often lead to minimal progress on outcomes. One commenter mentioned the lack of endorsed, public domain outcome measures for this setting. A few commenters recommended that CMS convene a technical expert panel (TEP) on patient reported outcomes for this setting. One commenter uses PHQ-9 to assess outcomes. Another commenter uses BASIS-32 or CABA-Y depending on the patient population.

Response. We thank the commenters for their input and will consider this feedback as we continue to evaluate a functional outcomes measure for this setting. 3. Measures for Electronic Data Reporting As we seek to improve digital measurement across our quality reporting and value-based payment programs, we are considering measures both within and appropriate to adopt for the IPFQR Program measure set that would be appropriate for digital data collection. In our assessment of the current measure set, we identified the Transition Record with Specified Elements Received by Discharged Patients (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure as a potential option for digital data collection.

We sought stakeholder input on the current data collection burden associated with this measure, concerns regarding potential electronic specification and data collection for this measure, and other measures that may be appropriate for electronic data collection, either those currently in the IPFQR Program measure set, or those that we could adopt in the future. We received the following comments in response to our request. Comment. Several commenters supported transitioning the IPFQR Program to electronic reporting. Many commenters observed that IPFs have not received Federal incentives to support EHR adoption and expressed the belief that electronic data reporting without such funding is premature.

Some commenters observed that the Transition Record measure is a complicated measure for e-specification. Some of these commenters noted that this measure requires a large number of data elements, some of which are not available in structured fields. One commenter recommended considering Metabolic Screening or Influenza Immunization for electronic specification as these measures have fewer data elements and those elements are available in structured fields. Another commenter observed that e-specification of existing chart measures often does not provide comparable results. Response.

We thank commenters for this input. We acknowledge that IPFs were not eligible to receive prior Federal incentives to support EHR adoption and will consider this and other input as we seek to transition the IPFQR Program to electronic data reporting. I. Public Display and Review Requirements We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53653 through 53654), the FY 2014 IPPS/LTCH PPS final rule (78 FR 50897 through 50898), and the FY 2017 IPPS/LTCH PPS final rule (81 FR 57248 through 57249) for discussion of our previously finalized public display and review requirements. We did not propose any changes to these requirements.

J. Form, Manner, and Timing of Quality Data Submission for the FY 2022 Payment Determination and Subsequent Years 1. Procedural Requirements for the FY 2023 Payment Determination and Subsequent Years We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53654 through 53655), the FY 2014 IPPS/LTCH PPS final rule (78 FR 50898 through 50899), and the FY 2018 IPPS/LTCH PPS final rule (82 FR 38471 through 38472) for our previously finalized procedural requirements. In this final rule, we are finalizing our proposal to use the term “QualityNet security official” instead of “QualityNet system administrator,” finalizing our proposal to revise § 412.434(b)(3) by replacing the term “QualityNet system administrator” with the term “QualityNet security official,” and clarifying our policy under the previously finalized requirement that hospitals “[i]dentify a QualityNet Administrator who follows the registration process located on the QualityNet website” (77 FR 53654). A.

Updated References to QualityNet System Administrator and to No Longer Require Active Account To Qualify for Payment The previously finalized QualityNet security administrator requirements, including those for setting up a QualityNet account and the associated timelines, are described in the FY 2013 IPPS/LTCH final rule (77 FR 53654). In the FY 2022 IPF PPS proposed rule, we proposed to use the term “QualityNet security official” instead of “QualityNet system administrator” to denote the exercise of authority invested in the role and align with the Hospital Outpatient Quality Reporting Program and other programs (86 FR 19512). The term “security official” would refer to “the individual(s)” who have responsibilities for security and account management requirements for a IPF's QualityNet account. To clarify, this update in terminology will not change the individual's responsibilities or add burden. We invited public comment on our proposal to replace the term “QualityNet system administrator” with “QualityNet security official.”Start Printed Page 42657 We did not receive any public comments on this proposal.

We are finalizing our proposal to replace the term “Quality Net system administrator” with “QualityNet security official” as proposed. Additionally, we proposed to no longer require IPFs to maintain an active QualityNet security official account to qualify for payment. As we reviewed the requirements for the security official role and the basic user [] role to identify the most appropriate language to describe the distinguishing authority invested in the security official role, we recognized that the QualityNet security official is not required for submitting data—a basic user can serve in this role—but remains necessary to set up QualityNet basic user accounts and for security purposes. Therefore, consistent with adopting the security official term to differentiate the unique security authority and responsibilities of the role from the data submission responsibilities of the basic user role, we would continue to require a QualityNet basic user account to meet IPFQR Program requirements, including data submission and administrative requirements, while recommending, but not requiring, that hospitals maintain an active QualityNet security official account. We welcomed public comments on our proposal to no longer require facilities to maintain an active QualityNet security official account to qualify for payment.

We received the following comments in response to our proposal. Comment. Many commenters supported removal of the requirement to have an active QualityNet Security Official for the complete year to meet IPFQR Program requirements and therefore be eligible to receive a full payment update. Response. We thank these commenters for their support.

We note that IPFs that do not meet all IPFQR Program requirements must receive a 2 percent reduction to their annual payment update. After review of the public comments received, we are finalizing our proposal to no longer require facilities to maintain an active QualityNet security official account to qualify for payment as proposed. B. Updated Reference to QualityNet Administrator in Code of Federal Regulations We proposed to revise our regulation at § 412.434(b)(3) by replacing “QualityNet system administrator” with “QualityNet security official.” The term “QualityNet security official” refers to the individual(s) who have responsibilities for security and account management requirements for a hospital's QualityNet account. To clarify, this update in terminology would not change the individual's responsibilities or add burden.

The revised paragraph (b)(3) reads. €œContact information for the inpatient psychiatric facility's chief executive officer and QualityNet security official, including each individual's name, email address, telephone number, and physical mailing address.” We invited public comment on our proposal to replace the term “QualityNet system administrator” with “QualityNet security official” at § 412.434(b)(3). We did not receive any public comments in response to our proposal. We are finalizing our proposal to no longer require facilities to replace the term “QualityNet system administrator” with “QualityNet security official” at § 412.434(b)(3) as proposed. 2.

Data Submission Requirements We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53655 through 53657), the FY 2014 IPPS/LTCH PPS final rule (78 FR 50899 through 50900), and the FY 2018 IPPS/LTCH PPS final rule (82 FR 38472 through 38473) for our previously finalized data submission requirements. In this final rule, we are finalizing our proposal to adopt one measure for the FY 2023 payment determination and subsequent years and one measure for the FY 2024 payment determination and subsequent years. Data submission requirements for each of these measures are described in the following subsections. Additionally, we are finalizing our proposal to adopt patient level data submission for certain chart abstracted measures beginning with data submitted for the FY 2023 payment determination and subsequent years. Details of this proposal are in subsection c.

Of this section. A. Data Submission Requirements for FY 2023 Payment Determination and Subsequent Years The measure we are finalizing for FY 2023 payment determination and subsequent years (the erectile dysfunction treatment Vaccination Coverage Among HCP measure) requires facilities to report data on the number of HCP who have received completed vaccination course of a erectile dysfunction treatment through the CDC's National Healthcare Safety Network (NHSN). Specific details on data submission for this measure can be found in the CDC's Overview of the Healthcare Safety Component, available at https://www.cdc.gov/​nhsn/​PDFs/​slides/​NHSN-Overview-HPS_​Aug2012.pdf. For each CMS Certification Number (CCN), a percentage of the HCP who received a completed treatment course of the erectile dysfunction treatment vaccination would be calculated and publicly reported, so that the public would know what percentage of the HCP have been vaccinated in each IPF.

For the erectile dysfunction treatment HCP Vaccination measure, we proposed that facilities would report the numerator and denominator for the erectile dysfunction treatment HCP vaccination measure to the NHSN for at least one week each month, beginning in October 2021 for the October 1, 2021 through December 31, 2021 reporting period affecting the FY 2023 payment determination. If facilities report more than one week of data in a month, the most recent week's data would be used to calculate the measure. Each quarter, the CDC would calculate a single quarterly result of erectile dysfunction treatment vaccination coverage which would summarize the data submitted by IPFs for each of the three weeks of data submitted over the three-month period. CMS will publicly report the CDC's quarterly summary of erectile dysfunction treatment vaccination coverage for IPFs. We invited public comment on our proposal to require facilities to report the erectile dysfunction treatment HCP vaccination measure.

We did not receive any comments in response to our proposal. We are finalizing our proposal to require facilities to report the erectile dysfunction treatment HCP vaccination measure as proposed. B. Data Submission Requirements for FY 2024 Payment Determination and Subsequent Years Because the Follow-Up After Psychiatric Hospitalization (FAPH) measure would be calculated by CMS using Medicare Fee-for-Service claims, there will be no additional data submission requirements for the FY 2024 payment determination and subsequent years. Therefore, we did not propose any changes to our data submission policies associated with the proposal to adopt this measure.Start Printed Page 42658 c.

Patient-Level Reporting for Certain Chart-Abstracted Measures Beginning With FY 2024 Payment Determination and Subsequent Years In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53655 through 53657), we finalized that IPFs participating in the IPFQR Program must submit data to the Web-Based Measures Tool found in the Inpatient Psychiatric Facility section of the QualityNet website's secure portal between July 1 and August 15 of each year. We noted that the data input forms within the Quality Net secure portal require submission of aggregate data for each separate quarter. In the FY 2014 IPPS/LTCH PPS final rule, we clarified our intent to require that IPFs submit aggregate data on measures on an annual basis via the Web-Based Measures Tool found in the IPF section of the Quality Net website's secure portal and that the forms available require aggregate data for each separate quarter (78 FR 50899 through 50900). In the FY 2016 IPF PPS final rule (80 FR 46716), we updated our data submission requirements to require facilities to report data for chart-abstracted measures to the Web-Based Measures Tool on an aggregate basis by year, rather than by quarter. Additionally, we discontinued the requirement for reporting by age group.

We updated these policies in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38472 through 38473) to change the specification of the submission deadline from exact dates to a 45-day submission period beginning at least 30 days following the end of the data collection period. In the FY 2019 IPF PPS final rule (83 FR 38607), we observed that reporting aggregate measure data increases the possibility of human error, such as making typographical errors while entering data, which cannot be detected by CMS or by data submission systems. We noted that unlike patient-level data reporting, aggregate measure data reporting does not allow for data accuracy validation, thereby lowering the ability to detect error. We stated that we were considering requiring patient-level data reporting (data regarding each patient included in a measure and whether the patient was included in each numerator and denominator of the measure) of IPFQR measure data in the future. We sought public comment on including patient-level data collection in the IPFQR program.

Several commenters expressed support for patient-level data collection, observing that it provides greater confidence in the data's validity and reliability. Other commenters recommended that CMS use a system that has already been tested and used for IPF data reporting or work with IPFs in selecting a system so that any selected system would avoid additional burden. We believe that patient-level data reporting would improve the accuracy of the submitted and publicly reported data without increasing burden. As we considered the current IPFQR measure set, we determined that patient-level reporting of the Hours of Physical Restraint Use (HBIPS-2, NQF #0640) measure and Hours of Seclusion Use (HBIPS-3,[] NQF #0641) measure would be appropriate for the numerators of these measures only, because these measures are calculated with a denominator of 1,000 hours rather than a denominator of patients who meet specific criteria for inclusion in the measure. Therefore, we proposed to require reporting patient-level information for the numerators of these measures only.

For the remainder of the chart-abstracted measures in the IPFQR Program we proposed to require patient-level reporting of the both the numerator and the denominator. Table 7 lists the proposed FY 2023 IPFQR measure set categorized by whether we would require patient-level data submission through the QualityNet secure portal. Start Printed Page 42659 Submission of aggregate data requires facilities to abstract patient-level data, then calculate measure performance prior to submitting data through the QualityNet website's secure portal. For measures for which we would require patient-level data submission, we would allow facilities to submit data using a tool such as the CMS Abstraction &. Reporting Tool (CART).

This is the tool we use in our other quality reporting and value-based purchasing programs, and therefore, we believe that many facilities may already have familiarity with using this tool to abstract and report data. Additionally, the tool has been specifically designed to facilitate data reporting and minimize provider burden. We note that under aggregate data reporting, facilities submit aggregate numerators and aggregate denominators for all measures to CMS in the Hospital Quality Reporting (HQR) system. These aggregate numerators and denominators are generally calculated by manually abstracting the medical record of each included patient using the algorithm, a paper tool, or a vendor abstraction tool. After each required medical record has been abstracted, the numerator and denominator results are added up and submitted as aggregate values in the HQR system.

Under our patient level data reporting proposal, facilities would still manually abstract the medical record using either a vendor abstraction tool or an abstraction tool provided by CMS. The vendor abstraction tool or the CMS tool would then produce an individual XML file for each of the cases abstracted. Instead of submitting the aggregate data, the IPF would log into HQR and upload batches of XML files that contain patient level data for each measure with data from all patients whose records were abstracted, and CMS would calculate the aggregate numerators, aggregate denominators, and measure rates from those XML file submissions. Because facilities must abstract patient-level data as one step in calculating measure results, we do not believe that requiring patient-level data submission would increase provider costs or burden associated with measure submission. Start Printed Page 42660 Because we believe that patient-level data would improve the data accuracy without increasing provider burden, we proposed to adopt patient-level data reporting for numerators only for the Hours of Physical Restraint Use (HBIPS-2, NQF #0640) and the Hours of Seclusion Use (HBIPS-3, NQF #0631) for numerators and denominators for the following 9 chart-abstracted IPFQR Program measures as detailed in Table 7.

Patients Discharged on Multiple Antipsychotic Medications with Appropriate Justification (NQF #0560). Alcohol Use Brief Intervention Provided or Offered and SUB-2a Alcohol Use Brief Intervention. Alcohol and Other Drug Use Disorder Treatment Provided or Offered at Discharge and SUB-3a Alcohol and Other Drug Use Disorder Treatment at Discharge. Tobacco Use Treatment Provided or Offered and TOB-2a Tobacco Use Treatment. Tobacco Use Treatment Provided or Offered at Discharge and TOB-3a Tobacco Use Treatment at Discharge.

Influenza Immunization (NQF #1659). Transition Record with Specified Elements Received by Discharged Patients (discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care). Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or any Other Site of Care). And Screening for Metabolic Disorders. We believe that it is appropriate to transition to patient-level reporting incrementally.

This would allow facilities to become familiar with the data submission systems and to provide feedback on any challenges they face in reporting data to us. Therefore, we proposed to allow voluntary patient-level data submission for the FY 2023 payment determination (that is, data submitted during CY 2022). We note that because participation in patient-level reporting for these chart-abstracted measures would be voluntary for this one-year period, facilities would be able to choose whether to submit measure data in aggregate or at the patient level, and would not face a payment reduction as long as they submit all measure data either at the patient level or in aggregate for each measure for which reporting is required, and as long as they met all other IPFQR Program requirements. Therefore, we are proposed to allow voluntary patient-level reporting prior to requiring such data submission for one year prior to the FY 2024 payment determination. We will ensure that facilities have guidance available through our standard communications channels (that is, listserv announcements, educational webinars, and training material on the QualityNet website).

We also proposed to require patient-level data submission for these chart-abstracted measures for the FY 2024 payment determination (that is, data submitted during CY 2023) and subsequent years. We welcomed comment on our proposals to allow voluntary patient-level data reporting for these chart-abstracted measures for the FY 2023 payment determination and then to require patient-level data reporting for the FY 2024 payment determination and subsequent years. We received the following comments in response to our proposal. Comment. Many commenters supported the adoption of patient-level reporting.

Many of these commenters supported initiating the process with one year of voluntary participation. One commenter observed that having patient level data would help accurately identify trends and improve outcomes and with demographic data could help identify health disparities. One commenter specifically supported the numerator only patient-level reporting for HBIPS-2 and HBIPS-3. One commenter observed that HBIPS-2 was listed twice in the proposed rule (86 FR 19514). Response.

We thank these commenters for their support. Comment. Some commenters recommended that CMS use a more gradual transition to patient-level reporting. One commenter specifically recommended two cycles of voluntary reporting to ensure that the data submission system works properly. Others recommended that CMS provide additional guidance and education, including XML specifications or other reporting templates prior to the voluntary reporting period.

One commenter recommended aligning guidance across programs. One commenter observed that the start date for collecting data for the mandatory reporting period is before the data submission timeframe for the voluntary reporting period. Response. We recognize that IPFs will need additional guidance and education in preparation for patient-level reporting. We will provide templates, guidance, and education and outreach sessions prior to beginning patient level reporting.

We note that, to the extent feasible, we will align guidance across programs. We do not believe that it is necessary to have a longer voluntary reporting period because many IPFs also have experience with these tools already and we have extensive experience with patient-level reporting, both using electronic data reporting systems, and using tools such as the CMS Abstraction &. Reporting Tool (CART) in our other quality reporting programs and intend to provide templates, guidance and education and outreach to IPFs. Comment. Some commenters recommended that CMS not require patient level reporting for measures proposed for removal.

Response. We note that the measure being removed from the IPFQR Program (Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or any Other Site of Care)) is being removed for FY 2024 payment determination and subsequent years. The first year of mandatory patient-level reporting is FY 2024 payment determination. Therefore, this measure will no longer be in the program when patient-level reporting is required. We further note that we are not finalizing our proposals to remove Alcohol Use Brief Intervention Provided or Offered and Alcohol Use Brief Intervention (SUB-2/2a) and Tobacco Use Treatment Provided or Offered and Tobacco Use Treatment (TOB-2/2a).

And therefore these patient-level data reporting will be required for these measures beginning with the FY 2024 payment determination. Comment. Some commenters oppose patient level reporting because of a lack of technology. Some commenters observed that CMS should assist with development of EHRs in the same way they did for acute care hospitals. One commenter observed that patient-level reporting would be burdensome without EHR technology.

Response. We disagree with commenters that EHR technology is necessary for patient level reporting and note that acute care hospitals reported patient-level data for the Hospital IQR Program prior to the introduction of the HITECH act and associated meaningful use incentives. We further note that because IPFs must abstract the same data from patient records regardless of whether they are reporting at the patient-level or in aggregate, we do not believe that submitting patient-level data is more burdensome than aggregate data reporting for providers whether or not they have EHR technology. Comment. One commenter requested clarification on the start date for voluntary patient-level data submission for FY 2023.

This commenter specifically requested clarification on whether that would be for discharges beginning for FY 2023 or CY 2023. Response. The voluntary patient-level data submission period is for FY 2023 payment determination. This applies to the data submitted during CY 2022 Start Printed Page 42661(which affects FY 2023 payment determination). Data submitted during CY 2022 covers discharges that occur during CY 2021.

After review of the public comments we received, we are finalizing our proposal to allow voluntary patient-level data reporting for these chart-abstracted measures for the FY 2023 payment determination and then to require patient-level data reporting for the FY 2024 payment determination and subsequent years as proposed. 3. Considerations for Data Validation Pilot As discussed in section IV.J.4 and in the FY 2019 IPF PPS final rule, we are concerned about the limitations of aggregate data submission (83 FR 28607). One such concern was that the ability to detect error is lower for aggregate measure data reporting than for patient-level data reporting (that is, data regarding each patient included in a measure and whether the patient was included in the numerator and denominator of the measure). In the FY 2022 IPF PPS proposed rule, we noted that if we finalize our proposal to adopt patient-level data requirements, we would be able to adopt a data validation policy for the IPFQR Program in the future (86 FR 19515).

We believe that it would be appropriate to develop such a policy incrementally through adoption of a data validation pilot prior to national implementation of data validation within the IPFQR Program. We sought public input on elements of a potential data validation pilot, for example, the number of measures to validate, number of participating facilities, whether the pilot should be mandatory or voluntary, potential thresholds for determining measure accuracy, or any other policies that commenters believe would be appropriate to include in a data validation pilot or eventual data validation policy. We received the following comments in response to our request. Comment. Many commenters supported the concept of data validation but recommended that CMS ensure a stable and successful patient-level reporting process prior to developing a data validation plan.

One commenter recommended using two measures and 200 hospitals to pilot data validation. Some commenters did not support eventual adoption of validation for the IPFQR program because of the belief that data validation would be burdensome. One commenter observed data validation is only necessary in pay-for-performance programs. Response. We thank these commenters for this input and will take it into consideration if we develop a data validation program for the IPFQR Program.

4. Reporting Requirements for the FY 2022 Payment Determination and Subsequent Years We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53656 through 53657), the FY 2014 IPPS/LTCH PPS final rule (78 FR 50900 through 50901), and the FY 2015 IPF PPS final rule (79 FR 45976 through 45977) for our previously finalized reporting requirements. We did not propose any changes to these policies. 5. Quality Measure Sampling Requirements We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53657 through 53658), the FY 2014 IPPS/LTCH PPS final rule (78 FR 50901 through 50902), the FY 2016 IPF PPS final rule (80 FR 46717 through 46719), and the FY 2019 IPF PPS final rule (83 FR 38607 through 38608) for discussions of our previously finalized sampling policies.

In the FY 2022 IPF PPS proposed rule, we noted that neither the measure we proposed to remove (FUH—NQF #0576) nor the measure we proposed to adopt (FAPH) if we remove the FUH-NQF #0576 are affected by our sampling policies because these are both calculated by CMS using Medicare Fee-for-Service claims and, therefore, apply to all Medicare patients in the denominator (86 FR 19515). Furthermore, the denominator of the erectile dysfunction treatment Healthcare Personnel Vaccination measure we are adopting in this final rule is all healthcare personnel, and therefore, this measure is not eligible for sampling. We did not propose any changes to these policies. 6. Non-Measure Data Collection We refer readers to the FY 2015 IPF PPS final rule (79 FR 45973), the FY 2016 IPF PPS final rule (80 FR 46717), and the FY 2019 IPF PPS final rule (83 FR 38608) for our previously finalized non-measure data collection policies.

We did not propose any changes to these policies. 7. Data Accuracy and Completeness Acknowledgement (DACA) Requirements We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53658) for our previously finalized DACA requirements. We did not propose any changes to these policies. K.

Reconsideration and Appeals Procedures We refer readers to 42 CFR 412.434 for the IPFQR Program's reconsideration and appeals procedures. We did not propose any changes to these policies. L. Extraordinary Circumstances Exceptions (ECE) Policy We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53659 through 53660), the FY 2014 IPPS/LTCH PPS final rule (78 FR 50903), the FY 2015 IPF PPS final rule (79 FR 45978), and the FY 2018 IPPS/LTCH PPS final rule (82 FR 38473 through 38474) for our previously finalized ECE policies. We did not propose any changes to these policies.

V. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), we are required to provide 60-day notice in the Federal Register and solicit public comment before a “collection of information” (as defined under 5 CFR 1320.3(c) of the PRA's implementing regulations) requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency.

The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. In the FY 2022 IPF PPS proposed rule (86 FR 19480) we solicited public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs). As indicated in section V.2.c.(1) of this final rule, we received some comments that generally discuss the burden of reporting through NHSN, but not comments specific to our information collection estimates.

We have not made any changes from what was proposed. A. Final ICRs for the (IPFQR) Program The following final requirement and burden changes will be submitted to OMB for approval under control number 0938-1171 (CMS-10432).Start Printed Page 42662 1. Wage Estimates In the FY 2020 IPF PPS final rule (84 FR 38468), which was the most recent rule in which we adopted updates to the IPFQR Program, we estimated that reporting measures for the IPFQR Program could be accomplished by a Medical Records and Health Information Technician (BLS Occupation Code. 29-2071) with a median hourly wage of $18.83/hr (May 2017).

In May 2019, the U.S. Bureau of Labor Statistics (BLS) revised their $18.83/hr wage figure to $20.50/hr (May 2019).[] In response, we proposed to adjust our cost estimates using the updated median wage rate figure of $20.50/hr., an increase of $1.67/hr. We are finalizing our proposal to use the $20.50/hr wage in this FY 2022 final rule. Under OMB Circular A-76, in calculating direct labor, agencies should not only include salaries and wages, but also “other entitlements” such as fringe benefits and overhead.[] Consistent with our past approach, we continue to calculate the cost of fringe benefits and overhead at 100 percent of the median hourly wage (81 FR 57266). This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and methods of estimating these costs vary widely from study to study.

Therefore, using these assumptions, we estimate an hourly labor cost increase from $37.66/hr ($18.83/hr base salary + $18.83/hr fringe benefits and overhead) to $41.00/hr ($20.50/hr base salary + $20.50/hr fringe benefits and overhead). Table 8 presents these assumptions. 2. ICRs Regarding the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program In subsection 2.a., we restate our currently approved burden estimates. In subsection 2.b., we estimate the adjustments in burden associated with the updated BLS wage rate, our facility estimates, and our case estimates.

In subsection 2.c., we estimate the changes in burden associated with the finalized policies in this rule. Finally, in subsection 2.d., we provide an overview of the total estimated burden. A. Currently Approved Burden For a detailed discussion of the burden for the IPFQR Program requirements that we have previously adopted, we refer readers to the following rules. The FY 2013 IPPS/LTCH PPS final rule (77 FR 53673).

The FY 2014 IPPS/LTCH PPS final rule (78 FR 50964). The FY 2015 IPF PPS final rule (79 FR 45978 through 45980). The FY 2016 IPF PPS final rule (80 FR 46720 through 46721). The FY 2017 IPPS/LTCH PPS final rule (81 FR 57265 through 57266). The FY 2018 IPPS/LTCH PPS final rule (82 FR 38507 through 38508).

The FY 2019 IPF PPS final rule (83 FR 38609 through 38612). And The FY 2020 IPF PPS final rule (84 FR 38468 through 38476). Tables 9, 10, and 11 provide an overview of our currently approved burden. These tables use our previous estimate of $37.66/hr ($18.83/hr base salary plus $18.83/hr fringe benefits and overhead) hourly labor cost. For more information on our currently approved burden estimates, please see Supporting Statement A on the Office of Information and Regulatory Affairs (OIRA) website.169 Start Printed Page 42663 Start Printed Page 42664 Start Printed Page 42665 b.

Final Adjustments in Burden due to Updated Wage, Facility Count, and Case Count Estimates In the FY 2020 IPF PPS final rule (84 FR 38468), which is the most recent rule, that updated the IPFQR Program policies, we estimated that there were 1,679 participating IPFs and that (for measures that require reporting on the entire patient population) these facilities will report on an average of 1,283 cases per facility. In this FY 2022 rule, we are finalizing our proposal to update our facility count and case estimates by using the most recent data available. Specifically, we estimate that there are now approximately 1,634 facilities (a decrease of 45 facilities) and an average of 1,346 cases per facility (an increase of 63 cases per facility). Tables 12, 13, and 14, depict the effects of these updates, as well as the wage rate update to $41.00/hr described in section V.A.1 of the preamble of this final rule, on our previously estimated burden. Start Printed Page 42666 Start Printed Page 42667 Start Printed Page 42668 c.

Changes in Burden due to This Final Rule (1) Updates Due to Final Measure Adoptions In section IV.E of this preamble, we are adopting the following two measures. erectile dysfunction treatment Vaccination Among HCP for FY 2023 Payment Determination and Subsequent Years. And Follow-Up After Psychiatric Hospitalization (FAPH) for FY 2024 Payment Determination and Subsequent Years. We are adopting the erectile dysfunction treatment Vaccination among HCP measure beginning with an initial reporting period from October 1 to December 31, 2021 affecting the FY 2023 payment determination followed by quarterly reporting beginning with the FY 2024 payment determination and subsequent years. IPFs will submit data through the CDC's NHSN.

The NHSN is a secure, internet-based system that is maintained by the CDC and provided free. The CDC does not estimate burden for erectile dysfunction treatment vaccination reporting since the department has been granted a waiver under Section 321 of the National Childhood treatment Injury Act of 1986 (NCVIA).[] Although the burden associated with the erectile dysfunction treatment HCP Vaccination measure is not accounted for due to the NCVIA waiver, the burden is set forth here and will be accounted for by the CDC under OMB control number 0920-1317. Consistent with the CDC's experience of collecting data using the NHSN, we estimate that it will take each IPF on average approximately 1 hour per month to collect data for the erectile dysfunction treatment Vaccination Coverage among HCP measure and enter it into NHSN. We have estimated the time to complete this entire activity, since it could vary based on provider systems and staff availability. This burden is comprised of administrative time and wages.

We believe it would take an Administrative Assistant [] between 45 minutes (0.75 hr) and 1 hour and 15 minutes (1.25 hr) to enter the data into NHSN. For the CY 2021 reporting period (consisting of October 1, 2021 through December 31, 2021) 3 months are required. For the CY 2021 reporting period/FY 2023 payment determination, IPFs would incur an additional burden between 2.25 hours (0.75 hours * 3 responses at 1 response per month) and 3.75 hours (1.25 hours * 3 responses at 1 response per month) per IPF. For all 1,634 IPFs, the total time would range from 3,676.5 hours (2.25 hours * 1,634 IPFs) and 6,127.5 hours (3.75 hours * 1,634 IPFs). Each IPF would incur an estimated cost of between $27.47 (0.75 hour * $36.62/hr) and $45.78 (1.25 hours * $36.62/hr) monthly and between $82.40 (2.25 hours * $36.62/hr) and $137.33 (3.75 hours * $36.62/hr) in total over the CY 2021 reporting period to complete this task.

Thereafter, 12 months of data are required annually. Therefore, IPFs would incur an additional annual burden between 9 hours (0.75 hours/month * 12 months) and 15 hours (1.25 hours/month * 12 months) per IPF and between 14,706 hours (9 hours/IPF * 1,634 IPFs) and 24,510 hours (15 hours/IPF * 1,634 IPFs) for all IPFs. Each IPF would incur an estimated cost of between $329.58 (9 hours × $36.62/hr) and $549.30 annually (15 hours × $36.62/hr). The estimated cost across all 1,634 IPFs would be between $134,641.60 ($82.40/IPF * 1,634 IPFs) and $224,397.22 ($137.33/IPF * 1,634 IPFs) for the CY 2021 reporting period. The estimated cost across all 1,634 IPFs would be between $538,533.72 ($329.58/IPF * 1,634 IPFs) and $897,556.20 ($549.30/IPF * 1,634 IPFs) annually thereafter.

Since the burden falls under the authority of the CDC, we have not added such burden to Table 16. We recognize that many healthcare facilities are also reporting other erectile dysfunction treatment data to HHS. We believe the benefits of requiring IPFs to report data on the erectile dysfunction treatment HCP Vaccination measure to assess whether they are taking steps to limit the spread of Start Printed Page 42669erectile dysfunction treatment among their healthcare workers and to help sustain the ability of IPFs to continue serving their communities throughout the PHE and beyond outweigh the costs of reporting. In our proposed rule, we welcomed comments on the time to collect data and enter it into the NHSN. While we did receive some comments addressing the burden of NHSN reporting, which we address in section IV.E.2 of this rule, we did not receive any public comments on the estimated time to collect and submit such data.

We further note that as described in section IV.E.3 of this preamble, we will calculate the FAPH measure using Medicare Part A and Part B claims that IPFs and other providers (specifically outpatient providers who provide the follow-up care) submit for payment. Since this is a claims-based measure, there is no additional burden outside of submitting the claim. The claim submission is approved by OMB under control number 0938-0050 (CMS-2552-10). This rule does not warrant any changes under that control number. (2) Updates Due to Final Measure Removals In section IV.F.

Of this preamble, we are finalizing our proposals to remove the following two measures for the FY 2024 payment determination and subsequent years. Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care). And FUH—Follow-Up After Hospitalization for Mental Illness (NQF #0576). We note that we are not finalizing our proposals to remove the following two measures. SUB-2—Alcohol Use Brief Intervention Provided or Offered and the subset measure SUB-2a Alcohol Use Brief Intervention Provided.

And TOB-2—Tobacco Use Treatment Provided or Offered and the subset measure TOB-2a Tobacco Use Treatment. For the FY 2024 payment determination, data on CY 2022 performance would be reported during the summer of 2023. Therefore, we are applying the burden reduction that would occur to the FY 2023 burden calculation. One of the measures we are removing (the Timely Transmission of Transition Record (Discharges from an Inpatient Facility to Home/Self Care or Any Other Site of Care) measure) falls under our previously finalized “global sample” (80 FR 46717 through 46718) and, therefore, would require abstraction of 609 records. We estimate that removing this measure would result in a decrease in burden of 152.25 hours per facility (609 cases per facility * 0.25 hours per case), or 248,776.5 hours (152.25 hours/facility × 1,634 facilities) across all IPFs.

Therefore, the decrease in costs for each measure is approximately $6,242.25 per IPF ($41.00/hr * 152.25 hours), or $10,199,836.50 across all IPFs ($6,242.25/facility * 1,634 facilities). We have previously estimated that the FUH (NQF #0576) measure does not have any reporting burden because it is calculated from Medicare FFS claims. Therefore, we do not anticipate a reduction in facility burden associated with the removal of this measure. Table 15 describes our estimated reduction in burden associated with removing these two measures. Start Printed Page 42670 (3) Updates Due to Final Administrative Policies (a) Updates Associated With Final Updated Reference to QualityNet System Administrator In section IV.J.1.a of this preamble, we are finalizing our proposal to use the term “QualityNet security official” instead of “QualityNet system administrator.” Because this final update will not change the individual's responsibilities, we do not believe there would be any changes to the information collection burden as a result of this update.

We also do not believe that removing the requirement for facilities to have an active QualityNet security official account to qualify for payment updates will affect burden because we continue to recommend that facilities maintain an active QualityNet security official account. (b) Updates Associated With Adoption of Patient-Level Reporting for Certain Chart Abstracted Measures In section IV.J.2.c of this preamble, we are adopting patient-level data submission for the 11 chart-abstracted measures currently in the IPFQR Program measure set (for more details on these measures we refer readers to Table 7). Because submission of aggregate data requires facilities to abstract patient-level data, then calculate measure performance prior to submitting data through the QualityNet website's secure portal, facilities must already abstract patient-level data. Therefore, we do not believe that submitting data that facilities must already calculate through a tool that facilities already have experience using will change provider burden. D.

Overall Burden Summary Table 16 summarizes the estimated burden associated with the IPFQR Program. Start Printed Page 42671 Start Printed Page 42672 The total change in burden associated with this final rule (including all updates to wage rate, case counts, facility numbers, and the measures and administrative policies) is a reduction of 287,924 hours and $512,065 from our currently approved burden of 3,381,086 hours and $127,331,707. We refer readers to Table 17 for details. VI. Regulatory Impact Analysis A.

Statement of Need This rule finalizes updates to the prospective payment rates for Medicare inpatient hospital services provided by IPFs for discharges occurring during FY 2022 (October 1, 2021 through September 30, 2022). We are finalizing our proposal to apply the 2016-based IPF market basket increase of 2.7 percent, less the productivity adjustment of 0.7 percentage point as required by 1886(s)(2)(A)(i) of the Act for a final total FY 2022 payment rate update of 2.0 percent. In this final rule, we are finalizing our proposal to update the IPF labor-related share and update the IPF wage index to reflect the FY 2022 hospital inpatient wage index. B. Overall Impact We have examined the impacts of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.

L. 96 354), section 1102(b) of the Social Security Act (the Act), section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C.

804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”). (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency.

(3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s or with economically significant effects ($100 million or more in any 1 year). We estimate that the total impact of these changes for FY 2022 payments compared to FY 2021 payments will be a net increase of approximately $80 million. This reflects an $75 million increase from the update to the payment rates (+$100 million from the 2nd quarter 2021 IGI forecast of the 2016-based IPF market basket of 2.7 percent, and -$25 million for the productivity adjustment of 0.7 percentage point), as well as a $5 million increase as a result of the update to the outlier threshold amount.

Outlier payments are estimated to change from 1.9 percent in FY 2021 to 2.0 percent of total estimated IPF payments in FY 2022. Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined that this rulemaking is “economically significant,” and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act). C. Detailed Economic Analysis In this section, we discuss the historical background of the IPF PPS and the impact of this final rule on the Federal Medicare budget and on IPFs. 1.

Budgetary Impact As discussed in the November 2004 and RY 2007 IPF PPS final rules, we applied a budget neutrality factor to the Federal per diem base rate and ECT payment per treatment to ensure that total estimated payments under the IPF PPS in the implementation period would equal the amount that would have been paid if the IPF PPS had not been implemented. The budget neutrality factor includes the following components. Outlier adjustment, stop-loss adjustment, and the behavioral offset. As discussed in the RY 2009 IPF PPS notice (73 FR 25711), the stop-loss adjustment is no longer applicable under the IPF PPS. As discussed in section III.D.1 of this final rule, we are updating the wage index and labor-related share in a budget neutral manner by applying a wage index budget neutrality factor to the Federal per diem base rate and ECT payment per treatment.

Therefore, the budgetary impact to the Medicare program of this final rule will be due to the market basket update for FY 2022 of 2.7 percent (see section III.A.4 of this final rule) less the productivity adjustment of 0.7 percentage point required by section 1886(s)(2)(A)(i) of the Act and the update to the outlier fixed dollar loss threshold amount. We estimate that the FY 2022 impact will be a net increase of $80 million in payments to IPF providers. This reflects an estimated $75 million increase from the update to the payment rates and a $5 million increase due to the update to the outlier threshold amount to set total Start Printed Page 42673estimated outlier payments at 2.0 percent of total estimated payments in FY 2022. This estimate does not include the implementation of the required 2.0 percentage point reduction of the market basket update factor for any IPF that fails to meet the IPF quality reporting requirements (as discussed in section V.A. Of this final rule).

2. Impact on Providers To show the impact on providers of the changes to the IPF PPS discussed in this final rule, we compare estimated payments under the IPF PPS rates and factors for FY 2022 versus those under FY 2021. We determined the percent change in the estimated FY 2022 IPF PPS payments compared to the estimated FY 2021 IPF PPS payments for each category of IPFs. In addition, for each category of IPFs, we have included the estimated percent change in payments resulting from the update to the outlier fixed dollar loss threshold amount. The updated wage index data including the updated labor-related share.

And the market basket update for FY 2022, as reduced by the productivity adjustment according to section 1886(s)(2)(A)(i) of the Act. Our longstanding methodology uses the best available data as the basis for our estimates of payments. Typically, this is the most recent update of the latest available fiscal year of IPF PPS claims, and for this final rulemaking, that would be the FY 2020 claims. However, as discussed in section III.F.2 of this final rule, the U.S. Healthcare system undertook an unprecedented response to the erectile dysfunction treatment PHE during FY 2020.

Therefore, we considered whether the most recent available year of claims, FY 2020, or the prior year, FY 2019, would be the best for estimating IPF PPS payments in FY 2021 and FY 2022. As discussed in the FY 2022 IPF PPS proposed rule (86 FR 19524 through 19526), we examined the differences between the FY 2019 and FY 2020 claims distributions to better understand the disparity in the estimate of outlier payments as a percentage of total PPS payments between the two years, which was driving the divergent results in our proposed rule impacts between FY 2019 claims and FY 2020 claims. Based on our analysis, we stated that we believe it is likely that the response to the erectile dysfunction treatment PHE in FY 2020 has contributed to increases in estimated outlier payments and to decreases in estimated total PPS payments in the FY 2020 claims. Therefore, we proposed, in contrast to our usual methodology, to use the FY 2019 claims to calculate the outlier fixed dollar loss threshold and wage index budget neutrality factor. We requested comments from stakeholders about likely explanations for the declines in total PPS payments, covered IPF days, and covered IPF stays in FY 2020.

Additionally, we requested comments from stakeholders about likely explanations for the observed fluctuations and overall increases in covered lab charges per claim and per day, which we identified through our analysis. Lastly, we requested comments regarding likely explanations for the increases in estimated cost per stay relative to estimated IPF Federal per diem payment amounts per stay. Comment. We received 1 comment regarding our analysis of FY 2020 claims and 3 comments in support of our proposal to use FY 2019 claims for calculating the outlier fixed dollar loss threshold and wage index budget neutrality factor for FY 2022. One commenter appreciated CMS' recognition of the impact of the erectile dysfunction treatment PHE on providers.

Another commenter agreed with our analysis about the effect of the erectile dysfunction treatment PHE on the FY 2020 claims, stating their belief that FY 2020 cases were heavily impacted by the intensity of the erectile dysfunction treatment cialis, which continues to subside. Response. We appreciate the support from these commenters. As we discuss later in this section of this final rule, based on the results of our final impact analysis, we continue to believe that the FY 2019 claims are the best available data for estimating payments in this FY 2022 final rulemaking, due to the likely impact of the erectile dysfunction treatment PHE on IPF utilization in FY 2020. We will continue to analyze data in order to understand its short-term and long-term effects on IPF utilization.

Final Decision. In light of the comments received and after analyzing more recently updated FY 2020 claims, we are finalizing our proposal to use the FY 2019 claims to calculate the outlier fixed dollar loss threshold and wage index budget neutrality factor. To illustrate the impacts of the FY 2022 changes in this final rule, our analysis presents a side-by-side comparison of payments estimated using FY 2019 claims versus payments estimated using FY 2020 claims. We begin with FY 2019 IPF PPS claims (based on the 2019 MedPAR claims, June 2020 update) and FY 2020 IPF PPS claims (based on the 2020 MedPAR claims, March 2021 update). We estimate FY 2021 IPF PPS payments using these 2019 and 2020 claims, the finalized FY 2021 IPF PPS Federal per diem base rates, and the finalized FY 2021 IPF PPS patient and facility level adjustment factors (as published in the FY 2021 IPF PPS final rule (85 FR 47042 through 47070)).

We then estimate the FY 2021 outlier payments based on these simulated FY 2021 IPF PPS payments using the same methodology as finalized in the FY 2021 IPF PPS final rule (85 FR 47061 through 47062) where total outlier payments are maintained at 2 percent of total estimated FY 2021 IPF PPS payments. Each of the following changes is added incrementally to this baseline model in order for us to isolate the effects of each change. The final update to the outlier fixed dollar loss threshold amount. The final FY 2022 IPF wage index, the final FY 2022 labor-related share, and the final updated COLA factors. The final market basket update for FY 2022 of 2.7 percent less the productivity adjustment of 0.7 percentage point in accordance with section 1886(s)(2)(A)(i) of the Act for a payment rate update of 2.0 percent.

Our final column comparison in Table 18 illustrates the percent change in payments from FY 2021 (that is, October 1, 2020, to September 30, 2021) to FY 2022 (that is, October 1, 2021, to September 30, 2022) including all the payment policy changes in this final rule. For each column, Table 18 presents a side-by-side comparison of the results using FY 2019 and FY 2020 IPF PPS claims. Start Printed Page 42674 Start Printed Page 42675 3. Impact Results Table 18 displays the results of our analysis. The table groups IPFs into the categories listed here based on characteristics provided in the Provider of Services file, the IPF PSF, and cost report data from the Healthcare Cost Report Information System.

Facility Type. Location. Teaching Status Adjustment. Census Region. Size.

The top row of the table shows the overall impact on the 1,519 IPFs included in the analysis for FY 2019 claims or the 1,534 IPFs included in the analysis for FY 2020 claims. In column 2, we present the number of facilities of each type that had information available in the PSF and also had claims in the MedPAR dataset for FY 2019 or FY 2020. The number of providers in each category therefore differs slightly between the two years. In column 3, we present the effects of the update to the outlier fixed dollar loss threshold amount. Based on the FY 2019 claims, we would estimate that IPF outlier payments as a percentage of total IPF payments are 1.9 percent in FY 2021.

Alternatively, based on the FY 2020 claims, we would estimate that IPF outlier payments as a percentage of total IPF payments are 3.1 percent in FY 2021. Thus, we are finalizing our proposal to adjust the outlier threshold amount in this final rule to set total estimated outlier payments equal to 2.0 percent of total payments in FY 2022. Based on the FY 2019 claims, the estimated change in total IPF payments for FY 2022 would include an approximate 0.1 percent increase in payments because we would expect the outlier portion of total payments to increase from approximately 1.9 percent to 2.0 percent. Alternatively, based on the FY 2020 claims, the estimated change in total IPF payments for FY 2022 would include an approximate 1.1 percent decrease in payments because we would expect the outlier portion of total payments to decrease from approximately 3.1 percent to 2.0 percent. The overall impact of the estimated increase or decrease to payments due to updating the outlier fixed dollar loss threshold (as shown in column 3 of Table 18), across all hospital groups, is 0.1 percent based on the FY 2019 claims, or -1.1 percent based on the FY 2020 claims.

Based on the FY 2019 claims, the largest increase in payments due to this change is estimated to be 0.4 percent for teaching IPFs with more than 30 percent interns and residents to beds. Among teaching IPFs, this same provider facility type would experience the largest estimated decrease in payments if we were to instead increase the outlier fixed dollar loss threshold based on the FY 2020 claims distribution. In column 4, we present the effects of the budget-neutral update to the IPF wage index, the Labor-Related Share (LRS), and the final updated COLA factors discussed in section III.D.3. This represents the effect of using the concurrent hospital wage data as discussed in section III.D.1.a of this final rule. That is, the impact represented in this column reflects the final updated COLA factors and the update from the FY 2021 IPF wage index to the final FY 2022 IPF wage index, which includes basing the FY 2022 IPF wage index on the FY 2022 pre-floor, pre-reclassified IPPS hospital wage index data and updating the LRS from 77.3 percent in FY 2021 to 77.2 percent in FY 2022.

We note that there is no projected change in aggregate payments to IPFs, as indicated in the first row of column 4. However, there will be distributional effects among different categories of IPFs. We also note that when comparing the results using Start Printed Page 42676FY 2019 and FY 2020 claims, the distributional effects are very similar. For example, we estimate the largest increase in payments to be 0.6 percent for IPFs in the South Atlantic region, and the largest decrease in payments to be -0.5 percent for IPFs in the East South Central region, based on either the FY 2019 or FY 2020 claims. Finally, column 5 compares the total final changes reflected in this final rule for FY 2022 to the estimates for FY 2021 (without these changes).

The average estimated increase for all IPFs is approximately 2.1 percent based on the FY 2019 claims, or 0.9 percent based on the FY 2020 claims. These estimated net increases include the effects of the 2016-based market basket update of 2.7 percent reduced by the productivity adjustment of 0.7 percentage point, as required by section 1886(s)(2)(A)(i) of the Act. They also include the overall estimated 0.1 percent increase in estimated IPF outlier payments as a percent of total payments from updating the outlier fixed dollar loss threshold amount. In addition, column 5 includes the distributional effects of the final updates to the IPF wage index, the labor-related share, and the final updated COLA factors, whose impacts are displayed in column 4. Based on the FY 2020 claims distribution, the increase to estimated payments due to the market basket update factor are offset in large part for some provider types by the increase to the outlier fixed dollar loss threshold.

In summary, comparing the impact results for the FY 2019 and FY 2020 claims, the largest difference in the results continues to be due to the update to the outlier fixed dollar loss threshold, which is the same result we observed in the FY 2022 IPF PPS proposed rule (86 FR 19524). Estimated outlier payments increased and estimated total PPS payments decreased, when comparing FY 2020 to FY 2019. As a result, we continue to believe that FY 2019 claims, rather than FY 2020 claims, are the best available data for setting the FY 2022 final outlier fixed dollar loss threshold. Furthermore, the distributional effects of the updates presented in column 4 of Table 18 (the budget-neutral update to the IPF wage index, the LRS, and the final updated COLA factors) are very similar when using the FY 2019 or FY 2020 claims data. Therefore, we believe the FY 2019 claims are the best available data for estimating payments in this FY 2022 final rulemaking, and we are finalizing our proposal to use the FY 2019 claims to calculate the outlier fixed dollar loss threshold and wage index budget neutrality factor.

IPF payments are therefore estimated to increase by 2.1 percent in urban areas and 2.2 percent in rural areas based on this finalized policy. Overall, IPFs are estimated to experience a net increase in payments as a result of the updates in this final rule. The largest payment increase is estimated at 2.7 percent for IPFs in the South Atlantic region. 4. Effect on Beneficiaries Under the FY 2022 IPF PPS, IPFs will continue to receive payment based on the average resources consumed by patients for each day.

Our longstanding payment methodology reflects the differences in patient resource use and costs among IPFs, as required under section 124 of the BBRA. We expect that updating IPF PPS rates as finalized in this rule will improve or maintain beneficiary access to high quality care by ensuring that payment rates reflect the best available data on the resources involved in inpatient psychiatric care and the costs of these resources. We continue to expect that paying prospectively for IPF services under the FY 2022 IPF PPS will enhance the efficiency of the Medicare program. As discussed in sections IV.E.2, IV.E.3, and V.A.2.d of this final rule, we expect that additional program measures will improve follow-up for patients with both mental health and substance use disorders and ensure health-care personnel erectile dysfunction treatment vaccinations. We also estimate an annualized estimate of $512,065 reduction in information collection burden as a result our measure removals.

Therefore, we expect that the final updates to the IPFQR program will improve quality for beneficiaries. 5. Effects of Updates to the IPFQR Program As discussed in section V. Of this final rule and in accordance with section 1886(s)(4)(A)(i) of the Act, we will apply a 2 percentage point reduction to the FY 2022 market basket update for IPFs that have failed to comply with the IPFQR Program requirements for FY 2022, including reporting on the required measures. In section V.

Of this final rule, we discuss how the 2 percentage point reduction will be applied. For FY 2021, of the 1,634 IPFs eligible for the IPFQR Program, 43 IPFs (2.6 percent) did not receive the full market basket update because of the IPFQR Program. 31 of these IPFs chose not to participate and 12 did not meet the requirements of the program. We anticipate that even fewer IPFs would receive the reduction for FY 2022 as IPFs become more familiar with the requirements. Thus, we estimate that the IPFQR Program will have a negligible impact on overall IPF payments for FY 2022.

Based on the IPFQR Program policies finalized in this final rule, we estimate a total decrease in burden of 287,924 hours across all IPFs, resulting in a total decrease in information collection burden of $512,065 across all IPFs. As discussed in section VI. Of this final rule, we will attribute the cost savings associated with the proposals to the year in which these savings begin. For the purposes of all the policies in this final rule, that year is FY 2023. Further information on these estimates can be found in section VI.

Of this final rule. We intend to closely monitor the effects of the IPFQR Program on IPFs and help facilitate successful reporting outcomes through ongoing stakeholder education, national trainings, and a technical help desk. 6. Regulatory Review Costs If regulations impose administrative costs on private entities, such as the time needed to read and interpret this final rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will be directly impacted and will review this final rule, we assume that the total number of unique commenters on the most recent IPF proposed rule will be the number of reviewers of this final rule.

For this FY 2022 IPF PPS final rule, the most recent IPF proposed rule was the FY 2022 IPF PPS proposed rule, and we received 898 unique comments on this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this final rule. It is possible that not all commenters reviewed the FY 2021 IPF proposed rule in detail, and it is also possible that some reviewers chose not to comment on that proposed rule. For these reasons, we thought that the number of commenters would be a fair estimate of the number of reviewers who are directly impacted by this final rule. We solicited comments on this assumption.

We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this final rule. Therefore, for the purposes of our estimate, we assume that each reviewer reads approximately 50 percent of this final rule. Using the May, 2020 mean (average) wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this final rule is $114.24 per hour, including overhead and fringe benefits (https://www.bls.gov/​oes/​current/​oes119111.htm). Assuming Start Printed Page 42677an average reading speed of 250 words per minute, we estimate that it would take approximately 128 minutes (2.13 hours) for the staff to review half of this final rule, which is approximately 32,000 words. For each IPF that reviews the final rule, the estimated cost is (2.13 × $114.24) or $243.33.

Therefore, we estimate that the total cost of reviewing this final rule is $ 218,510.34 ($243.33 × 898 reviewers). D. Alternatives Considered The statute does not specify an update strategy for the IPF PPS and is broadly written to give the Secretary discretion in establishing an update methodology. We continue to believe it is appropriate to routinely update the IPF PPS so that it reflects the best available data about differences in patient resource use and costs among IPFs as required by the statute. Therefore, we are finalizing our proposal to update the IPF PPS using the methodology published in the November 2004 IPF PPS final rule.

Applying the 2016-based IPF PPS market basket update for FY 2022 of 2.7 percent, reduced by the statutorily required productivity adjustment of 0.7 percentage point along with the wage index budget neutrality adjustment to update the payment rates. And finalizing a FY 2022 IPF wage index which uses the FY 2022 pre-floor, pre-reclassified IPPS hospital wage index as its basis. As discussed in section VI.C.3 of this final rule, we also considered using FY 2020 claims data to determine the final FY 2022 outlier fixed dollar loss threshold, wage index budget neutrality factor, per diem base rate, and ECT rate. For the reasons discussed in that section, we are finalizing our proposal to use FY 2019 claims data. E.

Accounting Statement As required by OMB Circular A-4 (available at www.whitehouse.gov/​sites/​whitehouse.gov/​files/​omb/​circulars/​A4/​a-4.pdf), in Table 19, we have prepared an accounting statement showing the classification of the expenditures associated with the updates to the IPF wage index and payment rates in this final rule. Table 19 provides our best estimate of the increase in Medicare payments under the IPF PPS as a result of the changes presented in this final rule and based on the data for 1,519 IPFs with data available in the PSF and with claims in our FY 2019 MedPAR claims dataset. Table 19 also includes our best estimate of the cost savings for the 1,634 IPFs eligible for the IPFQR Program. Lastly, Table 19 also includes our best estimate of the costs of reviewing and understanding this final rule. F.

Regulatory Flexibility Act The RFA requires agencies to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most IPFs and most other providers and suppliers are small entities, either by nonprofit status or having revenues of $8 million to $41.5 million or less in any 1 year. Individuals and states are not included in the definition of a small entity. Because we lack data on individual hospital receipts, we cannot determine the number of small proprietary IPFs or the proportion of IPFs' revenue derived from Medicare payments.

Therefore, we assume that all IPFs are considered small entities. The Department of Health and Human Services generally uses a revenue impact of 3 to 5 percent as a significance threshold under the RFA. As shown in Table 18, we estimate that the overall revenue impact of this final rule on all IPFs is to increase estimated Medicare payments by approximately 2.1 percent. As a result, since the estimated impact of this final rule is a net increase in revenue across almost all categories of IPFs, the Secretary has determined that this final rule will have a positive revenue impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. As discussed in section V.C.1 of this final rule, the rates and policies set forth in this final rule will not have an adverse impact on the rural hospitals based on the data of the 239 rural excluded psychiatric units and 60 rural psychiatric hospitals in our database of 1,519 IPFs for which data were available. Therefore, the Secretary has certified that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals. G.

Unfunded Mandate Reform Act (UMRA) Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 Start Printed Page 42678million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158 million. This final rule does not mandate any requirements for state, local, or tribal governments, or for the private sector. This final rule would not impose a mandate that will result in the expenditure by state, local, and Tribal Governments, in the aggregate, or by the private sector, of more than $158 million in any one year. H.

Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This final rule does not impose substantial direct costs on state or local governments or preempt state law. I, Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &. Medicaid Services, approved this document on July 23, 2021. Start List of Subjects Administrative practice and procedureHealth facilitiesMedicarePuerto RicoReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &.

Medicaid Services is amending 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1. The authority citation for part 412 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh.

End Authority Start Amendment Part2. Section 412.402 is amended by adding definitions for “Closure of an IPF”, “Closure of an IPF's residency training program”, and “Displaced resident” in alphabetical order to read as follows. End Amendment Part Definitions. * * * * * Closure of an IPF means closure of a hospital as defined in § 413.79(h)(1)(i) by an IPF meeting the requirements of § 412.404(b) for the purposes of accounting for indirect teaching costs. Closure of an IPF's residency training program means closure of a hospital residency training program as defined in § 413.79(h)(1)(ii) by an IPF meeting the requirements of § 412.404(b) for the purposes of accounting for indirect teaching costs.

* * * * * Displaced resident means a displaced resident as defined in § 413.79(h)(1)(iii) for the purposes of accounting for indirect teaching costs. * * * * * Start Amendment Part3. Section 412.424 is amended by revising paragraph (d)(1)(iii)(F) to read as follows. End Amendment Part Methodology for calculating the Federal per diem payment system. * * * * * (d) * * * (1) * * * (iii) * * * (F) Closure of an IPF or IPF residency training program— (1) Closure of an IPF.

For cost reporting periods beginning on or after July 1, 2011, an IPF may receive a temporary adjustment to its FTE cap to reflect displaced residents added because of another IPF's closure if the IPF meets the following criteria. (i) The IPF is training additional displaced residents from an IPF that closed on or after July 1, 2011. (ii) No later than 60 days after the IPF begins to train the displaced residents, the IPF submits a request to its Medicare contractor for a temporary adjustment to its cap, documents that the IPF is eligible for this temporary adjustment by identifying the displaced residents who have come from the closed IPF and have caused the IPF to exceed its cap, and specifies the length of time the adjustment is needed. (2) Closure of an IPF's residency training program. If an IPF that closes its residency training program on or after July 1, 2011, agrees to temporarily reduce its FTE cap according to the criteria specified in paragraph (d)(1)(iii)(F)(2)(ii) of this section, another IPF(s) may receive a temporary adjustment to its FTE cap to reflect displaced residents added because of the closure of the residency training program if the criteria specified in paragraph (d)(1)(iii)(F)(2)(i) of this section are met.

(i) Receiving IPF(s). For cost reporting periods beginning on or after July 1, 2011, an IPF may receive a temporary adjustment to its FTE cap to reflect displaced residents added because of the closure of another IPF's residency training program if the IPF is training additional displaced residents from the residency training program of an IPF that closed a program. And if no later than 60 days after the IPF begins to train the displaced residents, the IPF submits to its Medicare Contractor a request for a temporary adjustment to its FTE cap, documents that it is eligible for this temporary adjustment by identifying the displaced residents who have come from another IPF's closed program and have caused the IPF to exceed its cap, specifies the length of time the adjustment is needed, and submits to its Medicare contractor a copy of the FTE reduction statement by the hospital that closed its program, as specified in paragraph (d)(1)(iii)(F)(2)(ii) of this section. (ii) IPF that closed its program. An IPF that agrees to train displaced residents who have been displaced by the closure of another IPF's program may receive a temporary FTE cap adjustment only if the hospital with the closed program temporarily reduces its FTE cap based on the FTE of displaced residents in each program year training in the program at the time of the program's closure.

This yearly reduction in the FTE cap will be determined based on the number of those displaced residents who would have been training in the program during that year had the program not closed. No later than 60 days after the displaced residents who were in the closed program begin training at another hospital, the hospital with the closed program must submit to its Medicare contractor a statement signed and dated by its representative that specifies that it agrees to the temporary reduction in its FTE cap to allow the IPF training the displaced residents to obtain a temporary adjustment to its cap. Identifies the displaced residents who were in training at the time of the program's closure. Identifies the IPFs to which the displaced residents are transferring once the program closes. And specifies the reduction for the applicable program years.

* * * * * Start Amendment Part4. Section 412.434 is amended by revising paragraph (b)(3) to read as follows. End Amendment Part Reconsideration and appeals procedures of Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program decisions * * * * * (b) * * * (3) Contact information for the inpatient psychiatric facility's chief executive officer and QualityNet security official, including each individual's name, email address, telephone number, and physical mailing address. * * * * * Start Signature Start Printed Page 42679 Dated. July 27, 2021.

Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information BILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-C[FR Doc. 2021-16336 Filed 7-29-21. 4:15 pm]BILLING CODE 4120-01-P.

Cialis pharmacy checker

	Cialis	Viagra capsules
Prescription is needed	Yes	No
For womens	60mg	Ask your Doctor
Cheapest price	16h	18h
Best way to get	Offline	At walgreens
Duration of action	No	Yes
Can you overdose	RX pharmacy	Canadian Pharmacy
Buy with visa	On the market	Pharmacy

Start Preamble Centers for cialis pharmacy checker click for source Medicare &. Medicaid Services (CMS), HHS. Interim final rule with cialis pharmacy checker comment period.

This interim final rule with comment period revises the requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate in the Medicare and Medicaid programs. These changes are necessary to help protect the health and safety of residents, clients, patients, PACE participants, and staff, and reflect lessons learned to date as a result of the erectile dysfunction treatment public health emergency. The revisions to the requirements establish erectile dysfunction treatment vaccination requirements for staff at the cialis pharmacy checker included Medicare- and Medicaid-certified providers and suppliers.

Effective date. These regulations are effective on November 5, 2021. Implementation dates cialis pharmacy checker.

The regulations included in Phase 1 [42 CFR 416.51(c) through (c)(3)(i) and (c)(3)(iii) through (x), 418.60(d) through (d)(3)(i) and (d)(3)(iii) through (x), 441.151(c) through (c)(3)(i) and (c)(3)(iii) through (x), 460.74(d) through (d)(3)(i) and (d)(3)(iii) through (x), 482.42(g) through (g)(3)(i) and (g)(3)(iii) through (x), 483.80(d)(3)(v) and 483.80(i) through (i)(3)(i) and (i)(3)(iii) through (x), 483.430(f) through (f)(3)(i) and (f)(3)(iii) through (x), 483.460(a)(4)(v), 484.70(d) through (d)(3)(i) and (d)(3)(iii) through (x), 485.58(d)(4), 485.70(n) through (n)(3)(i) and (n)(3)(iii) through (x), 485.640(f) through (f)(3)(i) and (f)(3)(iii) through (x), 485.725(f) through (f)(3)(i) through (f)(3)(iii) through (x), 485.904(c) through (c)(3)(i) and (c)(3)(iii) through (x), 486.525(c) through (c)(3)(i) and (c)(3)(iii) through (x), 491.8(d) through (d)(3)(i) and (d)(3)(iii) through (x), 494.30(b) through (b)((3)(i) and (b)(3)(iii) through (x) must be implemented by December 6, 2021. The regulations included in Phase 2 [42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii), 441.151(c)(3)(ii), 460.74(d)(3)(ii), 482.42(g)(3)(ii), 483.80(i)(3)(ii), 483.430(f)(3)(ii), 484.70(d)(3)(ii), 485.70(n)(3)(ii), 485.640(f)(3)(ii), 485.725(f)(3)(ii), 485.904(c)(3)(ii), 486.525(c)(3)(ii), 491.8(d)(3)(ii), 494.30(b)(3)(ii)] must be implemented by January 4, 2022. Staff who have completed a primary vaccination series by this date are considered to have met these requirements, even if they have not yet cialis pharmacy checker completed the 14-day waiting period required for full vaccination.

Comment date. To be assured consideration, comments must be received at one of the addresses provided below, no later than cialis pharmacy checker 5 p.m. On January 4, 2022.

In commenting, please refer to file code CMS-3415-IFC. Comments, including mass cialis pharmacy checker comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed). 1.

Electronically. You may submit cialis pharmacy checker electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail cialis pharmacy checker. You may mail written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human cialis pharmacy checker Services, Attention. CMS-3415-IFC, P.O.

Box 8016, cialis pharmacy checker Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. Start Printed Page 61556 3.

By express cialis pharmacy checker or overnight mail. You may send written comments to the following address ONLY. Centers for Medicare &.

Medicaid Services, Department of Health and cialis pharmacy checker Human Services, Attention. CMS-3415-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start cialis pharmacy checker Further Info For press inquiries. CMS Office of Communications, Department of Health and Human Services. Email press@cms.hhs.gov cialis pharmacy checker.

For technical inquiries. Contact CMS Center for Clinical Standards and Quality, Department of Health and Human Services, (410) 786-6633. End Further Info End Preamble Start Supplemental Information Inspection of cialis pharmacy checker Public Comments.

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov.

Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments.

We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. I. Background The Centers for Medicare &.

Medicaid Services (CMS) establishes health and safety standards, known as the Conditions of Participation, Conditions for Coverage, or Requirements for Participation for 21 types of providers and suppliers, ranging from hospitals to hospices and rural health clinics to long term care facilities (including skilled nursing facilities and nursing facilities, collectively known as nursing homes). Most of these providers and suppliers are regulated by this interim final rule with comment period (IFC). Specifically, this IFC directly regulates the following providers and suppliers, listed in the numerical order of the relevant CFR sections being revised in this rule.

Ambulatory Surgical Centers (ASCs) (§ 416.51) Hospices (§ 418.60) Psychiatric residential treatment facilities (PRTFs) (§ 441.151) Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74) Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children's hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) (§ 482.42) Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80) Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430) Home Health Agencies (HHAs) (§ 484.70) Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70) Critical Access Hospitals (CAHs) (§ 485.640) Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725) Community Mental Health Centers (CMHCs) (§ 485.904) Home Infusion Therapy (HIT) suppliers (§ 486.525) Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8) End-Stage Renal Disease (ESRD) Facilities (§ 494.30) This IFC directly applies only to the Medicare- and Medicaid-certified providers and suppliers listed above. It does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS. Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC.

We have not included requirements for Organ Procurement Organizations or Portable X-Ray suppliers, as these only provide services under contract to other health care entities and would thus be indirectly subject to the vaccination requirements of this rule, as discussed in section II.A.1. Of this rule. We note that entities not covered by this rule may still be subject to other State or Federal erectile dysfunction treatment vaccination requirements, such as those issued by Occupational Safety and Health Administration (OSHA) for certain employers.

Currently, the United States (U.S.) is responding to a public health emergency (PHE) of respiratory disease caused by a novel erectile dysfunction that has now been detected in more than 190 countries internationally, all 50 States, the District of Columbia, and all U.S. Territories. The cialis has been named “severe acute respiratory syndrome erectile dysfunction 2” (erectile dysfunction), and the disease it causes has been named “erectile dysfunction disease 2019” (erectile dysfunction treatment).

On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the outbreak a “Public Health Emergency of International Concern.” On January 31, 2020, pursuant to section 319 of the Public Health Service Act (PHSA) (42 U.S.C. 247d), the Secretary of the Department of Health and Human Services (Secretary) determined that a PHE exists for the U.S. (hereafter referred to as the PHE for erectile dysfunction treatment).

On March 11, 2020, the WHO publicly declared erectile dysfunction treatment a cialis. On March 13, 2020, the President of the United States declared the erectile dysfunction treatment cialis a national emergency. The January 31, 2020 determination that a PHE for erectile dysfunction treatment exists and has existed since January 27, 2020, lasted for 90 days, and was renewed on April 21, 2020.

July 23, 2020. October 2, 2020. January 7, 2021.

April 15, 2021. July 19, 2021. And October 18, 2021.

Pursuant to section 319 of the PHSA, the determination that a PHE continues to exist may be renewed at the end of each 90-day period.[] erectile dysfunction treatment has had significant negative health effects—on individuals, communities, and the nation as a whole. Consequences for individuals who have erectile dysfunction treatment include morbidity, hospitalization, mortality, and post-erectile dysfunction treatment conditions (also known as long erectile dysfunction treatment). As of mid-October 2021, over 44 million erectile dysfunction treatment cases, 3 million new erectile dysfunction treatment related hospitalizations, and 720,000 erectile dysfunction treatment deaths have been reported in the U.S.[] Indeed, erectile dysfunction treatment has overtaken the 1918 influenza cialis as the deadliest disease in American history.[] Start Printed Page 61557 Given recent estimates of undiagnosed s and under-reported deaths, these figures likely underestimate the full impact.[] In addition, these figures fail to capture the significant, detrimental effects of post-acute illness, including nervous system and neurocognitive disorders, cardiovascular disorders, gastrointestinal disorders, and signs and symptoms related to poor general well-being, including malaise, fatigue, musculoskeletal pain, and reduced quality of life.

Recent estimates suggest more than half of erectile dysfunction treatment survivors experienced post-acute sequelae of erectile dysfunction treatment 6 months after recovery.[] The individual and public health ramifications of erectile dysfunction treatment also extend beyond the direct effects of erectile dysfunction treatment s. Several studies have demonstrated significant mortality increases in 2020, beyond those attributable to erectile dysfunction treatment deaths. In some percentage, this could be a problem of misattribution (for example, the cause of death was indicated as “heart disease” but in fact the true cause was undiagnosed erectile dysfunction treatment), but some proportion are also believed to reflect increases in other causes of death that are sensitive to decreased access to care and/or increased mental/emotional strain.

One paper quantifies the net impact (direct and indirect effects) of the cialis on the U.S. Population during 2020 using three metrics. Excess deaths, life expectancy, and total years of life lost.

The findings indicate there were 375,235 excess deaths, with 83 percent attributable to direct, and 17 percent attributable to indirect effects of erectile dysfunction treatment. The decrease in life expectancy was 1.67 years, translating to a reversion of 14 years in historical life expectancy gains. Total years of life lost in 2020 was 7,362,555 across the U.S.

(73 percent directly attributable, 27 percent indirectly attributable to erectile dysfunction treatment), with considerable heterogeneity at the individual State level.[] One analysis published in February 2021 found that Black and Latino Americans have experienced a disproportionate burden of erectile dysfunction treatment morbidity and mortality, reflecting persistent structural inequalities that increase risk of exposure to erectile dysfunction treatment and mortality risk for those infected. The authors projected that erectile dysfunction treatment would reduce U.S. Life expectancy in 2020 by 1.13 years.

Furthermore, the estimated reduction for Black and Latino populations is 3-4 times the estimate for the White population, reversing over 10 years of progress in reducing the gaps in life expectancy between Black and White populations and reducing the Latino mortality advantage by over 70 percent. The study further expects that reductions in life expectancy may persist because of continued erectile dysfunction treatment mortality and term health, social, and economic impacts of the cialis.[] Because erectile dysfunction, the cialis that causes erectile dysfunction treatment disease, is highly transmissible,[] Centers for Disease Control and Prevention (CDC) has recommended, and CMS reiterated, that health care providers and suppliers implement robust prevention and control practices, including source control measures, physical distancing, universal use of personal protective equipment (PPE), erectile dysfunction testing, environmental controls, and patient isolation or quarantine.[] Available evidence suggests these prevention and control practices have been highly effective when implemented correctly and consistently.[]  [] Studies have also shown, however, that consistent adherence to recommended prevention and control practices can prove challenging—and those lapses can place patients in jeopardy.[] A retrospective analysis from England found up to 1 in 6 erectile dysfunction s among hospitalized patients with erectile dysfunction treatment in England during the first 6 months of the cialis could be attributed to healthcare-associated transmission.[] In outbreaks reported from acute care settings in the U.S. Following implementation of universal masking, unmasked exposures to other health care workers were frequently implicated.[] A retrospective cohort study of health care staff behaviors, exposures, and cases between June and December 2020 in a large health system found more employees were exposed via coworkers than patients—and secondary cases among employees typically followed unmasked interactions with infected colleagues (for example, convening in breakrooms without proper source control).[] The same study found that cases of health care worker associated with patient exposures could often be attributed to failure to adhere to PPE requirements (for example, eye protection).

Past experience with influenza, and available evidence, suggest that vaccination of health care staff offers a critical layer of protection against healthcare-associated erectile dysfunction treatment (HA-erectile dysfunction treatment). For example, evidence has shown that influenza vaccination of health care staff is associated with declines in nosocomial influenza in hospitalized patients,[] and among nursing home residents. 25 26 27 28 29 30 31Start Printed Page 61558 As a result, CDC, the Society for Healthcare Epidemiology of America, and others recommend—and a number of states require— annual influenza vaccination for health care staff.[] In addition to preventing morbidity and mortality associated with erectile dysfunction treatment, currently approved or authorized treatments also demonstrate effectiveness against asymptomatic erectile dysfunction .

A recent study of health care workers in 8 states found that, between December 14, 2020 through August 14, 2021, full vaccination with erectile dysfunction treatments was 80 percent effective in preventing RT-PCR-confirmed erectile dysfunction among frontline workers.[] Emerging evidence also suggests that vaccinated people who become infected with the erectile dysfunction Delta variant have potential to be less infectious than infected unvaccinated people, thus decreasing transmission risk.[] For example, in a study of breakthrough s among health care workers in the Netherlands, erectile dysfunction infectious cialis shedding was lower among vaccinated individuals with breakthrough s than among unvaccinated individuals with primary s.[] Fewer infected staff and lower transmissibility equates to fewer opportunities for transmission to patients, and emerging evidence indicates this is the case. The best data come from long term care facilities, as early implementation of national reporting requirements have resulted in a comprehensive, longitudinal, high quality data set. Data from CDC's National Healthcare Safety Network (NHSN) have shown that case rates among LTC facility residents are higher in facilities with lower vaccination coverage among staff.

Specifically, residents of LTC facilities in which vaccination coverage of staff is 75 percent or lower experience higher rates of preventable erectile dysfunction treatment.[] Several articles published in CDC's Morbidity and Mortality Weekly Reports (MMWRs) regarding nursing home outbreaks have also linked the spread of erectile dysfunction treatment to unvaccinated health care workers and stressed that maintaining a high vaccination rate is important for reducing transmission.[] There is also some published evidence from other settings that suggest similar dynamics can be expected in other health care delivery settings. For example, a recent analysis from Yale New Haven Hospital (YNHH) found health care units with at least 1 inpatient case of HA-erectile dysfunction treatment had lower staff vaccination rates.[] Similarly, a small study in Israel demonstrated that transmission of erectile dysfunction treatment was linked to unvaccinated persons. In 37 cases, patients for whom data were available regarding the source of , the suspected source was an unvaccinated person.

In 21 patients (57 percent), this person was a household member. In 11 cases (30 percent), the suspected source was an unvaccinated fellow health care worker or patient.[] While similarly comprehensive data are not available for all Medicare- and Medicaid-certified provider types, the available evidence for ongoing healthcare-associated erectile dysfunction treatment transmission risk is sufficiently alarming in and of itself to compel CMS to take action. The threats that unvaccinated staff pose to patients are not, however, limited to erectile dysfunction transmission.

Unvaccinated staff jeopardize patient access to recommended medical care and services, and these additional risks to patient health and safety further warrant CMS action. Fear of exposure to and with erectile dysfunction treatment from unvaccinated health care staff can lead patients to themselves forgo seeking medically necessary care. In a small but informative qualitative study of 33 home health care workers in New York City, one of the key themes to emerge from interviews with those workers was a keen recognition that “providing care to patients placed them in a unique position with respect to erectile dysfunction treatment transmission.

About transmitting the cialis to [their clients].” They also noted that care for home bound clients might involve other health care staff, and they worried about “transmitting erectile dysfunction treatment. . .

To one another.” [] Anecdotal evidence suggests health care consumers have drawn similar conclusions—and this, too, has implications for overall health and welfare in health care settings. For example, CMS has received anecdotal reports suggesting individuals in care are refusing care from unvaccinated staff, limiting the extent to which providers and suppliers can effectively meet the health care needs of their patients and residents. Further, nationwide there are reports of individuals avoiding or forgoing health care due to fears of contracting erectile dysfunction treatment from health care workers.[] While avoidance of necessary care appears to have abated somewhat since the first months of the erectile dysfunction treatment cialis, it remains an area of concern for many individuals.[] Because Start Printed Page 61559 unvaccinated staff are at greater risk for , they also present a threat to health care operations—absenteeism due to erectile dysfunction treatment-related exposures or illness can create staffing shortages that disrupt patient access to recommended care.

Data suggest the current surge in erectile dysfunction treatment cases associated with emergence of the Delta variant has exacerbated health care staffing shortages. For example, 1 in 5 hospitals report that they are currently experiencing a critical staffing shortage.[] Through the week ending September 19, 2021, approximately 23 percent of LTC facilities reported a shortage in nursing aides. 21 percent reported a shortage of nurses.

And 10 to 12 percent reported shortages in other clinical and non-clinical staff categories.[] And while some studies suggest overall staffing levels (as defined by nurse hours per resident day) have been relatively stable, this appears to be associated with concurrent decreases in patient demand (for example, resident census in nursing homes)—decreases that have ramifications for patient access to recommended and medically appropriate services.[] Over half (58 percent) of nursing homes participating in a recent survey conducted by the American Health Care Association and National Center for Assisted Living (AHCA/NCAL) indicated that they are limiting new admissions due to staffing shortages.[] Similarly, hospital administrators responding to an OIG pulse survey conducted during February 22-26, 2021, reported difficulty discharging erectile dysfunction treatment patients to post-acute facilities (for example, nursing homes, rehabilitation hospitals, and hospice facilities) following the acute stage of the patient's illness. These delays in discharge affected available bed space throughout the hospital (for example, creating bottlenecks in ICUs and EDs) and delayed patient access to specialized post-acute care (such as rehabilitation).[] The drivers of this staffing crisis are multi-factorial. They include.

Longstanding shortages in certain fields and professions. Prolonged physical, mental, and emotional stress and trauma associated with responding to the ongoing PHE. And competing personal or professional obligations (such as child care) or opportunities (for example, new careers).

But illnesses and deaths associated with erectile dysfunction treatment are exacerbating staffing shortages across the health care system. Over half a million erectile dysfunction treatment cases and 1,900 deaths among health care staff have been reported to CDC since the start of the PHE.[] When submitting case-level erectile dysfunction treatment reports, State and territorial jurisdictions may identify whether individuals are or are not health care workers. Since health care worker status has only been reported for a minority of cases (approximately 18 percent), these numbers are likely gross underestimates of true burden in this population.

erectile dysfunction treatment case rates among staff have also grown in tandem with broader national incidence trends since the emergence of the Delta variant. For example, as of mid-September 2021, erectile dysfunction treatment cases among LTC facility and ESRD facility staff have increased by over 1400 percent and 850 percent, respectively, since their lows in June 2021.[] Similarly, the number of cases among staff for whom case-level data were reported by State and territorial jurisdictions to CDC increased by nearly 600 percent between June and August 2021.[] Vaccination is thus a powerful tool for protecting health and safety of patients, and, with the emergence and spread of the highly transmissible Delta variant, it has been an increasingly critical one to address the extraordinary strain the erectile dysfunction treatment cialis continues to place on the U.S. Health system.

While erectile dysfunction treatment cases, hospitalizations, and deaths declined over the first 6 months of 2021, the emergence of the Delta variant reversed these trends.[] Between late June 2021 and September 2021, daily cases of erectile dysfunction treatment increased over 1200 percent. New hospital admissions, over 600 percent. And daily deaths, by nearly 800 percent.[] Available data also continue to suggest that the majority of erectile dysfunction treatment cases and hospitalizations are occurring among individuals who are not fully vaccinated.

In a recent study of reported erectile dysfunction treatment cases, hospitalizations, and deaths in 13 U.S. Jurisdictions that routinely link case surveillance and immunization registry data, CDC found that unvaccinated individuals accounted for over 85 percent of all hospitalizations in the period between June and July 2021, when Delta became the predominant circulating variant.[] Unfortunately, health care staff vaccination rates remain too low in too many health care facilities and regions. For example, national erectile dysfunction treatment vaccination rates for LTC facility, hospital, and ESRD facility staff are 67 percent, 64 percent, and 60 percent, respectively.

Moreover, these averages obscure sizable regional differences. LTC facility staff vaccination rates range from lows of 56 percent to highs of over 90 percent, depending upon the State. Similar patterns hold for ESRD facility and hospital staff.[] Given slow but steady increases in vaccination rates among staff working in these settings over time,[] widespread availability of treatments, and targeted efforts to facilitate treatment access like the Federal Retail Pharmacy program,[] treatment hesitancy,[] rather than other factors (for example, staff turnover) is likely to account for suboptimal staff vaccination rates.

While a significant number of health care staff have been infected with erectile dysfunction,[] evidence indicates their -induced immunity, also called “natural immunity,” is not equivalent to receiving the erectile dysfunction treatment. Available evidence indicates that erectile dysfunction treatments offer better protection than -induced immunity alone and that treatments, even after prior , help prevent Start Printed Page 61560 res.[] Consequently, CDC recommends that all people be vaccinated, regardless of their history of symptomatic or asymptomatic erectile dysfunction .[] Further, the risks of unvaccinated health care staff may disproportionately impact communities who experience social risk factors and populations described under Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, including members of racial and ethnic communities. Individuals with disabilities.

Individuals with limited English proficiency. Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ+) individuals. Individuals living in rural areas.

And others adversely affected by persistent poverty or inequality. CDC data show that across the U.S., physicians and advanced practice providers have significantly higher vaccination rates than aides.[] Among aides, lower vaccination coverage was observed in those facilities located in zip codes where communities experience greater social risk factors. The finding that vaccination coverage among aides was lower among those working at LTC facilities located in zip code areas with higher social vulnerability is consistent with an earlier analysis of overall county-level vaccination coverage by indices of social vulnerability.[] CDC notes that together, these data suggest that vaccination disparities among job categories are likely to mirror social disparities as well as disparities in surrounding communities.

In addition, nurses and aides who may have the most patient contact have the lowest rates of vaccination coverage among health care staff. erectile dysfunction treatment outbreaks have occurred in LTC facilities in which residents were highly vaccinated, but transmission occurred through unvaccinated staff members.[] These findings have implications regarding occupational safety and health outcome equity—national data indicates that aides in nursing homes are disproportionately women and members of racial and ethnic communities with lower hourly wages than physicians and advance practice clinicians,[] and are also more likely to have underlying conditions that put them at risk for adverse outcomes from erectile dysfunction treatment.[] Ensuring full vaccination coverage across health care settings is critical to addressing these disparities among health care workers, particularly those from communities who experience social risk, and to equitably protecting individuals CMS serves from unnecessary and significant harm associated with erectile dysfunction treatment cases and the ongoing cialis. It is essential to reduce the transmission and spread of erectile dysfunction treatment, and vaccination is central to any multi-pronged approach for reducing health system burden, safeguarding health care workers and the people they serve, and ending the erectile dysfunction treatment cialis.

Currently FDA-approved and FDA-authorized treatments in use in the U.S. Are both safe and highly effective at protecting vaccinated people against symptomatic and severe erectile dysfunction treatment.[] Higher rates of vaccination, especially in health care settings, will contribute to a reduction in the transmission of erectile dysfunction and associated morbidity and mortality across providers and communities, contributing to maintaining and increasing the amount of healthy and productive health care staff, and reducing risks to patients, resident, clients, and PACE program participants. In light of our responsibility to protect the health and safety of individuals providing and receiving care and services from for Medicare- and Medicaid-certified providers and suppliers, and CMS's broad statutory authority to establish health and safety regulations, we are compelled to require staff vaccinations for erectile dysfunction treatment in these settings.

For these reasons, we are issuing this IFC based on these authorities and in accordance with established rule making processes. Specifically, sections 1102 and 1871 of the Social Security Act (the Act) grant the Secretary of Health and Human Services authority to make and publish such rules and regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is charged under this Act and as may be necessary to carry out the administration of the insurance programs under the Act. The discussions of the provider- and supplier-specific provisions in section II.

Of this IFC set out the specific authorities for each provider or supplier type. Provider and supplier compliance with the Federal rules issued under these statutory authorities are mandatory for participation in the Medicare and Medicaid programs. To the extent a court may enjoin any part of the rule, the Department intends that other provisions or parts of provisions should remain in effect.

Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. A. Regulatory Responses to the PHE 1.

Waivers CMS and other Federal agencies have taken many actions and exercised extensive regulatory flexibilities to help health care providers contain the spread of erectile dysfunction. When the President declares a national emergency under the National Emergencies Act or an emergency or disaster under the Stafford Act, CMS is empowered to take proactive steps by waiving certain CMS regulations, as authorized under section 1135 of the Act (“1135 waivers”). CMS may also grant certain flexibilities to skilled nursing facilities (SNFs) under Medicare, as authorized separately under section 1812(f) of the Act (“1812(f) flexibilities”).

The 1135 waivers and 1812(f) flexibilities allowed us to rapidly expand efforts to help control the spread of erectile dysfunction. We have issued PHE waivers for most Medicare- and Medicaid-certified Start Printed Page 61561 providers and suppliers, with the goal of supporting each facility's operational flexibility while preserving health and safety and core health care functions. 2.

Rulemaking Since the onset of the PHE, we have issued five IFCs to help contain the spread of erectile dysfunction. On April 6, 2020, we issued an IFC (Medicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency (85 FR 19230 through 19292), which established that certain requirements for face-to-face/in-person encounters will not apply during the PHE for erectile dysfunction treatment effective for claims with dates of service on or after March 1, 2020, and for the duration of the PHE for erectile dysfunction treatment.

On May 8, 2020, we issued a second IFC (Medicare and Medicaid Programs, Basic Health Program, and Exchanges. Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (85 FR 27550 through 27629)) (“May 8, 2020 erectile dysfunction treatment IFC”). This second IFC contained additional information on changes Medicare made to existing regulations to provide flexibilities for Medicare beneficiaries and providers to respond effectively to the PHE for erectile dysfunction treatment.

On September 2, 2020, we issued a third IFC (Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act. Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency (85 FR 54820 through 54874)) (“September 2, 2020 erectile dysfunction treatment IFC”), that included new requirements for hospitals and CAHs to report data in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for erectile dysfunction treatment. On November 6, 2020, we issued a fourth IFC (Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency (85 FR 71142 through 71205)).

This IFC discussed CMS's implementation of section 3713 of the erectile dysfunction Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for erectile dysfunction Disease 2019 (erectile dysfunction treatment) treatment and its administration. This IFC implemented requirements in the CARES Act that providers of erectile dysfunction treatment diagnostic tests make public their cash prices for those tests and established an enforcement scheme to enforce those requirements. This IFC also established an add-on payment for cases involving the use of new erectile dysfunction treatments under the Medicare Inpatient Prospective Payment System (IPPS).

Most recently, on May 13, 2021, we issued the fifth IFC (Medicare and Medicaid Programs. erectile dysfunction treatment Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff (86 FR 26306)) (“May 13, 2021 erectile dysfunction treatment IFC”), that revised the control requirements that LTC facilities and ICFs-IID must meet to participate in the Medicare and Medicaid programs. OSHA has also engaged in rulemaking in response to the PHE for erectile dysfunction treatment.

On June 21, 2021, OSHA issued the erectile dysfunction treatment Healthcare Emergency Temporary Standard (ETS) at 29 CFR 1910 subpart U (86 FR 32376) to protect health care and health care support service workers from occupational exposure to erectile dysfunction treatment.[] Health care employers covered by the ETS must develop and implement a erectile dysfunction treatment plan for each workplace to identify and control erectile dysfunction treatment hazards in the workplace and implement requirements to reduce transmission of erectile dysfunction in their workplaces related to the following. (1) Patient screening and management, (2) standard and transmission-based precautions, (3) personal protective equipment (including facemasks, and respirators), (4) controls for aerosol-generating procedures performed on persons with suspected or confirmed erectile dysfunction treatment, (5) physical distancing, (6) physical barriers, (7) cleaning and dis, (8) ventilation, (9) health screening and medical management, (10) training, (11) anti-retaliation, (12) recordkeeping, and, (13) reporting. In addition, the ETS requires covered employers to support erectile dysfunction treatment vaccination for each employee by providing reasonable time and paid leave for employees to receive treatments and recover from side effects.

The ETS generally applies to all workplace settings where any employee provides health care services or health care support services. However, because the ETS targets settings where care is provided for individuals with known or suspected erectile dysfunction treatment, the rule contains several exceptions. The ETS does not apply to.

(1) Provision of first aid by any employee who is not a licensed health care provider, (2) dispensing of prescriptions by pharmacists in retail settings, (3) non-hospital ambulatory care settings where all non-employees are screened prior to entry, and people with suspected or confirmed erectile dysfunction treatment are not permitted to enter, (4) well-defined hospital ambulatory care settings where all employees are fully vaccinated, all non-employees are screened prior to entry, and people with suspected or confirmed erectile dysfunction treatment are not permitted to enter, (5) home health care settings where all employees are fully vaccinated, all non-employees are screened prior to entry, and people with suspected or confirmed erectile dysfunction treatment are not present, (6) health care support services not performed in a health care setting (for example, offsite laundry, off-site medical billing), and (7) telehealth services performed outside of a setting where direct patient care occurs. Furthermore, in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed erectile dysfunction treatment will be present, the ETS exempts fully vaccinated workers from masking, distancing, and barrier requirements. Moreover, the ETS requires employers to immediately remove employees from the workplace if they (1) have tested positive for erectile dysfunction treatment, (2) have been diagnosed with erectile dysfunction treatment by a licensed health care provider, (3) have been advised by a licensed health care provider that they are suspected to have erectile dysfunction treatment, or (4) are experiencing certain symptoms (defined as either loss of taste and/or smell with no other explanation, or fever of at least 100.4 degrees Fahrenheit and new unexplained cough associated with shortness of breath).

Employers must also immediately remove an employee who was not wearing a respirator and any other required PPE and had been in close contact with a erectile dysfunction treatment positive person in the workplace. However, removal from the workplace due to instances of close contact exposure in the workplace is not required for asymptomatic employees who either had erectile dysfunction treatment and recovered with the last 3 months, or have been fully vaccinated (that is, 2 or more weeks have passed since the final dose). Complementary to the OSHA ETS, this interim final rule requires certain providers and suppliers participating in Medicare and Medicaid programs to ensure staff are fully vaccinated for erectile dysfunction treatment, unless exempt, because vaccination of staff is necessary for the health and safety of individuals to whom care and services are furnished.

Health care staff are at high risk for erectile dysfunction exposure, the cialis that causes erectile dysfunction treatment, due to interactions with patients and individuals in the Start Printed Page 61562 community.[] Receiving a complete primary vaccination series reduces the risk of erectile dysfunction treatment by 90 percent or more thereby inhibiting the spread of disease to others.[] Furthermore, a erectile dysfunction treatment vaccination requirement reduces the likelihood of medical removal of health care staff from the workplace, as required by the OSHA erectile dysfunction treatment Healthcare ETS. This is yet another way in which this interim final rule protects the individuals who receive services from the providers and suppliers to whom the rule applies by minimizing unpredictable disruptions to operations and care. OSHA is the Federal agency responsible for setting and enforcing standards to ensure safe and healthy working conditions for workers.

The erectile dysfunction treatment Healthcare ETS addresses protections for health care and health care support service workers from the grave danger of erectile dysfunction treatment exposure in certain workplaces. CMS is the Federal agency responsible for establishing health and safety regulations for Medicare- and Medicaid-certified providers and suppliers. Hence, we are establishing a final rule requiring erectile dysfunction treatment vaccination of staff to safeguard the health and safety of patients, residents, clients, and PACE program participants who receive care and services from those providers and suppliers.

Providers and suppliers may be covered by both the OSHA ETS and our interim final rule. Although the requirements and purpose of each regulation text are different, they are complementary. B.

erectile dysfunction treatment Development and Approval FDA analysis has shown that all of the currently approved or authorized treatments are safe and CDC reports that over 408 million doses of the treatment have been given through October 18, 2021.[] Bringing a new treatment to the public involves many steps, including treatment development, clinical trials, and U.S. Food and Drug Administration (FDA) authorization or approval. While erectile dysfunction treatments were developed rapidly, all steps have been taken to ensure their safety and effectiveness.

Scientists have been working for many years to develop treatments against erectile dysfunctiones, such as those that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). erectile dysfunction, the cialis that causes erectile dysfunction treatment, is related to these other erectile dysfunctiones and the knowledge that was gained through past research on erectile dysfunction treatments helped speed up the initial development of the current erectile dysfunction treatments. After initial development, treatments go through three phases of clinical trials to make sure they are safe and effective.

For other treatments routinely used in the U.S., the three phases of clinical trials are performed one at a time. During the development of erectile dysfunction treatments, these phases overlapped to speed up the process so the treatments could be used as quickly as possible to control the cialis. No trial phases were skipped.[] All erectile dysfunction treatments currently licensed (approved) [] or authorized for use in the U.S.

Were tested in clinical trials involving tens of thousands of people. FDA evaluated all of the information submitted to it in requests for Emergency Use Authorization (EUA) for the authorized erectile dysfunction treatments and, for the Comirnaty erectile dysfunction treatment, in a Biologics License Application (the conventional path to FDA approval of a treatment). FDA determined that these treatments meet FDA's standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization and licensure, as applicable.

The clinical trials included participants of different races, ethnicities, and ages, including adults over the age of 65.[] Because erectile dysfunction treatment continues to be widespread, researchers have been able to conduct treatment clinical trials more quickly than if the disease were less common. Side effects following vaccination are dependent on the specific treatment that an individual receives, and the most common include pain, redness, and swelling at the injection site, tiredness, headache, muscle pain, nausea, vomiting, fever, and chills.[] After a review of all available information, the Advisory Committee on Immunization Practices (ACIP) and CDC have concluded the lifesaving benefits of erectile dysfunction treatment vaccination outweigh the risks or possible side effects.[] The erectile dysfunction treatments currently licensed or authorized for use in the U.S. Are generally administered as either a single dose or a two-dose series given at least 21 or 28 days apart.

Following completion of that primary series, a subsequent dose or doses may be recommended for one of two purposes. In the first instance, an additional dose of treatment is administered when the immune response following a primary treatment series is likely to be insufficient. In other words, the additional dose augments the original primary series.

Currently, the EUA for the Moderna mRNA erectile dysfunction treatment has been amended to include the use of a third primary series dose (that is, “additional dose”) in certain immunocompromised individuals 18 years of age or older. Similarly, the EUA for the Pfizer BioNTech mRNA erectile dysfunction treatment has been amended to include the use of an additional, or third primary series, dose in certain immunocompromised individuals 12 years of age and older. In the second instance, a booster dose of treatment is administered when the initial immune response to a primary treatment series is likely to have waned over time.

In other words, although an adequate immune response occurred after the primary treatment series, over time, immunity decreases.[] On September 22, 2021, the FDA amended the EUA for the Pfizer BioNTech mRNA erectile dysfunction treatment to allow for use of a single booster dose in certain individuals, to be administered at least 6 months after completion of the primary series. Specifically, this booster dose is authorized for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe erectile dysfunction treatment, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to erectile dysfunction puts them at high risk of serious complications of erectile dysfunction treatment including severe erectile dysfunction treatment. 90 Start Printed Page 61563 Throughout this rule, we will use the terms “additional dose” and “booster” to differentiate between the two use cases outlined above.

Every person who receives a erectile dysfunction treatment receives a vaccination record card noting which treatment and the dose that was received. treatment materials specific to each treatment are located on CDC [] and FDA [] websites. CDC has posted a collection of informational toolkits for specific communities and settings at https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​toolkits.html.

These toolkits provide staff, facility administrators, clinical leadership, caregivers, and health care consumers with information and resources. While we are not requiring participation, we encourage staff who use smartphones to use CDC's smartphone-based tool called “v-safe After Vaccination Health Checker” (v-safe) [] to self-report on one's health after receiving a erectile dysfunction treatment. V-safe is a program that differs from the treatment Adverse Event Reporting System (VAERS), which we discuss in section I.C.

Of this rule. Individuals may report adverse reactions to a erectile dysfunction treatment to either program. Enrollment in v-safe allows any participating treatment recipient to directly and efficiently report to CDC how they are feeling after receiving a specific treatment, including any problems or adverse reactions.

When an individual receives the treatment, they should also receive a v-safe information sheet telling them how to enroll in v-safe or they can register at http://www.vsafe.cdc.gov. Individuals who enroll will receive regular text messages providing links to surveys where they can report any problems or adverse reactions after receiving a erectile dysfunction treatment, as well as receive “check-ins,” and reminders for a second dose if applicable.[] We note again that participation in v-safe is not mandatory, and further that staff participation and any health information provided is not traced to or shared with employers. Based on current CDC guidance,[] individuals are considered fully vaccinated for erectile dysfunction treatment 14 days after receipt of either a single-dose treatment (Janssen/Johnson &.

Johnson) or the second dose of a two-dose primary vaccination series (Pfizer-BioNTech/Comirnaty or Moderna). This guidance can also be applied to erectile dysfunction treatments listed for emergency use by the World Health Organization (WHO) and some treatments used in erectile dysfunction treatment clinical trials conducted in the U.S. These circumstances are addressed in more detail in section I.C.

Of this IFC. To improve immune response for those individuals with moderately to severely compromised immune systems who receive the Pfizer-BioNTech treatment, Comirnaty, or Moderna treatment, the CDC advises an additional (third) dose of an mRNA erectile dysfunction treatment after completing the primary vaccination series.[] In addition, certain individuals who received the Pfizer-BioNTech erectile dysfunction treatment may receive a booster dose at least 6 months after completing the primary vaccination series.[] This IFC requires Medicare- and Medicaid-certified providers and suppliers to ensure that staff are fully vaccinated for erectile dysfunction treatment, unless the individual is exempted. Consistent with CDC guidance, we consider staff fully vaccinated if it has been 2 or more weeks since they completed a primary vaccination series for erectile dysfunction treatment.

We define completion of a primary vaccination series as having received a single-dose treatment or all doses of a multi-dose treatment. Currently, CDC guidance does not include either the additional (third) dose of an mRNA erectile dysfunction treatment for individuals with moderately or severely immunosuppression or the booster dose for certain individuals who received the Pfizer-BioNTech treatment in their definition of fully vaccinated.[] Therefore, for purposes of this IFC, neither additional (third) doses nor booster doses are required. The OSHA Emergency Temporary Standard for Healthcare discussed in section I.A.2.

Of this IFC also defines fully vaccinated in accordance with CDC guidance. Hence, definitions of fully vaccinated are consistent among the requirements in these regulations. C.

Administration of treatments Outside the U.S., Listed for Emergency Use by the WHO, Heterologous Primary Series, and Clinical Trials We expect the majority of staff will likely receive a erectile dysfunction treatment authorized for emergency use by the FDA or licensed by the FDA. Currently, this would include the authorized Pfizer-BioNTech (interchangeable with the licensed Comirnaty treatment made by Pfizer for BioNTech), Moderna, and Janssen (Johnson &. Johnson) erectile dysfunction treatments.

We also expect erectile dysfunction treatment administration will likely occur within the U.S. For the majority of staff. However, some staff may receive FDA approved or authorized erectile dysfunction treatments outside of the U.S., treatments administered outside of the U.S.

That are listed by the WHO for emergency use that are not approved or authorized by the FDA, or treatments during their participation in a clinical trial at a site in the U.S. For these staff, we defer to CDC guidance for erectile dysfunction treatment vaccination briefly discussed here. For more information, providers and suppliers should consult the CDC website at https://www.cdc.gov/​treatments/​erectile dysfunction treatment/​clinical-considerations/​erectile dysfunction treatment-treatments-us.html#.

Repeat treatment doses are not recommended by CDC for individuals who previously completed the primary series of a treatment approved or authorized by the FDA, even if administration of the treatment occurred outside of the U.S. Individuals who receive a erectile dysfunction treatment for which two doses are required to complete the primary vaccination series should adhere as closely as possible to the recommended intervals. Following completion of their second dose, certain individuals who had received the Pfizer-BioNTech erectile dysfunction treatment may receive a booster dose at least 6 months after completion of the primary vaccination series.

Moderately to severely immunocompromised individuals who have received 2 doses of an mRNA treatment may receive a third dose at least 28 days after the second dose. treatment administration may occur inside or outside of the U.S. Furthermore, the WHO maintains a list of erectile dysfunction treatments for emergency use.[] The CDC advises that doses of an FDA approved or authorized erectile dysfunction treatment are not recommended for individuals who have previously completed the primary series of a treatment listed for emergency use by Start Printed Page 61564 the WHO.

For those who have not completed the primary series of a treatment listed for emergency use by the WHO, they may receive an FDA approved or authorized erectile dysfunction treatment vaccination series. In addition, individuals who have received a erectile dysfunction treatment that is neither approved nor authorized by the FDA, nor listed on the WHO emergency use list, may receive an FDA approved or authorized vaccination series. The CDC guidelines recommend at least 28 days between administration of an FDA licensed or authorized treatment, a non-FDA approved or authorized treatment, and a treatment listed by WHO for emergency use.

For the completion of the primary series of erectile dysfunction treatment vaccination, individuals should generally avoid using heterologous treatments—meaning receiving doses of different treatments—to complete a primary erectile dysfunction treatment vaccination series. Nevertheless, CDC does recognize that, in certain situations (for example, when the treatment product given for the first dose cannot be determined or is no longer available), a different treatment may be used to complete the primary erectile dysfunction treatment vaccination series. Accordingly, staff may be considered compliant with the requirements within this regulation if they have received any combination of two doses of a treatment licensed or authorized by the FDA or listed on the WHO emergency use list as part of a two-dose series.

Of note, the recommended interval between the first and second doses of a treatment licensed or authorized by FDA, or listed on the WHO emergency use list, varies by treatment type. For interpretation of vaccination records and compliance with this rule, people who received a heterologous primary series (with any combination of FDA-authorized, FDA-approved, or WHO EUL-listed products) can be considered fully vaccinated if the second dose in a two dose heterologous series must have been received no earlier than 17 days (21 days with a 4 day grace period) after the first dose.[] Because the science and clinical recommendations are evolving rapidly, we refer individuals to CDC's Interim Public Health Recommendations for Fully Vaccinated People for additional details. Some staff may receive erectile dysfunction treatments due to their participation in a clinical trial at a site in the U.S.

Repeat treatment doses are not recommended by CDC for participants in a clinical trial who previously completed the primary series of a treatment approved or authorized by FDA, or listed for emergency use by the WHO. Likewise, for individuals who participated in a clinical trial at a site in the U.S. And received the full series of an “active” treatment candidate (not placebo) and “treatment efficacy has been independently confirmed (for example, by a data and safety monitoring board),” CDC does not recommend repeat doses.[] D.

FDA Emergency Use Authorization (EUA) and Licensure of erectile dysfunction treatments The FDA provides scientific and regulatory advice to treatment developers and undertakes a rigorous evaluation of the scientific information it receives from all phases of clinical trials. Such evaluation continues after a treatment has been licensed by FDA or authorized for emergency use. On August 23, 2021, FDA licensed the first erectile dysfunction treatment.

The treatment had been known as the Pfizer-BioNTech erectile dysfunction treatment, and will now be marketed as Comirnaty, for the prevention of erectile dysfunction treatment in individuals 16 years of age and older.[] The treatment continues to be available in the U.S. Under EUA, including for individuals 12 through 15 years of age. This EUA has been amended to allow for the use of a third dose for certain immunocompromised individuals 12 years of age and older.

This EUA has also been amended to allow for use of a single booster dose in certain individuals. FDA has issued EUAs for two additional treatments for the prevention of erectile dysfunction treatment, one for the Moderna erectile dysfunction treatment (December 18, 2020) (indicated for use in individuals 18 years of age and older), and the other for Janssen (Johnson &. Johnson) erectile dysfunction treatment (February 27, 2021) (indicated for use in individuals 18 years of age and older).

The EUA for the Moderna erectile dysfunction treatment has been amended to allow for the use of a third dose in certain immunocompromised individuals. Package inserts and fact sheets for health care providers administering erectile dysfunction treatments are available for each licensed and authorized treatment from the FDA.[] Section 564 of the Federal Food, Drug, and Cosmetic Act authorizes FDA to issue EUAs. An EUA is a mechanism to facilitate the availability and use of medical countermeasures, including treatments, during public health emergencies, such as the current erectile dysfunction treatment cialis.

FDA may authorize certain unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.[] The safety of the approved and authorized erectile dysfunction treatments is closely monitored. VAERS is a safety and monitoring system that can be used by anyone to report adverse events after treatments. For erectile dysfunction treatments, vaccination providers and licensed and authorized treatment manufacturers, must report select adverse events to VAERS following receipt of erectile dysfunction treatments (including serious adverse events, cases of multisystem inflammatory syndrome (MIS), and erectile dysfunction treatment cases that result in hospitalization or death).[] Providers also must adhere to any revised safety reporting requirements.

FDA's website includes letters of authorization and fact sheets and these documents should be checked for any updates that may occur. Other adverse events following vaccination may also be reported to VAERS. Additionally, adverse events are also monitored through electronic health record- and claims-based systems (through CDC's treatment Safety Datalink and FDA's Biologics Effectiveness and Safety System (BEST)).

FDA is closely monitoring the safety of the erectile dysfunction treatments both authorized for emergency use and licensed use. Vaccination providers are responsible for mandatory reporting to VAERS of certain adverse events as listed on the Health Care Provider Fact Sheets for the authorized erectile dysfunction treatments and for Comirnaty. treatment safety is critically important for all vaccination programs.

Side effects following vaccinations often include swelling, redness, and pain at the injection site. Flu-like symptoms. Headache.

And nausea. All typically of Start Printed Page 61565 short duration.[] Serious adverse reactions also have been reported following erectile dysfunction treatments. However, they are rare.[] For example, it is estimated that anaphylaxis following the mRNA erectile dysfunction treatments occurs in 2-5 individuals per million vaccinated ( https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​safety/​adverse-events.html ).

For these individuals, another shot of an mRNA erectile dysfunction treatment is not recommended,[] and they should discuss receiving a different type of erectile dysfunction treatment with their health care practitioner.[] Other rare serious adverse reactions that have been reported to occur following erectile dysfunction treatments include thrombosis with thrombocytopenia syndrome (TTS) following the Janssen erectile dysfunction treatment and myocarditis and/or pericarditis following the mRNA erectile dysfunction treatments ( https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​safety/​adverse-events.html ). In the face of the erectile dysfunction treatment cialis, global researchers were able to build upon decades of treatment development, research, and use to produce safe treatments that have been highly effective in protecting individuals from erectile dysfunction treatment. From December 14, 2020, through October 12, 2021, over 403 million doses of erectile dysfunction treatment have been administered in the U.S.

Https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​safety/​safety-of-treatments.html. €œCDC recommends everyone 12 years and older get vaccinated as soon as possible to help protect against erectile dysfunction treatment and the related, potentially severe complications that can occur.” [] They state that the “potential benefits of erectile dysfunction treatment vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis.” [] E. erectile dysfunction treatment Effectiveness erectile dysfunction treatments currently approved or authorized by FDA are highly effective in preventing serious outcomes of erectile dysfunction treatment, including severe disease, hospitalization, and death.[] Moreover, available evidence suggests that these treatments offer protection against known variants, including the Delta variant (B.1.617.2), particularly against hospitalization and death.[] Furthermore, a recent study found that, between December 14, 2020, and August 14, 2021, full vaccination with erectile dysfunction treatments was 80 percent effective in preventing RT-PCR-confirmed erectile dysfunction among frontline workers, further affirming the highly protective benefit of full vaccination up to and through the 2021 summer erectile dysfunction treatment cialis waves in the U.S.[] While treatment effectiveness point estimates did decline over the course of the study as the Delta variant became predominant, the protection afforded by vaccination remained significant, underscoring the continued importance and benefits of erectile dysfunction treatment vaccination.[] Like most treatments, erectile dysfunction treatments are not 100 percent effective in preventing erectile dysfunction treatment.

Consequently, some “breakthrough” cases are expected and, as the number of people who have completed a primary vaccination series and are considered fully vaccinated for erectile dysfunction treatment increases, breakthrough erectile dysfunction treatment cases will also increase commensurately. However, the risk of developing erectile dysfunction treatment, including severe illness, remains much higher for unvaccinated than vaccinated people. Vaccinated people with a breakthrough erectile dysfunction treatment case are less likely to develop serious disease, be hospitalized, and die than those who are unvaccinated and get erectile dysfunction treatment.[] The combined protections offered by vaccination and ongoing implementation of other control measures, especially source control (masking),[] remain critical to safeguarding patients, residents, clients, PACE program participants, and staff.

F. Stakeholder Response to treatments There has been growing national interest in erectile dysfunction treatment vaccination requirements among health care workers, including requests from various national health care stakeholders. In a joint statement released on July 26, 2021, more than 50 health care professional societies and organizations called for all health care employers and facilities to require that all their staff be vaccinated against erectile dysfunction treatment.

Included as signatories to this statement were organizations representing millions of workers throughout the U.S. Health care industry, including those representing doctors, nurses, pharmacists, physician assistants, public health workers, and epidemiologists as well as long term care, home care, and hospice workers.[] In addition, a large nonprofit, nonpartisan organization focused on empowering Americans over the age of 50 recently called on all LTC facilities to require vaccinations for staff and residents.[] A non-profit organization dedicated to advancing dignity in aging issued a statement in support of erectile dysfunction treatment mandates for staff and residents of long-term care facilities.[] In a policy statement dated July 21, 2021, a large long term care association, “strongly urges all residents and staff in long-term care to get vaccinated” and “supports requiring treatments for current and new staff in long-term care and other healthcare settings. erectile dysfunction treatment vaccination should be a condition of employment for all healthcare workers, including employees, contract staff and others, with appropriate exemptions for those with medical reasons or as specified by federal or state law.” [] The statement further notes that “erectile dysfunction treatments are safe.

. . Effective for preventing , and especially severe illness and death [and] reduce the risk of spreading the cialis.” [] Moreover, the Start Printed Page 61566 statement observes that “the erectile dysfunction treatment crisis exacerbated long-standing workforce challenges, and some in the sector fear that a treatment mandate could lead to worker resignations.

But providers that have required staff vaccination have reported high treatment accepted by previously hesitant care professionals, and many providers report that when staff vaccination rates are high, they become providers of choice in their communities.” [] A non-profit federation of affiliated State health organizations, representing more than 14,000 non-profit and for-profit nursing homes, assisted living communities, and facilities for individuals with disabilities expressed support for all health care “strongly urges the vaccination of all health care personnel” to “protect all residents, staff and others in our communities from the known and substantial risks of erectile dysfunction treatment.” They also assert that “erectile dysfunction treatments protect health care personnel when working both in health care facilities and in the community,” and “provide strong protection against workers unintentionally carrying the disease to work and spreading it to patients and peers.” [] Numerous health systems and individual health care employers across the country have implemented treatment mandates independent of this rule. For example, a health care system that is the largest private employer in Delaware with more than 14,000 employees, a health care system and academic medical center with over 26,000 employees in Texas, and an integrated health system in North Carolina with more than 35,000 employees, to name a few, have all preceded this rule with their own vaccination requirements, achieving rates of at least 97 percent vaccination among their staff.[] These organizations are already realizing the effectiveness of strong vaccination policies. Despite the successes of these organizations in increasing levels of staff vaccination, there remains an inconsistent patchwork of requirements and laws that is only effective at local levels and has not successfully raised staff vaccination rates nationwide.

Patients, residents, clients, PACE program participants, and staff alike are not adequately protected from erectile dysfunction treatment. In September 2021, Jeffrey Zients, the White House erectile dysfunction Response Coordinator, noted that “vaccination requirements work. .

. And are the best path out of the cialis.” He further noted that vaccination requirements are not only key to the nation's path out of the cialis, but also accelerate our economic recovery, keeping workplaces safer, and helping to curb the spread of the cialis in communities, and boost job growth, the labor market, and the nation's overall economy. G.

Populations at Higher Risk for Severe erectile dysfunction treatment Outcomes erectile dysfunction treatment can affect anyone, with symptoms ranging from mild (s not requiring hospitalization) to very severe (requiring intensive care in a hospital). Nonetheless, studies have shown that erectile dysfunction treatment does not affect all population groups equally.[] Age remains a strong risk factor for severe erectile dysfunction treatment outcomes. Approximately 54.1 million people aged 65 years or older reside in the U.S..

This age group accounts for more than 80 percent of U.S. erectile dysfunction treatment related deaths. Residents of LTC facilities make up less than 1 percent of the U.S.

Population but accounted for more than 35 percent of all erectile dysfunction treatment deaths in the first 12 months of the cialis.[] Additionally, adults of any age with certain underlying medical conditions are at increased risk for severe illness from erectile dysfunction treatment. These include, but are not limited to, cancer, cerebrovascular disease, diabetes (Type 1 and Type 2), chronic kidney disease, COPD, heart conditions, Down Syndrome, obesity, substance use, smoking status, and pregnancy.[] The risk of severe erectile dysfunction treatment also increases as the number of underlying medical conditions increases in a particular individual. A confluence of structural and epidemiological factors has also contributed to disparate risk for erectile dysfunction treatment , severe illness, and death in certain populations.

For example, evidence clearly indicates that racial and ethnic minority groups, including Black and Hispanic or Latino, have disproportionately higher hospitalization rates among every age group, including children aged younger than 18 years.[] These same groups are disproportionately affected by long-standing inequities in social determinants of health, such as poverty and health care access, that increase risk of severe illness and death from erectile dysfunction treatment.[] People with intellectual disabilities are more likely to have chronic health conditions, live in congregate settings, and face more barriers to health care. Some studies suggest they are also more likely to get erectile dysfunction treatment and have worse outcomes.[] Finally, rural communities often have a higher proportion of residents who live with comorbidities or disabilities and are aged ≥65 years. These risk factors, combined with more limited access to health care facilities with intensive care capabilities, place rural dwellers at increased risk for erectile dysfunction treatment-associated morbidity and mortality.[] In addition, CDC data indicate that vaccination rates are disproportionately low among nurses and health care aides in long term care settings, particularly in communities that experience social risk factors.

Further, CDC data indicate that nurses and aides in these settings are more likely to be members of racial and ethnic minority communities.[] This disparity in vaccination coverage may be exacerbating existing and emerging disparities related to erectile dysfunction treatment cases and impact, placing members of communities who experience social risk factors—those in rural areas with geographic and transportation barriers to care, those in low income areas who experience persistent poverty and inequality, and others—at further increased risk for erectile dysfunction treatment-associated morbidity and mortality.[] This disparity may be, in part, reduced by the potential positive health equity impacts of requiring staff vaccination among provider and supplier types subject to rulemaking. Start Printed Page 61567 CMS believes that the developing data about staff vaccination rates and rates of erectile dysfunction treatment cases, and the urgent need to address erectile dysfunction treatment-related staffing shortages that are disrupting patient access to care, provides strong justification as to the need to issue this IFC requiring staff vaccination for most provider and supplier types over which we have authority. H.

CMS Authority To Require Staff Vaccinations CMS has broad statutory authority to establish health and safety regulations, which includes authority to establish vaccination requirements. Section 1102 of the Act grants the Secretary of Health and Human Services authority to make and publish such rules and regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is charged under the Act. Section 1871 of the Act grants the Secretary of Health and Human Services authority to prescribe regulations as may be necessary to carry out the administration of the Medicare program.

The statutory authorities to establish health and safety requirements for erectile dysfunction treatment vaccination for each provider and supplier included in this IFC are listed in Table 1 and discussed in sections II.C. Through II.F. Of this IFC.

Section 1863 of the Act provides that “[i]n carrying out his functions, relating to determination of conditions of participation by providers. . .

The Secretary shall consult with appropriate State agencies and recognized national listing or accrediting bodies[.]” For the reasons discussed in greater detail throughout sections I. Through III. This IFC, the erectile dysfunction treatment cialis presents a serious and continuing threat to the health and to the lives of staff of health care facilities and of consumers of these providers' and suppliers' services.

This threat has grown to be particularly severe since the emergence of the Delta variant. Any delay in the implementation of this rule would result in additional deaths and serious illnesses among health care staff and consumers, further exacerbating the newly-arising, and ongoing, strain on the capacity of health care facilities to serve the public. For these reasons, in carrying out the agency's functions relating to determination of conditions of participation, conditions for coverage, and requirements, we intend to engage in consultations with appropriate State agencies and listing or accrediting bodies following the issuance of this rule, and toward that end we invite these entities to submit comments on this IFC.

Given the urgent need to issue this rule, however, we do not believe that there exists an entity with which it would be appropriate to engage in these consultations in advance of issuing this IFC, nor do we understand the statute to impose a temporal requirement to do so in advance of the issuance of this rule. We have not previously required any vaccinations, but we recognize that many health care workers already comply with employer or State government vaccination requirements (for example, influenza, and hepatitis B cialis (HBV)) and invasive employer or State government-required screening procedures (such as tuberculosis screening). Further, most of these Start Printed Page 61568 individuals met State and local vaccination requirements in order to attend school to complete the necessary education to qualify for health care positions.

In addition to these longstanding vaccination requirements, many now require vaccination for erectile dysfunction treatment as well. However, studies on annual seasonal influenza treatment uptake consistently show that half of health care workers may resist seasonal influenza vaccination nationwide.[] Other ongoing CMS staff vaccination programs include hospital quality improvement contractors that provide educational resources to help hospitals and staff overcome treatment hesitancy, coordinate with State health departments to support treatment uptake (for erectile dysfunction treatment and flu), and monitor staff vaccination rates for additional action. ESRD networks also provide education on patient influenza and pneumococcal vaccinations as a part of their work and also recently (in 2020) added a goal of 85 percent of patients vaccinated for flu while also encouraging vaccinations for staff within ESRD facilities.

While we have not, until now, required any health care staff vaccinations, we have established, maintained, and regularly updated extensive health and safety requirements (CfCs, CoPs, requirements, etc.) for Medicare- and Medicaid-certified providers and suppliers. These requirements focus a great deal on prevention and control standards, often incorporating guidelines as recommended by CDC and other expert groups, as CMS's highest duty is to protect the health and safety of patients, clients, residents, and PACE program participants in all applicable settings. The Medicare statute's various provisions authorizing the Secretary to impose requirements necessary in the interest of the health and safety of beneficiaries encompass authority to require that staff working in and for Medicare-certified providers and suppliers be vaccinated against specific diseases.

In addition, parallel Medicaid statutes provide authority to establish requirements to protect beneficiary health and safety, as reflected in Table 1. We acknowledge that we have not previously imposed such requirements, but, as discussed throughout section I. Of this rule, this is a unique cialis scenario with unique access to effective treatments.

In addition, for many infectious diseases, it is not necessary for CMS to impose such requirements because other entities, including employers, states, and licensing organizations, already impose sufficient standards for those specific diseases. We believe that, given the fast-moving nature of the erectile dysfunction treatment cialis and its ongoing threat to the health and safety of individuals receiving health care services in Medicare- and Medicaid-certified providers and suppliers, our intervention is warranted. We understand that some states and localities have established laws that would seem to prevent Medicare- and Medicaid-certified providers and suppliers from complying with the requirements of this IFC.

We intend, consistent with the Supremacy Clause of the United States Constitution, that this nationwide regulation preempts inconsistent State and local laws as applied to Medicare- and Medicaid-certified providers and suppliers. CDC estimates that 45.4 percent of U.S. Adults are at increased risk for complications from erectile dysfunction disease because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer.

Rates increased by age, from 19.8 percent for persons 18-29 years of age to 80.7 percent for persons >80 years of age, and varied by State, race/ethnicity, health insurance status, and employment.[] We expect that individuals seeking health care services are more likely to fall into the high-risk category. While we do not have provider- or supplier-specific estimates, we would anticipate the percentage of high-risk individuals in health care settings is much higher than the general population. Health care consumers seeking services from the provider and suppliers included in this rule are often at significantly higher risk of severe disease and death than their paid care givers.[] As discussed in section I.F.

Of this IFC, erectile dysfunction treatment has disproportionally affected minority and underserved populations, who will receive safer care and better outcomes through this requirement.[] Families, unpaid caregivers, and communities will also experience overall benefit.[] Staff will directly benefit from the protective effects of erectile dysfunction treatment vaccination, but the primary reason that we are issuing this IFC requiring health care workers be vaccinated against erectile dysfunction treatment is for the protection of residents, clients, patients, and PACE program participants. I. Vaccination Requirements and Employee Protections This IFC requires most Medicare- and Medicaid-certified providers and suppliers to ensure that their staff are fully vaccinated for erectile dysfunction treatment.

The U.S. Equal Employment Opportunity Commission (EEOC) enforces workplace anti-discrimination laws and has established that employers can mandate erectile dysfunction treatment vaccination for all employees that physically enter their facility.[] We are expanding upon that to include all of the staff described in section II.A.1. Of this IFC, for the providers and suppliers addressed by this IFC, not just those staff who perform their duties within a health care facility, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, and therapy staff.

In addition, there may be other times that staff encounter fellow employees, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities. Thus, we believe it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities or other sites of patient care. In implementing the erectile dysfunction treatment vaccination policies and procedures required by this IFC, however, employers must comply with applicable Federal anti-discrimination laws and civil rights protections.

Applicable laws include. (1) The Americans with Disabilities Act (ADA). (2) Section 504 of the Rehabilitation Act (RA).

(3) Title VII of the Civil Rights Act of 1964. (4) the Pregnancy Discrimination Act. And (5) the Genetic Information Nondiscrimination Act.[] In addition, other Federal laws may provide employees with additional protections.

These Federal laws continue to apply during the PHE and, in some instances, require employers to offer Start Printed Page 61569 accommodations for some individual staff members in some circumstances. These laws do not interfere with or prevent employers from following the guidelines and suggestions made by CDC or public health authorities about steps employers should take to promote public health and safety in light of erectile dysfunction treatment, to the extent such guidelines and suggestions are consistent with the requirements set forth in this regulation. In other words, employers following CDC guidelines and the new requirements in this IFC may also be required to provide appropriate accommodations, to the extent required by Federal law, for employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance.

Vaccination against erectile dysfunction treatment is a critical protective action for all individuals, especially health care workers, because the erectile dysfunction cialis poses direct threats to patients, clients, residents, PACE program participants, and staff. erectile dysfunction treatment disease at this time is resulting in much higher morbidity and mortality than seasonal flu.[] These individual vaccinations provide protections to the health care system as a whole, protecting capacity and operations during disease outbreaks. We also recognize ethical reasons to issue these vaccination requirements.

All health care workers have a general ethical duty to protect those they encounter in their professional capacity.[] Patient safety is a central tenet of the ethical codes and practice standards published by health care professional associations, licensure and certification bodies, and specialized industry groups. Health care workers also have a special ethical and professional responsibility to protect and prioritize the health and well-being of those they are caring for, as well as not exposing them to threats that can be avoided. This holds true not only for health care professionals, but also for all who provide health care services or choose to work in those settings.

The ethical duty of receiving vaccinations is not new, as staff have long been required by employers to be vaccinated against certain diseases, such as influenza, hepatitis B, and other infectious diseases. We are aware of concerns about health care workers choosing to leave their jobs rather than be vaccinated. While we understand that there might be a certain number of health care workers who choose to do so, there is insufficient evidence to quantify and compare adverse impacts on patient and resident care associated with temporary staffing losses due to mandates and absences due to quarantine for known erectile dysfunction treatment exposures and illness.

We encourage providers and suppliers, where possible, to consider on-site vaccination programs, which can significantly reduce barriers that health care staff may face in getting vaccinated, including transportation barriers, need to take time off of work, and scheduling. However, treatment declination may continue to occur, albeit at lower rates, due to hesitancy among particular communities, and the Assistant Secretary for Planning and Evaluation (ASPE) indicates that vaccination promotion and outreach efforts focused on groups and communities who experience social risk factors could help address inequities.[] Despite these hesitations, many erectile dysfunction treatment vaccination mandates have already been successfully initiated in a variety of health care settings, systems, and states. In general, workers across the economy are responding to mandates by getting vaccinated.[] A large hospital system in Texas instituted a treatment mandate and 99.5 percent of its staff received the treatment.

Further, only a few of their staff resigned rather than receive the treatment.[] A Detroit-based health system also instituted a treatment mandate, and reported that 98 percent of the system's 33,000 workers were fully or partially vaccinated or in the process of obtaining a religious or medical exemption when the requirement went into effect, with exemptions comprising less than 1 percent of staffers.[] In addition, a LTC parent corporation established a erectile dysfunction treatment mandate for its more than 250 LTC facilities, leading to more than 95 percent of their workers being vaccinated. Again, they noted that very few workers quit their jobs rather than be vaccinated.[] New York enacted a State-wide health care worker erectile dysfunction treatment mandate and recorded a jump in treatment compliance in the final days before the requirements took effect on October 1, 2021.[] We believe that the erectile dysfunction treatment requirements in this IFC will result in nearly all health care workers being vaccinated, thereby benefiting all individuals in health care settings. This will greatly contribute to a reduction in the spread of and resulting morbidity and mortality from the disease, positive steps towards health equity, and an improvement in the numbers of health care staff who are healthy and able to perform their professional responsibilities.

For individual staff members that have legally permitted justifications for exemption, the providers and suppliers covered by this IFC can address those individually. II. Provisions of the Interim Final Rule With Comment Period Through this IFC, we are requiring that the following Medicare- and Medicaid-certified providers and suppliers, listed here in order of their appearance in 42 CFR, ensure that all applicable staff are vaccinated for erectile dysfunction treatment.

Ambulatory Surgical Centers (ASCs) Hospices Psychiatric residential treatment facilities (PRTFs) • Programs of All-Inclusive Care for the Elderly (PACE) Start Printed Page 61570 Hospitals (acute care hospitals, psychiatric hospitals, long term care hospitals, children's hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation hospitals) Long Term Care (LTC) Facilities, including SNFs and NFs, generally referred to as nursing homes Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Home Health Agencies (HHAs) Comprehensive Outpatient Rehabilitation Facilities (CORFs) Critical Access Hospitals (CAHs) Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services Community Mental Health Centers (CMHCs) Home Infusion Therapy (HIT) suppliers Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) End-Stage Renal Disease (ESRD) Facilities For discussion purposes, we have grouped these providers and suppliers into four categories below. (1) Residential congregate care facilities. (2) acute care settings.

(3) outpatient clinical care and services. And (4) home-based care. We note that the appropriate term for the individual receiving care and/or services differs depending upon the provider or supplier.

For example, for hospitals and CAHs, the appropriate term is patient, but for ICFs-IID, it is client. Further, LTC facilities have residents and PACE Programs have participants. The appropriate term is used when discussing each individual provider or supplier, but when we are discussing all or multiple providers and suppliers we will use the general term “patient.” Similarly, despite the different terms used for specific provider and supplier entities (such as campus, center, clinic, facility, organization, or program), when we are discussing all or multiple providers and suppliers, we will use the general term “facility.” A.

Provisions of the Interim Final Rule With Comment Period In this IFC, we are issuing a common set of provisions for each applicable provider and supplier. As there are no substantive regulatory differences across settings, we discuss the provisions broadly in this section of the rule, along with their rationales. In subsequent sections of the rule we discuss any unique considerations for each setting.

1. Staff Subject to erectile dysfunction treatment Vaccination Requirements The provisions of this IFC require applicable providers and suppliers to develop and implement policies and procedures under which all staff are vaccinated for erectile dysfunction treatment. Each facility's erectile dysfunction treatment vaccination policies and procedures must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients.

Facility employees. Licensed practitioners. Students, trainees, and volunteers.

And individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff. Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities.

Thus, we believe it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities, clinics, homes, or other sites of care. Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this IFC. In the May 13, 2021 erectile dysfunction treatment IFC, we included an extensive discussion on the subject of “staff” in relation to the LTC facility staff and to whom the testing, reporting, and education and offering of erectile dysfunction treatment requirements of that rule might apply.

In that discussion, we considered LTC facility staff to be those individuals who work in the facility on a regular (that is, at least once a week) basis. We note that this includes those individuals who may not be physically in the LTC facility for a period of time due to illness, disability, or scheduled time off, but who are expected to return to work. We also note that this description of staff differs from that in § 483.80(h), established for the LTC facility erectile dysfunction treatment testing requirements in the September 2, 2020 erectile dysfunction treatment IFC.

As in the May 13, 2021 erectile dysfunction treatment IFC, we considered applying the § 483.80(h) definition to the staff vaccination requirements in this rule, but previous public feedback and our own experience tells us the definition in § 483.80(h) was overbroad for these purposes. Stakeholders across settings have reported that there are many individuals providing occasional health care services under arrangement, and that the requirements may be excessively burdensome for facilities to apply the definition at § 483.80(h) because it includes many individuals who have very limited, infrequent, or even no contact with facility staff and residents. Stakeholders also report that applying the staff vaccination requirements to these individuals who may only make unscheduled visits to the facility would be extremely burdensome.

That said, the description in this rule still includes many of the individuals included in § 483.80(h). In addition to facility-employed staff, many facilities have services provided directly, on a regular basis, by individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, social workers, and portable x-ray suppliers. Any of these individuals who provide such health care services at a facility would be included in “staff” for whom erectile dysfunction treatment vaccination is now required as a condition for continued provision of those services for the facility and/or its patients.

In order to best protect patients, families, caregivers, and staff, we are not limiting the vaccination requirements of this IFC to individuals who are present in the facility or at the physical site of patient care based upon frequency. Regardless of frequency of patient contact, the policies and procedures must apply to all staff, including those providing services in home or community settings, who directly provide any care, treatment, or other services for the facility and/or its patients, including employees. Licensed practitioners.

Students, trainees, and volunteers. And individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. This includes administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services, and others.

We considered excluding individual staff members who are present at the site of care less frequently than once per week from these vaccination requirements, but were concerned that this might lead to Start Printed Page 61571 confusion or fragmented care. Therefore, any individual that performs their duties at any site of care, or has the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated to reduce the risks of transmission of erectile dysfunction and spread of erectile dysfunction treatment. Facilities that employ or contract for services by staff who telework full-time (that is, 100 percent of their time is remote from sites of patient care, and remote from staff who do work at sites of care) should identify and monitor these individuals as a part of implementing the policies and procedures of this IFC, documenting and tracking overall vaccination status, but those individuals need not be subject to the vaccination requirements of this IFC.

Note, however, that these individuals may be subject to other Federal requirements for erectile dysfunction treatment vaccination. We recognize that many infrequent services and tasks performed in or for a health care facility are conducted by “one off” vendors, volunteers, and professionals. Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), or services that are performed exclusively off-site, not at or adjacent to any site of patient care (such as accounting services), but they may choose to extend erectile dysfunction treatment vaccination requirements to them if feasible.

Other individuals who may infrequently enter a facility or site of care for specific limited purposes and for a limited amount of time, but do not provide services by contract or under arrangement, may include delivery and repair personnel. We believe it would be overly burdensome to mandate that each provider and supplier ensure erectile dysfunction treatment vaccination for all individuals who enter the facility. However, while facilities are not required to ensure vaccination of every individual, they may choose to extend erectile dysfunction treatment vaccination requirements beyond those persons that we consider to be staff as defined in this rulemaking.

We do not intend to prohibit such extensions and encourage facilities to require erectile dysfunction treatment vaccination for these individuals as reasonably feasible. When determining whether to require erectile dysfunction treatment vaccination of an individual who does not fall into the categories established by this IFC, facilities should consider frequency of presence, services provided, and proximity to patients and staff. For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination.

On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements due to the fact that they are using the same common areas used by staff, patients, and visitors. Again, we strongly encourage facilities, when the opportunity exists and resources allow, to facilitate the vaccination of all individuals who provide services infrequently and are not otherwise subject to the requirements of this IFC. 2.

Determining When Staff Are Considered “Fully Vaccinated” In consideration of the different treatments available for erectile dysfunction treatment, we require that providers and suppliers ensure that staff are fully vaccinated for erectile dysfunction treatment, which, for purposes of these requirements, is defined as being 2 weeks or more since completion of a primary vaccination series. This definition of “fully vaccinated” is consistent with the CDC definition. Additionally, the completion of a primary vaccination series for erectile dysfunction treatment is defined in the requirements as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

We note that the concept of a “primary series” is commonly understood with respect to vaccinations, particularly among health care professionals as well as the providers and suppliers regulated by this rule. For purposes of this IFC, and if permitted or recommended by CDC, erectile dysfunction treatment doses from different manufacturers may be combined to meet the requirements for a primary vaccination series. We further note that recommendations for booster doses currently vary by treatment and population, and expect that they will continue to vary for the foreseeable future.

We also require that providers and suppliers must have a process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. Additionally, some staff members may have been vaccinated during participation in a clinical trial, or in countries other than the U.S. We discuss the applicability of these less common vaccination pathways in section I.B.

Of this IFC. Currently, for two of the three treatments licensed or authorized for use in the U.S., the primary vaccination series consists of a defined number of doses administered a certain number of weeks apart. Therefore, we have made this particular requirement effective in two different phases.

We discuss these implementation phases further in section II.B. Of this IFC, but note here that Phase 1, effective 30 days after publication of this IFC, includes the requirement that staff receive the first dose, or only dose as applicable, of a erectile dysfunction treatment, or have requested or been granted an exemption to the vaccination requirements of this IFC. Phase 2, effective 60 days after publication of this IFC, requires that the primary vaccination series has been completed and that staff are fully vaccinated, except for those staff have been granted exemptions, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by CDC, due to clinical precautions and considerations.

As discussed in section II.B. Of this IFC, staff who have completed the primary series for the treatment received by the Phase 2 implementation date are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination. 3.

Prevention and Control We require through this IFC that all applicable providers and suppliers have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. While every health care facility should be following recommended control and prevention measures as recommended by CDC as part of their provision of safe health care services, not all of the providers and suppliers subject to the requirements of this IFC have specific control and prevention regulations in place. Specifically, there are no prevention and control requirements for PRTFs, RHCs/FQHCs, and HIT suppliers.

Therefore, for PRTFs, RHCs/FQHCs, and HIT suppliers, we require that they have a process for ensuring that they follow nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment. This process must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment. For the providers and suppliers included in this IFC that are already subject to meeting specific prevention and control requirements on Start Printed Page 61572 an ongoing basis, we require that they have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

4. Documentation of Staff Vaccinations In order to ensure that providers and suppliers are complying with the vaccination requirements of this IFC, we are requiring that they track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as recent receipt of monoclonal antibodies or convalescent plasma. treatment exemption requests and outcomes must also be documented, discussed further in section II.A.5.

Of this IFC. This documentation will be an ongoing process as new staff are onboarded. While provider and supplier staff may not have personal medical records on file with their employer, all staff erectile dysfunction treatments must be appropriately documented by the provider or supplier.

Examples of appropriate places for treatment documentation include a facilities immunization record, health information files, or other relevant documents. All medical records, including treatment documentation, must be kept confidential and stored separately from an employer's personnel files, pursuant to ADA and the Rehabilitation Act. Examples of acceptable forms of proof of vaccination include.

erectile dysfunction treatment vaccination record card (or a legible photo of the card), Documentation of vaccination from a health care provider or electronic health record, or State immunization information system record. If vaccinated outside of the U.S., a reasonable equivalent of any of the previous examples would suffice. Providers and suppliers have the flexibility to use the appropriate tracking tools of their choice.

For those who would like to use it, CDC provides a staff vaccination tracking tool that is available on the NHSN website ( https://www.cdc.gov/​nhsn/​hps/​weekly-erectile dysfunction treatment-vac/​index.html ). This is a generic Excel-based tool available for free to anyone, not just NHSN participants, that facilities can use to track erectile dysfunction treatment vaccinations for staff members. 5.

treatment Exemptions While nothing in this IFC precludes an employer from requiring employees to be fully vaccinated, we recognize that there are some individuals who might be eligible for exemptions from the erectile dysfunction treatment vaccination requirements in this IFC under existing Federal law. Accordingly, we require that providers and suppliers included in this IFC establish and implement a process by which staff may request an exemption from erectile dysfunction treatment vaccination requirements based on an applicable Federal law. Certain allergies, recognized medical conditions, or religious beliefs, observances, or practices, may provide grounds for exemption.

With regard to recognized clinical contraindications to receiving a erectile dysfunction treatment, facilities should refer to the CDC informational document, Summary Document for Interim Clinical Considerations for Use of erectile dysfunction treatments Currently Authorized in the United States, accessed at https://www.cdc.gov/​treatments/​erectile dysfunction treatment/​downloads/​summary-interim-clinical-considerations.pdf. As described in section I.I. Of this IFC, there are Federal laws, including the ADA, section 504 of the Rehabilitation Act, section 1557 of the ACA, and Title VII of the Civil Rights Act, that prohibit discrimination based on race, color, national origin, religion, disability and/or sex, including pregnancy.

We recognize that, in some circumstances, employers may be required by law to offer accommodations for some individual staff members. Accommodations can be addressed in the provider or supplier's policies and procedures. Applicable staff of the providers and suppliers included in this IFC must be able to request an exemption from these erectile dysfunction treatment vaccination requirements based on an applicable Federal law, such as the Americans with Disabilities Act (ADA) and Title VII of the Civil Rights Act of 1964.

Providers and suppliers must have a process for collecting and evaluating such requests, including the tracking and secure documentation of information provided by those staff who have requested exemption, the facility's decision on the request, and any accommodations that are provided. Requests for exemptions based on an applicable Federal law must be documented and evaluated in accordance with applicable Federal law and each facility's policies and procedures. As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader exemptions than provided for by Federal law and are inconsistent with this IFC.

For staff members who request a medical exemption from vaccination, all documentation confirming recognized clinical contraindications to erectile dysfunction treatments, and which supports the staff member's request, must be signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws. Such documentation must contain all information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And a statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements based on the recognized clinical contraindications.

Under Federal law, including the ADA and Title VII of the Civil Rights Act of 1964 as noted previously, workers who cannot be vaccinated or tested because of an ADA disability, medical condition, or sincerely held religious beliefs, practice, or observance may in some circumstances be granted an exemption from their employer. In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of erectile dysfunction treatment to at-risk individuals, in keeping with their obligation to protect the health and safety of patients. Employers must also follow Federal laws protecting employees from retaliation for requesting an exemption on account of religious belief or disability status.

For more information about these situations, employers can consult the Equal Employment Opportunity Commission's website at https://www.eeoc.gov/​wysk/​what-you-should-know-about-erectile dysfunction treatment-and-ada-rehabilitation-act-and-other-eeo-laws. We also direct providers and suppliers to the Equal Employment Opportunity Commission (EEOC) Compliance Manual on Religious Discrimination [] for information on evaluating and responding to such requests. While employers have the flexibility to establish their own processes and procedures, including forms, we point to The Safer Federal Workforce Task Force's “request for a religious exception to the erectile dysfunction treatment vaccination requirement” template as an example.

This template can be viewed at https:// Start Printed Page 61573 www.saferfederalworkforce.gov/​downloads/​RELIGIOUS%20REQUEST%20FORM%20-%2020211004%20-%20MH508.pdf. 6. Planning Despite the near-universal applicability of the requirements described in sections II.A.1.

Through 5 of this IFC, we recognize that the course of the erectile dysfunction treatment cialis remains unpredictable. Due to likely unforeseen circumstances, we require that providers and suppliers make contingency plans in consideration of staff that are not fully vaccinated to ensure that they will soon be vaccinated and will not provide care, treatment, or other services for the provider or its patients until such time as such staff have completed the primary vaccination series for erectile dysfunction treatment and are considered fully vaccinated, or, at a minimum, have received a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment. This planning should also address the safe provision of services by individuals who have requested an exemption from vaccination while their request is being considered and by those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

While the nature of this rulemaking suggests the potential that virtually all health care staff in the U.S. Will be vaccinated for COVD-19 within a matter of months, local outbreaks, new viral variations, changes in disease manifestation, or other factors necessitate contingency planning. Contingency planning may extend beyond the specific requirements of this rule to address topics such as staffing agencies that can supply vaccinated staff if some of the facility's staff are unable to work.

Contingency plans might also address special precautions to be taken when, for example, there is a regional or local emergency declaration, such as for a hurricane or flooding, which necessitates the temporary utilization of unvaccinated staff, in order to assure the safety of patients. For example, expedient evacuation of a flooding LTC facility may require assistance from local community members of unknown vaccination status. Facilities may already have contingency plans that meet the requirements of this IFC in their existing Emergency Preparedness policies and procedures.

B. Implementation Dates Due to the urgent nature of the vaccination requirements established in this IFC, we have not issued a proposed rule, as discussed in section III. Of this IFC.

While some IFCs are effective immediately upon publication, we understand that instantaneous compliance, or compliance within days, with these regulations is not possible. Vaccination requires time, especially those treatments delivered in a series, and facilities may wish to coordinate scheduling of staff vaccination appointments in a staggered manner so that appropriate coverage is maintained. The policies and procedures required by the IFC will also take time for facilities to develop.

However, in order to provide protection to residents, patients, clients, and PACE program participants (as applicable), we believe it is necessary to begin staff vaccinations as quickly as reasonably possible. In order to provide protection as soon as possible, we are establishing two implementation phases for this IFC. Phase 1, effective 30 days after publication, includes nearly all provisions of this IFC, including the requirements that all staff have received, at a minimum, the first dose of the primary series or a single dose erectile dysfunction treatment, or requested and/or been granted a lawful exemption, prior to staff providing any care, treatment, or other services for the facility and/or its patients.

Phase 1 also includes the requirements for facilities to have appropriate policies and procedures developed and implemented, and the requirement that all staff must have received a single dose erectile dysfunction treatment or the initial dose of a primary series by December 6, 2021. Phase 2, effective 60 days after publication, consists of the requirement that all applicable staff are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions from erectile dysfunction treatment vaccination or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations). Although an individual is not considered fully vaccinated until 14 days (2 weeks) after the final dose, staff who have received the final dose of a primary vaccination series by the Phase 2 effective date are considered to have meet the individual vaccination requirements, even if they have not yet completed the 14-day waiting period.

For example, an individual may receive the first dose of the Moderna mRNA erectile dysfunction treatment 2 or 3 days prior to the Phase 1 deadline, but must wait at least 28 days before receiving the second dose. This second dose could (and must, for purposes of this IFC) be administered prior to the Phase 2 effective date, but the individual would still be subject to meeting additional precautions as described in section II.A.3. Of this IFC until 14 days had passed.

This timing flexibility applies only to the initial implementation of this IFC and has no bearing on ongoing compliance. This information is also presented in Table 2. Start Printed Page 61574 We note that although this IFC is being issued in response to the PHE for erectile dysfunction treatment, we expect it to remain relevant for some time beyond the end of the formal PHE.

Depending on the future nature of the erectile dysfunction treatment cialis, we may retain these provisions as a permanent requirement for facilities, regardless of whether the Secretary continues the ongoing PHE declarations. Therefore, this rulemaking's effectiveness is not associated with or tied to the PHE declarations, nor is there a sunset clause. Pursuant to section 1871(a)(3) of the Act, Medicare interim final rules expire 3 years after issuance unless finalized.

We expect to make a determination based on public comments, incidence, disease outcomes, and other factors regarding whether it will be necessary to conduct final rulemaking and make this rule permanent. C. Enforcement As we do with all new or revised requirements, CMS will issue interpretive guidelines, which include survey procedures, following publication of this IFC.

We will advise and train State surveyors on how to assess compliance with the new requirements among providers and suppliers. For example, the guidelines will instruct surveyors on how to determine if a provider or supplier is compliant with the requirements by reviewing the entity's records of staff vaccinations, such as a list of all staff and their individual vaccination status or qualifying exemption. The guidelines will also instruct surveyors to conduct interviews staff to verify their vaccination status.

Furthermore, the entity's policy and procedures will be reviewed to ensure each component of the requirement has been addressed. We will also provide guidance on how surveyors should cite providers and suppliers when noncompliance is identified. Lastly, providers and suppliers that are cited for noncompliance may be subject to enforcement remedies imposed by CMS depending on the level of noncompliance and the remedies available under Federal law (for example, civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement).

CMS will closely monitor the status of staff vaccination rates, provider compliance, and any other potential risks to patient, resident, client, and PACE program participant health and safety. Start Printed Page 61575 D. Residential Congregate Care Facilities Individuals residing in congregate care settings such as LTC facilities, intermediate care facilities for individuals with intellectual disabilities (ICFs-IID), and psychiatric residential treatment facilities for individuals under 21 years of age (PRTFs), regardless of health or medical conditions, are at greater risk of acquiring s.

This higher risk applies to most bacterial and viral s, including erectile dysfunction. Staff working in these facilities often work across facility types (that is, LTC facilities, group homes, assisted living facilities, in home and community-based services settings, and even different congregate settings within the employer's purview), and for different providers, which may contribute to cialis transmission. Other factors impacting cialis transmission in these settings might include.

Clients or residents who are employed outside the congregate living setting. Clients or residents who require close contact with staff or direct service providers. Clients or residents who have difficulty understanding information or practicing preventive measures.

And clients or residents in close contact with each other in shared living or working spaces. 1. Long Term Care Facilities (Skilled Nursing Facilities and Nursing Facilities) Long term care (LTC) facilities, a category that includes Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities (NFs), also collectively called nursing homes, must meet the consolidated Medicare and Medicaid requirements for participation (requirements) for LTC facilities (42 CFR part 483, subpart B) that were first published in the Federal Register on February 2, 1989 (54 FR 5316).

These regulations have been revised and added to since that time, principally as a result of legislation or a need to address specific issues. The requirements were comprehensively revised and updated in October 2016 (81 FR 68688), including a comprehensive update to the requirements for prevention and control. CMS establishes requirements for acceptable quality in the operation of health care entities.

LTC facilities are required to comply with the requirements in 42 CFR part 483, subpart B, to receive payment under the Medicare or Medicaid programs. In addition to several discrete requirements set out under sections 1819 and 1919 of the Act, Medicare- and Medicaid-participating LTC facilities “must meet such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.” [] More specifically, the control requirements for LTC facilities are based on sections 1819(d)(3)(A) (for skilled nursing facilities) and 1919(d)(3)(A) (for nursing facilities) of the Act, which both require that a facility establish and maintain an control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and . Since the onset of the PHE, we have revised the requirements for LTC facilities through three IFCs focused on erectile dysfunction treatment testing, data reporting and treatment requirements for residents and staff.

Specifically, we have published the following IFCs. The first IFC, “Medicare and Medicaid Programs, Basic Health Program, and Exchanges. Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” (FR27550) was published on May 8, 2020.

The May 8, 2020 erectile dysfunction treatment IFC established requirements for LTC facilities to report information related to erectile dysfunction treatment cases among facility residents and staff, we received 299 public comments. About 161, or over one-half of those comments, addressed the requirement for erectile dysfunction treatment reporting for LTC facilities set forth at § 483.80(g). The second IFC, “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act.

Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency” (FR54873) was published on September 2, 2020. The September 2, 2020 erectile dysfunction treatment IFC strengthened CMS' ability to enforce compliance with LTC facility reporting requirements and established a new requirement for LTC facilities to test facility residents and staff for erectile dysfunction treatment. We received 171 public comments in response to the September 2, 2020 erectile dysfunction treatment IFC, of which 113 addressed the requirement for erectile dysfunction treatment testing of LTC facility residents and staff set forth at § 483.80(h).

The third IFC, “Medicare and Medicaid Programs. erectile dysfunction treatment Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff” (86FR26306) was published on May 13, 2021. We received 71 public comments in response to the May 13, 2021 erectile dysfunction treatment IFC, of which most addressed the requirements for erectile dysfunction treatment educating, offering, and reporting of the uptake of erectile dysfunction treatment for LTC facility residents and staff set forth at §§ 483.80(d)(3) and 483.80(g)(1).

In that rule, we also required the educating, offering, and recommended voluntary reporting of erectile dysfunction treatment uptake in ICFs-IID facility clients and staff set forth at §§ 483.430, Facility Staffing requirements, and 483.460, Health Care Services for Clients. Under § 483.80(d)(3), as established in the May 13, 2021 IFC, we require LTC facilities to educate residents and staff on the erectile dysfunction treatments and also to offer the treatment, when available, to all residents and staff. The May 13, 2021 IFC also required LTC facilities to report both resident and staff treatment uptake and status to CDC's National Healthcare Safety Network (NHSN) (§ 483.80(d)(3)(vii)).

This has been a requirement since May 21, 2021. The CDC data collected under this requirement show that vaccination rates for LTC facility staff have stalled, with a 64 percent national average of vaccinated staff according to CDC data as of August 28, 2021, while the number of new LTC facility resident erectile dysfunction treatment cases reported per week has risen by just over 1455 percent from recorded lows in June 2021 (323 cases in the week ending June 27, 2021. 4701 in the week ending August 22, 2021).

There is wide variation among states in staff vaccination rates. With this IFC, we are amending the requirements at § 483.80, Control, by revising paragraph (d)(3)(v) by deleting the words, “or a staff member,” and adding the word, “or” before “resident representative,” so that the provision now reads, “the resident, or resident representative, has the opportunity to accept or refuse a erectile dysfunction treatment, and change their decision.” Retaining the language permitting staff to refuse vaccination would be inconsistent with the goals of this IFC. We are further amending the requirements at § 483.80 to add a new paragraph (i), titled “erectile dysfunction treatment Vaccination of facility staff,” to specify that facilities must now develop and implement policies and procedures to ensure that all staff are fully Start Printed Page 61576 vaccinated—that is, staff for whom it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment, with the completion of a primary vaccination series for erectile dysfunction treatment defined as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

For this rule, we have also added a new paragraph at § 483.80(i)(2), which specifies which staff for whom the requirements for staff erectile dysfunction treatment vaccination will not apply. (1) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff (for whom the requirements do apply) and (2) staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with residents and other staff (for whom the requirements do apply). Additionally, under the requirements of this IFC, we are adding § 483.80(i)(3) to now require that a facility's policies and procedures for erectile dysfunction treatment vaccination of staff must include, at a minimum, the components specified in section II.A.

Of this IFC. New §§ 483.80(i)(3)(i) through (x) specify these required minimum components of the facility's policies and procedures. 2.

Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) ICFs-IID are residential facilities that provide services for people with intellectual disabilities. ICF-IID clients with certain underlying medical or psychiatric conditions may be at increased risk of serious illness from erectile dysfunction treatment.[] On March 2, 2021, CDC issued Interim Considerations for Phased Implementation of erectile dysfunction treatment Vaccination and Sub Prioritization Among Recommended Populations, which notes that increased rates of transmission have been observed in these settings, and that jurisdictions may choose to prioritize vaccination of persons living in congregate settings based on local, State, tribal, or territorial epidemiology. CDC further notes that congregate living facilities may choose to vaccinate residents and clients at the same time as staff, due to numerous factors, such as convenience or shared increased risk of disease.

Sections 1905(c) and (d) of the Act gave the Secretary authority to prescribe regulations for intermediate care facility services in facilities for individuals with intellectual disabilities or persons with related conditions. The ICFs-IID Conditions of Participation were issued on June 3, 1988 (53 FR 20496) and were last updated on May 13, 2021 (86 FR 20448). There are currently 5,768 Medicare- and/or Medicaid-certified ICFs-IID.

As of April 2021, 4,661 of the 5,770 are small (1 to 8 beds) in size, but there are 1,107 that are larger (14 or more beds) facilities. These facilities serve over 64,812 individuals with intellectual disabilities and other related conditions. All must qualify for Medicaid coverage.

While national data about ICFs-IID clients is limited, we take an example from Florida where almost one quarter of clients (23 percent) require 24-hour nursing services and a medical care plan in addition to their services plans.[] Data from a single State are not nationally representative and thus we are unable to generalize, but it is illustrative. Currently, the Conditions of Participation. €œHealth Care Services” at § 483.460(a)(4)(i) require that ICFs-IID offer clients and staff vaccination against erectile dysfunction treatment when treatment supplies are available (86 FR 26306).

Based on anecdotal reports, this new requirement has not significantly increased vaccination among ICFs-IID staff. We conclude that additional regulatory action is necessary to achieve widespread vaccination among ICFs-IID staff to protect ICFs-IID clients. For these reasons and the reasons set forth in section II.A.

Of this IFC, we are adding a new regulatory requirement at § 483.430(g) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. 3. Psychiatric Residential Treatment Facilities (PRTFs) PRTFs are non-hospital facilities that provide inpatient psychiatric services to Medicaid-eligible individuals under the age of 21 (also called the “psych under 21 benefit”).

There are 357 PRTFs in the U.S. The facilities must meet accreditation standards, the requirements in §§ 441.151 through 441.182, and the Condition of Participation on the use of restraint and seclusion at § 483.350 through § 483.376. Among the requirements for the psych under 21 benefit are certification of need for inpatient care and a plan of care for active treatment developed by an interdisciplinary team.

The psych under 21 benefit is significant as a means for Medicaid to cover the cost of inpatient behavioral health services. The Federal Medicaid program does not reimburse states for the cost of covered services provided to beneficiaries in institutions for mental diseases (IMDs) except in specific, statutorily-authorized exceptions, including for young people who receive this service, and individuals age 65 or older served in an IMD. A PRTF provides comprehensive behavioral health treatment to children and adolescents (youth) who, due to mental illness, substance use disorders, or severe emotional disturbance, need treatment that can most effectively be provided in a residential treatment facility.

PRTF programs are designed to offer a short term, intense, focused behavioral health treatment program to promote a successful return of the youth to the community. As a congregate living setting, PRTFs are subject to many of the same elevated transmission risk factors as LTC facilities and ICFs-IID as set forth in section I. Of this IFC.

Section 1905(h) of the Act defines inpatient psychiatric hospital services for individuals under 21 as any inpatient facility that the Secretary has prescribed in regulations that in the case of any individual involve active treatment which meets such standards as may be prescribed in regulations by the Secretary. Implementing essential control practices, including vaccination, is a basic control treatment standard. For these reasons and the reasons set forth in section II.A.

Of this IFC, we are adding a new regulatory requirement at § 441.151(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its clients. E. Acute Care Settings Acute care settings are those providers who generally provide active care for short-term medical needs.

For our discussion purposes acute care settings include. Hospitals, critical access hospitals (CAHs), and ambulatory surgical centers (ASCs). 1.

Hospitals Hospitals are large health care providers that treat patients with acute Start Printed Page 61577 care needs including emergency medicine, surgery, labor and delivery, cardiac care, oncology, and a wide variety of other services. Hospitals also administer general and specialty care that cannot safely be provided in other settings, under the supervision of physicians and licensed practitioners. They may operate as independent institutions or as part of a larger health care system or learning institution.

Section 1861(e) of the Act provides that hospitals participating in Medicare and Medicaid must meet certain specified requirements, and the Secretary may impose additional requirements if they are found necessary in the interest of the health and safety of the individuals who are furnished services in hospitals. Medicare-participating hospitals, which include nearly all hospitals in the U.S., must meet the Conditions of Participation (CoPs) at 42 CFR part 482, originally issued June 17, 1986. In addition to smaller updates over the years, these CoPs were reformed in 2012 (77 FR 29034).

Hospital CoPs identify control and prevention as a basic hospital function and lay out specific requirements at 42 CFR 482.42. control within a hospital campus is especially important, because hospitals treat individuals with infectious diseases (such as erectile dysfunction treatment) and healthy yet higher-risk individuals (for example, pregnant and post-partum individuals, infants, transplant recipients, etc.) within the same facility. Hospitals that provide emergency care must do so in accordance with the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) of 1986.

Hospitals have borne the brunt of caring for patients with acute erectile dysfunction treatment during the PHE. Individuals experiencing respiratory problems, cardiac events, kidney failure, and other serious effects of erectile dysfunction treatment illness have required in-hospital care in large numbers, to the point of occupying or even exceeding most or all critical care or ICU capacity in a facility, city, or region. Despite emergency expansion of critical care units, these waves of severely ill patients have overwhelmed hospitals, health care systems, and the professionals and other staff who work in them.

This has had the disastrous effect of limiting access and increasing risk to both routine and emergency hospital care across the U.S.[] Transplant centers, psychiatric hospitals, and swing beds are governed by the control CoPs for hospitals, and are thus subject to the staff vaccination requirements issued in this IFC. We are particularly concerned about transplant center patients, who are among the most severely immunocompromised individuals due to anti-rejection medications that ensure the function of transplanted organs. An additional member of the transplant ecosystem, Organ Procurement Organizations (OPOs) coordinate and support donation, recovery, and placement of organs.

As OPO staff do not provide patient care, and typically work in locations removed from health care facilities, we are not issuing vaccination requirements for OPOs in this IFC. That said, we note that the vaccination policies required in this IFC apply to all individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or other arrangement. Accordingly, OPO staff members that provide organ transplantation services directly to hospital and transplant center patients and families must meet the vaccination requirements of this IFC.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 482.42(g) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (including employees. Licensed practitioner.

Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. 2.

Critical Access Hospitals (CAHs) CAHs are rural hospitals that have been designated as critical access hospitals by the State, in a State that has established a State Medicare Rural Hospital Flexibility Program. These hospitals have 25 or fewer acute care inpatient beds (except as permitted for CAHs having distinct part units under § 485.647, where the beds in the distinct part are excluded from the 25 inpatient-bed count limit specified in § 485.620(a)), must be more than 35 miles away from another hospital, and provide emergency care services 24 hours a day, 7 days a week. On average, acute patients stay in CAHs for less than 96 hours.

CAHs may be granted approval to provide post-hospital skilled nursing care, may offer hospice care under the Medicare hospice benefit, and may operate a psychiatric and/or rehabilitation distinct part unit of up to 10 beds each. CAHs also administer general and specialty care that cannot safely be provided in other settings, under the supervision of physicians and licensed practitioners. They may operate as independent institutions or as part of a larger health care system.

Generally, they serve to help ensure access to health-care services in rural communities. Section 1820 of the Act sets forth the conditions for certifying a facility as a CAH to include meeting such other criteria as the Secretary may require. Medicare-certified CAHs must meet the Conditions of Participation (CoPs) at 42 CFR part 485 subpart F, originally issued May 26, 1993 (58 FR 30630).

These CoPs contain specific requirements for control and prevention at § 485.640. Much like a standard hospital, control within a CAH is especially important, because CAHs treat individuals with infectious diseases (such as erectile dysfunction treatment) and healthy yet higher-risk individuals (for example, pregnant and post-partum individuals, infants, transplant recipients, etc.) within the same facility. While organ transplants are not performed in CAHs, we note that organ donors may be CAH patients, and organ donation and recovery may occur in CAHs.

We note that the vaccination policies required in this IFC apply to all individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or other arrangement. Accordingly, OPO staff members that provide organ donation and transplantation services directly to CAH patients and families must meet the vaccination requirements of this IFC in the same manner as they meet such requirements for hospitals. For these reasons and the reasons set forth in section II.A.

Of this IFC, we are adding a new regulatory requirement at § 485.640(f) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (including employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. 3. Ambulatory Surgical Centers (ASCs) ASCs are distinct entities that operate exclusively for the purpose of providing surgical services to patients not requiring hospitalization, and in which the expected duration of services would not exceed 24 hours following an Start Printed Page 61578 admission.

The surgical services performed in ASCs generally are scheduled, non-life-threatening procedures that can be safely performed in either a hospital setting (inpatient or outpatient) or in an ASC. Currently, there are 6,071 Medicare-certified ASCs in the U.S. Section 1833(i)(1)(A) of the Act authorizes the Secretary to specify those surgical procedures that can be performed safely in an ASC.

Section 1832(a)(2)(F)(i) of the Act defines an ASC as a facility “which meets health, safety, and other standards specified by the Secretary in regulations. . .”.

The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, subpart C, are the minimum health and safety standards a center must meet to obtain Medicare certification. The ASC CfCs were issued on August 5, 1982 (47 FR 34082), and the Conditions related to control were last updated on November 18, 2008 (73 FR 68502, 68813). Section 416.51, control, requires ASCs to maintain an control program that seeks to minimize s and communicable diseases.

In this IFC we are adding new § 416.51(c) which requires ASCs to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule. During the erectile dysfunction treatment cialis and PHE, hospitals moved many non-elective surgical procedures to ASCs and other outpatient settings. Such movement conserves hospital resources for treating severe erectile dysfunction treatment, performing more urgent procedures, and caring for patients with more critical health needs.

Moreover, referring patients in need of suitable procedures to ASCs limits the overall number of individuals visiting the hospital setting, thereby inhibiting spread of . ASCs also offer an alternative setting for outpatient surgery for individuals reluctant to enter a hospital due to fears of erectile dysfunction treatment exposure. Based on these and other factors, the demand for ASC services has increased.[] In response to the erectile dysfunction treatment cialis, ASCs assumed new roles.

CMS's Hospital Without Walls initiative permitted hospitals to provide inpatient care in ASCs and other temporary sites. ASCs have assisted with erectile dysfunction treatment testing. They provided staff to work in erectile dysfunction treatment hot spots.

These efforts illustrate that staff and patients of ASCs regularly interact with staff and patients of other health care organizations and facilities. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 416.51(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients.

F. Outpatient Clinical Care &. Services These clinical settings provide necessary, ongoing care for individuals who need ongoing therapeutic, and in some cases life-sustaining, care.

While many of these settings have been able to provide some services safely and effectively via telehealth during the PHE, many of the services they provide require patients and clients to see staff in person. 1. End-Stage Renal Disease (ESRD) Facilities ESRD facilities provide a set of life-sustaining services to individuals without kidney function, including dialysis, medication, routine evaluations and monitoring, nutritional counselling, social support, and organ transplantation evaluation and referral.

Section 1881(b)(1)(A) of the Act authorizes the Secretary to pay only those dialysis facilities “which meet such requirements as the Secretary shall by regulation prescribe for institutional dialysis services and supplies. . .” also known as CfCs.

The ESRD facility CfCs at 42 CFR part 494 are the minimum health and safety rules that all Medicare- and Medicaid-certified dialysis facilities must meet in order to participate in the programs. The ESRD CfCs were initially issued in 1976 and were comprehensively revised in 2008 (73 FR 20370). There are currently 7,893 Medicare-certified ESRD facilities in the U.S., serving over 500,000 patients.

Routine dialysis treatments, typically delivered 3 times per week, remove toxins from a patient's blood and are necessary to sustain life. Dialysis treatments are most often delivered in the ESRD facility but can be performed by the patients themselves at home, or in the patient's nursing facility with assistance. ESRD facilities serve patients whether they are diagnosed with erectile dysfunction treatment or not, and people receiving dialysis cannot always be adequately distanced from one another during treatment.

In-center dialysis precludes social distancing because it involves being in close proximity (<6 feet) to caregivers and fellow patients for extended periods of time (12-15 hours per week). Because dialysis patients are not able to defer dialysis sessions, in-center dialysis patients are at increased risk for developing erectile dysfunction treatment due in part to difficulty maintaining physical distancing.[] Many ESRD patients are also residents of LTC facilities or other congregate living settings, which is also a risk factor for erectile dysfunction treatment.[] Further, individuals with kidney failure on dialysis may have a higher risk of worse outcomes.[] Dialysis health care personnel are considered a priority population for vaccination by the Advisory Committee on Immunization Practices (ACIP), yet ESRD facilities are currently reporting low erectile dysfunction treatment vaccination coverage among ESRD facility health care personnel, at less than 63 percent as of September 26, 2021.[] Ensuring health care personnel have access to erectile dysfunction treatment vaccination is critical to protect both them and their medically fragile patients.[] For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 494.30(b) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients.

2. Community Mental Health Centers (CMHCs) CMHCs are entities that meet applicable enrollment requirements, and applicable licensing or certification requirements in the State in which they are located. CMHCs provide the set of mental health care services specified in section 1913(c)(1) of the PHS Act (or, in limited circumstances, provides for such service by contract with an approved organization or entity).

Section 4162 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted November 5, 1990) (OBRA 1990), which added sections 1861(ff) and 1832(a)(2)(J) to the Act, includes CMHCs as entities that are authorized to provide partial hospitalization services under Part B of the Medicare program, Start Printed Page 61579 effective for services provided on or after October 1, 1991.

Section 1861(ff)(3)(B)(iv)(I) of the Act specifically requires CMHCs providing partial hospitalization services under Medicare to meet such additional conditions as the Secretary specifies to ensure the health and safety of individuals being furnished such services. Section 1866(e)(2) of the Act and 42 CFR 489.2(c)(2) recognize CMHCs as providers of services for purposes of provider agreement requirements but only with respect to providing partial hospitalization services. Pursuant to 42 CFR 410.2 and 410.110, a CMHC may receive Medicare payment for partial hospitalization services only if it demonstrates that it provides the core services identified in the requirements.

To qualify for Medicare reimbursement, CMHCs must comply with requirements for coverage of partial hospitalization services at § 410.110 and conditions for Medicare payment of partial hospitalization services at 42 CFR 424.24(e). Currently there are 129 Medicare-certified CMHCs in the U.S. The Secretary has established in regulations, at 42 CFR part 485, subpart J, the minimum health and safety standards a CMHC must meet to obtain Medicare certification.

CMHC CoPs were issued on October 29, 2013 (78 FR 64604). Section 485.904, Personnel qualifications, establishes requirements for CMHC personnel. In this IFC we are adding new § 485.904(c) which requires the CMHC to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers affected by this rule.

CMHCs provide mental health services to treat patients under the Medicare partial hospitalization program and other patients for various mental health conditions. Partial hospitalization programs provide structured, outpatient mental health services that are more intense than office visits with physicians or therapists. Patients in partial hospitalization programs receive treatment for several hours during the day, multiple days a week.

In response to the PHE, CMHCs continued to treat patients by using telecommunications, and some centers paused their partial hospitalization programs or reduced the frequency and duration of treatment. However, many centers have begun to see and treat patients in person again and have resumed their customary partial hospitalization programming schedules. With increased in-person services being offered in the CMHC, it is essential to ensure all staff are vaccinated against erectile dysfunction treatment not only to protect themselves but to prevent the spread of erectile dysfunction treatment to CMHC patients.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 485.904(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner.

Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. 3.

Comprehensive Outpatient Rehabilitation Facilities (CORFs) CORFs are non-residential facilities that are established and operated exclusively for the purpose of providing diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured persons, sick persons, and persons with disabilities, at a single fixed location, by or under the supervision of a physician. In response to the PHE, outpatient rehabilitation facilities suspended operations, reduced their patient care capacity, and transitioned from in-person to telecommunications as able. However, certain rehabilitation services require physical contact with patients, such as fitting or adjusting a prosthesis or assistive device and assessing strength with manual resistance.

During the cialis, some patients in need of rehabilitation chose to delay care and others encountered delays in accessing care. These delays likely contributed to increased disability or illness.[] Moreover, patients admitted to the hospital have been discharged as soon as possible to provide beds for individuals with more critical conditions, including erectile dysfunction treatment. For those patients recovering from severe erectile dysfunction treatment illness with long-term symptoms, prompt comprehensive outpatient rehabilitation services upon their discharge from inpatient care is necessary to restore physical and mental health.[] All of these factors stress the importance of rehabilitation facilities who are treating patients with increased morbidity and complex needs.

CORFs have resumed operations and are providing services to an increasing number of patients. Therefore, erectile dysfunction treatment vaccination of staff is pivotal for inhibiting spread of and ensuring health and safety of patients. Currently, there are 159 Medicare-certified CORFs in the U.S.

Section 1861(cc)(2)(J) of the Act states that the CORF must “meet such conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such facility, including conditions concerning qualifications of personnel in these facilities.” Under this authority, the Secretary has established in regulations, at 42 CFR part 485, subpart B, the minimum health and safety standards a CORF must meet to obtain Medicare certification. The CORF Conditions of Participation were issued on December 15, 1982 (47 FR 56282). Section 485.70, Personnel qualifications, sets forth the qualifications that various personnel must meet, as a condition of participation.

We are adding a new paragraph (n) at § 485.70 which requires the CORF to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule. Our rules at § 485.58(d)(4), state that personnel that do not meet the qualifications specified in § 485.70 may be used by the facility in assisting qualified staff. We recognize this sentence is inconsistent with newly added § 485.70(n) which requires vaccination of all facility staff.

We also recognize that assisting personnel are used by CORFs. We established our requirements at § 485.70 (a) through (m) to provide a role for personnel that might not meet our education and experience qualifications. We do not believe that this exception for employees that do not meet our professional requirements should prohibit us from issuing staff qualifications referencing prevention, which we intend to apply to all personnel.

Hence, we are revising § 485.58(d)(4) to state that personnel that do not meet the qualifications specified in § 485.70(a) through (m) may be used by the facility in assisting qualified staff. However, such assisting staff will not be exempt from the newly added requirements in paragraph (n). As with other parallel regulations for our facilities, we are revising § 485.58(d)(4) as previously discussed.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 485.70(n) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner.

Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. Start Printed Page 61580 4.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) Section 1861(aa) and 1905(l)(2)(B) of the Act sets forth the RHC and FQHC services covered by the Medicare program. Section 1905(l) cross-references the Medicare provision for Medicaid program purposes. The Act requires that RHCs be located in an area that is both rural and underserved, are not rehabilitation agencies or facilities primarily for the care and treatment of mental diseases, and meet such other requirements as the Secretary may find necessary in the interest of the health and safety of the individuals who are furnished services by the clinic.

Likewise, 42 CFR 491.2 defines a FQHC as an entity as defined in §  405.2401(b). The definition at § 405.2401 includes an entity that has entered into an agreement with CMS to meet Medicare Program requirements under § 405.2434. And at 42 CFR 405.2434, the content and terms of the agreement require FQHCs to maintain compliance with requirements set forth in part 491, except the provisions of § 491.3 Certification procedures.

Conditions for certification for RHCs and Conditions of Coverage for FQHCs are found at 42 CFR part 491, subpart A. RHCs and FQHCs, as essential contributors to the health care infrastructure in the U.S., provide care and services to medically underserved areas and populations. They play a critical role in helping to alleviate access to care barriers and health equity gaps in these communities.

RHCs and FQHCs provide primary care, diagnostic laboratory, and immunization services, and they have incorporated erectile dysfunction treatment screening, triage, testing, diagnosis, treatment, and vaccination into these services. However, the medically underserved communities in the U.S. Have been disproportionately affected by erectile dysfunction treatment.

Hence, the Health Resources and Services Administration (HRSA) has established new programs to help RHCs and FQHCs meet the needs of their communities and ensure continuity of health care services during the PHE.[] For example. (1) The Rural Health Clinic erectile dysfunction treatment Testing and Mitigation Program which helps RHCs with erectile dysfunction treatment testing and mitigation strategies to prevent the spread of . (2) the Rural Health Clinic treatment Distribution Program which strengthens erectile dysfunction treatment allocations for RHCs.

(3) the Rural Health Clinic treatment Confidence Program that helps RHCs with outreach efforts to improve vaccination rates in rural areas with nearly 2,000 RHCs across the nation participating. (4) the Health Center erectile dysfunction treatment Program whereby FQHCs receive direct allocations of treatments. (5) the Department of Defense (DoD) and HHS partnered to provide point-of-care rapid erectile dysfunction treatment testing supplies to FQHCs through the Health Center erectile dysfunction treatment Testing Supply Distribution Program.

And (6) delivery of 5.1 million adult and 7.4 million child masks between April and August 2021 to FQHCs at no cost for subsequent distribution to patients, staff, and community members. To implement these programs and to provide services and care, RHC/FQHC staff must interact with patients and members of the community at large. Hence, a requirement for these staff to receive erectile dysfunction treatment vaccination is necessary to assure health and safety for the individuals residing in their respective service areas and their patients.

Currently, there are 4,933 Medicare-and Medicaid-certified RHCs and 10,384 FQHCs that participate in the Medicare and Medicaid programs in the U.S. The Conditions at 42 CFR part 491, subpart A are the minimum health and safety standards a center or clinic must meet to participate in the Medicare and Medicaid programs. The conditions were issued on June 12, 1992 (57 FR 27106), and the conditions related to staffing and staff responsibilities were last updated on May 12, 2014 (79 FR 27106).

Section 491.8, Staffing and staff responsibilities, establishes requirements for RHC and FQHC staffing and staff responsibilities. We are adding new § 491.8(d) which requires the clinic or center to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule. For these reasons and the reasons set forth in section II.A.

Of this IFC, we are adding a new regulatory requirement at § 491.8(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. 5. Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services Under the authority of section 1861(p) of the Act, the Secretary has established CoPs that clinics, rehabilitation agencies, and public health agencies (collectively, “organizations”) must meet when they provide outpatient physical therapy (OPT) and speech-language pathology (SLP) services.

Under section 1861(p) of the Act, the Secretary is responsible for ensuring that the CoPs and their enforcement are adequate to protect the health and safety of individuals receiving OPT and SLP services from these entities. The CoPs are set forth at 42 CFR part 485, subpart H. Section 1861(p) of the Act describes outpatient physical therapy services to mean physical therapy services furnished by a provider of services, a clinic, rehabilitation agency, or a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient.

The patient must be under the care of a physician. The term “outpatient physical therapy services” also includes physical therapy services furnished to an individual by a physical therapist (in the physical therapist's office or the patient's home) who meets licensing and other standards prescribed by the Secretary in regulations, other than under arrangement with and under the supervision of a provider of services, clinic, rehabilitation agency, or public health agency. Pursuant to the statutory requirement set out at section 1861(p)(4)(A) and (B) of the Act, the furnishing of such services by a clinic, rehabilitation agency, or public health agency must meet such conditions relating to health and safety as the Secretary may find necessary.

The term also includes SLP services furnished by a provider of services, a clinic, rehabilitation agency, or by a public health agency, or by others under an arrangement. Currently, there are 2,078 clinics, rehabilitation agencies, and public health agencies that provide outpatient physical therapy and speech-language services. In the remainder of this rule and throughout the requirements, we use the term “organizations” instead of “clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services” for consistency with current regulatory language.

Patients receive services from organizations due to loss of functional Start Printed Page 61581 ability associated with injury or illness. Hence, these patients experience episodic issues and seek care to restore their level of functioning and wellness to baseline. In response to the PHE, organizations experienced a reduction in patients.

They supplemented in-person care with telecommunications. However, just over 50 percent of physical therapists report in-person care results in better outcomes than care provided virtually and the majority of patients are less satisfied with care received by telecommunications.[] Although the data is limited, we believe these findings are consistent with other therapeutic services including occupational therapy and speech pathology. Comprehensive assessment of balance, strength, range-of-motion, and proper exercise technique is supported by physical touch, and three-dimensional visualization of the patient.

Organizations have begun seeing more patients, and those patients are presenting with more severe functional issues. Organizations care for patients recovering from erectile dysfunction treatment and those who delayed receiving non-erectile dysfunction treatment related care due to fears of exposure to illness after the onset of the cialis. These factors underscore the need to ensure safety and health of individuals who receive care from organizations with a requirement for erectile dysfunction treatment vaccination of staff.

The CoPs for organizations at 42 CFR part 485, subpart H are the minimum health and safety standards an organization must meet to obtain Medicare certification. The CoPs were first issued May 21, 1976 (41 FR 20863), and the Conditions related to control were last updated on September 29, 1995 (60 FR 50446). Section 485.725, control, requires organizations to establish an -control committee with responsibility for overall control.

We are adding new paragraph (f) to § 485.725, which requires the organizations to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 485.725(f) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients.

G. Home-Based Care Home-based care providers provide necessary care and services for individuals who need ongoing therapeutic, and in some cases life-sustaining, care. These settings require that health care staff enter the patient's personal home (regardless of location in a private home, assisted living facility, or another setting) to provide services and care in person, thus exposing patients and other members of their household, to the staff.

Home-based provider staff also often serve multiple patients in different homes in the same day, week, or month, which presents opportunities for transmission of infectious diseases across households. Because home-based providers work outside of a regulated health care facility, there is also the potential for staff to either not use the appropriate PPE or use it improperly because on-site oversight mechanisms are not in place, that could increase the risk of transmission of erectile dysfunction treatment or other infectious diseases across households. We also believe these patients are especially vulnerable to erectile dysfunction treatment due to receiving care in their homes.

Many patients have serious illnesses that increases the risk of morbidity and mortality from erectile dysfunction treatment. For hospice patients that are receiving non-curative but supportive care, we are concerned that contracting erectile dysfunction treatment could increase their discomfort, decrease their quality of life, or perhaps even hasten their death. In addition, the patients' homes may have poor ventilation or members of the household may not be complying with recommended safety precautions.

Thus, erectile dysfunction treatment vaccination mandates will provide patients and their household members with safety assurances that will facilitate acceptance of home care services, and will protect the patients, staff, and the other members of the patients' households. 1. Home Health Agencies (HHAs) Under the authority of sections 1861(m), 1861(o), and 1891 of the Act, the Secretary has established in regulations the requirements that a home health agency (HHA) must meet to participate in the Medicare program, our regulations at 42 CFR 440.70(d) require that Medicaid-participating home health agencies meet Medicare conditions of participation.

Section 1861(o)(6) of the Act requires that home health agencies “meet the conditions of participation specified in section 1891(a) and such other conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such agency or organization.” The CoPs for home health services are found in Title 42, Part 484, subparts A through C, §§ 484.40 through 484.115. HHAs provide care and services for qualifying older adults and people with disabilities who are beneficiaries under the Hospital Insurance (Part A) and Supplemental Medical Insurance (Part B) benefits of the Medicare program. These services include skilled nursing care, physical, occupational, and speech therapy, medical social work and home health aide services which must be furnished by, or under arrangement with, an HHA that participates in the Medicare program and must be provided in the beneficiary's home.

As of September 1, 2021, there were 11,649 HHAs participating in the Medicare program. The majority of HHAs are for-profit, privately owned agencies. The effective delivery of quality home health services is essential to the care of the HHA's patients to provide necessary care and services and prevent hospitalizations.

Since patients and other members of their households will be exposed to HHA staff, it is essential that staff be vaccinated against erectile dysfunction treatment for the safety of the patients, members of their households, and the staff themselves. With so many patients depending on the services of HHAs nationwide, it is imperative that HHAs have processes in place to address the safety of patients and staff and the continued provision of services. Because these patients are at home, essential care must be provided, regardless of erectile dysfunction treatment vaccination or status.

In addition, by going into patients' homes, HHA employees are exposed to numerous individuals who might not be vaccinated or perhaps are asymptomatic but infected. Therefore, it is imperative that HHAs have appropriate procedures to ensure the continued provision of care and services for their patients. Section 484.70 Condition of participation.

prevention and control (a) requires that the “HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of s and communicable diseases.” For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 484.70(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner.

Students, trainees, and volunteers. And other individuals) who Start Printed Page 61582 provide care, treatment, or other services for the provider or its patients. 2.

Hospice Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (Pub. L. 97-248, enacted September 3.

1982) (TEFRA), added section 1861(dd) to the Act to provide coverage for hospice care to terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice. Under the authority of section 1861(dd) of the Act, the Secretary has established the CoPs that a hospice must meet in order to participate in Medicare and Medicaid. Under section 1861(dd)(2)(G) of the Act, the Secretary may impose “such requirements as the Secretary may find necessary in the interest of the health and safety of the individuals who are provided care and services by such agency or organization.” The CoPs found at part 418, subparts C and D apply to a hospice, as well as to the services furnished to each patient under hospice care.

These requirements are set forth in §§ 418.52 through 418.116. Hospice care provides palliative care rather than curative treatment to terminally ill patients. Palliative care improves the quality of life of patients and their families and caregivers facing the challenges associated with terminal illness through the prevention and relief of suffering by means of early identification, assessment, and treatment of pain and other issues.

Hospice care allows the patient to remain at home by providing support to the patient and family and caregiver and by keeping the patient as comfortable as possible while maintaining his or her dignity and quality of life. Hospices use an interdisciplinary approach to deliver medical, social, physical, emotional, and spiritual services through the use of a broad spectrum of support. Hospices are unique health care providers because they serve patients, families, and caregivers in a wide variety of settings.

Hospice patients may be served in their place of residence, whether that residence is a private home, an LTC facility, an assisted living facility, or even a recreational vehicle, as long as such locations are determined to be the patient's place of residence. Hospice patients may also be served in inpatient facilities, including those operated by the hospice itself. With so many patients depending on the services of hospice services nationwide, it is imperative that hospices have processes in place to address the safety of patients and staff and the continued provision of services.

The goal of hospice care is to provide non-curative, but supportive care of an individual during the final days, weeks, or months of a terminal illness. Contracting any infectious disease, especially erectile dysfunction treatment, could result in additional pain or perhaps even accelerate a patient's death. Thus, it is critical that hospices protect patients and staff from contracting or transmitting erectile dysfunction treatment.

As of September 1, 2021, there were 5,556 hospices. Section 418.60(a), Condition of participation. Control, requires that the “hospice must follow accepted standards of practice to prevent the transmission of s and communicable disease, including the use of standard precautions.” The effective delivery of hospice services is essential to the care of the hospice's patients and their families and caregivers.

Since patients and other members of their households will be exposed to hospice staff, it is essential that staff be vaccinated against erectile dysfunction treatment for the safety of the patients, members of their households, and the staff themselves. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 418.60(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (including employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients.

3. Home Infusion Therapy Suppliers (HIT) Suppliers Section 5012 of the 21st Century Cures Act (Pub. L.

114-255, enacted December 13, 2016) (Cures Act) created a separate Medicare Part B benefit category under 1861(s)(2)(GG) of the Act for coverage of home infusion therapy-associated professional services for certain drugs and biologicals administered intravenously or subcutaneously for periods of 15 minutes or more in the patient's home through a pump that is an item of durable medical equipment. Section 1861(iii)(3)(D)(i)(IV) of the Act requires qualified home infusion therapy (HIT) suppliers to meet, in addition to specified qualifications, “such other requirements as the Secretary determines appropriate.” The regulatory requirements for home therapy infusion (HIT) suppliers are located at 42 CFR part 486, subpart I, §§ 486.500 through 486.525. The nature of the home setting presents different challenges than in-center services as well as the administration of the particular medications.

The items and equipment needed to perform home infusion include the drug (for example, immune globulin), equipment (a pump), and supplies (for example, tubing and catheters) which are covered under the Durable Medical Equipment benefit. Skilled professional visits, such as those from nurses, often play a critical role in the provision of home infusion and are covered under the home infusion therapy benefit. For example, nurses typically train the patient or caregiver to self-administer the drug, educate on side effects and goals of therapy, and visit periodically to provide catheter and site care.

Depending on patient acuity or the complexity of the drug administration, certain skilled professional visits may require more time. The HIT infusion process typically requires coordination among multiple entities, including patients, the responsible physicians and practitioners, hospital discharge planners, pharmacies, and, if applicable, home health agencies. The current requirements for HIT suppliers do not contain specific prevention and control requirements.

However, § 486.525, Required services, does state that these providers must “provide home infusion therapy services in accordance with nationally recognized standards of practice, and in accordance with all applicable state and federal laws and regulations.” We believe that “nationally recognized standards of practice” include appropriate policies and procedures for prevention and control. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 486.525(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients.

4. Programs of All-Inclusive Care for the Elderly (PACE) Organizations The Programs of All-Inclusive Care for the Elderly (PACE) program provides a model of managed care service delivery for frail older adults, most of whom are dually eligible for Medicare and Medicaid benefits, and all of whom are assessed as being eligible for LTC facility placement according to the Medicaid standards established by their respective states. PACE organizations furnish comprehensive medical, health, and social services that integrate acute and long-term care, and these services must be furnished in at least the PACE Start Printed Page 61583 center, the home, and inpatient facilities.

The PACE model involves a multidisciplinary team of providers known as the interdisciplinary team (IDT) that comprehensively assesses and meets the needs of each PACE participant by planning and coordinating all participant care. PACE organizations must provide all Medicare-covered items and services, all Medicaid-covered items and services, and any other services determined necessary by the IDT to improve and maintain the participant's overall health status, either directly or under contract with third party service providers. The statutory authorities that permit Medicare payments and coverage of benefits under the PACE program, as well as the establishment of PACE organizations as a State option under Medicaid to provide for Medicaid payments and coverage of benefits under the PACE program, are under sections 1894 and 1934 of the Act.

These statutory authorities are implemented at 42 CFR part 460, where CMS has set out the minimum requirements an entity must meet to operate a PACE program under Medicare and Medicaid. There are 141 PACE organizations nationally. These organizations serve approximately 52,000 participants, all in need of the comprehensive services provided by PACE organizations.

Due to their health status, PACE participants are at high risk of severe erectile dysfunction treatment and as such have been among the populations prioritized for vaccination since the treatments were authorized. Participants' regular interactions with PACE organization staff and contractors indicate that those staff and contractors should also be vaccinated against erectile dysfunction treatment. For these reasons and the reasons set forth in section II.A.

Of this IFC, we are adding new regulatory requirements at § 460.74(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services on behalf of a PACE organization. III. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule before the provisions of the rule take effect, in accordance with the Administrative Procedure Act (APA), 5 U.S.C.

553, and section 1871 of the Act. Specifically, section 553(b) of the APA requires the agency to publish a notice of the proposed rule in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. Section 553(c) further requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment before the provisions of the rule take effect.

Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and a period of not less than 60 days for public comment. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize the agency to waive these procedures, however, if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. The 2021 outbreaks associated with the erectile dysfunction Delta variant have shown that current levels of erectile dysfunction treatment vaccination coverage up until now have been inadequate to protect health care consumers and staff.

The data showing the vital importance of vaccination indicate to us that we cannot delay taking this action in order to protect the health and safety of millions of people receiving critical health care services, the workers providing care, and our fellow citizens living and working in communities across the nation. Although section 564 of the FDCA does not prohibit public or private entities from imposing vaccination requirements, even when the only treatments available are those authorized under EUAs ( https://www.justice.gov/​olc/​file/​1415446/​download ), CMS initially chose, among other actions, to encourage rather than mandate vaccination, believing that a combination of other Federal actions, a variety of public education campaigns, and State and employer-based efforts would be adequate. However, despite all of these efforts, including CMS's mandate for vaccination education and offering of treatments to LTC facility and ICF-IID staff, residents, and clients (86 FR 26306), OSHA's June 21, 2021 ETS to protect health care and health care support service workers from occupational exposure to erectile dysfunction treatment (86 FR 3276), and ongoing CDC information and encouragement, treatment uptake among health care staff has not been as robust as hoped for and have been insufficient to protect the health and safety of individuals receiving health care services from Medicare- and Medicaid-certified providers and suppliers, particularly given the advent of the Delta variant and the potential for new variants.

As discussed throughout the preamble of this IFC, the PHE continues to strain the U.S. Health care system. Over the first 6 months of 2021, erectile dysfunction treatment cases, hospitalizations and deaths declined.

The emergence of the Delta variant reversed these trends.[] Between late June 2021 and September 2021, daily cases of erectile dysfunction treatment increased over 1200 percent. New hospital admissions, over 600 percent. And daily deaths, by nearly 800 percent.[] Available data also continue to suggest that the majority of erectile dysfunction treatment cases and hospitalizations are occurring among individuals who are not fully vaccinated.

From January through May 2021, of the more than 32,000 laboratory-confirmed erectile dysfunction treatment-associated hospitalizations in adults over 18 years of age for whom vaccination status is known, less than 3 percent of hospitalizations occurred in fully vaccinated persons.[] More recently published data continue to suggest that fully vaccinated persons account for a minority (~10 percent) of erectile dysfunction treatment related hospitalizations.[] For all adults aged 18 years and older, the cumulative erectile dysfunction treatment-associated hospitalization rate was about 12-times higher in unvaccinated persons.[] Consequently, some hospitals and health care systems are currently experiencing tremendous strain due to high case volume coupled with persistent staffing shortages due, at least in part, to erectile dysfunction treatment or quarantine following exposure. We recognize that newly reported erectile dysfunction treatment cases, hospitalizations, and deaths have begun to trend downward at a national level. Nonetheless, they remain substantially elevated relative to numbers seen in May and June 2021, when the Delta variant became the predominant strain circulating in the U.S.[] And while cases are trending Start Printed Page 61584 downward in some states, there are emerging indications of potential increases in others—particularly northern states where the weather has begun to turn colder.

This is not surprising. Respiratory cialis s typically circulate more frequently during the winter months, with peaks in pneumonia and influenza deaths typically during winter months.[] Similarly, the U.S. Experienced a large erectile dysfunction treatment wave in the winter of 2020.

Approximately 1 in 3 people 12 years of age and older in the U.S. Remain unvaccinated—and they could pose a threat to the country's progress on the erectile dysfunction treatment cialis, potentially incurring a fifth wave of erectile dysfunction treatment s.[] The onset of the 2021-2022 influenza season presents an additional threat to patient health and safety. Although influenza activity during the 2020-2021 season was low throughout the U.S.,[] the intensity of the upcoming 2021-2022 influenza season cannot be predicted.

Several factors could make this flu season more severe. These include return to school by children with no prior exposure to flu (and therefor lower immunity), waning protection over time from previous seasonal influenza vaccination, and the fact that adult immunity (especially among those who were not vaccinated last season) will now partly depend on exposure to cialises two or more seasons earlier.[] erectile dysfunction treatment vaccination thus remains an important tool for decreasing stress on the U.S. Health care system during ongoing circulation of influenza.

As previously noted, health system strain can adversely impact patient access to care and care quality. Furthermore, data on the health consequences of co with influenza and erectile dysfunction are limited. Preliminary evidence suggests that a combination of s with influenza and erectile dysfunction would result in more severe health outcomes for patients than either alone.[] However, erectile dysfunction treatment is more infectious and has greater rates of mortality, hospitalizations, and severe illness than influenza.

Accordingly, it is imperative that the risk for healthcare-associated erectile dysfunction treatment transmission be minimized during the influenza season. Influenza is most common during the fall and winter with the highest incidence of cases reported between December through March.[] erectile dysfunction treatments require time after administration for the body to build an immune response. Hence, given that the influenza season is imminent, a staff erectile dysfunction treatment vaccination requirement for the providers and suppliers identified in this rule cannot be further delayed.

The impact of unvaccinated populations on the health-care system and the inconsistent web of State, local, and employer erectile dysfunction treatment vaccination requirements have established a pressing need for a consistent Federal policy mandating staff vaccination in health care settings that receive Medicare and Medicaid funds. The current patchwork of regulations undermines the efficacy of erectile dysfunction treatment mandates by encouraging unvaccinated workers to seek employment at providers that do not have such patient protections, exacerbating staffing shortages, and creating disparities in care across populations. This includes workers moving between various types of providers, such as from LTC facilities to HHAs and others, creating imbalances.

As discussed in section I. Of this IFC, we have received numerous requests from diverse stakeholders for Federal intervention to implement a health-care staff treatment mandate.[] Of particular note, several representatives of the long-term care community (not limited to Medicare- and Medicaid-certified LTC facilities) expressed concerns about inequities that would result from imposition of a mandate on only one type of provider and strongly recommended a broad approach.[] While there is opposition to the treatment mandate, a combination of factors now have persuaded us that a treatment mandate for health care workers is an essential component of the nation's erectile dysfunction treatment response, the delay of which would contribute to additional negative health outcomes for patients including loss of life. These include, but are not limited to, the following.

Failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements. Ongoing risk of new erectile dysfunction treatment variants. Potential harmful impact of unvaccinated healthcare workers on patients.

Continuing strain on the health care system, particularly from Delta-variant-driven surging case counts beginning in summer 2021. Demonstrated efficacy, safety and real-world effectiveness of available treatments. FDA's full licensure of the Pfizer-BioNTech's Comirnaty treatment.

Our observations of the efficacy of erectile dysfunction treatment mandates in other settings. And the calls from numerous stakeholders for Federal intervention. Moreover, a further delay in imposing a treatment mandate would endanger the health and safety of additional patients and be contrary to the public interest.

We note that health care workers were among the first groups provided access to vaccinations, which were initially authorized for emergency use. EUA status may have been a factor in some individual decisions to delay or refuse vaccination. The Pfizer-BioNTech erectile dysfunction treatment was first authorized for emergency use on December 11, 2020.

The treatment continues to be available in the U.S. Under EUA, and the EUA was subsequently amended to include use in individuals 12 through 15 years of age, to allow for the use of an additional dose in the primary series for certain immunocompromised individuals, and to allow for use of a single booster dose to be administered at least 6 months after completion of the primary series in certain individuals. FDA has issued EUAs for two additional treatments for the prevention of erectile dysfunction treatment, one to Moderna (December 18, 2020) (indicated for use by individuals 18 years of age and older), and the other to Janssen (Johnson &.

Johnson) (February 27, 2021) (indicated for use by individuals 18 years of age and older). Fact sheets for health care providers administering treatment are available for each treatment product from FDA. However, on August 23, 2021, FDA licensed Pfizer-BioNTech's Comirnaty treatment.

Health care workers whose hesitancy was related to EUA status now have a fully licensed erectile dysfunction treatment option. Despite this, as noted earlier, health care staff vaccination rates remain sub-optimal in too many health care facilities and regions. For example, national erectile dysfunction treatment vaccination rates for LTC facility, hospital, and ESRD facility staff are 67 percent, 64 percent, and 60 percent, respectively.

Moreover, these averages obscure sizeable regional differences. Start Printed Page 61585 LTC facility staff vaccination rates range from lows of 56 percent to highs of over 90 percent, depending upon the State. Similar patterns hold for ESRD facility and hospital staff.[] Over half a million erectile dysfunction treatment cases and 1,900 deaths among health care staff have been reported to CDC since the start of the PHE.[] When submitting case-level erectile dysfunction treatment reports, State and territorial jurisdictions may identify whether individuals are or are not health care workers.

Since health care worker status has only been reported for a minority of cases (approximately 18 percent), these numbers are likely gross underestimates of true burden in this population. erectile dysfunction treatment case rates among staff have also grown in tandem with broader national incidence trends since the Delta variant's emergence. For example, as of mid-September 2021, erectile dysfunction treatment cases among LTC facility and ESRD facility staff have increased by over 1400 percent and 850 percent, respectively, since their lows in June 2021.[] Similarly, the number of cases among staff for whom case-level data were reported by State and territorial jurisdictions to CDC increased by nearly 600 percent between June and August 2021.[] Because they are at greater risk for developing erectile dysfunction treatment and severe disease,[] unvaccinated staff present a risk of exacerbating ongoing staffing shortages—particularly during periods of community surges in erectile dysfunction , when demand for health care services is most acute.

Health care staff who remain unvaccinated may also pose a direct threat to patient, resident, workplace, family, and community safety and population health. Data from CDC's National Healthcare Safety Network (NHSN) have shown that case rates among LTC facility residents are higher in facilities with lower vaccination coverage among staff. Specifically, residents of LTC facilities in which vaccination coverage of staff is 75 percent or lower experience higher crude rates of preventable erectile dysfunction .[] Similarly, several articles published in CDC's Morbidity and Mortality Weekly Reports (MMWRs) regarding nursing home outbreaks have also linked the spread of erectile dysfunction treatment to unvaccinated health care workers and stressed that maintaining a high vaccination rate is important for reducing transmission.[] And multiple studies have demonstrated erectile dysfunction transmissions between health-care workers and patients in hospitals, despite universal masking and other protocols.[] Acute and LTC facilities engage many, if not all, of the same health care professionals and support services of other provider and supplier types.

As a result, while similarly comprehensive data are not available for all Medicare- and Medicaid-certified provider and supplier types, we believe the LTC facilities experience may generally be extrapolated to other settings. The efficacy of erectile dysfunction treatment vaccinations has been demonstrated.[] An ASPE report published on October 5, 2021, found that erectile dysfunction treatments are a key component in controlling the erectile dysfunction treatment cialis. Clinical data show treatments are highly effective in preventing erectile dysfunction treatment cases and severe outcomes including hospitalization and death.

The ASPE analysis of individual-level health data and county-level vaccination rates found that higher county vaccination rates were associated with significant reductions in the odds of erectile dysfunction treatment , hospitalization, and death among Medicare fee-for-service (FFS) beneficiaries between January and May 2021. Further, comparing the rates of these outcomes to what ASPE modeling predicted would have happened without any vaccinations, we estimate erectile dysfunction treatment vaccinations were linked to estimated reductions of approximately 107,000 s, 43,000 hospitalizations, and 16,000 deaths in our study sample of 25.3 million beneficiaries. The report also noted that the difference in vaccination rates for those age 65 and older between the lowest (34 percent) and highest (85 percent) counties and states by the end of May highlights the continued opportunity to leverage erectile dysfunction treatment vaccinations to prevent erectile dysfunction treatment hospitalizations and deaths.[] treatments continue to be effective in preventing erectile dysfunction treatment associated with the now-dominant Delta variant.[] In addition to preventing morbidity and mortality associated with erectile dysfunction treatment, the treatments also appear to be effective against asymptomatic erectile dysfunction .

A recent study of health care workers in 8 states found that, between December 14, 2020, through August 14, 2021, full vaccination with erectile dysfunction treatments was 80 percent effective in preventing RT-PCR-confirmed erectile dysfunction among frontline workers.[] Emerging evidence also suggests that vaccinated people who become infected with Delta have potential to be less infectious than infected unvaccinated people, thus decreasing transmission risk.[] For example, in a study of breakthrough s among health care workers in the Netherlands, erectile dysfunction infectious cialis shedding was lower among vaccinated individuals with breakthrough s than Start Printed Page 61586 among unvaccinated individuals with primary s.[] As noted earlier in this section, a combination of factors, including but not limited to failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements, potential harm to patients from unvaccinated health-care workers, and continuing strain on the health care system and known efficacy and safety of available treatments, have persuaded us that a treatment mandate for health care workers is an essential component of the nation's erectile dysfunction treatment response. Further, it would endanger the health and safety of patients, and be contrary to the public interest to delay imposing it. Therefore, we believe it would be impracticable and contrary to the public interest for us to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC.

We find good cause to waive notice of proposed rulemaking under the APA, 5 U.S.C. 553(b)(B), and section 1871(b)(2)(C) of the Act. For those same reasons, as authorized by the Small Business Regulatory Enforcement Fairness Act of 1996 (the Congressional Review Act or CRA), 5 U.S.C.

808(2), we find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under section 801 of the CRA. Therefore, we find there is good cause to waive the CRA's delay in effective date pursuant to section 808(2) of the CRA. IV.

Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement (ICR) is submitted to the Office of Management and Budget (OMB) for review and approval. The ICRs in this section will be included in an emergency revision of the information collection request currently approved under the appropriate OMB Control number. All PRA-related comments received in response to this IFC will be reviewed and addressed in a subsequent, non-emergency, submission of the information collection request.

The emergency approval is only valid for 6 months. Within that 6-month approval period, CMS will seek a regular, non-emergency, approval and as required by the PRA, this action will be announced in the requisite 60-day and 30-day Federal Register notices. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues.

The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected.

Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs). For the estimated costs contained in the analysis below, we used data from the U.S.

Bureau of Labor Statistics (BLS) to determine the mean hourly wage for the positions used in this analysis.[] For the total hourly cost, we doubled the mean hourly wage for a 100 percent increase to cover overhead and fringe benefits, according to standard HHS estimating procedures. If the total cost after doubling resulted in 0.50 or more, the cost was rounded up to the next dollar. If it was 0.49 or below, the total cost was rounded down to the next dollar.

The total costs used in this analysis are indicated in Table 3. Start Printed Page 61587 Start Printed Page 61588 In this analysis, we used specific resources to estimate the burden for the providers and suppliers in this rule. Based upon our experience, there are minimal fluctuations in the numbers of providers and suppliers monthly.

Thus, unless otherwise indicated, all of the numbers for the providers and suppliers in this analysis were located on September 1, 2021 on the Quality, Certification &. Oversight Reports (QCOR) website at https://qcor.cms.gov/​main.jsp. For the number of employees for each provider and supplier, those numbers were obtained from Table 5.

Estimates of Number of Staff by Type of Provider (thousands) located in section VI.B. Of this IFC. This analysis is also based upon certain assumptions.

We believe that many of the providers and suppliers covered in this rule have already either encouraged their employees to get Start Printed Page 61589 vaccinated for erectile dysfunction treatment or have mandates for the treatment. Mandates for employees to be vaccinated for erectile dysfunction treatment can result from State, county, or local actions or result from a decision by the facility. These facilities would likely have already developed policies and procedures, as well as documentation requirements, related to their employees being vaccinated for erectile dysfunction treatment.

However, we have no reliable method to estimate the number or percentage of these facilities. In addition, it is likely that those facilities would not comply with all of the requirements in this rule. For example, many facilities might not define “employees” as set forth in this rule.

Each facility would have to review its policies, procedures, and documentation requirements to ensure that they comply with the requirements in this rule. Hence, based upon these assumptions, this analysis will assess the burden for all facilities and employees for each provider and supplier type. We also made some assumption regarding analysis of the burden for the documentation requirements.

If an employee receives the appropriate vaccinations, reviewing and documenting that the employee has been vaccinated would likely only require 1 to 3 minutes, depending upon how the facility is documenting the vaccination, which is likely to vary substantially between facilities. However, for employees that request exemptions or have to be contacted repeatedly for the appropriate documentation, it would likely take more time to comply with this requirement. At a minimum, both the initial request for the exemption and the final determination would have to be documented.

In cases where the exemption was denied and the employee receives the appropriate vaccinations, those treatment doses would also have to be documented. There might also be additional documentation that would need to be copied or scanned for their records. While the documentation for employees requesting an exemption would require more burden, we believe that there would only be a small percentage of employees that would request an exemption.

Since we have no reliable method for estimating a number or percentage of employees who would be in each category, we will analyze the burden for the documentation requirements using 5 minutes or 0.0833 hours for each employee. The position of the individual who would perform the activities related to the documentation requirement would also vary depending upon the type of provider or supplier and whether the employee requested an exemption. If the employee has been vaccinated in compliance with this rule, an administrative support person might review their vaccination card and document that the employee has been vaccinated.

However, if an administrative support person performs these activities, we believe an administrator or another member of the health care staff would be responsible for overseeing these activities. For other providers and suppliers, a nurse would likely be assigned to verify and document vaccination status. If an employee requests an exemption, we believe that a nurse, another health care professional, or an administrator would likely review the request and document it.

Some other providers or suppliers might have an administrator or another member of the health care staff perform these activities. Thus, for this analysis, if a provider is required to have at least one preventionist (IP), such as hospitals, we believe the IP would be responsible for documenting the vaccination status for all employees. For other providers and suppliers, we assessed the burden using a registered nurse (RN), another member of the health care staff, such as a physical therapist, or an administrator.

The estimates that follow are largely based on our experience with these various providers. However, given the uncertainty and rapidly changing nature of the current cialis, we acknowledge that there will likely need to be revisions to these requirements over time. We welcome comments that might improve these estimates.

A. ICRs Regarding the of Development of Policies and Procedures for ASCs § 416.51(c), “erectile dysfunction treatment Vaccination of Staff” 1. Policies and Procedures At § 416.51(c), we require ASCs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and track and maintain documentation of their vaccination status.

Each ASC must also have a contingency plan for any staff that are not fully vaccinated according to this rule. The ICRs for this section would require each ASC to develop the policies and procedures needed to satisfy all of the requirements in this section. Based upon our experience with ASCs, we believe some centers have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff.

However, each ASC will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC, especially that their policies and procedures cover all of the center staff as identified in this IFC. Hence, we will base our estimate for this ICR on all 6,071 ASCs. We believe activities associated with this IFC would be performed by the RN functioning as the designated and qualified control professional (ICP) and ASC administrator as analyzed below.

The ICP would conduct research and then either modify or develop the policies and procedures needed to comply with this section's requirements. The ICP would work with the ASC administrator in developing these policies and procedures. For the ICP, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements.

According to Table 3, the ICP's total hourly cost is $77. Thus, for each ASC, the burden for the ICP would be 8 hours at a cost of $616 (8 × $77). For the ICPs in all 6,071 ASCs, the burden would be 48,568 hours (8 × 6,071) at an estimated cost of $3,739,736 ($616 × 6,071).

As discussed above, the revision and approval of these initial policies and procedures would also require activities by the ASC administrator. The administrator would need to have meetings with the ICP to discuss the revisions and approve the final policies and procedures. We estimate this would require 2 hours for the administrator.

According to Table 3, the total hourly cost for the administrator is $98. The burden for the administrator in each ASC would be 2 hours at an estimated cost of $196 (2 × $98). For the administrators in all 6,071 ASCs, the burden would be 12,142 hours (2 × 6,071) at an estimated cost of $1,189,916 ($196 × 6,071).

Therefore, for all 6,071 ASCs, the estimated burden associated with the requirement for policies and procedures would be 67,010 hours (48,568 + 12,142) at a cost of $4,929,652 ($3,739,736 + $1,189,916). 2. Documentation and Storage Section 416.51(c) also requires ASCs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the center's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $77 for each employee. According to Table 3, ASCs have 200,000 employees.

Start Printed Page 61590 Hence, the burden for these documentation requirements for all 6,071 ASCs would be 16,660 (0.0833 × 200,000) hours at an estimated cost of $1,282,820 (16,660 × $77). The total burden for all 6,071 ASCs for this IFC would be 83,670 (67,010 + 16,660) hours at an estimated cost of $6,212,472 ($4,929,652 + $1,282,820). The requirements and burden will be submitted to OMB under OMB control number 0938-0266 (expiration date July 31, 2024).

B. ICRs Regarding the Development of Policies and Procedures for Hospices § 418.60(d), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures At § 418.60(d), we require hospices to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

The hospice must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each hospice to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations are set forth at § 418.60 Condition of participation.

control, and require each hospice to maintain and document an control program to prevent and control s and communicable diseases. The hospice must also follow accepted standards of practice, including the use of standard precautions to prevent the transmission of s and communicable diseases. Thus, all hospices should already have prevention and control policies and procedures, but they likely do not comply with all of the requirements in this IFC.

All hospices would need to review their current policies and procedures and modify them to comply with all of the requirements in § 418.60(d) as set forth in this IFC. While we believe that many hospices have already addressed erectile dysfunction treatment vaccination with their staff, we have no reliable means to estimate that number. Therefore, we will assess the burden for these requirements for all 5,556 hospices.

We believe these activities would be performed by the RN and an administrator. According to Table 3, an RN in these settings has a total hourly cost of $79. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures.

Thus, for each hospice, the burden for the RN would be 8 hours at a cost of $632 (8 hours × $79). For all 5,556 hospices, the burden would be 44,448 hours (8 hours × 5,556) at an estimated cost of $3,511,392 ($632 × 5,556). As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator.

The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator in this setting is $122.

Hence, for each hospice, the burden would be 2 hours at an estimated cost of $244 (2 × $122). For all 5,556 hospices, the total burden would be 11,112 hours (2 × 5,556) at an estimated cost of $1,355,664 (5,556 × $244). Thus, the total burden for hospices to comply with the requirements for policies and procedures in this IFC is 55,560 hours (44,448 + 11,112) at an estimated cost of $4,867,056 ($3,511,392 + $1,355,664).

2. Documentation and Storage Section 418.60(d) also requires hospices to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the hospice's policies and procedures for these activities is already accounted for above.

We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $79 for each employee. According to Table 3, hospices have 340,000 employees. Hence, the burden for these documentation requirements for all 5,556 hospices would be 28,322 (0.0833 × 340,000) hours at an estimated cost of $2,237,438 (28,322 × 79).

Therefore, the total burden for all 5,556 hospices for this rule would be 83,882 (55,560 + 28,322) hours at an estimated cost of $7,104,494 (4,867,056 + 2,237,438). The requirements and burden will be submitted to OMB under OMB control number 0938-1067 (expiration date March 31, 2024). C.

ICRs Regarding the Development of Policies and Procedures for PACE Organizations § 460.74(d), “erectile dysfunction treatment Vaccination of PACE Organization Staff” 1. Policies and Procedures Section 460.74(d) requires that programs for all-inclusive care for the elderly (PACE) organizations to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. Each PACE organization must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each PACE organization to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 460.74 already require that each PACE organization follow accepted policies and standard procedures with respect to control in place. Thus, all PACE organizations should have policies and procedures regarding prevention and control.

We also believe that many have already addressed erectile dysfunction treatment vaccination policies for their staff. However, since we do not have a reliable method to estimate how many have, we will assess the burden for all 141 PACE organizations. All PACE organizations would need to review their current prevention and control policies and procedures and develop or modify them to satisfy the requirements in this section.

We believe these activities would require an RN and an administrator. According to Table 3, an RN's total hourly cost is $74. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures.

Thus, for each PACE organization, the burden for the RN would be 8 hours at a cost of $592 (8 hours × $74). For all 141 PACE organizations, the burden would be 1,128 hours (8 hours × 141) at an estimated cost of $83,472 (592 × 141). As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator.

The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator is $122.

Hence, for each PACE organization, the burden would be 2 hours at an estimated cost of $244 (2 × 122). For all 141 PACE organizations, the total burden would be 282 hours (2 × 141) at an estimated cost of $34,404 (141 × $244). Thus, the total burden for all 141 PACE organizations to comply with the requirements for the policies and Start Printed Page 61591 procedures is 1,410 hours (1,128 + 282) at an estimated cost of $117,876 (83,472 + 34,404).

2. Documentation and Storage Section 460.74(d) also requires PACE organizations to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the PACE organization's policies and procedures for these activities is already accounted for above.

We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $74 for each employee. According to Table 3, PACE organizations have 10,000 employees. Hence, the burden for these documentation requirements for all 141 PACE organizations would be 833 (0.0833 × 10,000) hours at an estimated cost of $61,642 (833 × 74).

Therefore, the total burden for all 141 PACE organizations for this rule would be 2,243 (1,410 + 833) hours at an estimated cost of $179,518 (117,876 + 61,642). The requirements and burden will be submitted to OMB under OMB control number 0938-1326 (expiration date April 20, 2023). D.

ICRs Regarding the Development of Policies and Procedures for Hospitals § 482.42(g), “erectile dysfunction treatment Vaccination of Hospital Staff” 1. Policies and Procedures At § 482.42(g), we require hospitals to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The hospital must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each hospital to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 482.42 Condition of participation. prevention and control and antibiotic stewardship programs already require hospitals to have an prevention and control program (IPCP) and an preventionist (IP).

The IPCP must have methods to prevent and control the transmission of within the hospital and between the hospital and other settings. Thus, all 5,194 hospitals should already have prevention and control policies and procedures. However, each hospital would need to review their current policies and procedures and modify them, if necessary, to ensure compliance with all of the requirements in this IFC, especially that their policies and procedures cover all of the eligible facility staff identified in this IFC.

Based upon our experience with hospitals, we believe many hospitals have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff. Since we have no reliable means to estimate the number of hospitals that may have already addressed erectile dysfunction treatment vaccination of their staff, we will base our estimate for these requirements on all 5,194 hospitals. We believe these activities would be performed by the IP, the director of nursing (DON), and an administrator.

The IP would need to research erectile dysfunction treatments, modify the policies and procedures, as necessary, and work with the DON and administrator to develop the policies and procedures and obtain appropriate approval. For the IP, we estimate these activities would require 8 hours. According to Table 3, the IP's total hourly cost is $79.

Thus, for each hospital, the burden for the IP would be 8 hours at a cost of $632 (8 hours × 79). For the IPs in all 5,194 hospitals, the burden would be 41,552 hours (8 hours × 5,194) at an estimated cost of $3,282,608 (632 × 5,194). As discussed above, the revision and approval of these policies and procedures would also require activities by the DON and an administrator.

We believe these activities would require 2 hours each for the DON and an administrator. According to Table 3, the total adjusted hourly wage for both the DON and an administrator is $122. Hence, for each hospital, the burden would be 4 hours (2 × 2) at an estimated cost of $488 (4 × $122).

The total burden for all 5,194 hospitals would be 20,776 hours (4 × 5,194) at an estimated cost of $2,534,672 (5,194 × 488). Therefore, for all 5,194 hospitals, the total burden for the requirements for policies and procedures is 62,328 hours (41,552 + 20,776) at an estimated cost of $5,817,280 (3,282,608 + 2,534,672). 2.

Documentation and http://thieroutdoors.com/guest-stories/ Storage Section 482.42(g) also requires hospitals to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the hospital's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $79 for each employee.

According to Table 3, hospitals have 6,070,000 employees. We could not locate a reliable number for critical access hospital (CAH) employees so they are included here with the hospital employees. Hence, the burden for these documentation requirements for all 5,194 hospital and 1,358 CAHs would be 505,631 (0.0833 × 6,070,000) hours at an estimated cost of $39,944,849 (505,631 × 79).

Therefore, the total burden for this rule for all 5,194 hospitals and 1,358 CAHs (documentation burden only) would be 567,959 (62,328 + 505,631) hours at an estimated cost of $45,762,129 (5,817,280 + 39,944,849). The requirements and burden will be submitted to OMB as an emergency reinstatement of an existing OMB control number 0938-0328. E.

ICRs Regarding the Development of Policies and Procedures for LTC Facilities § 483.80(i), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures At § 483.80(i), we require LTC facilities to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The LTC facility must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each LTC facility to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 483.80(d)(1) and (2) already require LTC facilities to have policies and procedures to educate, offer, and document vaccination status for residents regarding the influenza and pneumococcal immunizations. In addition, § 483.80(d)(3) requires LTC facilities to educate, offer, and document the vaccination status for residents and staff for the erectile dysfunction treatment immunizations.

Based upon our experience with LTC facilities, we believe some facilities have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff, including erectile dysfunction treatment mandates. However, we have no reliable means to estimate the number or percentage of LTC facilities that have already mandated vaccination. Hence, we will base our estimate for this ICR on all 15,401 LTC facilities.

Each LTC facility would need to review its policies and procedures for § 483.80(d) and modify them to comply with the requirements in this rule at § 483.80(i) and obtain the appropriate review and approval. This would require conducting research and revising the policies and procedures as needed. We believe these activities Start Printed Page 61592 would be performed by the preventionist (IP), director of nursing (DON), and medical director for the first year and the IP in subsequent years as analyzed below.

The IP would need to work with the DON and medical director to revise and finalize the policies and procedures. For the IP, we estimate this would require 2 hours initially to perform research and revise the policies and procedures to meet these requirements. According to Table 3, the IP's total hourly cost is $69.

Thus, for each LTC facility, the burden for the IP would be 2 hours at a cost of $138 (2 hours × 69). For the IPs in all 15,401 LTC facilities, the burden would be 30,802 hours (2 hours × 15,401 facilities) at an estimated cost of $2,125,338 (138 × 15,401). As discussed above, the revision and approval of these policies and procedures would also require activities by the DON and medical director.

Both the DON and medical director would need to have meetings with the IP to discuss the revision, evaluation, and approval of the policies and procedures. We estimate this would require 1 hour for both the DON and medical director. According to Table 3, the total hourly cost for the DON is $96.

The burden in the first year for the DON in each LTC facility would be 1 hour at an estimated cost of $96 (1 hour × 96). The burden would be 15,401 hours (1 × 15,401) at an estimated cost of $1,478,496 (96 × 15,401) for all LTC facilities. For the medical director, we have estimated the revision of policies and procedures would also require 1 hour.

According to the chart above, the total hourly cost for the medical director is $171. For each LTC facility, this would require 1 hour for the medical director during the first year at an estimated cost of $171 (1 hour × $171). The burden for all LTC facilities would be 15,401 hours (1 × 15,401) at an estimated cost of $2,633,571 (171 × 15,401).

Therefore, for all 15,401 LTC facilities in the first year, the estimated burden for the policies and procedures requirement would be 61,604 hours (30,802 + 15,401 + 15,401) at a cost of $6,237,405 (2,125,338 + 1,478,496 + 2,633,571). 2. Documentation and Storage Section 483.80(i) also requires LTC facilities to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. The PRA package submitted under OMB Control No. 0938-1363 already provides for the documentation burden for the IP for the LTC facility's prevention and control program (IPCP) under which the requirements in this rule will also be located.

We believe the burden for the documentation requirements in this rule should be included in that burden. Therefore, we will not assess any additional burden for the documentation requirements in this rule. The requirements and burden will be submitted to OMB under OMB control number 0938-1363 (expiration date June 30, 2022).

F. ICRs Regarding the Development of Policies and Procedures for PRTFs § 441.151(c), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures Section 441.151(c) requires psychiatric residential treatment facilities (PRTFs) to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

The PRTF must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each PRTF to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations for PRTFs do not address prevention and control or vaccinations.

Hence, although we believe that at least some PRTFs have already addressed erectile dysfunction treatment vaccination of their staff, we will assess the burden for all 357 PRTFs. We believe these activities would be performed by an RN and an administrator. According to Table 3, an RN's total hourly cost is $74.

Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each PRTF, the burden for the RN would be 8 hours at a cost of $592 (8 hours × 74). For all 357 PRTFs, the burden would be 2,856 hours (8 hours × 357) at an estimated cost of $211,344 (592 × 357).

As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours.

According to Table 3, the total hourly cost for the administrator is $122. Hence, for each PRTF, the burden would be 2 hours at an estimated cost of $244 (2 × 122). For all 357 PRTFs, the total burden would be 714 hours (2 × 357) at an estimated cost of $87,108 (357 × 244).

Thus, the total burden for all 357 PRTFs to comply with the policies and procedures requirements in this IFC for policies and procedures is 3,570 hours (2,856 + 714) at an estimated cost of $298,452 (211,344 + 87,108). 2. Documentation and Storage Section 441.151(c) also requires PRTFs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $74 for each employee. According to Table 3, PRTFs have 30,000 employees.

Hence, the burden for these documentation requirements for all 357 PRTFs would be 2,499 (0.0833 × 30,000) hours at an estimated cost of $184,926 (2,499 × 74). Therefore, the total burden for all 357 PRTFs for this rule would be 6,069 (3,570 + 2,499) hours at an estimated cost of $483,378 (298,452 + 184,926) The requirements and burden will be submitted to OMB under OMB control number 0938-0833 (expiration date May 31, 2022). G.

ICRs Regarding the Development of Policies and Procedures for ICFs-IID § 483.430(f), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures At § 483.430(f), we require ICFs-IID to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The ICFs-IID must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each ICFs-IID to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 483.470(l) Standard. control requires that the ICFs-IID must provide a sanitary environment to avoid sources and transmission of s.

The facility must also implement successful corrective action in affected problem areas, maintain a record of incidents and corrective actions related to s, and prohibit employees with symptoms or sign of a communicable Start Printed Page 61593 disease from direct contact with clients and their food. Hence, ICFs-IID should already have policies and procedures for prevention and control. We believe these activities would be performed by the RN.

According to Table 3, an RN's total hourly cost is $69. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each ICFs-IID, the burden for the RN would be 8 hours at a cost of $552 (8 hours × 69).

For all 5,780 ICFs-IID, the burden would be 46,240 hours (8 hours × 5,780) at an estimated cost of $3,190,560 (552 × 5,780). As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes.

We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator is $96. Hence, for each ICFs-IID, the burden would be 2 hours at an estimated cost of $192 (2 × 96).

For all 5,780 ICFs-IID, the total burden would be 11,560 hours (2 × 5,780) at an estimated cost of $1,109,760 (5,780 × 192). Thus, the total burden for all 5,780 ICFs-IID to comply with the requirements for policies and procedures is 57,800 hours (46,240 + 11,560) at an estimated cost of $4,300,320 (3,190,560 + 1,109,760). 2.

Documentation and Storage Section 483.430(f) also requires ICFs-IID to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $69 for each employee.

According to Table 3, ICFs-IID have 80,000 employees. Hence, the burden for these documentation requirements for all 5,780 ICFs-IID would be 6,664 (0.0833 × 80,000) hours at an estimated cost of $459,816 (6,664 × $69). Therefore, the total burden for all 5,780 ICFs-IID for this rule would be 64,464 (57,800 + 6,664) hours at an estimated cost of $4,760,136 (4,300,320 + 459,816).

The requirements and burden will be submitted to OMB under OMB control number 0938-1402 (expiration date September 30, 2024). H. ICRs Regarding the Development of Policies and Procedures for HHAs § 484.70(d), “erectile dysfunction treatment Vaccination of Home Health Agency Staff” 1.

Policies and Procedures At § 483.70(d), we require HHAs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The HHA must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each HHA to develop the policies and procedures needed to satisfy all of the requirements in this section.

Current regulations at § 483.70, Condition of participation. prevention and control require each HHA to maintain and document an control program to prevent and control s and communicable diseases. The HHA must follow accepted standards of practice, including the use of standard precautions to prevent the transmission of s and communicable diseases.

Thus, all HHA should already have prevent and control policies and procedures, but they likely do not comply with all of the requirements in this IFC. All HHAs would need to review their current policies and procedures and modify them to comply with all of the requirements in § 483.70(d), as set forth in this IFC. While we believe that many HHAs have already addressed erectile dysfunction treatment vaccination with their staff, we have no reliable means to estimate that number.

Therefore, we will assess the burden for these requirements for all 11,649 HHAs. We believe these activities would be performed by the RN and an administrator. According to Table 3, an RN in home health services total hourly cost is $73.

Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each HHA, the burden for the RN would be 8 hours at a cost of $584 (8 hours × 73). For all 11,649 HHAs, the burden would be 93,192 hours (8 hours × 11,649) at an estimated cost of $6,803,016 (584 × 11,649).

As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours.

According to Table 3, the total hourly cost for the administrator in home health services is $97. Hence, for each HHA, the burden would be 2 hours at an estimated cost of $194 (2 × 97). For all 11,649 HHAs, the total burden would be 23,298 hours (2 × 11,649) at an estimated cost of $2,259,906 (11,649 × 194).

Thus, the total burden for all 11,649 HHAs to comply with the policies and procedures requirements for policies and procedures is 116,490 hours (93,192 + 23,298) at an estimated cost of $9,062,922 (6,803,016 + 2,259,906). 2. Documentation and Storage Section 483.70(d) also requires HHAs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the agency's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $73 for each employee. According to Table 3, HHAs have 2,110,000 employees.

Hence, the burden for these documentation requirements for all 11,649 HHAs would be 175,763 (0.0833 × 2,110,000) hours at an estimated cost of $12,830,699 (175,763 × 73). Therefore, the total burden for all 11,649 HHAs for this rule would be 292,253 (116,490 + 175,763) hours at an estimated cost of $21,893,621 (9,062,922 + 12,830,699). The requirements and burden will be submitted to OMB under OMB control number 0938-1299 (expiration date June 30, 2024).

I. ICRs Regarding the Development of Policies and Procedures for CORFs § 485.70(n), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures At § 485.70(n), we require CORFs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

Each CORF must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each CORF to develop the policies and procedures needed to satisfy all of the requirements in this section. This IFC requires CORF staff to receive the erectile dysfunction treatment unless medically contraindicated as determined by a physician, advance practice registered nurse, or physician Start Printed Page 61594 assistant acting within their respective scope of practice as defined by and in accordance with all applicable State and local laws.

Based upon our experience with CORFs, we believe some facilities have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated. However, each CORF will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC, especially that their policies and procedures cover all of the organization staff identified in this IFC. Hence, we will base our estimate for this ICR on all 159 CORFs.

The CORF's governing body appoints an administrator who implements and enforces the facility's policies and procedures. Hence, we believe activities associated with this IFC would be performed by the administrator as analyzed below. The governing body would also need to review these policies and procedures, which would be included in its “legal responsibility for establishing and implementing policies regarding the management and operation of the facility.” The administrator would conduct research to either modify or develop policies and procedures.

For the administrator, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements. According to Table 3, the administrator's total hourly cost is $98. Thus, for each CORF, the burden for the administrator would be 8 hours at a cost of $784 (8 × 98).

For the administrators in all 159 organizations, the burden would be 1,272 hours (8 × 159) at an estimated cost of $124,656 (784 × 159). The administrator would need to spend time attending governing body meetings to discuss and obtain approval for the policies and procedures. However, that would be a usual and customary business practice.

Therefore, activities for the administrator associated with governing body approval for the policies and procedures are exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). 2. Documentation and Storage Section 485.70(n) also requires CORFs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an administrator 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $98 for each employee. According to Table 3, CORFs have 10,000 employees.

Hence, the burden for these documentation requirements for all 159 CORFs would be 833 (0.0833 × 10,000) hours at an estimated cost of $81,634 (833 × 98). Therefore, the total burden for all 159 CORFs for this rule would be 2,105 (1,272 + 833) hours at an estimated cost of $206,290 (124,656 + 81,634). The requirements and burden will be submitted to OMB under OMB control number 0938-1091 (expiration date November 30, 2022).

J. ICRs Regarding the Development of Policies and Procedures for CAHs § 485.640(f), “erectile dysfunction treatment Vaccination of CAH Staff” 1. Policies and Procedures At § 485.640(f), we require critical access hospitals (CAHs) to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

The CAH must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each CAH to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 485.640 Condition of participation.

prevention and control and antibiotic stewardship programs already require CAHs to have an prevention and control program (IPCP) and an preventionist (IP). The IPCP must have methods to prevent and control the transmission of within the hospital and between the hospital and other settings. Thus, all 1,358 CAHs should already have prevention and control policies and procedures.

However, each CAH would need to review their current policies and procedures and modify them, if necessary, to ensure compliance with all of the requirements in this IFC, especially that their policies and procedures cover all of the eligible facility staff identified in this IFC. Based upon our experience with CAHs, we believe many CAHs have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff. Since we have no reliable means to estimate the number of CAHs that may have already addressed erectile dysfunction treatment vaccination of their staff, we will base our estimate for these requirements on all 1,358 CAHs.

We believe these activities would be performed by the IP, the director of nursing (DON), and an administrator. The IP would need to research erectile dysfunction treatments, modify the policies and procedures, as necessary, and work with the DON and administrator to develop the policies and procedures and obtain appropriate approval. For the IP, we estimate these activities would require 8 hours.

According to Table 3, the IP's total hourly cost is $79. Thus, for each hospital, the burden for the IP would be 8 hours at a cost of $632 (8 hours × 79). For the IPs in all 1,358 CAHs, the burden would be 10,864 hours (8 hours × 1,358) at an estimated cost of $858,256 (632 × 1,358).

As discussed above, the revision and approval of these policies and procedures would also require activities by the DON and an administrator. We believe these activities would require 2 hours each for the DON and an administrator. According to Table 3, the total adjusted hourly wage for both the DON and an administrator is $122.

Hence, for each CAH the burden would be 4 hours (2 × 2) at an estimated cost of $488 (4 × $122). The total burden for all 1,358 CAHs would be 5,432 hours (4 × 1,358) at an estimated cost of $662,704 (1,358 × 488). Therefore, for all 1,358 CAHs the total burden for the requirements for policies and procedures is 16,296 hours (10,864 + 5,432) at an estimated cost of $1,520,960 ($858,256 + $662,704).

2. Documentation and Storage Section 485.640(f) also requires CAHs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the CAH's policies and procedures for these activities is already accounted for above.

Since we were unable to located a reliable number for CAH employees, the documentation burden for CAHs resulting from the documentation requirement in this rule is included in the hospitals' burden above. The requirements and burden for CAHs without DPUs will be submitted to OMB under OMB control number 0938-1043 (expiration date March 31, 2024). The requirements and burden for CAHs with DPUs will be submitted to OMB under OMB control number 0938-0328(expired).

Start Printed Page 61595 K. ICRs Regarding the Development of Policies and Procedures for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (Organizations) § 485.725(f), “erectile dysfunction treatment Vaccination of Organization Staff” 1. Policies and Procedures At § 485.725(f), we require organizations to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and the appropriate documentation is tracked and maintained.

The organization must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each organization to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 485.725(a) require organizations to establish an -control committee of representative professional staff with overall responsibility for control.

This committee establishes policies and procedures for investigating, controlling, and preventing s in the organization and monitors staff performance to ensure compliance with those policies and procedures. Based upon these requirements and our experience with organizations, we believe some organizations have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated. However, since we have no reliable means to estimate how many organizations have done this, we will assess the burden for all 2,078 organizations.

All organizations would need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC. The types of therapists at each organization vary depending upon the services offered. For the purposes of determining the COI burden, we will assume that the therapist is a physical therapist.

We believe activities associated with this IFC would be performed by a physical therapist and administrator. A physical therapist would need to conduct research on the erectile dysfunction treatments and then develop or modify policies and procedures that comply with the requirements in this IFC. The physical therapist would need to work with an administrator to make the necessary revisions.

For the physical therapist, we estimate this would require 8 hours to perform research and revise or develop the policies and procedures to meet these requirements. According to Table 3, the physical therapist's total hourly cost is $84. Thus, for each organization, the burden for the physical therapist would be 8 hours at a cost of $672 (8 × 84).

For the physical therapists in all 2,078 organizations, the burden would be 16,624 hours (8 × 2,078) at an estimated cost of $1,396,416 (672 × 2,078). As discussed above, the revision and approval of these policies and procedures would also require activities by the administrator. The administrator would need to have meetings with the physical therapist to discuss the revisions and draft any necessary policies and procedures, as well as approve the final policies and procedures.

We estimate this would require 2 hours for the administrator. According to Table 3, the total hourly cost for the administrator is $98. The burden for the administrator in each organization would be 2 hours at an estimated cost of $196 (2 × 98).

For the administrators in all 2,078 organizations, the burden would be 4,156 hours (2 × 2,078) at an estimated cost of $407,288 (4,156 × 98). Therefore, for all 2,078 organizations, the total burden for the requirements for policies and procedures is 20,780 hours (16,624 + 4,156) at an estimated cost of $1,803,704 (1,396,416 + 407,288). 2.

Documentation and Storage Section 485.725(f) also requires organizations to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the organization's policies and procedures for these activities is already accounted for above. We believe that this would require a physical therapist 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $84 for each employee.

According to Table 3, these organizations have 10,000 employees. Hence, the burden for these documentation requirements for all 2,078 organizations would be 833 (0.0833 × 10,000) hours at an estimated cost of $69,972 (833 × 84). Therefore, the total burden for all 2,078 organizations for this rule would be 21,613 (20,780 + 833) hours at an estimated cost of $1,873,676 (1,803,704 + 69,972).

The requirements and burden will be submitted to OMB under OMB control number 0938-0273 (expiration date June 30, 2024). L. ICRs Regarding the Development of Policies and Procedures for CMHCs § 485.904(c), “erectile dysfunction treatment Vaccination of Center Staff” 1.

Policies and Procedures At § 485.904(c), we require CHMCs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. Each facility must maintain documentation of their staff's vaccination status. Also, each facility must have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each CHMC to develop the policies and procedures needed to satisfy all of the requirements in this section. Based upon our experience with CHMCs, we believe some centers have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated. However, since we do not have a reliable means to estimate how many CMHCs have done so, we will estimate the burden based on all 129 CHMCs.

Each CMHC will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC. Based on these requirements and our experience with CHMCs, we believe these activities would be performed by the CHMC administrator and a mental health counselor. The administrator would conduct research regarding the erectile dysfunction treatments and then either modify or develop the policies and procedures necessary to comply with the requirements in this IFC.

The administrator would send any recommendations for changes or additional policies or procedures to the mental health counselor. The administrator and mental health clinician would need to make the necessary revisions and draft any necessary policies and procedures. For the administrator, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements.

According to Table 3, the administrator's total hourly cost is $113. Thus, for each CMHC, the burden for the administrator would be 8 hours at a cost of $904 (8 × 113). The burden for the administrators in all 129 CHMCs would be 1,032 hours (8 × 129) at an estimated cost of $116,616 (904 × 129).

As discussed above, the revision and approval of these initial policies and procedures would also require activities Start Printed Page 61596 by the mental health counselor. The administrator would need to have meetings with the mental health counselor to discuss the revisions and draft any necessary policies and procedures. We estimate this would require 2 hours for the mental health counselor.

According to Table 3, the total hourly cost for the mental health counselor is $118. The burden for the mental health counselor in each CHMC would be 2 hours at an estimated cost of $236 (2 × 118). For the mental health counselors in all 129 CMHCs, the burden would be 258 hours (2 × 129) at an estimated cost of $30,444 (129 × 236).

Therefore, for all 129 CMHCs, the total burden for the requirements for policies and procedures is 1,290 hours (1,032 + 258) at an estimated cost of $147,060 (116,616 + 30,444). 2. Documentation and Storage Section 485.904(c) also requires CMHCs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the center's policies and procedures for these activities is already accounted for above. We believe that this would require an administrator 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $113 for each employee. According to Table 3, CMHCs have 140,000 employees.

Hence, the burden for these documentation requirements for all 129 CMHCs would be 11,662 (0.0833 × 140,000) hours at an estimated cost of $1,317,806 (11,662 × 113). Therefore, the total burden for all 129 CMHCs for this rule would be 12,952 (1,290 + 11,662) hours at an estimated cost of $1,464,866 (147,060 + 1,317,806). The requirements and burden will be submitted to OMB under OMB control number 0938-1245 (expiration date April 30, 2023).

M. ICRs Regarding the Development of Policies and Procedures for HIT Suppliers § 486.525(c), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures Section 486.525(c) requires home infusion therapy (HIT) suppliers to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

The HIT supplier must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each HIT supplier to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 486.525 already require that HIT suppliers provide their services in accordance with nationally recognized standards of practice.

Thus, we believe most HIT suppliers should already have prevention and control policies and procedures, including erectile dysfunction treatment vaccination. However, we have no reliable means to estimate how many suppliers have done so. Thus, we will base our burden estimate on all 337 HIT suppliers.

All HIT suppliers would need to review their current policies and procedures and develop or modify them to comply with all of the requirements in § 486.525(c) as set forth in this IFC. We believe these activities would be performed by the RN and an administrator working for the HIT supplier. According to Table 3, an RN working with for a HIT supplier would have a total hourly cost of $73.

Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each HIT supplier, the burden for the RN would be 8 hours at a cost of $584 (8 hours × 73). For all 337 HIT suppliers, the burden would be 2,696 hours (8 hours × 337) at an estimated cost of $24,601 (337 × 73).

The development and/or revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours.

According to Table 3, the total hourly cost for the administrator working for a HIT supplier is $97. Hence, for each HIT supplier, the burden would be 2 hours at an estimated cost of $194 (2 × 97). For all 337 HIT suppliers, the total burden for the administrator would be 674 hours (2 hours × 337) at an estimated cost of $65,378 (337 × 194).

Therefore, for all 337 HIT suppliers, the total burden for the requirements for policies and procedures is 3,370 hours (2,696 + 674) at an estimated cost of $89,979 (24,601 + 65,378). 2. Documentation and Storage Section 486.525(c) also requires HIT suppliers to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the supplier's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $73 for each employee. According to Table 3, HIT suppliers have 20,000 employees.

Hence, the burden for these documentation requirements for all 337 HIT suppliers would be 1,666 (0.0833 × 20,000) hours at an estimated cost of $121,618 (1,666 × 73). Therefore, the total burden for all 337 HIT suppliers for this rule would be 5,036 (3,370 + 1,666) hours at an estimated cost of $211,597 (89,979 + 121,618). The requirements and burden will be submitted to OMB under OMB control number 0938-855B (expiration date March 31, 2024).

N. ICRs Regarding the Development of Policies and Procedures for RHCs and FQHCs § 491.8(d), “erectile dysfunction treatment Vaccination of Staff” 1. Policies and Procedures At § 491.8(d), we require RHCs/FQHCs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

Each RHC/FQHC must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each RHC/FQHC to develop the policies and procedures needed to satisfy all of the requirements in this section. This IFC requires clinic or center staff to receive the erectile dysfunction treatment unless medically contraindicated as determined by a physician, advance practice registered nurse, or physician assistant acting within their respective scope of practice as defined by and in accordance with all applicable State and local laws.

Based upon experience with RHCs/FQHCs, we believe some clinics or centers have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated. However, since we do not have a reliable means to estimate how many facilities have already done so, we will base the burden analysis for this estimate on all 15,317 RHC/FQHCs (4,933 RHCs and 10,384 FQHCs). Each RHC/FQHC will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC, especially that their policies and procedures cover all of the clinic or center staff identified in this IFC.

Current regulations require a physician, Start Printed Page 61597 nurse practitioner, and physician assistant to participate in the development, execution, and periodic review of the policies and procedures.[] Moreover, the RHC/FQHC operates under the medical direction of a physician. Based on these requirements and our experience with RHCs/FQHCs, we believe activities associated with this IFC would be performed by the RHC administrator, physician, nurse practitioner, physician assistant, and medical director as analyzed below. The administrator would conduct research to either modify or develop policies and procedures.

The administrator would send any recommendations for changes or additional policies or procedures to the physician, nurse practitioner, and physician assistant. The administrator, physician, nurse practitioner, and physician assistant would need to make the necessary revisions and draft any necessary policies and procedures. The administrator would need to work with the medical director to obtain approval for the policies and procedures to be implemented.

For the administrator, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements. According to Table 3, the administrator's total hourly cost is $108. Thus, for each RHC/FQHC, the burden for the administrator would be 8 hours at a cost of $864 (8 × 108).

For the administrators in all 15,317 RHCs/FQHCs, the burden would be 122,536 hours (8 × 15,317) at an estimated cost of $13,233,888 (864 × 15,317). As discussed above, the revision and approval of these initial policies and procedures would also require activities by the physician, nurse practitioner, physician assistant, and medical director. The administrator would need to have meetings with the physician, nurse practitioner, and physician assistant to discuss the revisions and draft any necessary policies and procedures.

The administrator would also need to have meetings with the medical director to obtain approval for the policies and procedures. We estimate this would require 2 hours each for the physician, nurse practitioner, and physician assistant. For the medical director, we estimate 1 hour would be required to perform this function.

According to Table 3, the total hourly cost for the physician is $212. The burden for the physician in each RHC/FQHC would be 2 hours at an estimated cost of $424 (2 × 212). For the physicians in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours (2 × 15,317) at an estimated cost of $6,494,408 (424 × 15,317).

The hourly cost for the nurse practitioner is $107. The burden for the nurse practitioner in each RHC/FQHC would be 2 hours at an estimated cost of $214 (2 × 107). For the nurse practitioners in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours (2 × 15,317) at an estimated cost of $3,277,838 ($214 × 15,317).

The hourly cost for the physician assistant is $111. The burden for the physician assistant in each RHC/FQHC would be 2 hours at an estimated cost of $222 (2 × 111). For the physician assistants in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours (2 × 15,317) at an estimated cost of $3,400,374 (15,317 × 222).

The hourly cost for the medical director is $212. The burden for the medical director in each RHC/FQHC would be 1 hour at an estimated cost of $212. For the medical directors in all 15,317 RHCs/FQHCs, the burden would be 15,317 hours (1 × 15,317) at an estimated cost of $3,247,204 (15,317 × 212).

Therefore, for all 15,317 RHCs/FQHCs, the estimated burden associated with the policies and procedures requirement would be 229,755 hours (122,536 + 30,634 + 30,634 + 30,634 + 15,317) at a cost of $29,653,712 (13,233,888 + 6,494,408 + 3,277,838 + 3,400,374 + 3,247,204). 2. Documentation and Storage Section 491.8(d) also requires RHCs/FQHCs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the clinic's or center's policies and procedures for these activities is already accounted for above. We believe that this would require an administrator 5 minutes or 0.0833 hours to perform the required documentation at an adjusted hourly wage of $108 for each employee. According to Table 3, RHCs have 40,000 employees and FQHCs have 110,000 employees for a total of 150,000 employees.

Hence, the burden for these documentation requirements for all 15,317 RHCs and FQHCs would be 12,495 (0.0833 × 150,000) hours at an estimated cost of $1,349,460 (12,495 × 108). Therefore, the total burden for all 15,317 RHCs and FQHCs for this rule would be 242,250 (229,755 + 12,495) hours at an estimated cost of $31,003,172 (29,653,712 + 1,349,460). The requirements and burden will be submitted to OMB under OMB control number 0938-0334 (expiration date March 31, 2023).

O. ICRs Regarding the Development of Policies and Procedures for ESRD Facilities § 494.30(b), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures Section 494.30(b) requires the ESRD facilities to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

The ESRD facility must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each ESRD facility to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 494.30 already require that ESRD facilities follow standard control precautions.

Thus, all ESRD facilities should have prevention and control policies and procedures. We believe that many ESRD facilities have already addressed erectile dysfunction treatment vaccination for their staff. However, we have no reliable means to estimate how many ESRD facilities have done so.

Thus, we will base our burden estimate on all 7,893 ESRD facilities. All ESRD facilities would need to review their current policies and procedures and develop or modify them to comply with all of the requirements in § 494.30(b) as set forth in this IFC. We believe these activities would be performed by the RN and an administrator.

According to Table 3, an RN working with for an ESRD facility would have a total hourly cost of $73. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each ESRD facility, the burden for the RN would be 8 hours at a cost of $584 (8 hours × $73).

For all ESRD facilities, the burden would be 63,144 hours (8 hours × 7,893) at an estimated cost of $4,609,512 (7,893 × 584). The development and/or revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes.

We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator at an ESRD facility is $97. Hence, for each ESRD, the burden for the administrator would be 2 hours at an estimated cost of $194 (2 × 97).

For all ESRD facilities, the total burden would be 15,786 hours Start Printed Page 61598 (2 × 7,893) at an estimated cost of $1,531,242 (7,893 × 194). Thus, the total burden for all ESRD facilities for the policies and procedures requirement would be 78,930 hours (63,144 + 15,786) at an estimated cost of $6,140,754 ($4,609,512 + $1,531,242). 2.

Documentation and Storage Section 494.30(b) also requires ESRD facilities to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at an adjusted hourly wage of $73 for each employee.

According to Table 3, ESRD facilities have 170,000 employees. Hence, the burden for these documentation requirements for all 7,893 ESRD facilities would be 14,161 (0.0833 × 170,000) hours at an estimated cost of $1,033,753 (14,161 × 73). Therefore, the total burden for all 7,893 ESRD facilities for this rule would be 93,091 (78,930 + 14,161) hours at an estimated cost of $ 7,174,507 (6,140,754 + 1,033,753).

The requirements and burden will be submitted to OMB under OMB control number 0938-0386 (expiration date March 31, 2024). Based upon the above analysis, the total burden for all of the ICRs in this IFC is 1,555,487 hours at an estimated cost of $136,088,221. Start Printed Page 61599 Start Printed Page 61600 Start Printed Page 61601 If you comment on these information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments electronically as specified in the ADDRESSES section of this IFC.

Comments must be received on/by January 4, 2022. V. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually.

We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. VI. Regulatory Impact Analysis A.

Statement of Need The erectile dysfunction treatment cialis has precipitated the greatest public health crisis in the U.S. Since the 1918 Influenza cialis. The population of older adults, and LTC facility residents in particular, have been hard hit by the impacts of the cialis.

Among those infected, the death rate for older adults age 65 or higher was hundreds of time higher than for those in their 20s during 2020.[] Of the approximately 656,000 Americans estimated to have died from erectile dysfunction treatment through September 10, 2021,[] 30 percent are estimated to have died during or after an LTC facility stay, although these numbers are decreasing as vaccination rates increase in residents and staff as shown in the CDC Data Tracker. Despite the recent nation-wide surge in s from the Delta variant of erectile dysfunction treatment, uptake of treatments and other measures (masking, screening visitors, and social distancing in particular) to prevent erectile dysfunction treatment, in combination with available therapeutic options to treat, has reduced erectile dysfunction treatment-related patient deaths in all settings. But reductions in erectile dysfunction treatment-related morbidity and mortality depend critically on continued success in vaccination of all health care staff and patients.

The May 13, 2021 erectile dysfunction treatment IFC (86 FR 26306) required offering vaccination to residents and staff, but did not mandate vaccination. Recently, however the Departments of Defense and Veterans Affairs staff, and civilian Federal Government employees have become subject to requirements similar to those imposed in this rule.[] This IFC will close a gap in current regulations for all categories of health care provider whose health and safety practices are directly regulated by CMS. Almost all CMS-regulated providers and suppliers disproportionately serve people who are older, disabled, chronically ill, or who have complex health care needs.[] Because the health care sector has such widespread and direct contact with hundreds of millions of patients, clients, residents, and program participants, the protective scope of this rule is far broader than the health care staff that it directly affects.

B. Overall Impact We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L.

96-354), section 1102(b) of the Social Security Act, section 202 of the Start Printed Page 61602 Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L.

104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as “economically significant”). (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency.

(3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared an RIA that, taken together with COI section and other sections of the preamble, presents to the best of our ability the costs and benefits of the rulemaking. This RIA focuses on the overall costs and benefits of the rule, taking into account vaccination uptake to date or anticipated over the next year that is not due to this rule, and estimating the likely additional effects of this rule on both provider staff and the patients with whom they come in contact.

We analyze both the costs of the required actions and the payment of those costs. As intended under these requirements, this RIA's estimates cover only those costs and benefits that are likely to be the effects of this rule. There are also several unknowns that may affect current progress or this rule or both.

These include the duration of strong treatment protection with or without a booster shot and the possibility of new cialis variants that reduce the effectiveness of currently authorized and approved treatments. We cannot estimate the effects of each of the possible interactions among them, but throughout the analysis we point out some of the most important assumptions we have made and the possible effects of alternatives to those assumptions. The providers and suppliers regulated under this rule are diverse in nature, management structure, and size.

That said, we believe that the costs faced by regulated entities will be very similar on a “per person vaccinated” basis. Tables 5 and 6 show the full scope of provider and supplier types, facility structures, and staff sizes, taking into account part-time staff (Table 5) and estimated staff turnover (Table 6). As explained earlier in the preamble, this rule includes facility contractors and consulting specialists as well as other persons providing part-time or occasional services to these providers and suppliers and their patients.

In Table 5 we provide a rough estimate of the likely number of full-time employees and other employees and contractors subject to this rule. The “total staff” number in the rightmost column is the number of individual staff directly affected at the time this rule takes effect (adding the number of full-time employees to the number of part-time employees, contractors, and other business persons who have recurring patient or staff interactions). Start Printed Page 61603 This rule presents additional difficulties in estimating both costs and benefits due to the high degree to which all current provider and supplier staff Start Printed Page 61604 have already received information about the benefits and safety of erectile dysfunction treatment vaccination, and the rare serious risks associated with it.

Despite this progress, the proportion of fully vaccinated health care staff has approached but not hit the 70 percent with significant variation among states. Moreover, among the general population more than 600,000 persons a day are currently being vaccinated with the first or second shot and about 100,000 a day have recovered from and are only in very rare cases still infectious. These changes reduce the risk to both health care staff and patients substantially, likely by about 20 million persons a month who are no longer sources of future s.[] This in turn reduces the number of newly infected cases (currently about 100,000 a day and decreasing rapidly).

Yet another variable of importance is the increasing number of providers and suppliers that are mandating employee vaccination, and the increasing number of states that are doing so as well. To characterize the baseline scenario of no new regulatory action, from which we estimate the incremental impacts of the interim final rule, we assume that when Phase 1 of this IFC goes into effect, 75 percent of provider staff, 90 percent of LTC facility residents, and 80 percent of all other patients and clients will have been vaccinated, and that these rates will improve over time as a result of both this rule and the other factors previously discussed.[] These numbers leave a large range for the likely effects of this rule over time. They do indicate, however, that many cases of death or severe illness can be prevented by increasing the number of vaccinated persons, both for those vaccinated and for others they might otherwise infect.

As estimated in Table 6, the number of unvaccinated health care workers still remains in the millions despite recent progress. As discussed later in this analysis, we use the concept of the value per statistical life and per statistical case to capture this major potential benefit, as recommended by the Office of the Assistant Secretary for Planning and Evaluation based on standard practices in cost-benefit analysis.[] One additional factor affecting our estimates is remaining life expectancy. Life expectancy varies by age, being about 40 years across an entire population, close to 80 years for a younger population, and a relatively fewer number of years for an older population.

These numbers, of course, are overall averages and mask substantial differences by race and sex (among other factors), including access to affordable health care and prevalence of untreated or insufficiently controlled disease. Individuals with diabetes, for example, are disproportionately African American and disproportionately older, which leads to greater risks from kidney failure and other adverse health effects, including greater susceptibility to the ravages of erectile dysfunction treatment.[] Health care staff of most types of providers and suppliers are of typical working ages. But hospital patients, LTC facility residents, ESRD patients treated for kidney failure, and most other patients are heavily weighted towards older ages and are disproportionately members of African American and Native American minority groups.

This means that the morbidity and mortality reductions from this rule when they are adjusted for the age ranges affected disproportionally benefit racial minorities. In particular, LTC facility residents are near the upper end of the age spectrum. For a statistically average LTC facility resident, the average pre-erectile dysfunction treatment life expectancy if death occurs while in the facility is likely to be on the order of 3 years or fewer but taking into account residents who recover and leave the facility and those enrolled for skilled nursing services we estimate overall life expectancies to be about 5 years.[] We also estimate that vaccination reduces the chance of by about 95 percent, and the risk of death from the cialis to a fraction of 1 percent.[] In Israel, of the first 2.9 million people vaccinated with two doses there were only about 50 s involving severe conditions resulting from the cialis after the 14th day and of these so few deaths that they were not reported in statistical summaries.

These data also show that erectile dysfunction treatments are effective for both older and younger recipients. Of those who have received a full primary treatment series, after the 14th day after vaccination only 46 people over the age of 60 became infected and had a severe case, compared to 6 people under the age of 60. Given that these numbers are compared against 2.9 million recipients of the second dose, both rates are near zero.[] C.

Anticipated Costs of the Interim Final Rule With Comment Period We note that our cost estimates assume that all additional vaccination costs for providers and suppliers regulated by this rule are due to this rule. We estimate on this basis because we have no reliable way to estimate how much of these costs might be equally due to independent employer decisions, to other Federal standards, to State and local mandates, or even to individual personal choices. In our cost estimates we cover all providers regulated by CMS for health and safety standards, but we often use LTC facilities for examples because they pose some of the greatest risks for erectile dysfunction treatment morbidity and mortality.

As documented subsequently in this analysis and in a research report on this issue, about 1.5 million individuals work in LTC facilities at any one time.[] A number of these individuals work in multiple LTC facilities which may play additional roles in transmission.[] These individuals are at high risk both to become ill with erectile dysfunction treatment and to transmit the SARS- Start Printed Page 61605 CoV-2 cialis to residents or visitors, or among themselves. Far more than most occupations, LTC facility work requires sustained close contact with multiple persons daily. In Table 6 we present estimates of total numbers of staff individuals regulated under this rule, distinguishing between numbers at the beginning of a year and at any one time during the year, versus the much higher numbers when turnover is considered.

In Table 6 we assume that the number departing each year is the same as the number entering each year, which is a reasonable approximation to changes in just a few years, but do not take account of the aging of the population over time. We note that our estimates do not include a deduction for the overlap among individuals who work in more than one LTC facility. We know that this number is substantial, but have no basis for estimating its precise magnitude and, more importantly, how it may change after this rule goes into effect and facilities change their staffing and hiring patterns.

One recent study found about 17% of LTC nursing staff held second jobs, and another recent study found that about 5% held more than one LTC job. The second study, moreover, found that facilities with substantial staff sharing were disproportionally associated with as many as 49% of nursing home erectile dysfunction treatment cases.[] Start Printed Page 61606 These figures are approximations, because none of the data that is routinely collected and published on resident populations or staff counts focus on numbers of individuals residing or working in the facility during the course of a year or over time. Depending on the average length of stay (that is, turnover) in different facilities, Start Printed Page 61607 an average population at any one time of, for example, 100 persons could be consistent with radically different numbers of individuals, such as 112 individuals in one facility if one person left each month and was replaced by another person, compared to 365 if one person left each day and was replaced that same day by another person.

As a specific example, we assume that about 90 percent of existing LTC facility residents and 75 percent of existing staff will have been vaccinated by the date Phase 1 of this IFC takes effect (we use the same or similar assumptions for all provider types). There will be many new persons in each category during the first full year of the regulation, and likely almost all of these will have been vaccinated elsewhere (for simplicity we also assume a base rate 95 percent for this group, almost all of whom will have previously worked in a health care facility requiring vaccination). As presented in the third numeric column of Table 6, the total number of employees or otherwise compensated individuals working in all these different facilities over the course of a year is about 13 million persons, which is almost half again larger than the annual average number of staff shown in the first numeric column.

A recent study, using data from detailed payroll records, found that median turnover rates for all nurse staff in long term care facilities is approximately 90 percent a year, although other estimates are far lower (see subsequent discussion).[] We have not seen figures this high for other provider types but some may approach this level—home health care is well known for high turnover rates.[] Of course, most of these persons will have been vaccinated through other means when they enter the facilities during the next year. That said, it is likely that there will be approximately 2.4 million staff at the beginning or during the first year after this rule is published who will require vaccination (rightmost column of Table 6), possibly preceded in some cases by counseling efforts or employer inducements. While this IFC does not expressly require erectile dysfunction treatment counseling or education, we anticipate that some providers and suppliers will conduct such activities as a part of their procedures for ensuring compliance with the provisions of this rule.

Some staff counseling can take place in group settings and some will take place on a one-to-one level. What works best will depend on the circumstance of the employee and the best method for conveying the information and answering questions. Staff education, using CDC or FDA materials, can also take place in various formats and ways.

Individualized counseling, staff meetings, posters, bulletin boards, and e-newsletters are all approaches that can be used. Informal education may also occur as staff go about their daily duties, and some who have been vaccinated may promote vaccination to others. Facilities may find that reward techniques, among other strategies, may help.

For example, monetary or other benefits such as paid days off could be given to staff who agree to vaccination. Even simpler, the employer can bring vaccination providers onsite to vaccinate staff (or both staff and unvaccinated patients). Of importance in such efforts, the value of immunization as a crucial component of keeping patients healthy and well is already conveyed to staff about influenza and pneumococcal treatments.

erectile dysfunction treatment persuasion can build upon that knowledge. The most important inducement will be the fear of job loss, coupled with the examples set by fellow treatment-hesitant workers who are accepting vaccination more or less simultaneously. One hundred percent success is unlikely.

The HHS Guidelines for Regulatory Impact Analysis note that “[i]n most cases, the analysis focuses on estimating the incremental compliance costs incurred by the regulated entities, assuming full compliance with the regulation, and government costs.” These guidelines further recommend that “[a]nalysts should consider the uncertainty associated with an assumption of full compliance and provide analysis of alternative assumptions, as appropriate.” [] In preparing this analysis, we have identified several significant sources of uncertainty for these full-compliance estimates, one of which stands out. If only one health care provider in an area required staff vaccination, then those who refuse vaccination could quit and obtain employment at another location in the same field or type of position.[] But with many employers already mandating vaccination, and with nearly all local (and distant) health care employers requiring vaccination under this rule, we expect that such effects will be minimized (with exceptions for medical or other exemptions as required by law). That said, currently there are endemic staff shortages for almost all categories of employees at almost all kinds of health care providers and supplier and these may be made worse if any substantial number of unvaccinated employees leave health care employment altogether.

In this regard, we note that because CMS does not regulate health and safety in physician and dental offices, or in non-health care settings such as assisted living facilities, those entities may provide alternative places of employment for some of the staff currently working for providers and suppliers subject to this IFC who refuse vaccinations. On the other hand, staff shortages might be offset by persons returning to the labor market who were unwilling to work at locations where some other employees are unvaccinated and hence provide some risk, to those who have completed the primary vaccination series for erectile dysfunction treatment. Despite these uncertainties, we have developed an estimate of staffing disruption costs, primarily to provide a complete cost picture even if this element is particularly uncertain.

We note that these costs and benefits are highly dependent on whether, for example, staff vaccination refusals in coming months are closer to 1 percent than to 10 percent, and the extent to which increased confidence in the safety of working in a health care setting leads to offsetting increases in the return of former health care employees to the workforce. Both variables, in turn, may depend in significant ways on the overall labor market and on the ability of telehealth measures to replace in-person staff to patient encounters. The net outcomes of staff turnover over time could easily exceed or offset the administrative and vaccination costs we have estimated.

We welcome comments and information on these issues. The techniques for staff counseling, education, and incentives are so numerous and varied that there is no simple way to estimate likely costs. Staff hesitancy may and likely will change over time as the benefits of vaccination become clear to increasing numbers of individuals working in health care Start Printed Page 61608 settings.

For purposes of estimation, we assume that, on average, one hour of staff time or the equivalent will be devoted to counseling or incentives for each unvaccinated staff person, at the same average hourly cost of about $75 estimated for RNs in the Information Collection analysis. We assume that these efforts occur during paid working hours and that all costs will be borne by the facility. Since we estimate that about 2.4 million employees will need to be vaccinated (or replaced) in the first year (rightmost column of Table 6), most in the first two months after this rule is published, total costs would be about $180 million.

This estimate assumes that the 2.4 million will be some mix of existing and replacement staff. For example, if 95% of the existing unvaccinated staff were vaccinated, and 5% of the unvaccinated staff terminated, then in addition to the normal turnover of 2.7 million new hires (second column of Table 6) an additional 114 thousand (.05 × 2,270) persons would need to be hired, with 95% of them already fully vaccinated and the remainder getting vaccinated as a condition of hiring. For purposes of this estimate we ignore the existence of exemptions.

A third major cost component of compliance with this IFC is the vaccination, including both administration and the treatment itself. We estimate that the average cost of a vaccination is what the government pays under Medicare. $20 × 2 = $40 for two doses of a treatment, and $20 × 2 for treatment administration of two doses, for a total of $80 per employee.

For purposes of estimation (and not reflecting any more knowledge than recent press accounts), we further assume that there will be a “booster” shot at the same cost, for a total vaccination cost of $120 per employee. While these treatment costs are currently incurred by the Federal Government, we include them to provide an estimate of total costs, regardless of who pays. In addition, we expect that a significant amount of time—one hour on average—will be used per employee in treatment planning, arrangement, and administration, and related activities for three vaccinations per currently unvaccinated employee.

Together with the additional assumption that there will be an hour RN time or the equivalent needed for arranging or administering vaccination, at an average cost for that hour of $75, the total cost for vaccination compliance will be $195 per employee. We apply that cost to all currently unvaccinated employees. Like counseling and incentives, if 5% of the existing unvaccinated staff leave and are replaced by a slightly higher number of new hires than would otherwise be needed, a roughly equivalent fraction of the new hires will need to be vaccinated before they have patient contact.

As a result, we estimate the total costs of vaccination to be approximately $466 million (2,390,000 unvaccinated employees x $195). We note again that these estimates do not reflect the factor that multiple treatment mandates already do or will soon apply to many and perhaps most providers covered by our rule (employers' own self-imposed mandates, State and local mandates, and OSHA ETS, among others). This means the costs of this rule are overestimated due to this factor, a conservative assumption.

Our fourth and final major cost category is staffing and service disruptions. As discussed previously, it is possible there may be disruptions in cases where substantial numbers of health care staff refuse vaccination and are not granted exemptions and are terminated, with consequences for employers, employees, and patients. We do not have a cost estimate for those, since there are so many variables and unknowns, and it is unclear how they might be offset by reductions in current staffing disruptions caused by staff illness and quarantine once vaccination is more widespread.

We believe, however, that the disruptive forces are weaker than the return to normality. As shown in Table 6, it is normal for there to be roughly 2.66 million new hires (column two) in the health care settings we address in this rule, compared to a baseline of roughly 10.4 million staff (column one). These new hires replace a roughly equal number of employees leaving for one reason or another.

Health care providers are already in the business of finding and hiring replacement workers on a large scale. The terminated or self-terminated workers are not going to disappear. They still need to earn a living.

Many of the non-clinical staff may will find employment situations in settings that are not subject to vaccination mandates. Cooks, for example, may migrate to restaurant jobs. But in those cases, a cook who would otherwise have been hired by a restaurant may find a newly vacant health care position requiring vaccination and accept (or more likely already have) vaccination.

Similarly, nurses may find jobs in health care settings that are not subject to vaccination mandates, such as most schools or physician offices. But that means that nurses who would otherwise have been hired in schools or physician offices may find jobs in vacant jobs in health care settings requiring vaccination and accept (or more likely already have) vaccination. In a dynamic labor market such behaviors occur continuously on a massive scale.

If net employment opportunities and job-seeking behaviors do not change (and there is no reason to believe they will), these continuous adjustments will leave health care providers and suppliers subject to this rule with their desired staff levels, and former employees who refused vaccination in jobs that do not require vaccination. Because job seeking and worker seeking are already operating on a massive scale in the health care sector, there is no reason to expect any massive new costs in such routine functions as advertising jobs, checking applicant employment history, familiarizing new employees with the nuances of the new employment setting, training, and all the other steps and costs involved in the normal workings of the labor market. As an example of the likely magnitude of hiring costs, one analysis of direct hiring costs for workers in the long-term care sector (including LTC facilities, home health care, and ICFs-IID) found that the direct costs of hiring new workers was on average about $2,500 in 2004.[] Assuming that this amount should be raised to $4,000 based on inflation since then, that a comparable estimate for higher skills health care professions would be $6,000, and that health care workers covered by this rule are half lower skilled and half higher skilled, the recruitment and hiring cost for additional hires equal to 5 percent of the normal annual hiring total of 2.4 million workers would be $600 million (an average of $5,000 × 120,000).

(Costs could actually be lower because this study is almost a decade old and internet services have in recent years made recruitment and job application procedures far easier.) An additional cost category may result from erectile dysfunction treatment-related staff shortages, discussed extensively earlier in this IFC. Although, as noted earlier, erectile dysfunction treatment-related staff shortages are occurring absent the rule due to numerous factors, such as , quarantine and staff illness. Shortages at their most acute prevent facilities from admitting as patients, clients, residents, or participants persons they would normally admit for treatment of diseases or conditions that would in many cases result in death or serious disability.

We Start Printed Page 61609 are not aware of any data that would enable a reasonably accurate estimate of the total medical morbidity and mortality involved, but it is certainly massive. While it is true that compliance with this rule may create some short-term disruption of current staffing levels for some providers or suppliers in some places, there is no reason to think that this will be a net minus even in the short term, given the magnitude of normal turnover and the relatively small fraction of that turnover that will be due to vaccination mandates. Moreover, the benefits of vaccination are not just the lives directly saved, but the resources that vaccination frees up because hospital, LTC facility, and rehabilitation beds are now available and because health care staff themselves are not being incapacitated or killed by erectile dysfunction treatment .

The data on cumulative erectile dysfunction treatment cases among health care personnel show 677,000 cases (most of which incapacitated workers at least temporarily), and 2,200 deaths, all of which permanently eliminated those workers as sources of future care.[] Table 7 shows all of the costs that we have estimated. As previously explained, much and perhaps most of these costs would be incurred under other concurrent mandates, including employer-specific decisions, other Federal standards, and some State and local government mandates. Since these efforts overlap in scope, reach, and timing, there is no basis for assigning most of these costs to this rule or any other similar rule.

There are major uncertainties in these estimates. One obvious example is whether treatment efficacy will last more than the approximately 1 year proven to date and whether boosters are needed.[] Some in the scientific community believe that “booster” vaccinations after 6 or 8 months would be desirable to maintain a high level of protection against the predominant Delta version of the cialis. Delta may be overtaken by other cialis mutations, which creates another uncertainty.

Booster vaccination or use of treatments whose licenses or EUAs have been amended to address new variants would likely maintain the effectiveness of vaccination for residents and staff. At this time, as to second (and succeeding) year effects we assume no further major changes in treatment effectiveness. Yet another uncertainty is treatment costs, with a recently announced antiviral pill that could potentially provide substantial reductions in severity of illness and subsequent treatment costs, on a time schedule as yet unknown.[] D.

Anticipated Benefits of the Interim Final Rule With Comment Period There will be more than 180 million staff, patients, and residents employed or treated each year in the facilities covered by this rule. In our analysis of first-year benefits of this rule we focus first on prevention of death among staff of facilities as well as on reduction in disease severity. Second, we focus on resulting benefits from avoiding by unvaccinated staff among patients served in these facilities, who are likely to benefit more substantially because patients receiving health care in such facilities are disproportionately older than working age adults and are therefore more susceptible to severe illness or death from erectile dysfunction treatment.

A third group of beneficiaries are staff family members and caregivers and many other persons outside the health care settings who staff might subsequently infect if not vaccinated. We focus initially on LTC facilities because their residents and patients have been among the most severely affected by erectile dysfunction treatment as well as illustrating all the estimating issues involved, but the same estimates, uncertainties, and calculations apply to all types of providers and suppliers in varying degrees. HHS's Guidelines for Regulatory Impact Analysis outline a standard approach to valuing the health benefits of regulatory actions.

The approach for valuing mortality risk reductions is based on the value per statistical life (VSL), which estimates individuals' willingness to pay (WTP) to avoid fatal risks. The approach to valuing morbidity risk reductions is based on measures of the WTP to avoid non-fatal risks when specific estimates are available, and based on measures of the duration and severity of the illness, including quality of life consequences, when suitable WTP estimates are not available.[] Based on this approach, the Office of the Assistant Secretary for Planning and Evaluation published a report that develops an approach for valuing erectile dysfunction treatment mortality and morbidity risk reductions. Start Printed Page 61610 In addition to the avoided death and human suffering, one of the major benefits of vaccination is that it lowers the cost of treating the disease among those who would might otherwise be infected and have serious morbidity consequences.

The largest part of those costs is for hospitalization. As discussed later in the analysis we provide data on the average costs of hospitalization of these patients (it is, however, unclear as to how much that cost will change over time due to improving treatment options). There is a potential offset to benefits that we have not estimated because we believe it is at this time not relevant in the U.S.

If treatment supplies did not meet all demands for vaccination, giving priority to some persons over others necessarily meant that some persons would become infected who would not have been infected had the priorities been reversed. In this case, however, the priority for older adults (virtually all of whom have risk factors) who comprise the majority of hospital inpatients and the vast majority of LTC facility residents has already been established and is largely met. This rule provides a priority for staff at a far lower risk of mortality and severe disease that benefits both groups.[] It achieves this benefit because by preventing the spread of erectile dysfunction treatment from provider and supplier staff, it actually provides a higher mortality and morbidity reduction for patients at far higher risk than the staff who become vaccinated.[] The HHS “Guidelines for Regulatory Impact Analysis” explain in some detail the concept of Quality Adjusted Life Years (QALYs).[] QALYs, when multiplied by a monetary estimate such as the Value of a Statistical Life Year (VSLY), are estimates of the value that people are willing to pay for life-prolonging and life-improving health care interventions of any kind (see sections 3.2 and 3.3 of the HHS Guidelines for a detailed explanation).

The QALY and VSLY amounts used in any estimate of overall benefits are not meant to be precise, but instead are rough statistical measures that allow an overall estimate of benefits expressed in dollars. Under a common approach to benefit calculation, we can use a Value of a Statistical Life (VSL) to estimate the dollar value of the life-saving benefits of a policy intervention, for a person who more broadly represent a mixture of ages. We use the VSL of approximately $11.5 million in 2021 as described in the HHS Guidelines, adjusted for changes in real income and inflated to 2020 dollars using the Consumer Price Index.[] Using LTC facilities as an example, and assuming that the average rate of death from erectile dysfunction treatment (following erectile dysfunction ) at typical LTC facility resident ages and conditions is 5 percent, and the average rate of death after vaccination is essentially zero, the expected value of each resident who would, in the absence of this rule, otherwise be infected with erectile dysfunction is about $575,000 ($11.5 million × .05).

For staff, who are generally of working ages in roughly the same proportions as the population at large, the typical rate of death for the full course of two treatments (or possibly three with a booster) is roughly 1 percent of the older adult rate, and the expected value for each employee receiving the same vaccinations is about $57,500 ($11.5 million × .005).[] For community residents who unvaccinated staff might infect, the resulting calculation is similar (actually somewhat lower because the risk of death from erectile dysfunction treatment is even lower for those below employment ages). Under a second approach to benefit calculation, we can estimate the monetized value of extending the life of LTC facility residents, which is based on expectations of life expectancy and the value per life-year. As explained in the HHS Guidelines, the average individual in studies underlying the VSL estimates is approximately 40 years of age, allowing us to calculate a value per life-year of approximately $590,000 and $970,000 for 3 and 7 percent discount rates respectively.

This estimate of a value per life-year corresponds to 1 year at perfect health. (These amounts might reasonably be halved for average LTC facility residents, since non-institutionalized U.S. Adults aged 80-89 years report average health-related quality of life (HRQL) scores of 0.753, and this figure is likely to be lower for LTC facility residents.[] ) Assuming that the average life expectancy of long term care residents is 5 years, the monetized benefits of saving one statistical life would be about $3.0 million ($590,000 x annually for 5 years) at a 3 percent discount rate and about $4.8 million ($970,000 x annually for 5 years) at a 7 percent discount rate.

Assuming that the average rate of death from erectile dysfunction treatment (erectile dysfunction ) at LTC facility resident ages and conditions is 5 percent, and the average rate of death after vaccination is essentially zero, the expected life-extending value of each resident who would otherwise be infected is $150 thousand at a 3 percent discount rate and $240 thousand at a 7 percent discount rate. A similar calculation can be made for staff and for the community residents they might infect, who will gain many more years of life but whose risk of death is far smaller since their age distribution is so much younger. Deaths from erectile dysfunction treatment in unvaccinated LTC facility residents during 2020 were about 130,000, or close to one tenth of the average LTC facility resident census of 1.4 million, a huge contrast to the handful of deaths in the vaccination results from Israel.[] We do not have sufficient data so as to accurately estimate annual resident inflows and outflows over time, but it is clear that over two million new residents and over 700,000 new employees make the total number of individuals involved during the year far higher than point in time or average counts.

Moreover, these counts do not include family members and other visitors, whose total visits certainly number in the millions. Most of the preceding calculations address residential long-term care. Long term care residents are a major group within LTC facilities and are generally in the LTC facility because their needs are more substantial and they need assistance with the activities of daily living, such as cooking, bathing, and dressing.

These long-term stays are Start Printed Page 61611 primarily funded by the Medicaid program (also, through long term care insurance or self-financed), and the custodial care services these residents receive are not normally covered by Medicare or any other health insurance.[] A second major group within the same facilities receives short-term skilled nursing care services. These services are rehabilitative and generally last only days, weeks, or months. They usually follow a hospital stay and are primarily funded by the Medicare program or other health insurance.

The importance of these distinctions is that the numbers of residents and typical ages in each category regulated under this rule in each category are different. The average number of persons in facilities for long term care over the course of a year is about 1.2 million residents (as is the point-in-time number), and the total number of persons over the course of a year is about 1.6 million. The average number in skilled nursing care at any one time is about 2 thousand persons, because the average length of stay is weeks rather than years and the median length of stay is days rather than weeks.[] The annual turnover in this group is such that about 2.3 million residents are served each year.

There is some overlap between these two populations and the same person may be admitted on more than one occasion. For purposes of this analysis (these are rough estimates because there are no data routinely published on patient and resident turnover or providing unduplicated counts of persons served), we assume that the expected longevity for each group is identical on average, and that a total of 3.9 million different persons are served each year. The employee staff are a third group and the direct target of these rules.

Since both long-term and short-term residents are for the most part served in the same facilities, their care is managed and provided by the same facility staff. These nursing facilities have about 950,000 full-time equivalent employees at any one time and another 100,000 visiting staff or the equivalent, all covered by this rule. For these persons, the average age is about 45, which creates two offsetting effects.

They have more years of life expectancy than residents, but their risk of death from erectile dysfunction treatment is far lower. For purposes of this analysis, we assume that vaccination against erectile dysfunction treatment is effective for at least 1 year and use a 1-year period as our primary framework for calculation of potential benefits, not as a specific prediction but as a likely scenario that avoids forecasting major and unexpected changes that are either strongly adverse or strongly beneficial. If we were adding up totals for benefits we would assume that the risk of death after erectile dysfunction treatment is likely only one-half of one percent (one tenth of the resident rate) or less for the unvaccinated members of this group, reflecting the far lower mortality rates for persons who are almost all in the 18 to 65 year old age ranges compared to the far older residents.[] We assume that the total number of individual employees is 50 percent higher than the full-time equivalent but that only half that number are primarily employed at only one nursing facility, two offsetting assumptions about the number of employees working at each facility (many employees are part-time consultants or the equivalent who serve multiple nursing facilities on a part-time basis).

We further assume that employee turnover is 80 percent a year, lower than the results for nurses previously cited. Accordingly, we estimate that 80 percent of 950,000, or 760,000, are new employees each year and must be offered vaccination (again, most are already vaccinated), for a total of 1,710,000 eligible employees over the course of a year. (This number would likely drop in future years as employers decide to hire only persons previously vaccinated and as treatment uptake increases due to Federal, State, local, or employer requirements, as well as individual choice.) We have some data on the costs of treating serious illness among the unvaccinated who become infected, are hospitalized, and survive.

Among those age 65 years or above, or with severe risk factors, over 30 percent of those known to be infected required hospitalization in the first year of the cialis.[] That fraction is far lower now as treatments have improved and as vaccinations have greatly reduced severity of the disease. Among adults aged 21 years to 64 years, about 10 percent of those infected once required hospitalization, but that fraction is now far lower for the same reasons. For our estimates, we assume a 10 percent hospitalization rate among people aged 65 years or older in LTC facilities, reflecting both that their conditions are significantly worse than those of similarly aged adults living independently, and that pre-hospitalization treatments have improved.

For staff we assume one fifth of this rate, or 2 percent. Using LTC facilities as our main example, the LTC facility candidates for vaccination in the first year covered by this rule, about three-fourths are age 65 years or above. Hence, the age-weighted hospitalization rate that we project is about 8 percent.

Among those hospitalized at any age, the average cost is about $20,000.[] To put these cost, benefit, and volume numbers in perspective, vaccinating one hundred previously unvaccinated LTC facility residents who would otherwise become infected with erectile dysfunction and have a erectile dysfunction treatment illness would cost approximately $18,000 ($183 × 100) in vaccination costs. Using the VSL approach to estimation would produce life-saving benefits of about $400,000 for these 100 people ($20,000 × 100 × .05), again assuming the death rate for those ill from erectile dysfunction treatment of this age and condition is one in twenty. Reductions in health care costs from hospitalization would produce another $160,000 ($20,000 × 100 × .08) in benefits for this group assuming that 8 percent would otherwise be hospitalized.

However, this comparison should be taken as necessarily hypothetical and contingent due to the analytic, data, and uncertainty challenges discussed throughout this regulatory impact assessment. Patient benefits are simply a consequence of fewer s among staff. Vaccinating one hundred previously unvaccinated LTC facility employees would be higher than for staff.

Life-saving benefits to employees would be about $5,300,000 ($10,600,000 VSL × 100 × .005) for 100 people assuming that the death rate for these far younger 100 people is 1 in 500 hundred. Reductions in health care costs from hospitalizations of employees would produce another $20,000 ($20,000 × 100 × .01). Start Printed Page 61612 There remain difficult questions of estimating (1) likely numbers of individuals in staff and patient categories who are likely to be unvaccinated when the rule goes into effect and (2) numbers of staff likely to be willing to accept vaccination in the coming months and years.[] Both sets of numbers vary substantially by provider and supplier type.

LTC facility and home health care patients are on average both the oldest and most health-impaired of those in settings covered by this rule. At the other extreme, rural and other community-care oriented health centers serve the full age spectrum and a lower fraction of severely health-impaired. We do know that the life-saving benefits for staff are probably small but significant.

During the entire period of erectile dysfunction treatment s, since March 2020, there have been over 2,000 health care staff deaths recorded by the CDC through October 3, 2021.[] Of these, the great majority were in the year 2020. Even during the recent Delta variant surge, health care staff deaths decreased to lower levels. Specifically, during the last 6 months, April through September 2021, total staff deaths were 202, an average of 34 per month and no clear trend (the last 4 weeks, all in September, 2021 produced fewer than 20 deaths).

This is not surprising as the most effective precautions other than vaccination—masks, social distancing, and ventilation—have been essentially universal in the health care sector during all of 2021. Even more importantly, vaccination rates are considerably higher than in the population at large (although still well below optimal levels). Yet, using the last 6 months of CDC Data Tracker information, on an annual basis more than 400 deaths could be expected.

These data, moreover, are almost all among unvaccinated persons and are probably undercounted in current data. A major caution about these estimates. None of the sources of enrollment information for these programs regularly collect and publish information on client or staff turnover during a year.

These data have not previously been found useful in program management for individual agencies or programs, or when needed have been addressed through one-time research projects. The estimates in this analysis are based on inferences from scattered data on average length of stay, mortality, job vacancies, news accounts, and other sources that by happenstance are available for one type of facility or type of resident or another. Nor do we have data on the number of persons in these settings who will be vaccinated through other means during the remainder of the year.

All these data and estimation limitations apply to even the short-term impacts of this rule, and major uncertainties remain as to the future course of the cialis, including but not limited to treatment effectiveness in preventing “breakthrough” disease transmission from those vaccinated, the long-term effectiveness of vaccination, the emergence of treatment options, and the potential for some new disease variant even more dangerous than Delta. Another unknown is what currently unvaccinated employees would do when the vaccination deadline is reached, and how rapidly those quitting rather than being vaccinated could be replaced. Even a small fraction of recalcitrant unvaccinated employees could disrupt facility operations.

On the other hand, there have been significant reductions in provider and supplier staffing needs in some categories. For example, LTC facility admissions have declined in the last year, as families and caregivers sought to avoid the risks of exposing a care recipient to unvaccinated residents and staff in LTC facilities. The new vaccination requirement may reduce such fears and bring higher numbers of residents to these facilities and the essential services they provide.

Again, we have no way to estimate such behavioral changes. Regardless, we believe it is clear that reductions in patient/resident fatalities through avoiding staff-generated s are both likely to be a significantly larger benefit from staff vaccination than direct benefits to staff. Staff vaccination will also provide significant community benefits when staff are not at work.

Hence, total lives saved under this rule may well reach several hundred a month or perhaps several thousand a month for all three groups in total. Patient and resident benefits are especially likely to be many times higher because the risks of death and serious disease complications are so many times higher among older persons and people with multiple chronic conditions. As indicated by the preceding analysis, predicting the full range of benefits and costs in either the short run or the next full year with any degree of estimating precision is all but impossible.

As the minimum benefit level needed for benefits to exceed costs, however, we estimate that either saving 120 lives, or preventing 600 hundred hospitalizations for serious illness, or any combination of these two magnitudes, would produce benefits that exceed our estimate of costs over the next year. There have been about 200 staff deaths in the last 6 months and this is a likely undercount for this one category of persons alone, and potential life-saving benefits to more than 150 million mostly elderly patients and residents (about 10 percent of whom are likely to remain unvaccinated) who are exposed to provider staff probably would be many times higher. We note, however, as discussed in the preceding section on costs, much of these benefits could be as well attributed to other concurrent and parallel vaccination mandates and campaigns.

E. Other Effects 1. Sources of Payment The initial costs of this rule fall almost entirely on health care providers and suppliers and are extremely small in comparison to the $4 trillion a year spent on health care, mostly through these same entities.

In particular, the costs of the treatments are paid by the Federal Government and treatment costs are about two-thirds of the total costs we have estimated. Moreover, through the treatment cost savings to the hospitals and other care providers resulting from the vaccinations that will be made due to this rule, significant savings would accrue to payers. It is likely that half or more of these savings would primarily accrue to Medicare given the age or disability status of most clients and Medicare's role as primary payer, but there would also be substantial savings to Medicaid, private insurance paid by employers and employees, and private out-of-pocket payers including patients and residents.

In some rare cases funds under the CARES Act and the American Rescue Plan Act of 2021 might be available at State or local discretion, but it is hard to foresee any substantial budgetary impact on any insurance plan or service provider that would justify or require such assistance. 2. Regulatory Flexibility Act The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities.

Under the RFA, “small entities” include small businesses, nonprofit organizations, and small governmental jurisdictions. Individuals and states are not included in the definition of a small entity. For Start Printed Page 61613 purposes of the RFA, we estimate that most health care facilities are small entities as that term is used in the RFA because they are either nonprofit organizations or meet the SBA definition of a small business (having revenues of less than $8.0 million to $41.5 million in any 1 year).

HHS uses an increase in costs or decrease in revenues of more than 3 to 5 percent as its measure of “significant economic impact.” The HHS standard for “substantial number” is 5 percent or more of those that will be significantly impacted, but never fewer than 20. As estimated previously, the total costs of this rule for 1 year are about $1.3 billion, most of which is directly proportional to number of employees. Spread over 10.4 million full-time equivalent employees, this is about $125 per employee.

Assuming a fully loaded average wage per employee of $90,000, the first-year cost does not approach the 3 percent threshold. Moreover, since much of these costs (in particular, the treatment costs paid by the Federal Government) will not fall on providers or suppliers, the financial strain on these facilities should be negligible. Finally, as previously discussed, there are other concurrent mandates and much of these costs could as well be attributed to those efforts.

Therefore, the Department has determined that this IFC will not have a significant economic impact on a substantial number of small entities and that a final RIA is not required. Finally, this IFC was not preceded by a general notice of proposed rulemaking and the RFA requirement for a final regulatory flexibility analysis does not apply to final rules not preceded by a proposed rule. Regardless, this RIA and the main preamble, taken together, would meet the requirements for either an Initial or Final Regulatory Flexibility Analysis.

3. Small Rural Hospitals Section 1102(b) of the Act requires us to prepare an RIA if a proposed rule may have a significant impact on the operations of a substantial number of small rural hospitals. For purposes of this requirement, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds.

Because this rule has only the small impact per employee calculated for RFA purposes, the Department has determined that this IFC will not have a significant impact on the operations of a substantial number of small rural hospitals. This IFC is also exempt because that provision of law only applies to final rules for which a proposed rule was published. That said, early indications are that rural hospitals are having greater problems with employee vaccination refusals than urban hospitals, and we welcome comments on ways to ameliorate this problem.

4. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates will impose spending costs on State, local, or tribal governments, or by the private sector, require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158 million.

This rule contains no State, local, or tribal governmental mandates, but does contain mandates on private sector entities that exceed this amount. However, this IFC was not preceded by a notice of proposed rulemaking, and therefore the requirements of UMRA do not apply. The analysis in this RIA and the preamble as a whole would, however, meet the requirements of UMRA.

5. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule would pre-empt some State laws that prohibit employers from requiring their employees to be vaccinated for erectile dysfunction treatment.

Consistent with the Executive Order, we find that State and local laws that forbid employers in the State or locality from imposing treatment requirements on employees directly conflict with this exercise of our statutory health and safety authority to require vaccinations for staff of the providers and suppliers subject to this rule. Similarly, to the extent that State-run facilities that receive Medicare and Medicaid funding are prohibited by State or local law from imposing treatment mandates on their employees, there is direct conflict between the provisions of this rule (requiring such mandates) and the State or local law (forbidding them). As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader grounds for exemptions than provided for by Federal law and are inconsistent with this IFC.

In these cases, consistent with the Supremacy Clause of the Constitution, the agency intends that this rule preempts State and local laws to the extent the State and local laws conflict with this rule. The agency has considered other alternatives (for example, relying entirely on measures such as voluntary vaccination, source control alone, and social distancing) and has concluded that the mandate established by this rule is the minimum regulatory action necessary to achieve the objectives of the statute. Given the contagion rates of the existing strains of erectile dysfunction and their disproportionate impacts on Medicare and Medicaid beneficiaries, we believe that vaccination of almost all staff of covered providers and suppliers is necessary to promote and protect patient health and safety.

The agency has examined case studies from other employers and concludes that treatment mandates are vastly more effective than other measures at achieving ideal vaccination rates and the resulting patient protections from morbidity and mortality. Given the emergency situation with respect to the Delta variant detailed more fully above, time did not permit usual consultation procedures with the States, and such consultation would therefore be impracticable. We are, however, inviting State and local comments on the substance as well as legal issues presented by this rule, and on how we can fulfill the statutory requirements for health and safety protections of patients if we were to exempt any providers or suppliers based on State or local opposition to this rule.

F. Alternatives Considered As discussed earlier in the preamble, a major substantive alternative that we considered was to limit erectile dysfunction treatment vaccination requirements to full-time employees rather than to all persons who may provide paid or unpaid services, such as visiting specialists or volunteers, who are not on the regular payroll on a weekly or more frequent basis that is, individuals who work in the facility and in some cases infrequently or unpredictably, as well as individuals who are not on the payroll at all. We concluded that covering these persons would be readily manageable without creating major issues for compliance, enforcement, and record-keeping.

We did not, however, include some categories of visitors who do not have a business relationship with the provider, such as family member visitors. There are also many issues such as social isolation and loneliness related to potential discouragement of visiting volunteers or family members. Start Printed Page 61614 We also considered whether it would be appropriate to limit erectile dysfunction treatment vaccination requirements to staff who have not previously been infected by erectile dysfunction.

There remain many uncertainties about as to the strength and length of this immunity compared to people who are vaccinated, and—in recognizing that—the CDC recommends that previously infected individuals get vaccinated. Exempting previously infected individuals would have potentially reduced benefits while reducing costs, both roughly in proportion to the number affected. It would have also, complicated administration and likely require standards that do not now exist for reliably measuring the declining levels of antibodies over time in relation to risk of re.

Because of current CDC guidance and understanding of relevant scientific findings, we found that it was not warranted to exempt previously infected individuals. Another option would be to devise a standard with graduated compliance expectations such as 90 percent and then 95 percent and then 100 percent of staff vaccinated and a time period in which to reach each level. A variation of this would be to put providers on a probationary period if they failed to reach 100 percent compliance by the date set in the rule, and were allowed additional time in which to cross that last threshold.

Yet another variation would be to reduce payment to providers and suppliers not meeting the standard after the initial deadline. We recently put a phased system in place for Organ Procurement Organizations (OPOs), so we are not reflexively opposed to such options.[] Nonetheless, there are two major arguments against such a system in the context of this rule. First, to have any usefulness the time periods would have to have a reasonably extensive duration, such as a month each.

But that would be almost the same as extending this rule's deadline for an extra several months. We do not believe that extending the deadline to extend the employment of staff who will simply delay vaccination or final refusal to the last possible moment is in the interest of other staff, patients, and patients who would utilize the provider for needed health care if they did not fear unvaccinated staff. Second, it would not only delay the achievement of both staff and patient safety, but encourage procrastination.

For those few staff absolutely unwilling to accept vaccination, it would simply delay the day of final action and the day of hiring a vaccinated replacement. In the case of the OPO rule, an entire organization had to be slowly reformed to achieve compliance. In the context of this rule, and the lives at stake, there is no obvious ethical or managerial reason to give a relative handful of vaccination-resisting individuals more time until they leave the organization.

It would give management more time to find replacements, but it is not at all clear that this would be a fruitful grace period. As for a variation reducing payment to non-performing providers, perhaps by 20 percent per patient over some applicable time period, this would arguably provide something better than an “all of nothing” removal from provider status. It would require legislation but that is not a barrier to meeting E.O.

12866 analysis standards and in some rules may be essential to a valid benefit-cost analysis. The problem with this variation, however, is that for most providers and suppliers is it unlikely to be a realistic choice. Rather than accept lower payment levels, management can simply terminate the unvaccinated employees, a power they have with or without the reduced payment alternative.

Moreover, it would be hard to devise a system that treated equally and fairly providers of all sizes—whether with 5 or 50 employees. We further note that CMS already has and uses discretion in enforcement when inspectors find a violation. Termination of provider status is not normally an immediate consequence, as entities are typically given the opportunity to correct deficiencies.

Regardless, we welcome comments on this overall option and its variations, and on the closely-related option of simply adding a month to the compliance deadline in this rule. We considered what standards to apply regarding proof of compliance with exemptions requests base on medical contraindications and religious objections. We decided to establish minimal compliance burdens for both categories of exemptions.

This decision on the evidentiary standards could be revisited should an abuse problem arise on a significant scale. This may open the door to forged documents or false statements, and therefore validation of such claims raises administrative costs. Accordingly, we have allowed for relatively relaxed standards for verification in our administrative provisions and cost estimates but may reconsider in the future.

We considered alternative timelines for implementation but decided that this would not only delay badly needed live-saving compliance, but also provide little real management benefit to providers and suppliers. Staff have had almost a year to consider erectile dysfunction treatment vaccinations that are in their own interests as well as vital to patient protections and the protection of other workers. In this regard we note that one of the claimed barriers to vaccination has recently been removed, now that one treatment is now no longer emergency-authorized, but fully licensed.

We believe our requirements provide more than enough time for reasonable counselling and other management measures. Finally, we considered requiring daily or weekly testing of unvaccinated individuals. We have reviewed scientific evidence on testing and found that vaccination is a more effective control measure.

As such, we chose not to require such testing for now but welcome comment. Of course, nothing prevents a provider from exercising testing precautions voluntarily in addition to vaccination. We note that nothing in this rule removes the obligation on providers and suppliers to meet existing requirements to prevent the spread of , which in practice means that these entities may also conduct regular testing alongside such actions as source control and physical distancing.

CMS will continue to review the evidence and stakeholder feedback on this issue. These and some lesser options are presented and discussed in the main preamble. We do not have reliable dollar estimates for either costs or benefits of any alternatives, for the reasons already discussed in the RIA regarding the options we chose.

We welcome comments on these or other options. G. Accounting Statement and Table The Accounting Table summarizes the quantified impact of this rule.

It covers only 1 year because there will likely be many developments regarding treatments and vaccinations and their effects in future years and we have no way of knowing which will most likely occur. A longer period would be even more speculative than the current estimates. Nonetheless, assuming no major unforeseen events that would impinge on our estimates, we would expect lower costs in future years if for no other reason than increases in the fraction of new hires already vaccinated as well as other positive results from the President's plan or individual vaccination decisions.

We further note Start Printed Page 61615 that the vaccinations, and hence the benefits and costs, estimated for this rule are more or less simultaneously being created voluntarily by some employers (self-mandates), through the OSHA vaccination rule applicable to employers of 100 or more persons, and by some State or local mandates. There is no simple and non-arbitrary way to disentangle which vaccination benefits and which vaccination costs are due to which source. As explained in various places within this RIA and the preamble as a whole, there are major uncertainties as to the effects of current variants of erectile dysfunction on future rates, medical costs, and prevention of major illness or mortality.

For example, the duration of treatment effectiveness in preventing erectile dysfunction treatment, reducing disease severity, reducing the risk of death, and the effectiveness of the treatment to prevent disease transmission by those vaccinated are not currently known. These uncertainties also impinge on benefits estimates. For those reasons we have not quantified into annual totals either the life-extending or medical cost-reducing benefits of this rule and have used only a 1-year projection for the cost estimates in our Accounting Statement (our first-year estimates are for the last two months of 2021 and the first ten months of 2022).

We also show a large range for the upper and lower bounds of potential costs to emphasize the uncertainty as to several major variables, such as changes in voluntary vaccination levels, longer term effects, and others previously discussed. We welcome comments on all of our assumptions and welcome any additional information that would narrow the ranges of uncertainty or guide us in any important revisions to the requirements established in what is an “interim” final rule. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &. Medicaid Services, approved this document on October 19, 2021. Start List of Subjects 42 CFR Part 416 Health facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 418 Health facilitiesHospice careMedicareReporting and recordkeeping requirements 42 CFR Part 441 AgedFamily planningGrant programs—healthInfants and childrenMedicaidPenaltiesReporting and recordkeeping requirements 42 CFR Part 460 AgedCitizenship and naturalizationCivil rightsHealthHealth careHealth recordsIncorporation by referenceIndividuals with disabilitiesMedicaidMedicareReligious discriminationReporting and recordkeeping requirements 42 CFR Part 482 Grant program—-healthHospitalsMedicaidMedicareReporting and recordkeeping requirements 42 CFR Part 483 Grant programs—healthHealth facilitiesHealth professionsHealth recordsMedicaidMedicareNursing homesNutritionReporting and recordkeeping requirementsSafety 42 CFR Part 484 Administrative practice and procedureGrant programs—healthHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 485 Grant programs—healthHealth facilitiesMedicaidPrivacyReporting and recordkeeping requirements 42 CFR Part 486 Administrative practice and procedureGrant programs—healthHealth facilitiesHome infusion therapyMedicareReporting and recordkeeping requirementsX-rays 42 CFR Part 491 Grant programs—healthHealth facilitiesMedicaidMedicareReporting and recordkeeping requirementsRural and urban areas 42 CFR Part 494 DiseasesHealth facilitiesIncorporation by referenceMedicareReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &.

Medicaid Services amends 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1. The authority citation for part 416 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part2.

Amend § 416.51 by adding paragraph (c) to read as follows. End Amendment Part Conditions for coverage— control. * * * * * (c) Standard.

erectile dysfunction treatment vaccination of staff. The ASC must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following center staff, who provide any care, treatment, or other services for the center and/or its patients. (i) Center employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the center and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following center staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the center setting and who do not have any direct contact with patients and other staff specified in paragraph (c)(1) of this section. And (ii) Staff who provide support services for the center that are performed exclusively outside of the center setting and who do not have any direct contact with patients and other staff specified in paragraph (c)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment, prior to staff providing any care, treatment, or other services for the center and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (c)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the center has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized or licensed erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the center's erectile dysfunction treatment vaccination requirements based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part3. The authority citation for part 418 continues to read as follow.

End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part4.

Amend § 418.60 by adding paragraph (d) to read as follows. End Amendment Part Condition of participation. control.

* * * * * (d) Standard. erectile dysfunction treatment Vaccination of facility staff. The hospice must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment.

For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. Start Printed Page 61617 (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following hospice staff, who provide any care, treatment, or other services for the hospice and/or its patients.

(i) Hospice employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers.

And (iv) Individuals who provide care, treatment, or other services for the hospice and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following hospice staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where hospice services are provided to patients and who do not have any direct contact with patients, patient families and caregivers, and other staff specified in paragraph (d)(1) of this section.

And (ii) Staff who provide support services for the hospice that are performed exclusively outside of the settings where hospice services are provided to patients and who do not have any direct contact with patients, patient families and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the hospice and/or its patients.

(ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (d)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospice has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements.

(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the hospice's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part5.

The authority citation for part 441 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302.

End Authority Start Amendment Part6. Amend § 441.151 by adding paragraph (c) to read as follows. End Amendment Part General requirements.

* * * * * (c) erectile dysfunction treatment Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or resident contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its residents. (i) Facility employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its residents, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (c)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the center setting and who do not have any direct contact with residents and other staff specified in paragraph (c)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its residents. (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been Start Printed Page 61618 granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring that the facility follows nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment, and which must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (c)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part7. The authority citation for part 460 continues to read as follow.

End Amendment Part Start Authority 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f). End Authority Start Amendment Part8.

Amend § 460.74 by adding paragraph (d) to read as follows. End Amendment Part control. * * * * * (d) erectile dysfunction treatment Vaccination of PACE organization staff.

The PACE organization must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

(1) Regardless of clinical responsibility or participant contact, the policies and procedures must apply to the following PACE organization staff, who provide any care, treatment, or other services for the PACE organization and/or its participants. (i) PACE organization employees. (ii) Licensed practitioners providing services on behalf of the PACE organization.

(iii) Students, trainees, and volunteers providing services on behalf of the PACE organization. And (iv) Individuals who provide care, treatment, or other services on behalf of the PACE organization, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following PACE organization staff.

(i) Staff who exclusively provide telehealth or telemedicine services for the PACE organization and/or its participants and who do not have any direct contact with participants and other PACE organization staff specified in paragraph (d)(1) of this section. And (ii) Staff who provide support services for the PACE organization and/or its participants and who do not have any direct contact with participants and other PACE organization staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the PACE organization and/or its participants. (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

(iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (d)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law.

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the PACE organization has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements based on recognized clinical contraindications or applicable Federal laws. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as Start Printed Page 61619 defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.

And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the PACE organization's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Part End Part Start Amendment Part9. The authority citation for part 482 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302, 1395hh, and 1395rr, unless otherwise noted. End Authority Start Amendment Part10. Amend § 482.42 by adding paragraph (g) to read as follows.

End Amendment Part Condition of participation. prevention and control and antibiotic stewardship programs. * * * * * (g) Standard.

erectile dysfunction treatment Vaccination of hospital staff. The hospital must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following hospital staff, who provide any care, treatment, or other services for the hospital and/or its patients. (i) Hospital employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following hospital staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the hospital setting and who do not have any direct contact with patients and other staff specified in paragraph (g)(1) of this section. And (ii) Staff who provide support services for the hospital that are performed exclusively outside of the hospital setting and who do not have any direct contact with patients and other staff specified in paragraph (g)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (g)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the hospital and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (g)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (g)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospital has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the hospital's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment-. Start Part End Part Start Amendment Part11. The authority citation for part 483 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r. End Authority Start Amendment Part12.

Amend § 483.80 by revising paragraph (d)(3)(v) and adding paragraph (i) to read as follows. End Amendment Part control. (d) * * * (3) * * * (v) The resident or resident representative, has the opportunity to accept or refuse a erectile dysfunction treatment, and change their decision.

And * * * * * Start Printed Page 61620 (i) erectile dysfunction treatment Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or resident contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its residents. (i) Facility employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its residents, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (i)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (i)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (i)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its residents. (ii) A process for ensuring that all staff specified in paragraph (i)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (i)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part13. Amend § 483.430 by revising paragraph (f) to read as follows.

End Amendment Part Condition of participation. Facility staffing. * * * * * (f) Standard.

erectile dysfunction treatment Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or client contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its clients. (i) Facility employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its clients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, Start Printed Page 61621 treatment, or other services for the facility and/or its clients. (ii) A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (f)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.

And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Amendment Part14. Amend § 483.460 by revising paragraph (a)(4)(v) to read as follows. End Amendment Part Condition of participation.

Health care services. * * * * * (a) * * * (4) * * * (v) The client, or client's representative, has the opportunity to accept or refuse a erectile dysfunction treatment, and change their decision. * * * * * Start Part End Part Start Amendment Part15.

The authority citation for part 484 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh.

End Authority Start Amendment Part16. Amend § 484.70 by adding paragraph (d) to read as follows. End Amendment Part Condition of participation.

prevention and control. * * * * * (d) Standard. erectile dysfunction treatment Vaccination of Home Health Agency staff.

The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

(1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients. (i) HHA employees. (ii) Licensed practitioners.

(iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff.

(i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. And (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the HHA and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

(iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (d)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law.

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. Start Printed Page 61622 (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part17.

The authority citation for part 485 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395(hh).

End Authority Start Amendment Part18. Amend § 485.58 by revising paragraph (d)(4) to read as follows. End Amendment Part Condition of participation.

Comprehensive rehabilitation program. * * * * * (d) * * * (4) The services must be furnished by personnel that meet the qualifications of § 485.70 and the number of qualified personnel must be adequate for the volume and diversity of services offered. Personnel that do not meet the qualifications specified in § 485.70(a) through (m) may be used by the facility in assisting qualified staff.

When a qualified individual is assisted by these personnel, the qualified individual must be on the premises, and must instruct these personnel in appropriate patient care service techniques and retain responsibility for their activities. * * * * * Start Amendment Part19. Amend § 485.70 by adding paragraph (n) to read as follows.

End Amendment Part Personnel qualifications. * * * * * (n) The CORF must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its patients. (i) Facility employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (n)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (n)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (n)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (n)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (n)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.

And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions Start Printed Page 61623 and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Amendment Part20. Amend § 485.640 by adding paragraph (f) to read as follows. End Amendment Part Condition of participation.

prevention and control and antibiotic stewardship programs. * * * * * (f) Standard. erectile dysfunction treatment Vaccination of CAH staff.

The CAH must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

(1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following CAH staff, who provide any care, treatment, or other services for the CAH and/or its patients. (i) CAH employees. (ii) Licensed practitioners.

(iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the CAH and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following CAH staff.

(i) Staff who exclusively provide telehealth or telemedicine services outside of the CAH setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section. And (ii) Staff who provide support services for the CAH that are performed exclusively outside of the CAH setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the CAH and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

(iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (f)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law.

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the CAH has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements based on recognized clinical contraindications or applicable Federal laws. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the CAH's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part21.

Amend § 485.725 by adding paragraph (f) to read as follows. End Amendment Part Condition of participation. control.

* * * * * (f) Standard. erectile dysfunction treatment vaccination of organization staff. The organization that provides outpatient physical therapy must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment.

For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following organization staff, who provide any care, treatment, or other services for the organization and/or its patients.

(i) Organization employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers.

And (iv) Individuals who provide care, treatment, or other services for the organization and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following organization staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the organization setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section.

And (ii) Staff who provide support services for the organization that are performed exclusively outside of the organization setting and who do not have any direct contact with patients and other staff Start Printed Page 61624 specified in paragraph (f)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the organization and/or its patients.

(ii) A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (f)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the organization has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements.

(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the organization's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part22. Amend § 485.904 by adding paragraph (c) to read as follows.

End Amendment Part Condition of participation. Personnel qualifications. * * * * * (c) Standard.

erectile dysfunction treatment vaccination of center staff. The CMHC must develop and implement policies and procedures to ensure that all center staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or client contact, the policies and procedures must apply to the following center staff, who provide any care, treatment, or other services for the center and/or its clients. (i) Center employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the center and/or its clients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following center staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the center setting and who do not have any direct contact with clients and other staff specified in paragraph (c)(1) of this section. And (ii) Staff who provide support services for the center that are performed exclusively outside of the center setting and who do not have any direct contact with clients and other staff specified in paragraph (c)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the CMHC and/or its clients. (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (c)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the CMHC has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions Start Printed Page 61625 from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.

And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the CMHC's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Part End Part Start Amendment Part23. The authority citation for part 486 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

273, 1302, 1320b-8, and 1395hh. End Authority Start Amendment Part24. Amend § 486.525 by adding paragraph (c) to read as follows.

End Amendment Part Required services. * * * * * (c) erectile dysfunction treatment Vaccination of facility staff. The qualified home infusion therapy supplier must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment.

For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following qualified home infusion therapy supplier staff, who provide any care, treatment, or other services for the qualified home infusion therapy supplier and/or its patients.

(i) Qualified home infusion therapy supplier employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers.

And (iv) Individuals who provide care, treatment, or other services for the qualified home infusion therapy supplier and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following qualified home infusion therapy supplier staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home infusion therapy services are provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (c)(1) of this section.

And (ii) Staff who provide support services for the qualified home infusion therapy supplier that are performed exclusively outside of the settings where home infusion therapy services are provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (c)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the qualified home infusion therapy supplier and/or its patients.

(ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring that the facility follows nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment, and which must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (c)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the qualified home infusion therapy supplier has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements.

(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the qualified home infusion therapy supplier's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part Start Printed Page 61626 End Part Start Amendment Part25.

The authority citation for part 491 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 263a and 1302.

End Authority Start Amendment Part26. Amend § 491.8 by adding paragraph (d) to read as follows. End Amendment Part Staffing and staff responsibilities.

* * * * * (d) erectile dysfunction treatment vaccination of staff. The RHC/FQHC must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following clinic or center staff, who provide any care, treatment, or other services for the clinic or center and/or its patients. (i) RHC/FQHC employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the clinic or center and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following clinic or center staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the clinic or center setting and who do not have any direct contact with patients and other staff specified in paragraph (d)(1) of this section. And (ii) Staff who provide support services for the clinic or center that are performed exclusively outside of the clinic or center setting and who do not have any direct contact with patients and other staff specified in paragraph (d)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the clinic or center and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring that the clinic or center follows nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment, and which must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (d)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the clinic's or center's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part27. The authority citation for part 494 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. L302 and l395hh. End Authority Start Amendment Part28.

Amend § 494.30 by— End Amendment Part Start Amendment Parta. Redesignating paragraphs (b) and (c) as paragraphs (c) and (d) respectively, and End Amendment Part Start Amendment Partb. Adding a new paragraph (b).

End Amendment Part The addition reads as follows. Condition. control.

* * * * * (b) erectile dysfunction treatment Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its patients. (i) Facility employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with Start Printed Page 61627 patients and other staff specified in paragraph (b)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (b)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (b)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (b)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (b)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.

And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

* * * * * Start Signature Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information BILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-C[FR Doc. 2021-23831 Filed 11-4-21.

Start Preamble Centers for how to buy cialis online Medicare &. Medicaid Services (CMS), HHS. Interim final how to buy cialis online rule with comment period. This interim final rule with comment period revises the requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate in the Medicare and Medicaid programs.

These changes are necessary to help protect the health and safety of residents, clients, patients, PACE participants, and staff, and reflect lessons learned to date as a result of the erectile dysfunction treatment public health emergency. The revisions to the requirements establish erectile dysfunction treatment vaccination requirements for staff at the included how to buy cialis online Medicare- and Medicaid-certified providers and suppliers. Effective date. These regulations are effective on November 5, 2021.

Implementation dates how to buy cialis online. The regulations included in Phase 1 [42 CFR 416.51(c) through (c)(3)(i) and (c)(3)(iii) through (x), 418.60(d) through (d)(3)(i) and (d)(3)(iii) through (x), 441.151(c) through (c)(3)(i) and (c)(3)(iii) through (x), 460.74(d) through (d)(3)(i) and (d)(3)(iii) through (x), 482.42(g) through (g)(3)(i) and (g)(3)(iii) through (x), 483.80(d)(3)(v) and 483.80(i) through (i)(3)(i) and (i)(3)(iii) through (x), 483.430(f) through (f)(3)(i) and (f)(3)(iii) through (x), 483.460(a)(4)(v), 484.70(d) through (d)(3)(i) and (d)(3)(iii) through (x), 485.58(d)(4), 485.70(n) through (n)(3)(i) and (n)(3)(iii) through (x), 485.640(f) through (f)(3)(i) and (f)(3)(iii) through (x), 485.725(f) through (f)(3)(i) through (f)(3)(iii) through (x), 485.904(c) through (c)(3)(i) and (c)(3)(iii) through (x), 486.525(c) through (c)(3)(i) and (c)(3)(iii) through (x), 491.8(d) through (d)(3)(i) and (d)(3)(iii) through (x), 494.30(b) through (b)((3)(i) and (b)(3)(iii) through (x) must be implemented by December 6, 2021. The regulations included in Phase 2 [42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii), 441.151(c)(3)(ii), 460.74(d)(3)(ii), 482.42(g)(3)(ii), 483.80(i)(3)(ii), 483.430(f)(3)(ii), 484.70(d)(3)(ii), 485.70(n)(3)(ii), 485.640(f)(3)(ii), 485.725(f)(3)(ii), 485.904(c)(3)(ii), 486.525(c)(3)(ii), 491.8(d)(3)(ii), 494.30(b)(3)(ii)] must be implemented by January 4, 2022. Staff who have completed a primary vaccination series how to buy cialis online by this date are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination.

Comment date. To be assured consideration, comments must be received at one of how to buy cialis online the addresses provided below, no later than 5 p.m. On January 4, 2022. In commenting, please refer to file code CMS-3415-IFC.

Comments, including mass comment submissions, must be submitted in one of the following three how to buy cialis online ways (please choose only one of the ways listed). 1. Electronically. You may submit electronic comments on how to buy cialis online this regulation to http://www.regulations.gov.

Follow the “Submit a comment” instructions. 2. By regular mail how to buy cialis online. You may mail written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department how to buy cialis online of Health and Human Services, Attention. CMS-3415-IFC, P.O. Box 8016, Baltimore, how to buy cialis online MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment period. Start Printed Page 61556 3. By express how to buy cialis online or overnight mail. You may send written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, how to buy cialis online Attention. CMS-3415-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start Further Info For press inquiries how to buy cialis online. CMS Office of Communications, Department of Health and Human Services. Email press@cms.hhs.gov how to buy cialis online. For technical inquiries.

Contact CMS Center for Clinical Standards and Quality, Department of Health and Human Services, (410) 786-6633. End Further Info End Preamble Start Supplemental Information Inspection how to buy cialis online of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received.

Http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments.

We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. I. Background The Centers for Medicare &. Medicaid Services (CMS) establishes health and safety standards, known as the Conditions of Participation, Conditions for Coverage, or Requirements for Participation for 21 types of providers and suppliers, ranging from hospitals to hospices and rural health clinics to long term care facilities (including skilled nursing facilities and nursing facilities, collectively known as nursing homes).

Most of these providers and suppliers are regulated by this interim final rule with comment period (IFC). Specifically, this IFC directly regulates the following providers and suppliers, listed in the numerical order of the relevant CFR sections being revised in this rule. Ambulatory Surgical Centers (ASCs) (§ 416.51) Hospices (§ 418.60) Psychiatric residential treatment facilities (PRTFs) (§ 441.151) Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74) Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children's hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) (§ 482.42) Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80) Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430) Home Health Agencies (HHAs) (§ 484.70) Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70) Critical Access Hospitals (CAHs) (§ 485.640) Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725) Community Mental Health Centers (CMHCs) (§ 485.904) Home Infusion Therapy (HIT) suppliers (§ 486.525) Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8) End-Stage Renal Disease (ESRD) Facilities (§ 494.30) This IFC directly applies only to the Medicare- and Medicaid-certified providers and suppliers listed above. It does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS.

Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC. We have not included requirements for Organ Procurement Organizations or Portable X-Ray suppliers, as these only provide services under contract to other health care entities and would thus be indirectly subject to the vaccination requirements of this rule, as discussed in section II.A.1. Of this rule. We note that entities not covered by this rule may still be subject to other State or Federal erectile dysfunction treatment vaccination requirements, such as those issued by Occupational Safety and Health Administration (OSHA) for certain employers.

Currently, the United States (U.S.) is responding to a public health emergency (PHE) of respiratory disease caused by a novel erectile dysfunction that has now been detected in more than 190 countries internationally, all 50 States, the District of Columbia, and all U.S. Territories. The cialis has been named “severe acute respiratory syndrome erectile dysfunction 2” (erectile dysfunction), and the disease it causes has been named “erectile dysfunction disease 2019” (erectile dysfunction treatment). On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the outbreak a “Public Health Emergency of International Concern.” On January 31, 2020, pursuant to section 319 of the Public Health Service Act (PHSA) (42 U.S.C.

247d), the Secretary of the Department of Health and Human Services (Secretary) determined that a PHE exists for the U.S. (hereafter referred to as the PHE for erectile dysfunction treatment). On March 11, 2020, the WHO publicly declared erectile dysfunction treatment a cialis. On March 13, 2020, the President of the United States declared the erectile dysfunction treatment cialis a national emergency.

The January 31, 2020 determination that a PHE for erectile dysfunction treatment exists and has existed since January 27, 2020, lasted for 90 days, and was renewed on April 21, 2020. July 23, 2020. October 2, 2020. January 7, 2021.

April 15, 2021. July 19, 2021. And October 18, 2021. Pursuant to section 319 of the PHSA, the determination that a PHE continues to exist may be renewed at the end of each 90-day period.[] erectile dysfunction treatment has had significant negative health effects—on individuals, communities, and the nation as a whole.

Consequences for individuals who have erectile dysfunction treatment include morbidity, hospitalization, mortality, and post-erectile dysfunction treatment conditions (also known as long erectile dysfunction treatment). As of mid-October 2021, over 44 million erectile dysfunction treatment cases, 3 million new erectile dysfunction treatment related hospitalizations, and 720,000 erectile dysfunction treatment deaths have been reported in the U.S.[] Indeed, erectile dysfunction treatment has overtaken the 1918 influenza cialis as the deadliest disease in American history.[] Start Printed Page 61557 Given recent estimates of undiagnosed s and under-reported deaths, these figures likely underestimate the full impact.[] In addition, these figures fail to capture the significant, detrimental effects of post-acute illness, including nervous system and neurocognitive disorders, cardiovascular disorders, gastrointestinal disorders, and signs and symptoms related to poor general well-being, including malaise, fatigue, musculoskeletal pain, and reduced quality of life. Recent estimates suggest more than half of erectile dysfunction treatment survivors experienced post-acute sequelae of erectile dysfunction treatment 6 months after recovery.[] The individual and public health ramifications of erectile dysfunction treatment also extend beyond the direct effects of erectile dysfunction treatment s. Several studies have demonstrated significant mortality increases in 2020, beyond those attributable to erectile dysfunction treatment deaths.

In some percentage, this could be a problem of misattribution (for example, the cause of death was indicated as “heart disease” but in fact the true cause was undiagnosed erectile dysfunction treatment), but some proportion are also believed to reflect increases in other causes of death that are sensitive to decreased access to care and/or increased mental/emotional strain. One paper quantifies the net impact (direct and indirect effects) of the cialis on the U.S. Population during 2020 using three metrics. Excess deaths, life expectancy, and total years of life lost.

The findings indicate there were 375,235 excess deaths, with 83 percent attributable to direct, and 17 percent attributable to indirect effects of erectile dysfunction treatment. The decrease in life expectancy was 1.67 years, translating to a reversion of 14 years in historical life expectancy gains. Total years of life lost in 2020 was 7,362,555 across the U.S. (73 percent directly attributable, 27 percent indirectly attributable to erectile dysfunction treatment), with considerable heterogeneity at the individual State level.[] One analysis published in February 2021 found that Black and Latino Americans have experienced a disproportionate burden of erectile dysfunction treatment morbidity and mortality, reflecting persistent structural inequalities that increase risk of exposure to erectile dysfunction treatment and mortality risk for those infected.

The authors projected that erectile dysfunction treatment would reduce U.S. Life expectancy in 2020 by 1.13 years. Furthermore, the estimated reduction for Black and Latino populations is 3-4 times the estimate for the White population, reversing over 10 years of progress in reducing the gaps in life expectancy between Black and White populations and reducing the Latino mortality advantage by over 70 percent. The study further expects that reductions in life expectancy may persist because of continued erectile dysfunction treatment mortality and term health, social, and economic impacts of the cialis.[] Because erectile dysfunction, the cialis that causes erectile dysfunction treatment disease, is highly transmissible,[] Centers for Disease Control and Prevention (CDC) has recommended, and CMS reiterated, that health care providers and suppliers implement robust prevention and control practices, including source control measures, physical distancing, universal use of personal protective equipment (PPE), erectile dysfunction testing, environmental controls, and patient isolation or quarantine.[] Available evidence suggests these prevention and control practices have been highly effective when implemented correctly and consistently.[]  [] Studies have also shown, however, that consistent adherence to recommended prevention and control practices can prove challenging—and those lapses can place patients in jeopardy.[] A retrospective analysis from England found up to 1 in 6 erectile dysfunction s among hospitalized patients with erectile dysfunction treatment in England during the first 6 months of the cialis could be attributed to healthcare-associated transmission.[] In outbreaks reported from acute care settings in the U.S.

Following implementation of universal masking, unmasked exposures to other health care workers were frequently implicated.[] A retrospective cohort study of health care staff behaviors, exposures, and cases between June and December 2020 in a large health system found more employees were exposed via coworkers than patients—and secondary cases among employees typically followed unmasked interactions with infected colleagues (for example, convening in breakrooms without proper source control).[] The same study found that cases of health care worker associated with patient exposures could often be attributed to failure to adhere to PPE requirements (for example, eye protection). Past experience with influenza, and available evidence, suggest that vaccination of health care staff offers a critical layer of protection against healthcare-associated erectile dysfunction treatment (HA-erectile dysfunction treatment). For example, evidence has shown that influenza vaccination of health care staff is associated with declines in nosocomial influenza in hospitalized patients,[] and among nursing home residents. 25 26 27 28 29 30 31Start Printed Page 61558 As a result, CDC, the Society for Healthcare Epidemiology of America, and others recommend—and a number of states require— annual influenza vaccination for health care staff.[] In addition to preventing morbidity and mortality associated with erectile dysfunction treatment, currently approved or authorized treatments also demonstrate effectiveness against asymptomatic erectile dysfunction .

A recent study of health care workers in 8 states found that, between December 14, 2020 through August 14, 2021, full vaccination with erectile dysfunction treatments was 80 percent effective in preventing RT-PCR-confirmed erectile dysfunction among frontline workers.[] Emerging evidence also suggests that vaccinated people who become infected with the erectile dysfunction Delta variant have potential to be less infectious than infected unvaccinated people, thus decreasing transmission risk.[] For example, in a study of breakthrough s among health care workers in the Netherlands, erectile dysfunction infectious cialis shedding was lower among vaccinated individuals with breakthrough s than among unvaccinated individuals with primary s.[] Fewer infected staff and lower transmissibility equates to fewer opportunities for transmission to patients, and emerging evidence indicates this is the case. The best data come from long term care facilities, as early implementation of national reporting requirements have resulted in a comprehensive, longitudinal, high quality data set. Data from CDC's National Healthcare Safety Network (NHSN) have shown that case rates among LTC facility residents are higher in facilities with lower vaccination coverage among staff. Specifically, residents of LTC facilities in which vaccination coverage of staff is 75 percent or lower experience higher rates of preventable erectile dysfunction treatment.[] Several articles published in CDC's Morbidity and Mortality Weekly Reports (MMWRs) regarding nursing home outbreaks have also linked the spread of erectile dysfunction treatment to unvaccinated health care workers and stressed that maintaining a high vaccination rate is important for reducing transmission.[] There is also some published evidence from other settings that suggest similar dynamics can be expected in other health care delivery settings.

For example, a recent analysis from Yale New Haven Hospital (YNHH) found health care units with at least 1 inpatient case of HA-erectile dysfunction treatment had lower staff vaccination rates.[] Similarly, a small study in Israel demonstrated that transmission of erectile dysfunction treatment was linked to unvaccinated persons. In 37 cases, patients for whom data were available regarding the source of , the suspected source was an unvaccinated person. In 21 patients (57 percent), this person was a household member. In 11 cases (30 percent), the suspected source was an unvaccinated fellow health care worker or patient.[] While similarly comprehensive data are not available for all Medicare- and Medicaid-certified provider types, the available evidence for ongoing healthcare-associated erectile dysfunction treatment transmission risk is sufficiently alarming in and of itself to compel CMS to take action.

The threats that unvaccinated staff pose to patients are not, however, limited to erectile dysfunction transmission. Unvaccinated staff jeopardize patient access to recommended medical care and services, and these additional risks to patient health and safety further warrant CMS action. Fear of exposure to and with erectile dysfunction treatment from unvaccinated health care staff can lead patients to themselves forgo seeking medically necessary care. In a small but informative qualitative study of 33 home health care workers in New York City, one of the key themes to emerge from interviews with those workers was a keen recognition that “providing care to patients placed them in a unique position with respect to erectile dysfunction treatment transmission.

They worried. . . About transmitting the cialis to [their clients].” They also noted that care for home bound clients might involve other health care staff, and they worried about “transmitting erectile dysfunction treatment.

. . To one another.” [] Anecdotal evidence suggests health care consumers have drawn similar conclusions—and this, too, has implications for overall health and welfare in health care settings. For example, CMS has received anecdotal reports suggesting individuals in care are refusing care from unvaccinated staff, limiting the extent to which providers and suppliers can effectively meet the health care needs of their patients and residents.

Further, nationwide there are reports of individuals avoiding or forgoing health care due to fears of contracting erectile dysfunction treatment from health care workers.[] While avoidance of necessary care appears to have abated somewhat since the first months of the erectile dysfunction treatment cialis, it remains an area of concern for many individuals.[] Because Start Printed Page 61559 unvaccinated staff are at greater risk for , they also present a threat to health care operations—absenteeism due to erectile dysfunction treatment-related exposures or illness can create staffing shortages that disrupt patient access to recommended care. Data suggest the current surge in erectile dysfunction treatment cases associated with emergence of the Delta variant has exacerbated health care staffing shortages. For example, 1 in 5 hospitals report that they are currently experiencing a critical staffing shortage.[] Through the week ending September 19, 2021, approximately 23 percent of LTC facilities reported a shortage in nursing aides. 21 percent reported a shortage of nurses.

And 10 to 12 percent reported shortages in other clinical and non-clinical staff categories.[] And while some studies suggest overall staffing levels (as defined by nurse hours per resident day) have been relatively stable, this appears to be associated with concurrent decreases in patient demand (for example, resident census in nursing homes)—decreases that have ramifications for patient access to recommended and medically appropriate services.[] Over half (58 percent) of nursing homes participating in a recent survey conducted by the American Health Care Association and National Center for Assisted Living (AHCA/NCAL) indicated that they are limiting new admissions due to staffing shortages.[] Similarly, hospital administrators responding to an OIG pulse survey conducted during February 22-26, 2021, reported difficulty discharging erectile dysfunction treatment patients to post-acute facilities (for example, nursing homes, rehabilitation hospitals, and hospice facilities) following the acute stage of the patient's illness. These delays in discharge affected available bed space throughout the hospital (for example, creating bottlenecks in ICUs and EDs) and delayed patient access to specialized post-acute care (such as rehabilitation).[] The drivers of this staffing crisis are multi-factorial. They include. Longstanding shortages in certain fields and professions.

Prolonged physical, mental, and emotional stress and trauma associated with responding to the ongoing PHE. And competing personal or professional obligations (such as child care) or opportunities (for example, new careers). But illnesses and deaths associated with erectile dysfunction treatment are exacerbating staffing shortages across the health care system. Over half a million erectile dysfunction treatment cases and 1,900 deaths among health care staff have been reported to CDC since the start of the PHE.[] When submitting case-level erectile dysfunction treatment reports, State and territorial jurisdictions may identify whether individuals are or are not health care workers.

Since health care worker status has only been reported for a minority of cases (approximately 18 percent), these numbers are likely gross underestimates of true burden in this population. erectile dysfunction treatment case rates among staff have also grown in tandem with broader national incidence trends since the emergence of the Delta variant. For example, as of mid-September 2021, erectile dysfunction treatment cases among LTC facility and ESRD facility staff have increased by over 1400 percent and 850 percent, respectively, since their lows in June 2021.[] Similarly, the number of cases among staff for whom case-level data were reported by State and territorial jurisdictions to CDC increased by nearly 600 percent between June and August 2021.[] Vaccination is thus a powerful tool for protecting health and safety of patients, and, with the emergence and spread of the highly transmissible Delta variant, it has been an increasingly critical one to address the extraordinary strain the erectile dysfunction treatment cialis continues to place on the U.S. Health system.

While erectile dysfunction treatment cases, hospitalizations, and deaths declined over the first 6 months of 2021, the emergence of the Delta variant reversed these trends.[] Between late June 2021 and September 2021, daily cases of erectile dysfunction treatment increased over 1200 percent. New hospital admissions, over 600 percent. And daily deaths, by nearly 800 percent.[] Available data also continue to suggest that the majority of erectile dysfunction treatment cases and hospitalizations are occurring among individuals who are not fully vaccinated. In a recent study of reported erectile dysfunction treatment cases, hospitalizations, and deaths in 13 U.S.

Jurisdictions that routinely link case surveillance and immunization registry data, CDC found that unvaccinated individuals accounted for over 85 percent of all hospitalizations in the period between June and July 2021, when Delta became the predominant circulating variant.[] Unfortunately, health care staff vaccination rates remain too low in too many health care facilities and regions. For example, national erectile dysfunction treatment vaccination rates for LTC facility, hospital, and ESRD facility staff are 67 percent, 64 percent, and 60 percent, respectively. Moreover, these averages obscure sizable regional differences. LTC facility staff vaccination rates range from lows of 56 percent to highs of over 90 percent, depending upon the State.

Similar patterns hold for ESRD facility and hospital staff.[] Given slow but steady increases in vaccination rates among staff working in these settings over time,[] widespread availability of treatments, and targeted efforts to facilitate treatment access like the Federal Retail Pharmacy program,[] treatment hesitancy,[] rather than other factors (for example, staff turnover) is likely to account for suboptimal staff vaccination rates. While a significant number of health care staff have been infected with erectile dysfunction,[] evidence indicates their -induced immunity, also called “natural immunity,” is not equivalent to receiving the erectile dysfunction treatment. Available evidence indicates that erectile dysfunction treatments offer better protection than -induced immunity alone and that treatments, even after prior , help prevent Start Printed Page 61560 res.[] Consequently, CDC recommends that all people be vaccinated, regardless of their history of symptomatic or asymptomatic erectile dysfunction .[] Further, the risks of unvaccinated health care staff may disproportionately impact communities who experience social risk factors and populations described under Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, including members of racial and ethnic communities. Individuals with disabilities.

Individuals with limited English proficiency. Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ+) individuals. Individuals living in rural areas. And others adversely affected by persistent poverty or inequality.

CDC data show that across the U.S., physicians and advanced practice providers have significantly higher vaccination rates than aides.[] Among aides, lower vaccination coverage was observed in those facilities located in zip codes where communities experience greater social risk factors. The finding that vaccination coverage among aides was lower among those working at LTC facilities located in zip code areas with higher social vulnerability is consistent with an earlier analysis of overall county-level vaccination coverage by indices of social vulnerability.[] CDC notes that together, these data suggest that vaccination disparities among job categories are likely to mirror social disparities as well as disparities in surrounding communities. In addition, nurses and aides who may have the most patient contact have the lowest rates of vaccination coverage among health care staff. erectile dysfunction treatment outbreaks have occurred in LTC facilities in which residents were highly vaccinated, but transmission occurred through unvaccinated staff members.[] These findings have implications regarding occupational safety and health outcome equity—national data indicates that aides in nursing homes are disproportionately women and members of racial and ethnic communities with lower hourly wages than physicians and advance practice clinicians,[] and are also more likely to have underlying conditions that put them at risk for adverse outcomes from erectile dysfunction treatment.[] Ensuring full vaccination coverage across health care settings is critical to addressing these disparities among health care workers, particularly those from communities who experience social risk, and to equitably protecting individuals CMS serves from unnecessary and significant harm associated with erectile dysfunction treatment cases and the ongoing cialis.

It is essential to reduce the transmission and spread of erectile dysfunction treatment, and vaccination is central to any multi-pronged approach for reducing health system burden, safeguarding health care workers and the people they serve, and ending the erectile dysfunction treatment cialis. Currently FDA-approved and FDA-authorized treatments in use in the U.S. Are both safe and highly effective at protecting vaccinated people against symptomatic and severe erectile dysfunction treatment.[] Higher rates of vaccination, especially in health care settings, will contribute to a reduction in the transmission of erectile dysfunction and associated morbidity and mortality across providers and communities, contributing to maintaining and increasing the amount of healthy and productive health care staff, and reducing risks to patients, resident, clients, and PACE program participants. In light of our responsibility to protect the health and safety of individuals providing and receiving care and services from for Medicare- and Medicaid-certified providers and suppliers, and CMS's broad statutory authority to establish health and safety regulations, we are compelled to require staff vaccinations for erectile dysfunction treatment in these settings.

For these reasons, we are issuing this IFC based on these authorities and in accordance with established rule making processes. Specifically, sections 1102 and 1871 of the Social Security Act (the Act) grant the Secretary of Health and Human Services authority to make and publish such rules and regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is charged under this Act and as may be necessary to carry out the administration of the insurance programs under the Act. The discussions of the provider- and supplier-specific provisions in section II. Of this IFC set out the specific authorities for each provider or supplier type.

Provider and supplier compliance with the Federal rules issued under these statutory authorities are mandatory for participation in the Medicare and Medicaid programs. To the extent a court may enjoin any part of the rule, the Department intends that other provisions or parts of provisions should remain in effect. Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. A.

Regulatory Responses to the PHE 1. Waivers CMS and other Federal agencies have taken many actions and exercised extensive regulatory flexibilities to help health care providers contain the spread of erectile dysfunction. When the President declares a national emergency under the National Emergencies Act or an emergency or disaster under the Stafford Act, CMS is empowered to take proactive steps by waiving certain CMS regulations, as authorized under section 1135 of the Act (“1135 waivers”). CMS may also grant certain flexibilities to skilled nursing facilities (SNFs) under Medicare, as authorized separately under section 1812(f) of the Act (“1812(f) flexibilities”).

The 1135 waivers and 1812(f) flexibilities allowed us to rapidly expand efforts to help control the spread of erectile dysfunction. We have issued PHE waivers for most Medicare- and Medicaid-certified Start Printed Page 61561 providers and suppliers, with the goal of supporting each facility's operational flexibility while preserving health and safety and core health care functions. 2. Rulemaking Since the onset of the PHE, we have issued five IFCs to help contain the spread of erectile dysfunction.

On April 6, 2020, we issued an IFC (Medicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency (85 FR 19230 through 19292), which established that certain requirements for face-to-face/in-person encounters will not apply during the PHE for erectile dysfunction treatment effective for claims with dates of service on or after March 1, 2020, and for the duration of the PHE for erectile dysfunction treatment. On May 8, 2020, we issued a second IFC (Medicare and Medicaid Programs, Basic Health Program, and Exchanges. Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (85 FR 27550 through 27629)) (“May 8, 2020 erectile dysfunction treatment IFC”).

This second IFC contained additional information on changes Medicare made to existing regulations to provide flexibilities for Medicare beneficiaries and providers to respond effectively to the PHE for erectile dysfunction treatment. On September 2, 2020, we issued a third IFC (Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act. Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency (85 FR 54820 through 54874)) (“September 2, 2020 erectile dysfunction treatment IFC”), that included new requirements for hospitals and CAHs to report data in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for erectile dysfunction treatment. On November 6, 2020, we issued a fourth IFC (Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency (85 FR 71142 through 71205)).

This IFC discussed CMS's implementation of section 3713 of the erectile dysfunction Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for erectile dysfunction Disease 2019 (erectile dysfunction treatment) treatment and its administration. This IFC implemented requirements in the CARES Act that providers of erectile dysfunction treatment diagnostic tests make public their cash prices for those tests and established an enforcement scheme to enforce those requirements. This IFC also established an add-on payment for cases involving the use of new erectile dysfunction treatments under the Medicare Inpatient Prospective Payment System (IPPS). Most recently, on May 13, 2021, we issued the fifth IFC (Medicare and Medicaid Programs.

erectile dysfunction treatment Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff (86 FR 26306)) (“May 13, 2021 erectile dysfunction treatment IFC”), that revised the control requirements that LTC facilities and ICFs-IID must meet to participate in the Medicare and Medicaid programs. OSHA has also engaged in rulemaking in response to the PHE for erectile dysfunction treatment. On June 21, 2021, OSHA issued the erectile dysfunction treatment Healthcare Emergency Temporary Standard (ETS) at 29 CFR 1910 subpart U (86 FR 32376) to protect health care and health care support service workers from occupational exposure to erectile dysfunction treatment.[] Health care employers covered by the ETS must develop and implement a erectile dysfunction treatment plan for each workplace to identify and control erectile dysfunction treatment hazards in the workplace and implement requirements to reduce transmission of erectile dysfunction in their workplaces related to the following. (1) Patient screening and management, (2) standard and transmission-based precautions, (3) personal protective equipment (including facemasks, and respirators), (4) controls for aerosol-generating procedures performed on persons with suspected or confirmed erectile dysfunction treatment, (5) physical distancing, (6) physical barriers, (7) cleaning and dis, (8) ventilation, (9) health screening and medical management, (10) training, (11) anti-retaliation, (12) recordkeeping, and, (13) reporting.

In addition, the ETS requires covered employers to support erectile dysfunction treatment vaccination for each employee by providing reasonable time and paid leave for employees to receive treatments and recover from side effects. The ETS generally applies to all workplace settings where any employee provides health care services or health care support services. However, because the ETS targets settings where care is provided for individuals with known or suspected erectile dysfunction treatment, the rule contains several exceptions. The ETS does not apply to.

(1) Provision of first aid by any employee who is not a licensed health care provider, (2) dispensing of prescriptions by pharmacists in retail settings, (3) non-hospital ambulatory care settings where all non-employees are screened prior to entry, and people with suspected or confirmed erectile dysfunction treatment are not permitted to enter, (4) well-defined hospital ambulatory care settings where all employees are fully vaccinated, all non-employees are screened prior to entry, and people with suspected or confirmed erectile dysfunction treatment are not permitted to enter, (5) home health care settings where all employees are fully vaccinated, all non-employees are screened prior to entry, and people with suspected or confirmed erectile dysfunction treatment are not present, (6) health care support services not performed in a health care setting (for example, offsite laundry, off-site medical billing), and (7) telehealth services performed outside of a setting where direct patient care occurs. Furthermore, in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed erectile dysfunction treatment will be present, the ETS exempts fully vaccinated workers from masking, distancing, and barrier requirements. Moreover, the ETS requires employers to immediately remove employees from the workplace if they (1) have tested positive for erectile dysfunction treatment, (2) have been diagnosed with erectile dysfunction treatment by a licensed health care provider, (3) have been advised by a licensed health care provider that they are suspected to have erectile dysfunction treatment, or (4) are experiencing certain symptoms (defined as either loss of taste and/or smell with no other explanation, or fever of at least 100.4 degrees Fahrenheit and new unexplained cough associated with shortness of breath). Employers must also immediately remove an employee who was not wearing a respirator and any other required PPE and had been in close contact with a erectile dysfunction treatment positive person in the workplace.

However, removal from the workplace due to instances of close contact exposure in the workplace is not required for asymptomatic employees who either had erectile dysfunction treatment and recovered with the last 3 months, or have been fully vaccinated (that is, 2 or more weeks have passed since the final dose). Complementary to the OSHA ETS, this interim final rule requires certain providers and suppliers participating in Medicare and Medicaid programs to ensure staff are fully vaccinated for erectile dysfunction treatment, unless exempt, because vaccination of staff is necessary for the health and safety of individuals to whom care and services are furnished. Health care staff are at high risk for erectile dysfunction exposure, the cialis that causes erectile dysfunction treatment, due to interactions with patients and individuals in the Start Printed Page 61562 community.[] Receiving a complete primary vaccination series reduces the risk of erectile dysfunction treatment by 90 percent or more thereby inhibiting the spread of disease to others.[] Furthermore, a erectile dysfunction treatment vaccination requirement reduces the likelihood of medical removal of health care staff from the workplace, as required by the OSHA erectile dysfunction treatment Healthcare ETS. This is yet another way in which this interim final rule protects the individuals who receive services from the providers and suppliers to whom the rule applies by minimizing unpredictable disruptions to operations and care.

OSHA is the Federal agency responsible for setting and enforcing standards to ensure safe and healthy working conditions for workers. The erectile dysfunction treatment Healthcare ETS addresses protections for health care and health care support service workers from the grave danger of erectile dysfunction treatment exposure in certain workplaces. CMS is the Federal agency responsible for establishing health and safety regulations for Medicare- and Medicaid-certified providers and suppliers. Hence, we are establishing a final rule requiring erectile dysfunction treatment vaccination of staff to safeguard the health and safety of patients, residents, clients, and PACE program participants who receive care and services from those providers and suppliers.

Providers and suppliers may be covered by both the OSHA ETS and our interim final rule. Although the requirements and purpose of each regulation text are different, they are complementary. B. erectile dysfunction treatment Development and Approval FDA analysis has shown that all of the currently approved or authorized treatments are safe and CDC reports that over 408 million doses of the treatment have been given through October 18, 2021.[] Bringing a new treatment to the public involves many steps, including treatment development, clinical trials, and U.S.

Food and Drug Administration (FDA) authorization or approval. While erectile dysfunction treatments were developed rapidly, all steps have been taken to ensure their safety and effectiveness. Scientists have been working for many years to develop treatments against erectile dysfunctiones, such as those that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). erectile dysfunction, the cialis that causes erectile dysfunction treatment, is related to these other erectile dysfunctiones and the knowledge that was gained through past research on erectile dysfunction treatments helped speed up the initial development of the current erectile dysfunction treatments.

After initial development, treatments go through three phases of clinical trials to make sure they are safe and effective. For other treatments routinely used in the U.S., the three phases of clinical trials are performed one at a time. During the development of erectile dysfunction treatments, these phases overlapped to speed up the process so the treatments could be used as quickly as possible to control the cialis. No trial phases were skipped.[] All erectile dysfunction treatments currently licensed (approved) [] or authorized for use in the U.S.

Were tested in clinical trials involving tens of thousands of people. FDA evaluated all of the information submitted to it in requests for Emergency Use Authorization (EUA) for the authorized erectile dysfunction treatments and, for the Comirnaty erectile dysfunction treatment, in a Biologics License Application (the conventional path to FDA approval of a treatment). FDA determined that these treatments meet FDA's standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization and licensure, as applicable. The clinical trials included participants of different races, ethnicities, and ages, including adults over the age of 65.[] Because erectile dysfunction treatment continues to be widespread, researchers have been able to conduct treatment clinical trials more quickly than if the disease were less common.

Side effects following vaccination are dependent on the specific treatment that an individual receives, and the most common include pain, redness, and swelling at the injection site, tiredness, headache, muscle pain, nausea, vomiting, fever, and chills.[] After a review of all available information, the Advisory Committee on Immunization Practices (ACIP) and CDC have concluded the lifesaving benefits of erectile dysfunction treatment vaccination outweigh the risks or possible side effects.[] The erectile dysfunction treatments currently licensed or authorized for use in the U.S. Are generally administered as either a single dose or a two-dose series given at least 21 or 28 days apart. Following completion of that primary series, a subsequent dose or doses may be recommended for one of two purposes. In the first instance, an additional dose of treatment is administered when the immune response following a primary treatment series is likely to be insufficient.

In other words, the additional dose augments the original primary series. Currently, the EUA for the Moderna mRNA erectile dysfunction treatment has been amended to include the use of a third primary series dose (that is, “additional dose”) in certain immunocompromised individuals 18 years of age or older. Similarly, the EUA for the Pfizer BioNTech mRNA erectile dysfunction treatment has been amended to include the use of an additional, or third primary series, dose in certain immunocompromised individuals 12 years of age and older. In the second instance, a booster dose of treatment is administered when the initial immune response to a primary treatment series is likely to have waned over time.

In other words, although an adequate immune response occurred after the primary treatment series, over time, immunity decreases.[] On September 22, 2021, the FDA amended the EUA for the Pfizer BioNTech mRNA erectile dysfunction treatment to allow for use of a single booster dose in certain individuals, to be administered at least 6 months after completion of the primary series. Specifically, this booster dose is authorized for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe erectile dysfunction treatment, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to erectile dysfunction puts them at high risk of serious complications of erectile dysfunction treatment including severe erectile dysfunction treatment. 90 Start Printed Page 61563 Throughout this rule, we will use the terms “additional dose” and “booster” to differentiate between the two use cases outlined above. Every person who receives a erectile dysfunction treatment receives a vaccination record card noting which treatment and the dose that was received.

treatment materials specific to each treatment are located on CDC [] and FDA [] websites. CDC has posted a collection of informational toolkits for specific communities and settings at https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​toolkits.html. These toolkits provide staff, facility administrators, clinical leadership, caregivers, and health care consumers with information and resources. While we are not requiring participation, we encourage staff who use smartphones to use CDC's smartphone-based tool called “v-safe After Vaccination Health Checker” (v-safe) [] to self-report on one's health after receiving a erectile dysfunction treatment.

V-safe is a program that differs from the treatment Adverse Event Reporting System (VAERS), which we discuss in section I.C. Of this rule. Individuals may report adverse reactions to a erectile dysfunction treatment to either program. Enrollment in v-safe allows any participating treatment recipient to directly and efficiently report to CDC how they are feeling after receiving a specific treatment, including any problems or adverse reactions.

When an individual receives the treatment, they should also receive a v-safe information sheet telling them how to enroll in v-safe or they can register at http://www.vsafe.cdc.gov. Individuals who enroll will receive regular text messages providing links to surveys where they can report any problems or adverse reactions after receiving a erectile dysfunction treatment, as well as receive “check-ins,” and reminders for a second dose if applicable.[] We note again that participation in v-safe is not mandatory, and further that staff participation and any health information provided is not traced to or shared with employers. Based on current CDC guidance,[] individuals are considered fully vaccinated for erectile dysfunction treatment 14 days after receipt of either a single-dose treatment (Janssen/Johnson &. Johnson) or the second dose of a two-dose primary vaccination series (Pfizer-BioNTech/Comirnaty or Moderna).

This guidance can also be applied to erectile dysfunction treatments listed for emergency use by the World Health Organization (WHO) and some treatments used in erectile dysfunction treatment clinical trials conducted in the U.S. These circumstances are addressed in more detail in section I.C. Of this IFC. To improve immune response for those individuals with moderately to severely compromised immune systems who receive the Pfizer-BioNTech treatment, Comirnaty, or Moderna treatment, the CDC advises an additional (third) dose of an mRNA erectile dysfunction treatment after completing the primary vaccination series.[] In addition, certain individuals who received the Pfizer-BioNTech erectile dysfunction treatment may receive a booster dose at least 6 months after completing the primary vaccination series.[] This IFC requires Medicare- and Medicaid-certified providers and suppliers to ensure that staff are fully vaccinated for erectile dysfunction treatment, unless the individual is exempted.

Consistent with CDC guidance, we consider staff fully vaccinated if it has been 2 or more weeks since they completed a primary vaccination series for erectile dysfunction treatment. We define completion of a primary vaccination series as having received a single-dose treatment or all doses of a multi-dose treatment. Currently, CDC guidance does not include either the additional (third) dose of an mRNA erectile dysfunction treatment for individuals with moderately or severely immunosuppression or the booster dose for certain individuals who received the Pfizer-BioNTech treatment in their definition of fully vaccinated.[] Therefore, for purposes of this IFC, neither additional (third) doses nor booster doses are required. The OSHA Emergency Temporary Standard for Healthcare discussed in section I.A.2.

Of this IFC also defines fully vaccinated in accordance with CDC guidance. Hence, definitions of fully vaccinated are consistent among the requirements in these regulations. C. Administration of treatments Outside the U.S., Listed for Emergency Use by the WHO, Heterologous Primary Series, and Clinical Trials We expect the majority of staff will likely receive a erectile dysfunction treatment authorized for emergency use by the FDA or licensed by the FDA.

Currently, this would include the authorized Pfizer-BioNTech (interchangeable with the licensed Comirnaty treatment made by Pfizer for BioNTech), Moderna, and Janssen (Johnson &. Johnson) erectile dysfunction treatments. We also expect erectile dysfunction treatment administration will likely occur within the U.S. For the majority of staff.

However, some staff may receive FDA approved or authorized erectile dysfunction treatments outside of the U.S., treatments administered outside of the U.S. That are listed by the WHO for emergency use that are not approved or authorized by the FDA, or treatments during their participation in a clinical trial at a site in the U.S. For these staff, we defer to CDC guidance for erectile dysfunction treatment vaccination briefly discussed here. For more information, providers and suppliers should consult the CDC website at https://www.cdc.gov/​treatments/​erectile dysfunction treatment/​clinical-considerations/​erectile dysfunction treatment-treatments-us.html#.

Repeat treatment doses are not recommended by CDC for individuals who previously completed the primary series of a treatment approved or authorized by the FDA, even if administration of the treatment occurred outside of the U.S. Individuals who receive a erectile dysfunction treatment for which two doses are required to complete the primary vaccination series should adhere as closely as possible to the recommended intervals. Following completion of their second dose, certain individuals who had received the Pfizer-BioNTech erectile dysfunction treatment may receive a booster dose at least 6 months after completion of the primary vaccination series. Moderately to severely immunocompromised individuals who have received 2 doses of an mRNA treatment may receive a third dose at least 28 days after the second dose.

treatment administration may occur inside or outside of the U.S. Furthermore, the WHO maintains a list of erectile dysfunction treatments for emergency use.[] The CDC advises that doses of an FDA approved or authorized erectile dysfunction treatment are not recommended for individuals who have previously completed the primary series of a treatment listed for emergency use by Start Printed Page 61564 the WHO. For those who have not completed the primary series of a treatment listed for emergency use by the WHO, they may receive an FDA approved or authorized erectile dysfunction treatment vaccination series. In addition, individuals who have received a erectile dysfunction treatment that is neither approved nor authorized by the FDA, nor listed on the WHO emergency use list, may receive an FDA approved or authorized vaccination series.

The CDC guidelines recommend at least 28 days between administration of an FDA licensed or authorized treatment, a non-FDA approved or authorized treatment, and a treatment listed by WHO for emergency use. For the completion of the primary series of erectile dysfunction treatment vaccination, individuals should generally avoid using heterologous treatments—meaning receiving doses of different treatments—to complete a primary erectile dysfunction treatment vaccination series. Nevertheless, CDC does recognize that, in certain situations (for example, when the treatment product given for the first dose cannot be determined or is no longer available), a different treatment may be used to complete the primary erectile dysfunction treatment vaccination series. Accordingly, staff may be considered compliant with the requirements within this regulation if they have received any combination of two doses of a treatment licensed or authorized by the FDA or listed on the WHO emergency use list as part of a two-dose series.

Of note, the recommended interval between the first and second doses of a treatment licensed or authorized by FDA, or listed on the WHO emergency use list, varies by treatment type. For interpretation of vaccination records and compliance with this rule, people who received a heterologous primary series (with any combination of FDA-authorized, FDA-approved, or WHO EUL-listed products) can be considered fully vaccinated if the second dose in a two dose heterologous series must have been received no earlier than 17 days (21 days with a 4 day grace period) after the first dose.[] Because the science and clinical recommendations are evolving rapidly, we refer individuals to CDC's Interim Public Health Recommendations for Fully Vaccinated People for additional details. Some staff may receive erectile dysfunction treatments due to their participation in a clinical trial at a site in the U.S. Repeat treatment doses are not recommended by CDC for participants in a clinical trial who previously completed the primary series of a treatment approved or authorized by FDA, or listed for emergency use by the WHO.

Likewise, for individuals who participated in a clinical trial at a site in the U.S. And received the full series of an “active” treatment candidate (not placebo) and “treatment efficacy has been independently confirmed (for example, by a data and safety monitoring board),” CDC does not recommend repeat doses.[] D. FDA Emergency Use Authorization (EUA) and Licensure of erectile dysfunction treatments The FDA provides scientific and regulatory advice to treatment developers and undertakes a rigorous evaluation of the scientific information it receives from all phases of clinical trials. Such evaluation continues after a treatment has been licensed by FDA or authorized for emergency use.

On August 23, 2021, FDA licensed the first erectile dysfunction treatment. The treatment had been known as the Pfizer-BioNTech erectile dysfunction treatment, and will now be marketed as Comirnaty, for the prevention of erectile dysfunction treatment in individuals 16 years of age and older.[] The treatment continues to be available in the U.S. Under EUA, including for individuals 12 through 15 years of age. This EUA has been amended to allow for the use of a third dose for certain immunocompromised individuals 12 years of age and older.

This EUA has also been amended to allow for use of a single booster dose in certain individuals. FDA has issued EUAs for two additional treatments for the prevention of erectile dysfunction treatment, one for the Moderna erectile dysfunction treatment (December 18, 2020) (indicated for use in individuals 18 years of age and older), and the other for Janssen (Johnson &. Johnson) erectile dysfunction treatment (February 27, 2021) (indicated for use in individuals 18 years of age and older). The EUA for the Moderna erectile dysfunction treatment has been amended to allow for the use of a third dose in certain immunocompromised individuals.

Package inserts and fact sheets for health care providers administering erectile dysfunction treatments are available for each licensed and authorized treatment from the FDA.[] Section 564 of the Federal Food, Drug, and Cosmetic Act authorizes FDA to issue EUAs. An EUA is a mechanism to facilitate the availability and use of medical countermeasures, including treatments, during public health emergencies, such as the current erectile dysfunction treatment cialis. FDA may authorize certain unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.[] The safety of the approved and authorized erectile dysfunction treatments is closely monitored. VAERS is a safety and monitoring system that can be used by anyone to report adverse events after treatments.

For erectile dysfunction treatments, vaccination providers and licensed and authorized treatment manufacturers, must report select adverse events to VAERS following receipt of erectile dysfunction treatments (including serious adverse events, cases of multisystem inflammatory syndrome (MIS), and erectile dysfunction treatment cases that result in hospitalization or death).[] Providers also must adhere to any revised safety reporting requirements. FDA's website includes letters of authorization and fact sheets and these documents should be checked for any updates that may occur. Other adverse events following vaccination may also be reported to VAERS. Additionally, adverse events are also monitored through electronic health record- and claims-based systems (through CDC's treatment Safety Datalink and FDA's Biologics Effectiveness and Safety System (BEST)).

FDA is closely monitoring the safety of the erectile dysfunction treatments both authorized for emergency use and licensed use. Vaccination providers are responsible for mandatory reporting to VAERS of certain adverse events as listed on the Health Care Provider Fact Sheets for the authorized erectile dysfunction treatments and for Comirnaty. treatment safety is critically important for all vaccination programs. Side effects following vaccinations often include swelling, redness, and pain at the injection site.

Flu-like symptoms. Headache. And nausea. All typically of Start Printed Page 61565 short duration.[] Serious adverse reactions also have been reported following erectile dysfunction treatments.

However, they are rare.[] For example, it is estimated that anaphylaxis following the mRNA erectile dysfunction treatments occurs in 2-5 individuals per million vaccinated ( https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​safety/​adverse-events.html ). For these individuals, another shot of an mRNA erectile dysfunction treatment is not recommended,[] and they should discuss receiving a different type of erectile dysfunction treatment with their health care practitioner.[] Other rare serious adverse reactions that have been reported to occur following erectile dysfunction treatments include thrombosis with thrombocytopenia syndrome (TTS) following the Janssen erectile dysfunction treatment and myocarditis and/or pericarditis following the mRNA erectile dysfunction treatments ( https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​safety/​adverse-events.html ). In the face of the erectile dysfunction treatment cialis, global researchers were able to build upon decades of treatment development, research, and use to produce safe treatments that have been highly effective in protecting individuals from erectile dysfunction treatment. From December 14, 2020, through October 12, 2021, over 403 million doses of erectile dysfunction treatment have been administered in the U.S.

Https://www.cdc.gov/​erectile dysfunction/​2019-ncov/​treatments/​safety/​safety-of-treatments.html. €œCDC recommends everyone 12 years and older get vaccinated as soon as possible to help protect against erectile dysfunction treatment and the related, potentially severe complications that can occur.” [] They state that the “potential benefits of erectile dysfunction treatment vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis.” [] E. erectile dysfunction treatment Effectiveness erectile dysfunction treatments currently approved or authorized by FDA are highly effective in preventing serious outcomes of erectile dysfunction treatment, including severe disease, hospitalization, and death.[] Moreover, available evidence suggests that these treatments offer protection against known variants, including the Delta variant (B.1.617.2), particularly against hospitalization and death.[] Furthermore, a recent study found that, between December 14, 2020, and August 14, 2021, full vaccination with erectile dysfunction treatments was 80 percent effective in preventing RT-PCR-confirmed erectile dysfunction among frontline workers, further affirming the highly protective benefit of full vaccination up to and through the 2021 summer erectile dysfunction treatment cialis waves in the U.S.[] While treatment effectiveness point estimates did decline over the course of the study as the Delta variant became predominant, the protection afforded by vaccination remained significant, underscoring the continued importance and benefits of erectile dysfunction treatment vaccination.[] Like most treatments, erectile dysfunction treatments are not 100 percent effective in preventing erectile dysfunction treatment. Consequently, some “breakthrough” cases are expected and, as the number of people who have completed a primary vaccination series and are considered fully vaccinated for erectile dysfunction treatment increases, breakthrough erectile dysfunction treatment cases will also increase commensurately.

However, the risk of developing erectile dysfunction treatment, including severe illness, remains much higher for unvaccinated than vaccinated people. Vaccinated people with a breakthrough erectile dysfunction treatment case are less likely to develop serious disease, be hospitalized, and die than those who are unvaccinated and get erectile dysfunction treatment.[] The combined protections offered by vaccination and ongoing implementation of other control measures, especially source control (masking),[] remain critical to safeguarding patients, residents, clients, PACE program participants, and staff. F. Stakeholder Response to treatments There has been growing national interest in erectile dysfunction treatment vaccination requirements among health care workers, including requests from various national health care stakeholders.

In a joint statement released on July 26, 2021, more than 50 health care professional societies and organizations called for all health care employers and facilities to require that all their staff be vaccinated against erectile dysfunction treatment. Included as signatories to this statement were organizations representing millions of workers throughout the U.S. Health care industry, including those representing doctors, nurses, pharmacists, physician assistants, public health workers, and epidemiologists as well as long term care, home care, and hospice workers.[] In addition, a large nonprofit, nonpartisan organization focused on empowering Americans over the age of 50 recently called on all LTC facilities to require vaccinations for staff and residents.[] A non-profit organization dedicated to advancing dignity in aging issued a statement in support of erectile dysfunction treatment mandates for staff and residents of long-term care facilities.[] In a policy statement dated July 21, 2021, a large long term care association, “strongly urges all residents and staff in long-term care to get vaccinated” and “supports requiring treatments for current and new staff in long-term care and other healthcare settings. erectile dysfunction treatment vaccination should be a condition of employment for all healthcare workers, including employees, contract staff and others, with appropriate exemptions for those with medical reasons or as specified by federal or state law.” [] The statement further notes that “erectile dysfunction treatments are safe.

. . Effective for preventing , and especially severe illness and death [and] reduce the risk of spreading the cialis.” [] Moreover, the Start Printed Page 61566 statement observes that “the erectile dysfunction treatment crisis exacerbated long-standing workforce challenges, and some in the sector fear that a treatment mandate could lead to worker resignations. But providers that have required staff vaccination have reported high treatment accepted by previously hesitant care professionals, and many providers report that when staff vaccination rates are high, they become providers of choice in their communities.” [] A non-profit federation of affiliated State health organizations, representing more than 14,000 non-profit and for-profit nursing homes, assisted living communities, and facilities for individuals with disabilities expressed support for all health care “strongly urges the vaccination of all health care personnel” to “protect all residents, staff and others in our communities from the known and substantial risks of erectile dysfunction treatment.” They also assert that “erectile dysfunction treatments protect health care personnel when working both in health care facilities and in the community,” and “provide strong protection against workers unintentionally carrying the disease to work and spreading it to patients and peers.” [] Numerous health systems and individual health care employers across the country have implemented treatment mandates independent of this rule.

For example, a health care system that is the largest private employer in Delaware with more than 14,000 employees, a health care system and academic medical center with over 26,000 employees in Texas, and an integrated health system in North Carolina with more than 35,000 employees, to name a few, have all preceded this rule with their own vaccination requirements, achieving rates of at least 97 percent vaccination among their staff.[] These organizations are already realizing the effectiveness of strong vaccination policies. Despite the successes of these organizations in increasing levels of staff vaccination, there remains an inconsistent patchwork of requirements and laws that is only effective at local levels and has not successfully raised staff vaccination rates nationwide. Patients, residents, clients, PACE program participants, and staff alike are not adequately protected from erectile dysfunction treatment. In September 2021, Jeffrey Zients, the White House erectile dysfunction Response Coordinator, noted that “vaccination requirements work.

. . And are the best path out of the cialis.” He further noted that vaccination requirements are not only key to the nation's path out of the cialis, but also accelerate our economic recovery, keeping workplaces safer, and helping to curb the spread of the cialis in communities, and boost job growth, the labor market, and the nation's overall economy. G.

Populations at Higher Risk for Severe erectile dysfunction treatment Outcomes erectile dysfunction treatment can affect anyone, with symptoms ranging from mild (s not requiring hospitalization) to very severe (requiring intensive care in a hospital). Nonetheless, studies have shown that erectile dysfunction treatment does not affect all population groups equally.[] Age remains a strong risk factor for severe erectile dysfunction treatment outcomes. Approximately 54.1 million people aged 65 years or older reside in the U.S.. This age group accounts for more than 80 percent of U.S.

erectile dysfunction treatment related deaths. Residents of LTC facilities make up less than 1 percent of the U.S. Population but accounted for more than 35 percent of all erectile dysfunction treatment deaths in the first 12 months of the cialis.[] Additionally, adults of any age with certain underlying medical conditions are at increased risk for severe illness from erectile dysfunction treatment. These include, but are not limited to, cancer, cerebrovascular disease, diabetes (Type 1 and Type 2), chronic kidney disease, COPD, heart conditions, Down Syndrome, obesity, substance use, smoking status, and pregnancy.[] The risk of severe erectile dysfunction treatment also increases as the number of underlying medical conditions increases in a particular individual.

A confluence of structural and epidemiological factors has also contributed to disparate risk for erectile dysfunction treatment , severe illness, and death in certain populations. For example, evidence clearly indicates that racial and ethnic minority groups, including Black and Hispanic or Latino, have disproportionately higher hospitalization rates among every age group, including children aged younger than 18 years.[] These same groups are disproportionately affected by long-standing inequities in social determinants of health, such as poverty and health care access, that increase risk of severe illness and death from erectile dysfunction treatment.[] People with intellectual disabilities are more likely to have chronic health conditions, live in congregate settings, and face more barriers to health care. Some studies suggest they are also more likely to get erectile dysfunction treatment and have worse outcomes.[] Finally, rural communities often have a higher proportion of residents who live with comorbidities or disabilities and are aged ≥65 years. These risk factors, combined with more limited access to health care facilities with intensive care capabilities, place rural dwellers at increased risk for erectile dysfunction treatment-associated morbidity and mortality.[] In addition, CDC data indicate that vaccination rates are disproportionately low among nurses and health care aides in long term care settings, particularly in communities that experience social risk factors.

Further, CDC data indicate that nurses and aides in these settings are more likely to be members of racial and ethnic minority communities.[] This disparity in vaccination coverage may be exacerbating existing and emerging disparities related to erectile dysfunction treatment cases and impact, placing members of communities who experience social risk factors—those in rural areas with geographic and transportation barriers to care, those in low income areas who experience persistent poverty and inequality, and others—at further increased risk for erectile dysfunction treatment-associated morbidity and mortality.[] This disparity may be, in part, reduced by the potential positive health equity impacts of requiring staff vaccination among provider and supplier types subject to rulemaking. Start Printed Page 61567 CMS believes that the developing data about staff vaccination rates and rates of erectile dysfunction treatment cases, and the urgent need to address erectile dysfunction treatment-related staffing shortages that are disrupting patient access to care, provides strong justification as to the need to issue this IFC requiring staff vaccination for most provider and supplier types over which we have authority. H. CMS Authority To Require Staff Vaccinations CMS has broad statutory authority to establish health and safety regulations, which includes authority to establish vaccination requirements.

Section 1102 of the Act grants the Secretary of Health and Human Services authority to make and publish such rules and regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is charged under the Act. Section 1871 of the Act grants the Secretary of Health and Human Services authority to prescribe regulations as may be necessary to carry out the administration of the Medicare program. The statutory authorities to establish health and safety requirements for erectile dysfunction treatment vaccination for each provider and supplier included in this IFC are listed in Table 1 and discussed in sections II.C. Through II.F.

Of this IFC. Section 1863 of the Act provides that “[i]n carrying out his functions, relating to determination of conditions of participation by providers. . .

The Secretary shall consult with appropriate State agencies and recognized national listing or accrediting bodies[.]” For the reasons discussed in greater detail throughout sections I. Through III. This IFC, the erectile dysfunction treatment cialis presents a serious and continuing threat to the health and to the lives of staff of health care facilities and of consumers of these providers' and suppliers' services. This threat has grown to be particularly severe since the emergence of the Delta variant.

Any delay in the implementation of this rule would result in additional deaths and serious illnesses among health care staff and consumers, further exacerbating the newly-arising, and ongoing, strain on the capacity of health care facilities to serve the public. For these reasons, in carrying out the agency's functions relating to determination of conditions of participation, conditions for coverage, and requirements, we intend to engage in consultations with appropriate State agencies and listing or accrediting bodies following the issuance of this rule, and toward that end we invite these entities to submit comments on this IFC. Given the urgent need to issue this rule, however, we do not believe that there exists an entity with which it would be appropriate to engage in these consultations in advance of issuing this IFC, nor do we understand the statute to impose a temporal requirement to do so in advance of the issuance of this rule. We have not previously required any vaccinations, but we recognize that many health care workers already comply with employer or State government vaccination requirements (for example, influenza, and hepatitis B cialis (HBV)) and invasive employer or State government-required screening procedures (such as tuberculosis screening).

Further, most of these Start Printed Page 61568 individuals met State and local vaccination requirements in order to attend school to complete the necessary education to qualify for health care positions. In addition to these longstanding vaccination requirements, many now require vaccination for erectile dysfunction treatment as well. However, studies on annual seasonal influenza treatment uptake consistently show that half of health care workers may resist seasonal influenza vaccination nationwide.[] Other ongoing CMS staff vaccination programs include hospital quality improvement contractors that provide educational resources to help hospitals and staff overcome treatment hesitancy, coordinate with State health departments to support treatment uptake (for erectile dysfunction treatment and flu), and monitor staff vaccination rates for additional action. ESRD networks also provide education on patient influenza and pneumococcal vaccinations as a part of their work and also recently (in 2020) added a goal of 85 percent of patients vaccinated for flu while also encouraging vaccinations for staff within ESRD facilities.

While we have not, until now, required any health care staff vaccinations, we have established, maintained, and regularly updated extensive health and safety requirements (CfCs, CoPs, requirements, etc.) for Medicare- and Medicaid-certified providers and suppliers. These requirements focus a great deal on prevention and control standards, often incorporating guidelines as recommended by CDC and other expert groups, as CMS's highest duty is to protect the health and safety of patients, clients, residents, and PACE program participants in all applicable settings. The Medicare statute's various provisions authorizing the Secretary to impose requirements necessary in the interest of the health and safety of beneficiaries encompass authority to require that staff working in and for Medicare-certified providers and suppliers be vaccinated against specific diseases. In addition, parallel Medicaid statutes provide authority to establish requirements to protect beneficiary health and safety, as reflected in Table 1.

We acknowledge that we have not previously imposed such requirements, but, as discussed throughout section I. Of this rule, this is a unique cialis scenario with unique access to effective treatments. In addition, for many infectious diseases, it is not necessary for CMS to impose such requirements because other entities, including employers, states, and licensing organizations, already impose sufficient standards for those specific diseases. We believe that, given the fast-moving nature of the erectile dysfunction treatment cialis and its ongoing threat to the health and safety of individuals receiving health care services in Medicare- and Medicaid-certified providers and suppliers, our intervention is warranted.

We understand that some states and localities have established laws that would seem to prevent Medicare- and Medicaid-certified providers and suppliers from complying with the requirements of this IFC. We intend, consistent with the Supremacy Clause of the United States Constitution, that this nationwide regulation preempts inconsistent State and local laws as applied to Medicare- and Medicaid-certified providers and suppliers. CDC estimates that 45.4 percent of U.S. Adults are at increased risk for complications from erectile dysfunction disease because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer.

Rates increased by age, from 19.8 percent for persons 18-29 years of age to 80.7 percent for persons >80 years of age, and varied by State, race/ethnicity, health insurance status, and employment.[] We expect that individuals seeking health care services are more likely to fall into the high-risk category. While we do not have provider- or supplier-specific estimates, we would anticipate the percentage of high-risk individuals in health care settings is much higher than the general population. Health care consumers seeking services from the provider and suppliers included in this rule are often at significantly higher risk of severe disease and death than their paid care givers.[] As discussed in section I.F. Of this IFC, erectile dysfunction treatment has disproportionally affected minority and underserved populations, who will receive safer care and better outcomes through this requirement.[] Families, unpaid caregivers, and communities will also experience overall benefit.[] Staff will directly benefit from the protective effects of erectile dysfunction treatment vaccination, but the primary reason that we are issuing this IFC requiring health care workers be vaccinated against erectile dysfunction treatment is for the protection of residents, clients, patients, and PACE program participants.

I. Vaccination Requirements and Employee Protections This IFC requires most Medicare- and Medicaid-certified providers and suppliers to ensure that their staff are fully vaccinated for erectile dysfunction treatment. The U.S. Equal Employment Opportunity Commission (EEOC) enforces workplace anti-discrimination laws and has established that employers can mandate erectile dysfunction treatment vaccination for all employees that physically enter their facility.[] We are expanding upon that to include all of the staff described in section II.A.1.

Of this IFC, for the providers and suppliers addressed by this IFC, not just those staff who perform their duties within a health care facility, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, and therapy staff. In addition, there may be other times that staff encounter fellow employees, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities. Thus, we believe it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities or other sites of patient care. In implementing the erectile dysfunction treatment vaccination policies and procedures required by this IFC, however, employers must comply with applicable Federal anti-discrimination laws and civil rights protections.

Applicable laws include. (1) The Americans with Disabilities Act (ADA). (2) Section 504 of the Rehabilitation Act (RA). (3) Title VII of the Civil Rights Act of 1964.

(4) the Pregnancy Discrimination Act. And (5) the Genetic Information Nondiscrimination Act.[] In addition, other Federal laws may provide employees with additional protections. These Federal laws continue to apply during the PHE and, in some instances, require employers to offer Start Printed Page 61569 accommodations for some individual staff members in some circumstances. These laws do not interfere with or prevent employers from following the guidelines and suggestions made by CDC or public health authorities about steps employers should take to promote public health and safety in light of erectile dysfunction treatment, to the extent such guidelines and suggestions are consistent with the requirements set forth in this regulation.

In other words, employers following CDC guidelines and the new requirements in this IFC may also be required to provide appropriate accommodations, to the extent required by Federal law, for employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance. Vaccination against erectile dysfunction treatment is a critical protective action for all individuals, especially health care workers, because the erectile dysfunction cialis poses direct threats to patients, clients, residents, PACE program participants, and staff. erectile dysfunction treatment disease at this time is resulting in much higher morbidity and mortality than seasonal flu.[] These individual vaccinations provide protections to the health care system as a whole, protecting capacity and operations during disease outbreaks. We also recognize ethical reasons to issue these vaccination requirements.

All health care workers have a general ethical duty to protect those they encounter in their professional capacity.[] Patient safety is a central tenet of the ethical codes and practice standards published by health care professional associations, licensure and certification bodies, and specialized industry groups. Health care workers also have a special ethical and professional responsibility to protect and prioritize the health and well-being of those they are caring for, as well as not exposing them to threats that can be avoided. This holds true not only for health care professionals, but also for all who provide health care services or choose to work in those settings. The ethical duty of receiving vaccinations is not new, as staff have long been required by employers to be vaccinated against certain diseases, such as influenza, hepatitis B, and other infectious diseases.

We are aware of concerns about health care workers choosing to leave their jobs rather than be vaccinated. While we understand that there might be a certain number of health care workers who choose to do so, there is insufficient evidence to quantify and compare adverse impacts on patient and resident care associated with temporary staffing losses due to mandates and absences due to quarantine for known erectile dysfunction treatment exposures and illness. We encourage providers and suppliers, where possible, to consider on-site vaccination programs, which can significantly reduce barriers that health care staff may face in getting vaccinated, including transportation barriers, need to take time off of work, and scheduling. However, treatment declination may continue to occur, albeit at lower rates, due to hesitancy among particular communities, and the Assistant Secretary for Planning and Evaluation (ASPE) indicates that vaccination promotion and outreach efforts focused on groups and communities who experience social risk factors could help address inequities.[] Despite these hesitations, many erectile dysfunction treatment vaccination mandates have already been successfully initiated in a variety of health care settings, systems, and states.

In general, workers across the economy are responding to mandates by getting vaccinated.[] A large hospital system in Texas instituted a treatment mandate and 99.5 percent of its staff received the treatment. Further, only a few of their staff resigned rather than receive the treatment.[] A Detroit-based health system also instituted a treatment mandate, and reported that 98 percent of the system's 33,000 workers were fully or partially vaccinated or in the process of obtaining a religious or medical exemption when the requirement went into effect, with exemptions comprising less than 1 percent of staffers.[] In addition, a LTC parent corporation established a erectile dysfunction treatment mandate for its more than 250 LTC facilities, leading to more than 95 percent of their workers being vaccinated. Again, they noted that very few workers quit their jobs rather than be vaccinated.[] New York enacted a State-wide health care worker erectile dysfunction treatment mandate and recorded a jump in treatment compliance in the final days before the requirements took effect on October 1, 2021.[] We believe that the erectile dysfunction treatment requirements in this IFC will result in nearly all health care workers being vaccinated, thereby benefiting all individuals in health care settings. This will greatly contribute to a reduction in the spread of and resulting morbidity and mortality from the disease, positive steps towards health equity, and an improvement in the numbers of health care staff who are healthy and able to perform their professional responsibilities.

For individual staff members that have legally permitted justifications for exemption, the providers and suppliers covered by this IFC can address those individually. II. Provisions of the Interim Final Rule With Comment Period Through this IFC, we are requiring that the following Medicare- and Medicaid-certified providers and suppliers, listed here in order of their appearance in 42 CFR, ensure that all applicable staff are vaccinated for erectile dysfunction treatment. Ambulatory Surgical Centers (ASCs) Hospices Psychiatric residential treatment facilities (PRTFs) • Programs of All-Inclusive Care for the Elderly (PACE) Start Printed Page 61570 Hospitals (acute care hospitals, psychiatric hospitals, long term care hospitals, children's hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation hospitals) Long Term Care (LTC) Facilities, including SNFs and NFs, generally referred to as nursing homes Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Home Health Agencies (HHAs) Comprehensive Outpatient Rehabilitation Facilities (CORFs) Critical Access Hospitals (CAHs) Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services Community Mental Health Centers (CMHCs) Home Infusion Therapy (HIT) suppliers Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) End-Stage Renal Disease (ESRD) Facilities For discussion purposes, we have grouped these providers and suppliers into four categories below.

(1) Residential congregate care facilities. (2) acute care settings. (3) outpatient clinical care and services. And (4) home-based care.

We note that the appropriate term for the individual receiving care and/or services differs depending upon the provider or supplier. For example, for hospitals and CAHs, the appropriate term is patient, but for ICFs-IID, it is client. Further, LTC facilities have residents and PACE Programs have participants. The appropriate term is used when discussing each individual provider or supplier, but when we are discussing all or multiple providers and suppliers we will use the general term “patient.” Similarly, despite the different terms used for specific provider and supplier entities (such as campus, center, clinic, facility, organization, or program), when we are discussing all or multiple providers and suppliers, we will use the general term “facility.” A.

Provisions of the Interim Final Rule With Comment Period In this IFC, we are issuing a common set of provisions for each applicable provider and supplier. As there are no substantive regulatory differences across settings, we discuss the provisions broadly in this section of the rule, along with their rationales. In subsequent sections of the rule we discuss any unique considerations for each setting. 1.

Staff Subject to erectile dysfunction treatment Vaccination Requirements The provisions of this IFC require applicable providers and suppliers to develop and implement policies and procedures under which all staff are vaccinated for erectile dysfunction treatment. Each facility's erectile dysfunction treatment vaccination policies and procedures must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients. Facility employees. Licensed practitioners.

Students, trainees, and volunteers. And individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff. Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities.

Thus, we believe it is necessary to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities, clinics, homes, or other sites of care. Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this IFC. In the May 13, 2021 erectile dysfunction treatment IFC, we included an extensive discussion on the subject of “staff” in relation to the LTC facility staff and to whom the testing, reporting, and education and offering of erectile dysfunction treatment requirements of that rule might apply. In that discussion, we considered LTC facility staff to be those individuals who work in the facility on a regular (that is, at least once a week) basis.

We note that this includes those individuals who may not be physically in the LTC facility for a period of time due to illness, disability, or scheduled time off, but who are expected to return to work. We also note that this description of staff differs from that in § 483.80(h), established for the LTC facility erectile dysfunction treatment testing requirements in the September 2, 2020 erectile dysfunction treatment IFC. As in the May 13, 2021 erectile dysfunction treatment IFC, we considered applying the § 483.80(h) definition to the staff vaccination requirements in this rule, but previous public feedback and our own experience tells us the definition in § 483.80(h) was overbroad for these purposes. Stakeholders across settings have reported that there are many individuals providing occasional health care services under arrangement, and that the requirements may be excessively burdensome for facilities to apply the definition at § 483.80(h) because it includes many individuals who have very limited, infrequent, or even no contact with facility staff and residents.

Stakeholders also report that applying the staff vaccination requirements to these individuals who may only make unscheduled visits to the facility would be extremely burdensome. That said, the description in this rule still includes many of the individuals included in § 483.80(h). In addition to facility-employed staff, many facilities have services provided directly, on a regular basis, by individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, social workers, and portable x-ray suppliers. Any of these individuals who provide such health care services at a facility would be included in “staff” for whom erectile dysfunction treatment vaccination is now required as a condition for continued provision of those services for the facility and/or its patients.

In order to best protect patients, families, caregivers, and staff, we are not limiting the vaccination requirements of this IFC to individuals who are present in the facility or at the physical site of patient care based upon frequency. Regardless of frequency of patient contact, the policies and procedures must apply to all staff, including those providing services in home or community settings, who directly provide any care, treatment, or other services for the facility and/or its patients, including employees. Licensed practitioners. Students, trainees, and volunteers.

And individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. This includes administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services, and others. We considered excluding individual staff members who are present at the site of care less frequently than once per week from these vaccination requirements, but were concerned that this might lead to Start Printed Page 61571 confusion or fragmented care. Therefore, any individual that performs their duties at any site of care, or has the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated to reduce the risks of transmission of erectile dysfunction and spread of erectile dysfunction treatment.

Facilities that employ or contract for services by staff who telework full-time (that is, 100 percent of their time is remote from sites of patient care, and remote from staff who do work at sites of care) should identify and monitor these individuals as a part of implementing the policies and procedures of this IFC, documenting and tracking overall vaccination status, but those individuals need not be subject to the vaccination requirements of this IFC. Note, however, that these individuals may be subject to other Federal requirements for erectile dysfunction treatment vaccination. We recognize that many infrequent services and tasks performed in or for a health care facility are conducted by “one off” vendors, volunteers, and professionals. Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), or services that are performed exclusively off-site, not at or adjacent to any site of patient care (such as accounting services), but they may choose to extend erectile dysfunction treatment vaccination requirements to them if feasible.

Other individuals who may infrequently enter a facility or site of care for specific limited purposes and for a limited amount of time, but do not provide services by contract or under arrangement, may include delivery and repair personnel. We believe it would be overly burdensome to mandate that each provider and supplier ensure erectile dysfunction treatment vaccination for all individuals who enter the facility. However, while facilities are not required to ensure vaccination of every individual, they may choose to extend erectile dysfunction treatment vaccination requirements beyond those persons that we consider to be staff as defined in this rulemaking. We do not intend to prohibit such extensions and encourage facilities to require erectile dysfunction treatment vaccination for these individuals as reasonably feasible.

When determining whether to require erectile dysfunction treatment vaccination of an individual who does not fall into the categories established by this IFC, facilities should consider frequency of presence, services provided, and proximity to patients and staff. For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination. On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements due to the fact that they are using the same common areas used by staff, patients, and visitors. Again, we strongly encourage facilities, when the opportunity exists and resources allow, to facilitate the vaccination of all individuals who provide services infrequently and are not otherwise subject to the requirements of this IFC.

2. Determining When Staff Are Considered “Fully Vaccinated” In consideration of the different treatments available for erectile dysfunction treatment, we require that providers and suppliers ensure that staff are fully vaccinated for erectile dysfunction treatment, which, for purposes of these requirements, is defined as being 2 weeks or more since completion of a primary vaccination series. This definition of “fully vaccinated” is consistent with the CDC definition. Additionally, the completion of a primary vaccination series for erectile dysfunction treatment is defined in the requirements as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

We note that the concept of a “primary series” is commonly understood with respect to vaccinations, particularly among health care professionals as well as the providers and suppliers regulated by this rule. For purposes of this IFC, and if permitted or recommended by CDC, erectile dysfunction treatment doses from different manufacturers may be combined to meet the requirements for a primary vaccination series. We further note that recommendations for booster doses currently vary by treatment and population, and expect that they will continue to vary for the foreseeable future. We also require that providers and suppliers must have a process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

Additionally, some staff members may have been vaccinated during participation in a clinical trial, or in countries other than the U.S. We discuss the applicability of these less common vaccination pathways in section I.B. Of this IFC. Currently, for two of the three treatments licensed or authorized for use in the U.S., the primary vaccination series consists of a defined number of doses administered a certain number of weeks apart.

Therefore, we have made this particular requirement effective in two different phases. We discuss these implementation phases further in section II.B. Of this IFC, but note here that Phase 1, effective 30 days after publication of this IFC, includes the requirement that staff receive the first dose, or only dose as applicable, of a erectile dysfunction treatment, or have requested or been granted an exemption to the vaccination requirements of this IFC. Phase 2, effective 60 days after publication of this IFC, requires that the primary vaccination series has been completed and that staff are fully vaccinated, except for those staff have been granted exemptions, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by CDC, due to clinical precautions and considerations.

As discussed in section II.B. Of this IFC, staff who have completed the primary series for the treatment received by the Phase 2 implementation date are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination. 3. Prevention and Control We require through this IFC that all applicable providers and suppliers have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

While every health care facility should be following recommended control and prevention measures as recommended by CDC as part of their provision of safe health care services, not all of the providers and suppliers subject to the requirements of this IFC have specific control and prevention regulations in place. Specifically, there are no prevention and control requirements for PRTFs, RHCs/FQHCs, and HIT suppliers. Therefore, for PRTFs, RHCs/FQHCs, and HIT suppliers, we require that they have a process for ensuring that they follow nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment. This process must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment.

For the providers and suppliers included in this IFC that are already subject to meeting specific prevention and control requirements on Start Printed Page 61572 an ongoing basis, we require that they have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. 4. Documentation of Staff Vaccinations In order to ensure that providers and suppliers are complying with the vaccination requirements of this IFC, we are requiring that they track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as recent receipt of monoclonal antibodies or convalescent plasma. treatment exemption requests and outcomes must also be documented, discussed further in section II.A.5.

Of this IFC. This documentation will be an ongoing process as new staff are onboarded. While provider and supplier staff may not have personal medical records on file with their employer, all staff erectile dysfunction treatments must be appropriately documented by the provider or supplier. Examples of appropriate places for treatment documentation include a facilities immunization record, health information files, or other relevant documents.

All medical records, including treatment documentation, must be kept confidential and stored separately from an employer's personnel files, pursuant to ADA and the Rehabilitation Act. Examples of acceptable forms of proof of vaccination include. erectile dysfunction treatment vaccination record card (or a legible photo of the card), Documentation of vaccination from a health care provider or electronic health record, or State immunization information system record. If vaccinated outside of the U.S., a reasonable equivalent of any of the previous examples would suffice.

Providers and suppliers have the flexibility to use the appropriate tracking tools of their choice. For those who would like to use it, CDC provides a staff vaccination tracking tool that is available on the NHSN website ( https://www.cdc.gov/​nhsn/​hps/​weekly-erectile dysfunction treatment-vac/​index.html ). This is a generic Excel-based tool available for free to anyone, not just NHSN participants, that facilities can use to track erectile dysfunction treatment vaccinations for staff members. 5.

treatment Exemptions While nothing in this IFC precludes an employer from requiring employees to be fully vaccinated, we recognize that there are some individuals who might be eligible for exemptions from the erectile dysfunction treatment vaccination requirements in this IFC under existing Federal law. Accordingly, we require that providers and suppliers included in this IFC establish and implement a process by which staff may request an exemption from erectile dysfunction treatment vaccination requirements based on an applicable Federal law. Certain allergies, recognized medical conditions, or religious beliefs, observances, or practices, may provide grounds for exemption. With regard to recognized clinical contraindications to receiving a erectile dysfunction treatment, facilities should refer to the CDC informational document, Summary Document for Interim Clinical Considerations for Use of erectile dysfunction treatments Currently Authorized in the United States, accessed at https://www.cdc.gov/​treatments/​erectile dysfunction treatment/​downloads/​summary-interim-clinical-considerations.pdf.

As described in section I.I. Of this IFC, there are Federal laws, including the ADA, section 504 of the Rehabilitation Act, section 1557 of the ACA, and Title VII of the Civil Rights Act, that prohibit discrimination based on race, color, national origin, religion, disability and/or sex, including pregnancy. We recognize that, in some circumstances, employers may be required by law to offer accommodations for some individual staff members. Accommodations can be addressed in the provider or supplier's policies and procedures.

Applicable staff of the providers and suppliers included in this IFC must be able to request an exemption from these erectile dysfunction treatment vaccination requirements based on an applicable Federal law, such as the Americans with Disabilities Act (ADA) and Title VII of the Civil Rights Act of 1964. Providers and suppliers must have a process for collecting and evaluating such requests, including the tracking and secure documentation of information provided by those staff who have requested exemption, the facility's decision on the request, and any accommodations that are provided. Requests for exemptions based on an applicable Federal law must be documented and evaluated in accordance with applicable Federal law and each facility's policies and procedures. As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader exemptions than provided for by Federal law and are inconsistent with this IFC.

For staff members who request a medical exemption from vaccination, all documentation confirming recognized clinical contraindications to erectile dysfunction treatments, and which supports the staff member's request, must be signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws. Such documentation must contain all information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And a statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements based on the recognized clinical contraindications. Under Federal law, including the ADA and Title VII of the Civil Rights Act of 1964 as noted previously, workers who cannot be vaccinated or tested because of an ADA disability, medical condition, or sincerely held religious beliefs, practice, or observance may in some circumstances be granted an exemption from their employer.

In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of erectile dysfunction treatment to at-risk individuals, in keeping with their obligation to protect the health and safety of patients. Employers must also follow Federal laws protecting employees from retaliation for requesting an exemption on account of religious belief or disability status. For more information about these situations, employers can consult the Equal Employment Opportunity Commission's website at https://www.eeoc.gov/​wysk/​what-you-should-know-about-erectile dysfunction treatment-and-ada-rehabilitation-act-and-other-eeo-laws. We also direct providers and suppliers to the Equal Employment Opportunity Commission (EEOC) Compliance Manual on Religious Discrimination [] for information on evaluating and responding to such requests.

While employers have the flexibility to establish their own processes and procedures, including forms, we point to The Safer Federal Workforce Task Force's “request for a religious exception to the erectile dysfunction treatment vaccination requirement” template as an example. This template can be viewed at https:// Start Printed Page 61573 www.saferfederalworkforce.gov/​downloads/​RELIGIOUS%20REQUEST%20FORM%20-%2020211004%20-%20MH508.pdf. 6. Planning Despite the near-universal applicability of the requirements described in sections II.A.1.

Through 5 of this IFC, we recognize that the course of the erectile dysfunction treatment cialis remains unpredictable. Due to likely unforeseen circumstances, we require that providers and suppliers make contingency plans in consideration of staff that are not fully vaccinated to ensure that they will soon be vaccinated and will not provide care, treatment, or other services for the provider or its patients until such time as such staff have completed the primary vaccination series for erectile dysfunction treatment and are considered fully vaccinated, or, at a minimum, have received a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment. This planning should also address the safe provision of services by individuals who have requested an exemption from vaccination while their request is being considered and by those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. While the nature of this rulemaking suggests the potential that virtually all health care staff in the U.S.

Will be vaccinated for COVD-19 within a matter of months, local outbreaks, new viral variations, changes in disease manifestation, or other factors necessitate contingency planning. Contingency planning may extend beyond the specific requirements of this rule to address topics such as staffing agencies that can supply vaccinated staff if some of the facility's staff are unable to work. Contingency plans might also address special precautions to be taken when, for example, there is a regional or local emergency declaration, such as for a hurricane or flooding, which necessitates the temporary utilization of unvaccinated staff, in order to assure the safety of patients. For example, expedient evacuation of a flooding LTC facility may require assistance from local community members of unknown vaccination status.

Facilities may already have contingency plans that meet the requirements of this IFC in their existing Emergency Preparedness policies and procedures. B. Implementation Dates Due to the urgent nature of the vaccination requirements established in this IFC, we have not issued a proposed rule, as discussed in section III. Of this IFC.

While some IFCs are effective immediately upon publication, we understand that instantaneous compliance, or compliance within days, with these regulations is not possible. Vaccination requires time, especially those treatments delivered in a series, and facilities may wish to coordinate scheduling of staff vaccination appointments in a staggered manner so that appropriate coverage is maintained. The policies and procedures required by the IFC will also take time for facilities to develop. However, in order to provide protection to residents, patients, clients, and PACE program participants (as applicable), we believe it is necessary to begin staff vaccinations as quickly as reasonably possible.

In order to provide protection as soon as possible, we are establishing two implementation phases for this IFC. Phase 1, effective 30 days after publication, includes nearly all provisions of this IFC, including the requirements that all staff have received, at a minimum, the first dose of the primary series or a single dose erectile dysfunction treatment, or requested and/or been granted a lawful exemption, prior to staff providing any care, treatment, or other services for the facility and/or its patients. Phase 1 also includes the requirements for facilities to have appropriate policies and procedures developed and implemented, and the requirement that all staff must have received a single dose erectile dysfunction treatment or the initial dose of a primary series by December 6, 2021. Phase 2, effective 60 days after publication, consists of the requirement that all applicable staff are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions from erectile dysfunction treatment vaccination or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations).

Although an individual is not considered fully vaccinated until 14 days (2 weeks) after the final dose, staff who have received the final dose of a primary vaccination series by the Phase 2 effective date are considered to have meet the individual vaccination requirements, even if they have not yet completed the 14-day waiting period. For example, an individual may receive the first dose of the Moderna mRNA erectile dysfunction treatment 2 or 3 days prior to the Phase 1 deadline, but must wait at least 28 days before receiving the second dose. This second dose could (and must, for purposes of this IFC) be administered prior to the Phase 2 effective date, but the individual would still be subject to meeting additional precautions as described in section II.A.3. Of this IFC until 14 days had passed.

This timing flexibility applies only to the initial implementation of this IFC and has no bearing on ongoing compliance. This information is also presented in Table 2. Start Printed Page 61574 We note that although this IFC is being issued in response to the PHE for erectile dysfunction treatment, we expect it to remain relevant for some time beyond the end of the formal PHE. Depending on the future nature of the erectile dysfunction treatment cialis, we may retain these provisions as a permanent requirement for facilities, regardless of whether the Secretary continues the ongoing PHE declarations.

Therefore, this rulemaking's effectiveness is not associated with or tied to the PHE declarations, nor is there a sunset clause. Pursuant to section 1871(a)(3) of the Act, Medicare interim final rules expire 3 years after issuance unless finalized. We expect to make a determination based on public comments, incidence, disease outcomes, and other factors regarding whether it will be necessary to conduct final rulemaking and make this rule permanent. C.

Enforcement As we do with all new or revised requirements, CMS will issue interpretive guidelines, which include survey procedures, following publication of this IFC. We will advise and train State surveyors on how to assess compliance with the new requirements among providers and suppliers. For example, the guidelines will instruct surveyors on how to determine if a provider or supplier is compliant with the requirements by reviewing the entity's records of staff vaccinations, such as a list of all staff and their individual vaccination status or qualifying exemption. The guidelines will also instruct surveyors to conduct interviews staff to verify their vaccination status.

Furthermore, the entity's policy and procedures will be reviewed to ensure each component of the requirement has been addressed. We will also provide guidance on how surveyors should cite providers and suppliers when noncompliance is identified. Lastly, providers and suppliers that are cited for noncompliance may be subject to enforcement remedies imposed by CMS depending on the level of noncompliance and the remedies available under Federal law (for example, civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement). CMS will closely monitor the status of staff vaccination rates, provider compliance, and any other potential risks to patient, resident, client, and PACE program participant health and safety.

Start Printed Page 61575 D. Residential Congregate Care Facilities Individuals residing in congregate care settings such as LTC facilities, intermediate care facilities for individuals with intellectual disabilities (ICFs-IID), and psychiatric residential treatment facilities for individuals under 21 years of age (PRTFs), regardless of health or medical conditions, are at greater risk of acquiring s. This higher risk applies to most bacterial and viral s, including erectile dysfunction. Staff working in these facilities often work across facility types (that is, LTC facilities, group homes, assisted living facilities, in home and community-based services settings, and even different congregate settings within the employer's purview), and for different providers, which may contribute to cialis transmission.

Other factors impacting cialis transmission in these settings might include. Clients or residents who are employed outside the congregate living setting. Clients or residents who require close contact with staff or direct service providers. Clients or residents who have difficulty understanding information or practicing preventive measures.

And clients or residents in close contact with each other in shared living or working spaces. 1. Long Term Care Facilities (Skilled Nursing Facilities and Nursing Facilities) Long term care (LTC) facilities, a category that includes Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities (NFs), also collectively called nursing homes, must meet the consolidated Medicare and Medicaid requirements for participation (requirements) for LTC facilities (42 CFR part 483, subpart B) that were first published in the Federal Register on February 2, 1989 (54 FR 5316). These regulations have been revised and added to since that time, principally as a result of legislation or a need to address specific issues.

The requirements were comprehensively revised and updated in October 2016 (81 FR 68688), including a comprehensive update to the requirements for prevention and control. CMS establishes requirements for acceptable quality in the operation of health care entities. LTC facilities are required to comply with the requirements in 42 CFR part 483, subpart B, to receive payment under the Medicare or Medicaid programs. In addition to several discrete requirements set out under sections 1819 and 1919 of the Act, Medicare- and Medicaid-participating LTC facilities “must meet such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.” [] More specifically, the control requirements for LTC facilities are based on sections 1819(d)(3)(A) (for skilled nursing facilities) and 1919(d)(3)(A) (for nursing facilities) of the Act, which both require that a facility establish and maintain an control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and .

Since the onset of the PHE, we have revised the requirements for LTC facilities through three IFCs focused on erectile dysfunction treatment testing, data reporting and treatment requirements for residents and staff. Specifically, we have published the following IFCs. The first IFC, “Medicare and Medicaid Programs, Basic Health Program, and Exchanges. Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” (FR27550) was published on May 8, 2020.

The May 8, 2020 erectile dysfunction treatment IFC established requirements for LTC facilities to report information related to erectile dysfunction treatment cases among facility residents and staff, we received 299 public comments. About 161, or over one-half of those comments, addressed the requirement for erectile dysfunction treatment reporting for LTC facilities set forth at § 483.80(g). The second IFC, “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act. Additional Policy and Regulatory Revisions in Response to the erectile dysfunction treatment Public Health Emergency” (FR54873) was published on September 2, 2020.

The September 2, 2020 erectile dysfunction treatment IFC strengthened CMS' ability to enforce compliance with LTC facility reporting requirements and established a new requirement for LTC facilities to test facility residents and staff for erectile dysfunction treatment. We received 171 public comments in response to the September 2, 2020 erectile dysfunction treatment IFC, of which 113 addressed the requirement for erectile dysfunction treatment testing of LTC facility residents and staff set forth at § 483.80(h). The third IFC, “Medicare and Medicaid Programs. erectile dysfunction treatment Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff” (86FR26306) was published on May 13, 2021.

We received 71 public comments in response to the May 13, 2021 erectile dysfunction treatment IFC, of which most addressed the requirements for erectile dysfunction treatment educating, offering, and reporting of the uptake of erectile dysfunction treatment for LTC facility residents and staff set forth at §§ 483.80(d)(3) and 483.80(g)(1). In that rule, we also required the educating, offering, and recommended voluntary reporting of erectile dysfunction treatment uptake in ICFs-IID facility clients and staff set forth at §§ 483.430, Facility Staffing requirements, and 483.460, Health Care Services for Clients. Under § 483.80(d)(3), as established in the May 13, 2021 IFC, we require LTC facilities to educate residents and staff on the erectile dysfunction treatments and also to offer the treatment, when available, to all residents and staff. The May 13, 2021 IFC also required LTC facilities to report both resident and staff treatment uptake and status to CDC's National Healthcare Safety Network (NHSN) (§ 483.80(d)(3)(vii)).

This has been a requirement since May 21, 2021. The CDC data collected under this requirement show that vaccination rates for LTC facility staff have stalled, with a 64 percent national average of vaccinated staff according to CDC data as of August 28, 2021, while the number of new LTC facility resident erectile dysfunction treatment cases reported per week has risen by just over 1455 percent from recorded lows in June 2021 (323 cases in the week ending June 27, 2021. 4701 in the week ending August 22, 2021). There is wide variation among states in staff vaccination rates.

With this IFC, we are amending the requirements at § 483.80, Control, by revising paragraph (d)(3)(v) by deleting the words, “or a staff member,” and adding the word, “or” before “resident representative,” so that the provision now reads, “the resident, or resident representative, has the opportunity to accept or refuse a erectile dysfunction treatment, and change their decision.” Retaining the language permitting staff to refuse vaccination would be inconsistent with the goals of this IFC. We are further amending the requirements at § 483.80 to add a new paragraph (i), titled “erectile dysfunction treatment Vaccination of facility staff,” to specify that facilities must now develop and implement policies and procedures to ensure that all staff are fully Start Printed Page 61576 vaccinated—that is, staff for whom it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment, with the completion of a primary vaccination series for erectile dysfunction treatment defined as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. For this rule, we have also added a new paragraph at § 483.80(i)(2), which specifies which staff for whom the requirements for staff erectile dysfunction treatment vaccination will not apply. (1) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff (for whom the requirements do apply) and (2) staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with residents and other staff (for whom the requirements do apply).

Additionally, under the requirements of this IFC, we are adding § 483.80(i)(3) to now require that a facility's policies and procedures for erectile dysfunction treatment vaccination of staff must include, at a minimum, the components specified in section II.A. Of this IFC. New §§ 483.80(i)(3)(i) through (x) specify these required minimum components of the facility's policies and procedures. 2.

Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) ICFs-IID are residential facilities that provide services for people with intellectual disabilities. ICF-IID clients with certain underlying medical or psychiatric conditions may be at increased risk of serious illness from erectile dysfunction treatment.[] On March 2, 2021, CDC issued Interim Considerations for Phased Implementation of erectile dysfunction treatment Vaccination and Sub Prioritization Among Recommended Populations, which notes that increased rates of transmission have been observed in these settings, and that jurisdictions may choose to prioritize vaccination of persons living in congregate settings based on local, State, tribal, or territorial epidemiology. CDC further notes that congregate living facilities may choose to vaccinate residents and clients at the same time as staff, due to numerous factors, such as convenience or shared increased risk of disease. Sections 1905(c) and (d) of the Act gave the Secretary authority to prescribe regulations for intermediate care facility services in facilities for individuals with intellectual disabilities or persons with related conditions.

The ICFs-IID Conditions of Participation were issued on June 3, 1988 (53 FR 20496) and were last updated on May 13, 2021 (86 FR 20448). There are currently 5,768 Medicare- and/or Medicaid-certified ICFs-IID. As of April 2021, 4,661 of the 5,770 are small (1 to 8 beds) in size, but there are 1,107 that are larger (14 or more beds) facilities. These facilities serve over 64,812 individuals with intellectual disabilities and other related conditions.

All must qualify for Medicaid coverage. While national data about ICFs-IID clients is limited, we take an example from Florida where almost one quarter of clients (23 percent) require 24-hour nursing services and a medical care plan in addition to their services plans.[] Data from a single State are not nationally representative and thus we are unable to generalize, but it is illustrative. Currently, the Conditions of Participation. €œHealth Care Services” at § 483.460(a)(4)(i) require that ICFs-IID offer clients and staff vaccination against erectile dysfunction treatment when treatment supplies are available (86 FR 26306).

Based on anecdotal reports, this new requirement has not significantly increased vaccination among ICFs-IID staff. We conclude that additional regulatory action is necessary to achieve widespread vaccination among ICFs-IID staff to protect ICFs-IID clients. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 483.430(g) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. 3.

Psychiatric Residential Treatment Facilities (PRTFs) PRTFs are non-hospital facilities that provide inpatient psychiatric services to Medicaid-eligible individuals under the age of 21 (also called the “psych under 21 benefit”). There are 357 PRTFs in the U.S. The facilities must meet accreditation standards, the requirements in §§ 441.151 through 441.182, and the Condition of Participation on the use of restraint and seclusion at § 483.350 through § 483.376. Among the requirements for the psych under 21 benefit are certification of need for inpatient care and a plan of care for active treatment developed by an interdisciplinary team.

The psych under 21 benefit is significant as a means for Medicaid to cover the cost of inpatient behavioral health services. The Federal Medicaid program does not reimburse states for the cost of covered services provided to beneficiaries in institutions for mental diseases (IMDs) except in specific, statutorily-authorized exceptions, including for young people who receive this service, and individuals age 65 or older served in an IMD. A PRTF provides comprehensive behavioral health treatment to children and adolescents (youth) who, due to mental illness, substance use disorders, or severe emotional disturbance, need treatment that can most effectively be provided in a residential treatment facility. PRTF programs are designed to offer a short term, intense, focused behavioral health treatment program to promote a successful return of the youth to the community.

As a congregate living setting, PRTFs are subject to many of the same elevated transmission risk factors as LTC facilities and ICFs-IID as set forth in section I. Of this IFC. Section 1905(h) of the Act defines inpatient psychiatric hospital services for individuals under 21 as any inpatient facility that the Secretary has prescribed in regulations that in the case of any individual involve active treatment which meets such standards as may be prescribed in regulations by the Secretary. Implementing essential control practices, including vaccination, is a basic control treatment standard.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 441.151(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its clients. E. Acute Care Settings Acute care settings are those providers who generally provide active care for short-term medical needs. For our discussion purposes acute care settings include.

Hospitals, critical access hospitals (CAHs), and ambulatory surgical centers (ASCs). 1. Hospitals Hospitals are large health care providers that treat patients with acute Start Printed Page 61577 care needs including emergency medicine, surgery, labor and delivery, cardiac care, oncology, and a wide variety of other services. Hospitals also administer general and specialty care that cannot safely be provided in other settings, under the supervision of physicians and licensed practitioners.

They may operate as independent institutions or as part of a larger health care system or learning institution. Section 1861(e) of the Act provides that hospitals participating in Medicare and Medicaid must meet certain specified requirements, and the Secretary may impose additional requirements if they are found necessary in the interest of the health and safety of the individuals who are furnished services in hospitals. Medicare-participating hospitals, which include nearly all hospitals in the U.S., must meet the Conditions of Participation (CoPs) at 42 CFR part 482, originally issued June 17, 1986. In addition to smaller updates over the years, these CoPs were reformed in 2012 (77 FR 29034).

Hospital CoPs identify control and prevention as a basic hospital function and lay out specific requirements at 42 CFR 482.42. control within a hospital campus is especially important, because hospitals treat individuals with infectious diseases (such as erectile dysfunction treatment) and healthy yet higher-risk individuals (for example, pregnant and post-partum individuals, infants, transplant recipients, etc.) within the same facility. Hospitals that provide emergency care must do so in accordance with the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) of 1986. Hospitals have borne the brunt of caring for patients with acute erectile dysfunction treatment during the PHE.

Individuals experiencing respiratory problems, cardiac events, kidney failure, and other serious effects of erectile dysfunction treatment illness have required in-hospital care in large numbers, to the point of occupying or even exceeding most or all critical care or ICU capacity in a facility, city, or region. Despite emergency expansion of critical care units, these waves of severely ill patients have overwhelmed hospitals, health care systems, and the professionals and other staff who work in them. This has had the disastrous effect of limiting access and increasing risk to both routine and emergency hospital care across the U.S.[] Transplant centers, psychiatric hospitals, and swing beds are governed by the control CoPs for hospitals, and are thus subject to the staff vaccination requirements issued in this IFC. We are particularly concerned about transplant center patients, who are among the most severely immunocompromised individuals due to anti-rejection medications that ensure the function of transplanted organs.

An additional member of the transplant ecosystem, Organ Procurement Organizations (OPOs) coordinate and support donation, recovery, and placement of organs. As OPO staff do not provide patient care, and typically work in locations removed from health care facilities, we are not issuing vaccination requirements for OPOs in this IFC. That said, we note that the vaccination policies required in this IFC apply to all individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or other arrangement. Accordingly, OPO staff members that provide organ transplantation services directly to hospital and transplant center patients and families must meet the vaccination requirements of this IFC.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 482.42(g) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (including employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. 2. Critical Access Hospitals (CAHs) CAHs are rural hospitals that have been designated as critical access hospitals by the State, in a State that has established a State Medicare Rural Hospital Flexibility Program. These hospitals have 25 or fewer acute care inpatient beds (except as permitted for CAHs having distinct part units under § 485.647, where the beds in the distinct part are excluded from the 25 inpatient-bed count limit specified in § 485.620(a)), must be more than 35 miles away from another hospital, and provide emergency care services 24 hours a day, 7 days a week.

On average, acute patients stay in CAHs for less than 96 hours. CAHs may be granted approval to provide post-hospital skilled nursing care, may offer hospice care under the Medicare hospice benefit, and may operate a psychiatric and/or rehabilitation distinct part unit of up to 10 beds each. CAHs also administer general and specialty care that cannot safely be provided in other settings, under the supervision of physicians and licensed practitioners. They may operate as independent institutions or as part of a larger health care system.

Generally, they serve to help ensure access to health-care services in rural communities. Section 1820 of the Act sets forth the conditions for certifying a facility as a CAH to include meeting such other criteria as the Secretary may require. Medicare-certified CAHs must meet the Conditions of Participation (CoPs) at 42 CFR part 485 subpart F, originally issued May 26, 1993 (58 FR 30630). These CoPs contain specific requirements for control and prevention at § 485.640.

Much like a standard hospital, control within a CAH is especially important, because CAHs treat individuals with infectious diseases (such as erectile dysfunction treatment) and healthy yet higher-risk individuals (for example, pregnant and post-partum individuals, infants, transplant recipients, etc.) within the same facility. While organ transplants are not performed in CAHs, we note that organ donors may be CAH patients, and organ donation and recovery may occur in CAHs. We note that the vaccination policies required in this IFC apply to all individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or other arrangement. Accordingly, OPO staff members that provide organ donation and transplantation services directly to CAH patients and families must meet the vaccination requirements of this IFC in the same manner as they meet such requirements for hospitals.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 485.640(f) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (including employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. 3. Ambulatory Surgical Centers (ASCs) ASCs are distinct entities that operate exclusively for the purpose of providing surgical services to patients not requiring hospitalization, and in which the expected duration of services would not exceed 24 hours following an Start Printed Page 61578 admission. The surgical services performed in ASCs generally are scheduled, non-life-threatening procedures that can be safely performed in either a hospital setting (inpatient or outpatient) or in an ASC.

Currently, there are 6,071 Medicare-certified ASCs in the U.S. Section 1833(i)(1)(A) of the Act authorizes the Secretary to specify those surgical procedures that can be performed safely in an ASC. Section 1832(a)(2)(F)(i) of the Act defines an ASC as a facility “which meets health, safety, and other standards specified by the Secretary in regulations. .

.”. The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, subpart C, are the minimum health and safety standards a center must meet to obtain Medicare certification. The ASC CfCs were issued on August 5, 1982 (47 FR 34082), and the Conditions related to control were last updated on November 18, 2008 (73 FR 68502, 68813). Section 416.51, control, requires ASCs to maintain an control program that seeks to minimize s and communicable diseases.

In this IFC we are adding new § 416.51(c) which requires ASCs to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule. During the erectile dysfunction treatment cialis and PHE, hospitals moved many non-elective surgical procedures to ASCs and other outpatient settings. Such movement conserves hospital resources for treating severe erectile dysfunction treatment, performing more urgent procedures, and caring for patients with more critical health needs. Moreover, referring patients in need of suitable procedures to ASCs limits the overall number of individuals visiting the hospital setting, thereby inhibiting spread of .

ASCs also offer an alternative setting for outpatient surgery for individuals reluctant to enter a hospital due to fears of erectile dysfunction treatment exposure. Based on these and other factors, the demand for ASC services has increased.[] In response to the erectile dysfunction treatment cialis, ASCs assumed new roles. CMS's Hospital Without Walls initiative permitted hospitals to provide inpatient care in ASCs and other temporary sites. ASCs have assisted with erectile dysfunction treatment testing.

They provided staff to work in erectile dysfunction treatment hot spots. These efforts illustrate that staff and patients of ASCs regularly interact with staff and patients of other health care organizations and facilities. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 416.51(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. F.

Outpatient Clinical Care &. Services These clinical settings provide necessary, ongoing care for individuals who need ongoing therapeutic, and in some cases life-sustaining, care. While many of these settings have been able to provide some services safely and effectively via telehealth during the PHE, many of the services they provide require patients and clients to see staff in person. 1.

End-Stage Renal Disease (ESRD) Facilities ESRD facilities provide a set of life-sustaining services to individuals without kidney function, including dialysis, medication, routine evaluations and monitoring, nutritional counselling, social support, and organ transplantation evaluation and referral. Section 1881(b)(1)(A) of the Act authorizes the Secretary to pay only those dialysis facilities “which meet such requirements as the Secretary shall by regulation prescribe for institutional dialysis services and supplies. . .” also known as CfCs.

The ESRD facility CfCs at 42 CFR part 494 are the minimum health and safety rules that all Medicare- and Medicaid-certified dialysis facilities must meet in order to participate in the programs. The ESRD CfCs were initially issued in 1976 and were comprehensively revised in 2008 (73 FR 20370). There are currently 7,893 Medicare-certified ESRD facilities in the U.S., serving over 500,000 patients. Routine dialysis treatments, typically delivered 3 times per week, remove toxins from a patient's blood and are necessary to sustain life.

Dialysis treatments are most often delivered in the ESRD facility but can be performed by the patients themselves at home, or in the patient's nursing facility with assistance. ESRD facilities serve patients whether they are diagnosed with erectile dysfunction treatment or not, and people receiving dialysis cannot always be adequately distanced from one another during treatment. In-center dialysis precludes social distancing because it involves being in close proximity (<6 feet) to caregivers and fellow patients for extended periods of time (12-15 hours per week). Because dialysis patients are not able to defer dialysis sessions, in-center dialysis patients are at increased risk for developing erectile dysfunction treatment due in part to difficulty maintaining physical distancing.[] Many ESRD patients are also residents of LTC facilities or other congregate living settings, which is also a risk factor for erectile dysfunction treatment.[] Further, individuals with kidney failure on dialysis may have a higher risk of worse outcomes.[] Dialysis health care personnel are considered a priority population for vaccination by the Advisory Committee on Immunization Practices (ACIP), yet ESRD facilities are currently reporting low erectile dysfunction treatment vaccination coverage among ESRD facility health care personnel, at less than 63 percent as of September 26, 2021.[] Ensuring health care personnel have access to erectile dysfunction treatment vaccination is critical to protect both them and their medically fragile patients.[] For these reasons and the reasons set forth in section II.A.

Of this IFC, we are adding a new regulatory requirement at § 494.30(b) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients.

2. Community Mental Health Centers (CMHCs) CMHCs are entities that meet applicable enrollment requirements, and applicable licensing or certification requirements in the State in which they are located. CMHCs provide the set of mental health care services specified in section 1913(c)(1) of the PHS Act (or, in limited circumstances, provides for such service by contract with an approved organization or entity). Section 4162 of the Omnibus Budget Reconciliation Act of 1990 (Pub.

L. 101-508, enacted November 5, 1990) (OBRA 1990), which added sections 1861(ff) and 1832(a)(2)(J) to the Act, includes CMHCs as entities that are authorized to provide partial hospitalization services under Part B of the Medicare program, Start Printed Page 61579 effective for services provided on or after October 1, 1991. Section 1861(ff)(3)(B)(iv)(I) of the Act specifically requires CMHCs providing partial hospitalization services under Medicare to meet such additional conditions as the Secretary specifies to ensure the health and safety of individuals being furnished such services. Section 1866(e)(2) of the Act and 42 CFR 489.2(c)(2) recognize CMHCs as providers of services for purposes of provider agreement requirements but only with respect to providing partial hospitalization services.

Pursuant to 42 CFR 410.2 and 410.110, a CMHC may receive Medicare payment for partial hospitalization services only if it demonstrates that it provides the core services identified in the requirements. To qualify for Medicare reimbursement, CMHCs must comply with requirements for coverage of partial hospitalization services at § 410.110 and conditions for Medicare payment of partial hospitalization services at 42 CFR 424.24(e). Currently there are 129 Medicare-certified CMHCs in the U.S. The Secretary has established in regulations, at 42 CFR part 485, subpart J, the minimum health and safety standards a CMHC must meet to obtain Medicare certification.

CMHC CoPs were issued on October 29, 2013 (78 FR 64604). Section 485.904, Personnel qualifications, establishes requirements for CMHC personnel. In this IFC we are adding new § 485.904(c) which requires the CMHC to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers affected by this rule. CMHCs provide mental health services to treat patients under the Medicare partial hospitalization program and other patients for various mental health conditions.

Partial hospitalization programs provide structured, outpatient mental health services that are more intense than office visits with physicians or therapists. Patients in partial hospitalization programs receive treatment for several hours during the day, multiple days a week. In response to the PHE, CMHCs continued to treat patients by using telecommunications, and some centers paused their partial hospitalization programs or reduced the frequency and duration of treatment. However, many centers have begun to see and treat patients in person again and have resumed their customary partial hospitalization programming schedules.

With increased in-person services being offered in the CMHC, it is essential to ensure all staff are vaccinated against erectile dysfunction treatment not only to protect themselves but to prevent the spread of erectile dysfunction treatment to CMHC patients. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 485.904(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner.

Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. 3. Comprehensive Outpatient Rehabilitation Facilities (CORFs) CORFs are non-residential facilities that are established and operated exclusively for the purpose of providing diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured persons, sick persons, and persons with disabilities, at a single fixed location, by or under the supervision of a physician.

In response to the PHE, outpatient rehabilitation facilities suspended operations, reduced their patient care capacity, and transitioned from in-person to telecommunications as able. However, certain rehabilitation services require physical contact with patients, such as fitting or adjusting a prosthesis or assistive device and assessing strength with manual resistance. During the cialis, some patients in need of rehabilitation chose to delay care and others encountered delays in accessing care. These delays likely contributed to increased disability or illness.[] Moreover, patients admitted to the hospital have been discharged as soon as possible to provide beds for individuals with more critical conditions, including erectile dysfunction treatment.

For those patients recovering from severe erectile dysfunction treatment illness with long-term symptoms, prompt comprehensive outpatient rehabilitation services upon their discharge from inpatient care is necessary to restore physical and mental health.[] All of these factors stress the importance of rehabilitation facilities who are treating patients with increased morbidity and complex needs. CORFs have resumed operations and are providing services to an increasing number of patients. Therefore, erectile dysfunction treatment vaccination of staff is pivotal for inhibiting spread of and ensuring health and safety of patients. Currently, there are 159 Medicare-certified CORFs in the U.S.

Section 1861(cc)(2)(J) of the Act states that the CORF must “meet such conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such facility, including conditions concerning qualifications of personnel in these facilities.” Under this authority, the Secretary has established in regulations, at 42 CFR part 485, subpart B, the minimum health and safety standards a CORF must meet to obtain Medicare certification. The CORF Conditions of Participation were issued on December 15, 1982 (47 FR 56282). Section 485.70, Personnel qualifications, sets forth the qualifications that various personnel must meet, as a condition of participation. We are adding a new paragraph (n) at § 485.70 which requires the CORF to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule.

Our rules at § 485.58(d)(4), state that personnel that do not meet the qualifications specified in § 485.70 may be used by the facility in assisting qualified staff. We recognize this sentence is inconsistent with newly added § 485.70(n) which requires vaccination of all facility staff. We also recognize that assisting personnel are used by CORFs. We established our requirements at § 485.70 (a) through (m) to provide a role for personnel that might not meet our education and experience qualifications.

We do not believe that this exception for employees that do not meet our professional requirements should prohibit us from issuing staff qualifications referencing prevention, which we intend to apply to all personnel. Hence, we are revising § 485.58(d)(4) to state that personnel that do not meet the qualifications specified in § 485.70(a) through (m) may be used by the facility in assisting qualified staff. However, such assisting staff will not be exempt from the newly added requirements in paragraph (n). As with other parallel regulations for our facilities, we are revising § 485.58(d)(4) as previously discussed.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 485.70(n) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. Start Printed Page 61580 4. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) Section 1861(aa) and 1905(l)(2)(B) of the Act sets forth the RHC and FQHC services covered by the Medicare program. Section 1905(l) cross-references the Medicare provision for Medicaid program purposes.

The Act requires that RHCs be located in an area that is both rural and underserved, are not rehabilitation agencies or facilities primarily for the care and treatment of mental diseases, and meet such other requirements as the Secretary may find necessary in the interest of the health and safety of the individuals who are furnished services by the clinic. Likewise, 42 CFR 491.2 defines a FQHC as an entity as defined in §  405.2401(b). The definition at § 405.2401 includes an entity that has entered into an agreement with CMS to meet Medicare Program requirements under § 405.2434. And at 42 CFR 405.2434, the content and terms of the agreement require FQHCs to maintain compliance with requirements set forth in part 491, except the provisions of § 491.3 Certification procedures.

Conditions for certification for RHCs and Conditions of Coverage for FQHCs are found at 42 CFR part 491, subpart A. RHCs and FQHCs, as essential contributors to the health care infrastructure in the U.S., provide care and services to medically underserved areas and populations. They play a critical role in helping to alleviate access to care barriers and health equity gaps in these communities. RHCs and FQHCs provide primary care, diagnostic laboratory, and immunization services, and they have incorporated erectile dysfunction treatment screening, triage, testing, diagnosis, treatment, and vaccination into these services.

However, the medically underserved communities in the U.S. Have been disproportionately affected by erectile dysfunction treatment. Hence, the Health Resources and Services Administration (HRSA) has established new programs to help RHCs and FQHCs meet the needs of their communities and ensure continuity of health care services during the PHE.[] For example. (1) The Rural Health Clinic erectile dysfunction treatment Testing and Mitigation Program which helps RHCs with erectile dysfunction treatment testing and mitigation strategies to prevent the spread of .

(2) the Rural Health Clinic treatment Distribution Program which strengthens erectile dysfunction treatment allocations for RHCs. (3) the Rural Health Clinic treatment Confidence Program that helps RHCs with outreach efforts to improve vaccination rates in rural areas with nearly 2,000 RHCs across the nation participating. (4) the Health Center erectile dysfunction treatment Program whereby FQHCs receive direct allocations of treatments. (5) the Department of Defense (DoD) and HHS partnered to provide point-of-care rapid erectile dysfunction treatment testing supplies to FQHCs through the Health Center erectile dysfunction treatment Testing Supply Distribution Program.

And (6) delivery of 5.1 million adult and 7.4 million child masks between April and August 2021 to FQHCs at no cost for subsequent distribution to patients, staff, and community members. To implement these programs and to provide services and care, RHC/FQHC staff must interact with patients and members of the community at large. Hence, a requirement for these staff to receive erectile dysfunction treatment vaccination is necessary to assure health and safety for the individuals residing in their respective service areas and their patients. Currently, there are 4,933 Medicare-and Medicaid-certified RHCs and 10,384 FQHCs that participate in the Medicare and Medicaid programs in the U.S.

The Conditions at 42 CFR part 491, subpart A are the minimum health and safety standards a center or clinic must meet to participate in the Medicare and Medicaid programs. The conditions were issued on June 12, 1992 (57 FR 27106), and the conditions related to staffing and staff responsibilities were last updated on May 12, 2014 (79 FR 27106). Section 491.8, Staffing and staff responsibilities, establishes requirements for RHC and FQHC staffing and staff responsibilities. We are adding new § 491.8(d) which requires the clinic or center to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 491.8(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. 5. Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services Under the authority of section 1861(p) of the Act, the Secretary has established CoPs that clinics, rehabilitation agencies, and public health agencies (collectively, “organizations”) must meet when they provide outpatient physical therapy (OPT) and speech-language pathology (SLP) services. Under section 1861(p) of the Act, the Secretary is responsible for ensuring that the CoPs and their enforcement are adequate to protect the health and safety of individuals receiving OPT and SLP services from these entities.

The CoPs are set forth at 42 CFR part 485, subpart H. Section 1861(p) of the Act describes outpatient physical therapy services to mean physical therapy services furnished by a provider of services, a clinic, rehabilitation agency, or a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient. The patient must be under the care of a physician. The term “outpatient physical therapy services” also includes physical therapy services furnished to an individual by a physical therapist (in the physical therapist's office or the patient's home) who meets licensing and other standards prescribed by the Secretary in regulations, other than under arrangement with and under the supervision of a provider of services, clinic, rehabilitation agency, or public health agency.

Pursuant to the statutory requirement set out at section 1861(p)(4)(A) and (B) of the Act, the furnishing of such services by a clinic, rehabilitation agency, or public health agency must meet such conditions relating to health and safety as the Secretary may find necessary. The term also includes SLP services furnished by a provider of services, a clinic, rehabilitation agency, or by a public health agency, or by others under an arrangement. Currently, there are 2,078 clinics, rehabilitation agencies, and public health agencies that provide outpatient physical therapy and speech-language services. In the remainder of this rule and throughout the requirements, we use the term “organizations” instead of “clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services” for consistency with current regulatory language.

Patients receive services from organizations due to loss of functional Start Printed Page 61581 ability associated with injury or illness. Hence, these patients experience episodic issues and seek care to restore their level of functioning and wellness to baseline. In response to the PHE, organizations experienced a reduction in patients. They supplemented in-person care with telecommunications.

However, just over 50 percent of physical therapists report in-person care results in better outcomes than care provided virtually and the majority of patients are less satisfied with care received by telecommunications.[] Although the data is limited, we believe these findings are consistent with other therapeutic services including occupational therapy and speech pathology. Comprehensive assessment of balance, strength, range-of-motion, and proper exercise technique is supported by physical touch, and three-dimensional visualization of the patient. Organizations have begun seeing more patients, and those patients are presenting with more severe functional issues. Organizations care for patients recovering from erectile dysfunction treatment and those who delayed receiving non-erectile dysfunction treatment related care due to fears of exposure to illness after the onset of the cialis.

These factors underscore the need to ensure safety and health of individuals who receive care from organizations with a requirement for erectile dysfunction treatment vaccination of staff. The CoPs for organizations at 42 CFR part 485, subpart H are the minimum health and safety standards an organization must meet to obtain Medicare certification. The CoPs were first issued May 21, 1976 (41 FR 20863), and the Conditions related to control were last updated on September 29, 1995 (60 FR 50446). Section 485.725, control, requires organizations to establish an -control committee with responsibility for overall control.

We are adding new paragraph (f) to § 485.725, which requires the organizations to meet the same erectile dysfunction treatment vaccination of staff requirements as those we are issuing for the other providers and suppliers identified in this rule. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 485.725(f) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner.

Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. G. Home-Based Care Home-based care providers provide necessary care and services for individuals who need ongoing therapeutic, and in some cases life-sustaining, care.

These settings require that health care staff enter the patient's personal home (regardless of location in a private home, assisted living facility, or another setting) to provide services and care in person, thus exposing patients and other members of their household, to the staff. Home-based provider staff also often serve multiple patients in different homes in the same day, week, or month, which presents opportunities for transmission of infectious diseases across households. Because home-based providers work outside of a regulated health care facility, there is also the potential for staff to either not use the appropriate PPE or use it improperly because on-site oversight mechanisms are not in place, that could increase the risk of transmission of erectile dysfunction treatment or other infectious diseases across households. We also believe these patients are especially vulnerable to erectile dysfunction treatment due to receiving care in their homes.

Many patients have serious illnesses that increases the risk of morbidity and mortality from erectile dysfunction treatment. For hospice patients that are receiving non-curative but supportive care, we are concerned that contracting erectile dysfunction treatment could increase their discomfort, decrease their quality of life, or perhaps even hasten their death. In addition, the patients' homes may have poor ventilation or members of the household may not be complying with recommended safety precautions. Thus, erectile dysfunction treatment vaccination mandates will provide patients and their household members with safety assurances that will facilitate acceptance of home care services, and will protect the patients, staff, and the other members of the patients' households.

1. Home Health Agencies (HHAs) Under the authority of sections 1861(m), 1861(o), and 1891 of the Act, the Secretary has established in regulations the requirements that a home health agency (HHA) must meet to participate in the Medicare program, our regulations at 42 CFR 440.70(d) require that Medicaid-participating home health agencies meet Medicare conditions of participation. Section 1861(o)(6) of the Act requires that home health agencies “meet the conditions of participation specified in section 1891(a) and such other conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such agency or organization.” The CoPs for home health services are found in Title 42, Part 484, subparts A through C, §§ 484.40 through 484.115. HHAs provide care and services for qualifying older adults and people with disabilities who are beneficiaries under the Hospital Insurance (Part A) and Supplemental Medical Insurance (Part B) benefits of the Medicare program.

These services include skilled nursing care, physical, occupational, and speech therapy, medical social work and home health aide services which must be furnished by, or under arrangement with, an HHA that participates in the Medicare program and must be provided in the beneficiary's home. As of September 1, 2021, there were 11,649 HHAs participating in the Medicare program. The majority of HHAs are for-profit, privately owned agencies. The effective delivery of quality home health services is essential to the care of the HHA's patients to provide necessary care and services and prevent hospitalizations.

Since patients and other members of their households will be exposed to HHA staff, it is essential that staff be vaccinated against erectile dysfunction treatment for the safety of the patients, members of their households, and the staff themselves. With so many patients depending on the services of HHAs nationwide, it is imperative that HHAs have processes in place to address the safety of patients and staff and the continued provision of services. Because these patients are at home, essential care must be provided, regardless of erectile dysfunction treatment vaccination or status. In addition, by going into patients' homes, HHA employees are exposed to numerous individuals who might not be vaccinated or perhaps are asymptomatic but infected.

Therefore, it is imperative that HHAs have appropriate procedures to ensure the continued provision of care and services for their patients. Section 484.70 Condition of participation. prevention and control (a) requires that the “HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of s and communicable diseases.” For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 484.70(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who Start Printed Page 61582 provide care, treatment, or other services for the provider or its patients. 2.

Hospice Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (Pub. L. 97-248, enacted September 3. 1982) (TEFRA), added section 1861(dd) to the Act to provide coverage for hospice care to terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice.

Under the authority of section 1861(dd) of the Act, the Secretary has established the CoPs that a hospice must meet in order to participate in Medicare and Medicaid. Under section 1861(dd)(2)(G) of the Act, the Secretary may impose “such requirements as the Secretary may find necessary in the interest of the health and safety of the individuals who are provided care and services by such agency or organization.” The CoPs found at part 418, subparts C and D apply to a hospice, as well as to the services furnished to each patient under hospice care. These requirements are set forth in §§ 418.52 through 418.116. Hospice care provides palliative care rather than curative treatment to terminally ill patients.

Palliative care improves the quality of life of patients and their families and caregivers facing the challenges associated with terminal illness through the prevention and relief of suffering by means of early identification, assessment, and treatment of pain and other issues. Hospice care allows the patient to remain at home by providing support to the patient and family and caregiver and by keeping the patient as comfortable as possible while maintaining his or her dignity and quality of life. Hospices use an interdisciplinary approach to deliver medical, social, physical, emotional, and spiritual services through the use of a broad spectrum of support. Hospices are unique health care providers because they serve patients, families, and caregivers in a wide variety of settings.

Hospice patients may be served in their place of residence, whether that residence is a private home, an LTC facility, an assisted living facility, or even a recreational vehicle, as long as such locations are determined to be the patient's place of residence. Hospice patients may also be served in inpatient facilities, including those operated by the hospice itself. With so many patients depending on the services of hospice services nationwide, it is imperative that hospices have processes in place to address the safety of patients and staff and the continued provision of services. The goal of hospice care is to provide non-curative, but supportive care of an individual during the final days, weeks, or months of a terminal illness.

Contracting any infectious disease, especially erectile dysfunction treatment, could result in additional pain or perhaps even accelerate a patient's death. Thus, it is critical that hospices protect patients and staff from contracting or transmitting erectile dysfunction treatment. As of September 1, 2021, there were 5,556 hospices. Section 418.60(a), Condition of participation.

Control, requires that the “hospice must follow accepted standards of practice to prevent the transmission of s and communicable disease, including the use of standard precautions.” The effective delivery of hospice services is essential to the care of the hospice's patients and their families and caregivers. Since patients and other members of their households will be exposed to hospice staff, it is essential that staff be vaccinated against erectile dysfunction treatment for the safety of the patients, members of their households, and the staff themselves. For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 418.60(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (including employees.

Licensed practitioner. Students, trainees, and volunteers. And other individuals) who provide care, treatment, or other services for the provider or its patients. 3.

Home Infusion Therapy Suppliers (HIT) Suppliers Section 5012 of the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 2016) (Cures Act) created a separate Medicare Part B benefit category under 1861(s)(2)(GG) of the Act for coverage of home infusion therapy-associated professional services for certain drugs and biologicals administered intravenously or subcutaneously for periods of 15 minutes or more in the patient's home through a pump that is an item of durable medical equipment. Section 1861(iii)(3)(D)(i)(IV) of the Act requires qualified home infusion therapy (HIT) suppliers to meet, in addition to specified qualifications, “such other requirements as the Secretary determines appropriate.” The regulatory requirements for home therapy infusion (HIT) suppliers are located at 42 CFR part 486, subpart I, §§ 486.500 through 486.525.

The nature of the home setting presents different challenges than in-center services as well as the administration of the particular medications. The items and equipment needed to perform home infusion include the drug (for example, immune globulin), equipment (a pump), and supplies (for example, tubing and catheters) which are covered under the Durable Medical Equipment benefit. Skilled professional visits, such as those from nurses, often play a critical role in the provision of home infusion and are covered under the home infusion therapy benefit. For example, nurses typically train the patient or caregiver to self-administer the drug, educate on side effects and goals of therapy, and visit periodically to provide catheter and site care.

Depending on patient acuity or the complexity of the drug administration, certain skilled professional visits may require more time. The HIT infusion process typically requires coordination among multiple entities, including patients, the responsible physicians and practitioners, hospital discharge planners, pharmacies, and, if applicable, home health agencies. The current requirements for HIT suppliers do not contain specific prevention and control requirements. However, § 486.525, Required services, does state that these providers must “provide home infusion therapy services in accordance with nationally recognized standards of practice, and in accordance with all applicable state and federal laws and regulations.” We believe that “nationally recognized standards of practice” include appropriate policies and procedures for prevention and control.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding a new regulatory requirement at § 486.525(c) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services for the provider or its patients. 4. Programs of All-Inclusive Care for the Elderly (PACE) Organizations The Programs of All-Inclusive Care for the Elderly (PACE) program provides a model of managed care service delivery for frail older adults, most of whom are dually eligible for Medicare and Medicaid benefits, and all of whom are assessed as being eligible for LTC facility placement according to the Medicaid standards established by their respective states. PACE organizations furnish comprehensive medical, health, and social services that integrate acute and long-term care, and these services must be furnished in at least the PACE Start Printed Page 61583 center, the home, and inpatient facilities.

The PACE model involves a multidisciplinary team of providers known as the interdisciplinary team (IDT) that comprehensively assesses and meets the needs of each PACE participant by planning and coordinating all participant care. PACE organizations must provide all Medicare-covered items and services, all Medicaid-covered items and services, and any other services determined necessary by the IDT to improve and maintain the participant's overall health status, either directly or under contract with third party service providers. The statutory authorities that permit Medicare payments and coverage of benefits under the PACE program, as well as the establishment of PACE organizations as a State option under Medicaid to provide for Medicaid payments and coverage of benefits under the PACE program, are under sections 1894 and 1934 of the Act. These statutory authorities are implemented at 42 CFR part 460, where CMS has set out the minimum requirements an entity must meet to operate a PACE program under Medicare and Medicaid.

There are 141 PACE organizations nationally. These organizations serve approximately 52,000 participants, all in need of the comprehensive services provided by PACE organizations. Due to their health status, PACE participants are at high risk of severe erectile dysfunction treatment and as such have been among the populations prioritized for vaccination since the treatments were authorized. Participants' regular interactions with PACE organization staff and contractors indicate that those staff and contractors should also be vaccinated against erectile dysfunction treatment.

For these reasons and the reasons set forth in section II.A. Of this IFC, we are adding new regulatory requirements at § 460.74(d) related to establishing and implementing policies and procedures for erectile dysfunction treatment vaccination of all staff (includes employees. Licensed practitioner. Students, trainees, and volunteers.

And other individuals) who provide care, treatment, or other services on behalf of a PACE organization. III. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule before the provisions of the rule take effect, in accordance with the Administrative Procedure Act (APA), 5 U.S.C. 553, and section 1871 of the Act.

Specifically, section 553(b) of the APA requires the agency to publish a notice of the proposed rule in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. Section 553(c) further requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment before the provisions of the rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and a period of not less than 60 days for public comment. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize the agency to waive these procedures, however, if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.

The 2021 outbreaks associated with the erectile dysfunction Delta variant have shown that current levels of erectile dysfunction treatment vaccination coverage up until now have been inadequate to protect health care consumers and staff. The data showing the vital importance of vaccination indicate to us that we cannot delay taking this action in order to protect the health and safety of millions of people receiving critical health care services, the workers providing care, and our fellow citizens living and working in communities across the nation. Although section 564 of the FDCA does not prohibit public or private entities from imposing vaccination requirements, even when the only treatments available are those authorized under EUAs ( https://www.justice.gov/​olc/​file/​1415446/​download ), CMS initially chose, among other actions, to encourage rather than mandate vaccination, believing that a combination of other Federal actions, a variety of public education campaigns, and State and employer-based efforts would be adequate. However, despite all of these efforts, including CMS's mandate for vaccination education and offering of treatments to LTC facility and ICF-IID staff, residents, and clients (86 FR 26306), OSHA's June 21, 2021 ETS to protect health care and health care support service workers from occupational exposure to erectile dysfunction treatment (86 FR 3276), and ongoing CDC information and encouragement, treatment uptake among health care staff has not been as robust as hoped for and have been insufficient to protect the health and safety of individuals receiving health care services from Medicare- and Medicaid-certified providers and suppliers, particularly given the advent of the Delta variant and the potential for new variants.

As discussed throughout the preamble of this IFC, the PHE continues to strain the U.S. Health care system. Over the first 6 months of 2021, erectile dysfunction treatment cases, hospitalizations and deaths declined. The emergence of the Delta variant reversed these trends.[] Between late June 2021 and September 2021, daily cases of erectile dysfunction treatment increased over 1200 percent.

New hospital admissions, over 600 percent. And daily deaths, by nearly 800 percent.[] Available data also continue to suggest that the majority of erectile dysfunction treatment cases and hospitalizations are occurring among individuals who are not fully vaccinated. From January through May 2021, of the more than 32,000 laboratory-confirmed erectile dysfunction treatment-associated hospitalizations in adults over 18 years of age for whom vaccination status is known, less than 3 percent of hospitalizations occurred in fully vaccinated persons.[] More recently published data continue to suggest that fully vaccinated persons account for a minority (~10 percent) of erectile dysfunction treatment related hospitalizations.[] For all adults aged 18 years and older, the cumulative erectile dysfunction treatment-associated hospitalization rate was about 12-times higher in unvaccinated persons.[] Consequently, some hospitals and health care systems are currently experiencing tremendous strain due to high case volume coupled with persistent staffing shortages due, at least in part, to erectile dysfunction treatment or quarantine following exposure. We recognize that newly reported erectile dysfunction treatment cases, hospitalizations, and deaths have begun to trend downward at a national level.

Nonetheless, they remain substantially elevated relative to numbers seen in May and June 2021, when the Delta variant became the predominant strain circulating in the U.S.[] And while cases are trending Start Printed Page 61584 downward in some states, there are emerging indications of potential increases in others—particularly northern states where the weather has begun to turn colder. This is not surprising. Respiratory cialis s typically circulate more frequently during the winter months, with peaks in pneumonia and influenza deaths typically during winter months.[] Similarly, the U.S. Experienced a large erectile dysfunction treatment wave in the winter of 2020.

Approximately 1 in 3 people 12 years of age and older in the U.S. Remain unvaccinated—and they could pose a threat to the country's progress on the erectile dysfunction treatment cialis, potentially incurring a fifth wave of erectile dysfunction treatment s.[] The onset of the 2021-2022 influenza season presents an additional threat to patient health and safety. Although influenza activity during the 2020-2021 season was low throughout the U.S.,[] the intensity of the upcoming 2021-2022 influenza season cannot be predicted. Several factors could make this flu season more severe.

These include return to school by children with no prior exposure to flu (and therefor lower immunity), waning protection over time from previous seasonal influenza vaccination, and the fact that adult immunity (especially among those who were not vaccinated last season) will now partly depend on exposure to cialises two or more seasons earlier.[] erectile dysfunction treatment vaccination thus remains an important tool for decreasing stress on the U.S. Health care system during ongoing circulation of influenza. As previously noted, health system strain can adversely impact patient access to care and care quality. Furthermore, data on the health consequences of co with influenza and erectile dysfunction are limited.

Preliminary evidence suggests that a combination of s with influenza and erectile dysfunction would result in more severe health outcomes for patients than either alone.[] However, erectile dysfunction treatment is more infectious and has greater rates of mortality, hospitalizations, and severe illness than influenza. Accordingly, it is imperative that the risk for healthcare-associated erectile dysfunction treatment transmission be minimized during the influenza season. Influenza is most common during the fall and winter with the highest incidence of cases reported between December through March.[] erectile dysfunction treatments require time after administration for the body to build an immune response. Hence, given that the influenza season is imminent, a staff erectile dysfunction treatment vaccination requirement for the providers and suppliers identified in this rule cannot be further delayed.

The impact of unvaccinated populations on the health-care system and the inconsistent web of State, local, and employer erectile dysfunction treatment vaccination requirements have established a pressing need for a consistent Federal policy mandating staff vaccination in health care settings that receive Medicare and Medicaid funds. The current patchwork of regulations undermines the efficacy of erectile dysfunction treatment mandates by encouraging unvaccinated workers to seek employment at providers that do not have such patient protections, exacerbating staffing shortages, and creating disparities in care across populations. This includes workers moving between various types of providers, such as from LTC facilities to HHAs and others, creating imbalances. As discussed in section I.

Of this IFC, we have received numerous requests from diverse stakeholders for Federal intervention to implement a health-care staff treatment mandate.[] Of particular note, several representatives of the long-term care community (not limited to Medicare- and Medicaid-certified LTC facilities) expressed concerns about inequities that would result from imposition of a mandate on only one type of provider and strongly recommended a broad approach.[] While there is opposition to the treatment mandate, a combination of factors now have persuaded us that a treatment mandate for health care workers is an essential component of the nation's erectile dysfunction treatment response, the delay of which would contribute to additional negative health outcomes for patients including loss of life. These include, but are not limited to, the following. Failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements. Ongoing risk of new erectile dysfunction treatment variants.

Potential harmful impact of unvaccinated healthcare workers on patients. Continuing strain on the health care system, particularly from Delta-variant-driven surging case counts beginning in summer 2021. Demonstrated efficacy, safety and real-world effectiveness of available treatments. FDA's full licensure of the Pfizer-BioNTech's Comirnaty treatment.

Our observations of the efficacy of erectile dysfunction treatment mandates in other settings. And the calls from numerous stakeholders for Federal intervention. Moreover, a further delay in imposing a treatment mandate would endanger the health and safety of additional patients and be contrary to the public interest. We note that health care workers were among the first groups provided access to vaccinations, which were initially authorized for emergency use.

EUA status may have been a factor in some individual decisions to delay or refuse vaccination. The Pfizer-BioNTech erectile dysfunction treatment was first authorized for emergency use on December 11, 2020. The treatment continues to be available in the U.S. Under EUA, and the EUA was subsequently amended to include use in individuals 12 through 15 years of age, to allow for the use of an additional dose in the primary series for certain immunocompromised individuals, and to allow for use of a single booster dose to be administered at least 6 months after completion of the primary series in certain individuals.

FDA has issued EUAs for two additional treatments for the prevention of erectile dysfunction treatment, one to Moderna (December 18, 2020) (indicated for use by individuals 18 years of age and older), and the other to Janssen (Johnson &. Johnson) (February 27, 2021) (indicated for use by individuals 18 years of age and older). Fact sheets for health care providers administering treatment are available for each treatment product from FDA. However, on August 23, 2021, FDA licensed Pfizer-BioNTech's Comirnaty treatment.

Health care workers whose hesitancy was related to EUA status now have a fully licensed erectile dysfunction treatment option. Despite this, as noted earlier, health care staff vaccination rates remain sub-optimal in too many health care facilities and regions. For example, national erectile dysfunction treatment vaccination rates for LTC facility, hospital, and ESRD facility staff are 67 percent, 64 percent, and 60 percent, respectively. Moreover, these averages obscure sizeable regional differences.

Start Printed Page 61585 LTC facility staff vaccination rates range from lows of 56 percent to highs of over 90 percent, depending upon the State. Similar patterns hold for ESRD facility and hospital staff.[] Over half a million erectile dysfunction treatment cases and 1,900 deaths among health care staff have been reported to CDC since the start of the PHE.[] When submitting case-level erectile dysfunction treatment reports, State and territorial jurisdictions may identify whether individuals are or are not health care workers. Since health care worker status has only been reported for a minority of cases (approximately 18 percent), these numbers are likely gross underestimates of true burden in this population. erectile dysfunction treatment case rates among staff have also grown in tandem with broader national incidence trends since the Delta variant's emergence.

For example, as of mid-September 2021, erectile dysfunction treatment cases among LTC facility and ESRD facility staff have increased by over 1400 percent and 850 percent, respectively, since their lows in June 2021.[] Similarly, the number of cases among staff for whom case-level data were reported by State and territorial jurisdictions to CDC increased by nearly 600 percent between June and August 2021.[] Because they are at greater risk for developing erectile dysfunction treatment and severe disease,[] unvaccinated staff present a risk of exacerbating ongoing staffing shortages—particularly during periods of community surges in erectile dysfunction , when demand for health care services is most acute. Health care staff who remain unvaccinated may also pose a direct threat to patient, resident, workplace, family, and community safety and population health. Data from CDC's National Healthcare Safety Network (NHSN) have shown that case rates among LTC facility residents are higher in facilities with lower vaccination coverage among staff. Specifically, residents of LTC facilities in which vaccination coverage of staff is 75 percent or lower experience higher crude rates of preventable erectile dysfunction .[] Similarly, several articles published in CDC's Morbidity and Mortality Weekly Reports (MMWRs) regarding nursing home outbreaks have also linked the spread of erectile dysfunction treatment to unvaccinated health care workers and stressed that maintaining a high vaccination rate is important for reducing transmission.[] And multiple studies have demonstrated erectile dysfunction transmissions between health-care workers and patients in hospitals, despite universal masking and other protocols.[] Acute and LTC facilities engage many, if not all, of the same health care professionals and support services of other provider and supplier types.

As a result, while similarly comprehensive data are not available for all Medicare- and Medicaid-certified provider and supplier types, we believe the LTC facilities experience may generally be extrapolated to other settings. The efficacy of erectile dysfunction treatment vaccinations has been demonstrated.[] An ASPE report published on October 5, 2021, found that erectile dysfunction treatments are a key component in controlling the erectile dysfunction treatment cialis. Clinical data show treatments are highly effective in preventing erectile dysfunction treatment cases and severe outcomes including hospitalization and death. The ASPE analysis of individual-level health data and county-level vaccination rates found that higher county vaccination rates were associated with significant reductions in the odds of erectile dysfunction treatment , hospitalization, and death among Medicare fee-for-service (FFS) beneficiaries between January and May 2021.

Further, comparing the rates of these outcomes to what ASPE modeling predicted would have happened without any vaccinations, we estimate erectile dysfunction treatment vaccinations were linked to estimated reductions of approximately 107,000 s, 43,000 hospitalizations, and 16,000 deaths in our study sample of 25.3 million beneficiaries. The report also noted that the difference in vaccination rates for those age 65 and older between the lowest (34 percent) and highest (85 percent) counties and states by the end of May highlights the continued opportunity to leverage erectile dysfunction treatment vaccinations to prevent erectile dysfunction treatment hospitalizations and deaths.[] treatments continue to be effective in preventing erectile dysfunction treatment associated with the now-dominant Delta variant.[] In addition to preventing morbidity and mortality associated with erectile dysfunction treatment, the treatments also appear to be effective against asymptomatic erectile dysfunction . A recent study of health care workers in 8 states found that, between December 14, 2020, through August 14, 2021, full vaccination with erectile dysfunction treatments was 80 percent effective in preventing RT-PCR-confirmed erectile dysfunction among frontline workers.[] Emerging evidence also suggests that vaccinated people who become infected with Delta have potential to be less infectious than infected unvaccinated people, thus decreasing transmission risk.[] For example, in a study of breakthrough s among health care workers in the Netherlands, erectile dysfunction infectious cialis shedding was lower among vaccinated individuals with breakthrough s than Start Printed Page 61586 among unvaccinated individuals with primary s.[] As noted earlier in this section, a combination of factors, including but not limited to failure to achieve sufficiently high levels of vaccination based on voluntary efforts and patchwork requirements, potential harm to patients from unvaccinated health-care workers, and continuing strain on the health care system and known efficacy and safety of available treatments, have persuaded us that a treatment mandate for health care workers is an essential component of the nation's erectile dysfunction treatment response. Further, it would endanger the health and safety of patients, and be contrary to the public interest to delay imposing it.

Therefore, we believe it would be impracticable and contrary to the public interest for us to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC. We find good cause to waive notice of proposed rulemaking under the APA, 5 U.S.C. 553(b)(B), and section 1871(b)(2)(C) of the Act. For those same reasons, as authorized by the Small Business Regulatory Enforcement Fairness Act of 1996 (the Congressional Review Act or CRA), 5 U.S.C.

808(2), we find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under section 801 of the CRA. Therefore, we find there is good cause to waive the CRA's delay in effective date pursuant to section 808(2) of the CRA. IV. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement (ICR) is submitted to the Office of Management and Budget (OMB) for review and approval.

The ICRs in this section will be included in an emergency revision of the information collection request currently approved under the appropriate OMB Control number. All PRA-related comments received in response to this IFC will be reviewed and addressed in a subsequent, non-emergency, submission of the information collection request. The emergency approval is only valid for 6 months. Within that 6-month approval period, CMS will seek a regular, non-emergency, approval and as required by the PRA, this action will be announced in the requisite 60-day and 30-day Federal Register notices.

In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected.

Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs). For the estimated costs contained in the analysis below, we used data from the U.S. Bureau of Labor Statistics (BLS) to determine the mean hourly wage for the positions used in this analysis.[] For the total hourly cost, we doubled the mean hourly wage for a 100 percent increase to cover overhead and fringe benefits, according to standard HHS estimating procedures.

If the total cost after doubling resulted in 0.50 or more, the cost was rounded up to the next dollar. If it was 0.49 or below, the total cost was rounded down to the next dollar. The total costs used in this analysis are indicated in Table 3. Start Printed Page 61587 Start Printed Page 61588 In this analysis, we used specific resources to estimate the burden for the providers and suppliers in this rule.

Based upon our experience, there are minimal fluctuations in the numbers of providers and suppliers monthly. Thus, unless otherwise indicated, all of the numbers for the providers and suppliers in this analysis were located on September 1, 2021 on the Quality, Certification &. Oversight Reports (QCOR) website at https://qcor.cms.gov/​main.jsp. For the number of employees for each provider and supplier, those numbers were obtained from Table 5.

Estimates of Number of Staff by Type of Provider (thousands) located in section VI.B. Of this IFC. This analysis is also based upon certain assumptions. We believe that many of the providers and suppliers covered in this rule have already either encouraged their employees to get Start Printed Page 61589 vaccinated for erectile dysfunction treatment or have mandates for the treatment.

Mandates for employees to be vaccinated for erectile dysfunction treatment can result from State, county, or local actions or result from a decision by the facility. These facilities would likely have already developed policies and procedures, as well as documentation requirements, related to their employees being vaccinated for erectile dysfunction treatment. However, we have no reliable method to estimate the number or percentage of these facilities. In addition, it is likely that those facilities would not comply with all of the requirements in this rule.

For example, many facilities might not define “employees” as set forth in this rule. Each facility would have to review its policies, procedures, and documentation requirements to ensure that they comply with the requirements in this rule. Hence, based upon these assumptions, this analysis will assess the burden for all facilities and employees for each provider and supplier type. We also made some assumption regarding analysis of the burden for the documentation requirements.

If an employee receives the appropriate vaccinations, reviewing and documenting that the employee has been vaccinated would likely only require 1 to 3 minutes, depending upon how the facility is documenting the vaccination, which is likely to vary substantially between facilities. However, for employees that request exemptions or have to be contacted repeatedly for the appropriate documentation, it would likely take more time to comply with this requirement. At a minimum, both the initial request for the exemption and the final determination would have to be documented. In cases where the exemption was denied and the employee receives the appropriate vaccinations, those treatment doses would also have to be documented.

There might also be additional documentation that would need to be copied or scanned for their records. While the documentation for employees requesting an exemption would require more burden, we believe that there would only be a small percentage of employees that would request an exemption. Since we have no reliable method for estimating a number or percentage of employees who would be in each category, we will analyze the burden for the documentation requirements using 5 minutes or 0.0833 hours for each employee. The position of the individual who would perform the activities related to the documentation requirement would also vary depending upon the type of provider or supplier and whether the employee requested an exemption.

If the employee has been vaccinated in compliance with this rule, an administrative support person might review their vaccination card and document that the employee has been vaccinated. However, if an administrative support person performs these activities, we believe an administrator or another member of the health care staff would be responsible for overseeing these activities. For other providers and suppliers, a nurse would likely be assigned to verify and document vaccination status. If an employee requests an exemption, we believe that a nurse, another health care professional, or an administrator would likely review the request and document it.

Some other providers or suppliers might have an administrator or another member of the health care staff perform these activities. Thus, for this analysis, if a provider is required to have at least one preventionist (IP), such as hospitals, we believe the IP would be responsible for documenting the vaccination status for all employees. For other providers and suppliers, we assessed the burden using a registered nurse (RN), another member of the health care staff, such as a physical therapist, or an administrator. The estimates that follow are largely based on our experience with these various providers.

However, given the uncertainty and rapidly changing nature of the current cialis, we acknowledge that there will likely need to be revisions to these requirements over time. We welcome comments that might improve these estimates. A. ICRs Regarding the of Development of Policies and Procedures for ASCs § 416.51(c), “erectile dysfunction treatment Vaccination of Staff” 1.

Policies and Procedures At § 416.51(c), we require ASCs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and track and maintain documentation of their vaccination status. Each ASC must also have a contingency plan for any staff that are not fully vaccinated according to this rule. The ICRs for this section would require each ASC to develop the policies and procedures needed to satisfy all of the requirements in this section. Based upon our experience with ASCs, we believe some centers have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff.

However, each ASC will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC, especially that their policies and procedures cover all of the center staff as identified in this IFC. Hence, we will base our estimate for this ICR on all 6,071 ASCs. We believe activities associated with this IFC would be performed by the RN functioning as the designated and qualified control professional (ICP) and ASC administrator as analyzed below. The ICP would conduct research and then either modify or develop the policies and procedures needed to comply with this section's requirements.

The ICP would work with the ASC administrator in developing these policies and procedures. For the ICP, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements. According to Table 3, the ICP's total hourly cost is $77. Thus, for each ASC, the burden for the ICP would be 8 hours at a cost of $616 (8 × $77).

For the ICPs in all 6,071 ASCs, the burden would be 48,568 hours (8 × 6,071) at an estimated cost of $3,739,736 ($616 × 6,071). As discussed above, the revision and approval of these initial policies and procedures would also require activities by the ASC administrator. The administrator would need to have meetings with the ICP to discuss the revisions and approve the final policies and procedures. We estimate this would require 2 hours for the administrator.

According to Table 3, the total hourly cost for the administrator is $98. The burden for the administrator in each ASC would be 2 hours at an estimated cost of $196 (2 × $98). For the administrators in all 6,071 ASCs, the burden would be 12,142 hours (2 × 6,071) at an estimated cost of $1,189,916 ($196 × 6,071). Therefore, for all 6,071 ASCs, the estimated burden associated with the requirement for policies and procedures would be 67,010 hours (48,568 + 12,142) at a cost of $4,929,652 ($3,739,736 + $1,189,916).

2. Documentation and Storage Section 416.51(c) also requires ASCs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the center's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $77 for each employee.

According to Table 3, ASCs have 200,000 employees. Start Printed Page 61590 Hence, the burden for these documentation requirements for all 6,071 ASCs would be 16,660 (0.0833 × 200,000) hours at an estimated cost of $1,282,820 (16,660 × $77). The total burden for all 6,071 ASCs for this IFC would be 83,670 (67,010 + 16,660) hours at an estimated cost of $6,212,472 ($4,929,652 + $1,282,820). The requirements and burden will be submitted to OMB under OMB control number 0938-0266 (expiration date July 31, 2024).

B. ICRs Regarding the Development of Policies and Procedures for Hospices § 418.60(d), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures At § 418.60(d), we require hospices to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The hospice must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each hospice to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations are set forth at § 418.60 Condition of participation. control, and require each hospice to maintain and document an control program to prevent and control s and communicable diseases. The hospice must also follow accepted standards of practice, including the use of standard precautions to prevent the transmission of s and communicable diseases.

Thus, all hospices should already have prevention and control policies and procedures, but they likely do not comply with all of the requirements in this IFC. All hospices would need to review their current policies and procedures and modify them to comply with all of the requirements in § 418.60(d) as set forth in this IFC. While we believe that many hospices have already addressed erectile dysfunction treatment vaccination with their staff, we have no reliable means to estimate that number. Therefore, we will assess the burden for these requirements for all 5,556 hospices.

We believe these activities would be performed by the RN and an administrator. According to Table 3, an RN in these settings has a total hourly cost of $79. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each hospice, the burden for the RN would be 8 hours at a cost of $632 (8 hours × $79).

For all 5,556 hospices, the burden would be 44,448 hours (8 hours × 5,556) at an estimated cost of $3,511,392 ($632 × 5,556). As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours.

According to Table 3, the total hourly cost for the administrator in this setting is $122. Hence, for each hospice, the burden would be 2 hours at an estimated cost of $244 (2 × $122). For all 5,556 hospices, the total burden would be 11,112 hours (2 × 5,556) at an estimated cost of $1,355,664 (5,556 × $244). Thus, the total burden for hospices to comply with the requirements for policies and procedures in this IFC is 55,560 hours (44,448 + 11,112) at an estimated cost of $4,867,056 ($3,511,392 + $1,355,664).

2. Documentation and Storage Section 418.60(d) also requires hospices to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the hospice's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $79 for each employee.

According to Table 3, hospices have 340,000 employees. Hence, the burden for these documentation requirements for all 5,556 hospices would be 28,322 (0.0833 × 340,000) hours at an estimated cost of $2,237,438 (28,322 × 79). Therefore, the total burden for all 5,556 hospices for this rule would be 83,882 (55,560 + 28,322) hours at an estimated cost of $7,104,494 (4,867,056 + 2,237,438). The requirements and burden will be submitted to OMB under OMB control number 0938-1067 (expiration date March 31, 2024).

C. ICRs Regarding the Development of Policies and Procedures for PACE Organizations § 460.74(d), “erectile dysfunction treatment Vaccination of PACE Organization Staff” 1. Policies and Procedures Section 460.74(d) requires that programs for all-inclusive care for the elderly (PACE) organizations to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. Each PACE organization must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each PACE organization to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 460.74 already require that each PACE organization follow accepted policies and standard procedures with respect to control in place. Thus, all PACE organizations should have policies and procedures regarding prevention and control. We also believe that many have already addressed erectile dysfunction treatment vaccination policies for their staff.

However, since we do not have a reliable method to estimate how many have, we will assess the burden for all 141 PACE organizations. All PACE organizations would need to review their current prevention and control policies and procedures and develop or modify them to satisfy the requirements in this section. We believe these activities would require an RN and an administrator. According to Table 3, an RN's total hourly cost is $74.

Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each PACE organization, the burden for the RN would be 8 hours at a cost of $592 (8 hours × $74). For all 141 PACE organizations, the burden would be 1,128 hours (8 hours × 141) at an estimated cost of $83,472 (592 × 141). As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator.

The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator is $122. Hence, for each PACE organization, the burden would be 2 hours at an estimated cost of $244 (2 × 122).

For all 141 PACE organizations, the total burden would be 282 hours (2 × 141) at an estimated cost of $34,404 (141 × $244). Thus, the total burden for all 141 PACE organizations to comply with the requirements for the policies and Start Printed Page 61591 procedures is 1,410 hours (1,128 + 282) at an estimated cost of $117,876 (83,472 + 34,404). 2. Documentation and Storage Section 460.74(d) also requires PACE organizations to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the PACE organization's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $74 for each employee. According to Table 3, PACE organizations have 10,000 employees. Hence, the burden for these documentation requirements for all 141 PACE organizations would be 833 (0.0833 × 10,000) hours at an estimated cost of $61,642 (833 × 74).

Therefore, the total burden for all 141 PACE organizations for this rule would be 2,243 (1,410 + 833) hours at an estimated cost of $179,518 (117,876 + 61,642). The requirements and burden will be submitted to OMB under OMB control number 0938-1326 (expiration date April 20, 2023). D. ICRs Regarding the Development of Policies and Procedures for Hospitals § 482.42(g), “erectile dysfunction treatment Vaccination of Hospital Staff” 1.

Policies and Procedures At § 482.42(g), we require hospitals to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The hospital must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each hospital to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 482.42 Condition of participation.

prevention and control and antibiotic stewardship programs already require hospitals to have an prevention and control program (IPCP) and an preventionist (IP). The IPCP must have methods to prevent and control the transmission of within the hospital and between the hospital and other settings. Thus, all 5,194 hospitals should already have prevention and control policies and procedures. However, each hospital would need to review their current policies and procedures and modify them, if necessary, to ensure compliance with all of the requirements in this IFC, especially that their policies and procedures cover all of the eligible facility staff identified in this IFC.

Based upon our experience with hospitals, we believe many hospitals have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff. Since we have no reliable means to estimate the number of hospitals that may have already addressed erectile dysfunction treatment vaccination of their staff, we will base our estimate for these requirements on all 5,194 hospitals. We believe these activities would be performed by the IP, the director of nursing (DON), and an administrator. The IP would need to research erectile dysfunction treatments, modify the policies and procedures, as necessary, and work with the DON and administrator to develop the policies and procedures and obtain appropriate approval.

For the IP, we estimate these activities would require 8 hours. According to Table 3, the IP's total hourly cost is $79. Thus, for each hospital, the burden for the IP would be 8 hours at a cost of $632 (8 hours × 79). For the IPs in all 5,194 hospitals, the burden would be 41,552 hours (8 hours × 5,194) at an estimated cost of $3,282,608 (632 × 5,194).

As discussed above, the revision and approval of these policies and procedures would also require activities by the DON and an administrator. We believe these activities would require 2 hours each for the DON and an administrator. According to Table 3, the total adjusted hourly wage for both the DON and an administrator is $122. Hence, for each hospital, the burden would be 4 hours (2 × 2) at an estimated cost of $488 (4 × $122).

The total burden for all 5,194 hospitals would be 20,776 hours (4 × 5,194) at an estimated cost of $2,534,672 (5,194 × 488). Therefore, for all 5,194 hospitals, the total burden for the requirements for policies and procedures is 62,328 hours (41,552 + 20,776) at an estimated cost of $5,817,280 (3,282,608 + 2,534,672). 2. Documentation and Storage Section 482.42(g) also requires hospitals to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the hospital's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $79 for each employee. According to Table 3, hospitals have 6,070,000 employees. We could not locate a reliable number for critical access hospital (CAH) employees so they are included here with the hospital employees.

Hence, the burden for these documentation requirements for all 5,194 hospital and 1,358 CAHs would be 505,631 (0.0833 × 6,070,000) hours at an estimated cost of $39,944,849 (505,631 × 79). Therefore, the total burden for this rule for all 5,194 hospitals and 1,358 CAHs (documentation burden only) would be 567,959 (62,328 + 505,631) hours at an estimated cost of $45,762,129 (5,817,280 + 39,944,849). The requirements and burden will be submitted to OMB as an emergency reinstatement of an existing OMB control number 0938-0328. E.

ICRs Regarding the Development of Policies and Procedures for LTC Facilities § 483.80(i), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures At § 483.80(i), we require LTC facilities to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The LTC facility must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each LTC facility to develop the policies and procedures needed to satisfy all of the requirements in this section.

Current regulations at § 483.80(d)(1) and (2) already require LTC facilities to have policies and procedures to educate, offer, and document vaccination status for residents regarding the influenza and pneumococcal immunizations. In addition, § 483.80(d)(3) requires LTC facilities to educate, offer, and document the vaccination status for residents and staff for the erectile dysfunction treatment immunizations. Based upon our experience with LTC facilities, we believe some facilities have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff, including erectile dysfunction treatment mandates. However, we have no reliable means to estimate the number or percentage of LTC facilities that have already mandated vaccination.

Hence, we will base our estimate for this ICR on all 15,401 LTC facilities. Each LTC facility would need to review its policies and procedures for § 483.80(d) and modify them to comply with the requirements in this rule at § 483.80(i) and obtain the appropriate review and approval. This would require conducting research and revising the policies and procedures as needed. We believe these activities Start Printed Page 61592 would be performed by the preventionist (IP), director of nursing (DON), and medical director for the first year and the IP in subsequent years as analyzed below.

The IP would need to work with the DON and medical director to revise and finalize the policies and procedures. For the IP, we estimate this would require 2 hours initially to perform research and revise the policies and procedures to meet these requirements. According to Table 3, the IP's total hourly cost is $69. Thus, for each LTC facility, the burden for the IP would be 2 hours at a cost of $138 (2 hours × 69).

For the IPs in all 15,401 LTC facilities, the burden would be 30,802 hours (2 hours × 15,401 facilities) at an estimated cost of $2,125,338 (138 × 15,401). As discussed above, the revision and approval of these policies and procedures would also require activities by the DON and medical director. Both the DON and medical director would need to have meetings with the IP to discuss the revision, evaluation, and approval of the policies and procedures. We estimate this would require 1 hour for both the DON and medical director.

According to Table 3, the total hourly cost for the DON is $96. The burden in the first year for the DON in each LTC facility would be 1 hour at an estimated cost of $96 (1 hour × 96). The burden would be 15,401 hours (1 × 15,401) at an estimated cost of $1,478,496 (96 × 15,401) for all LTC facilities. For the medical director, we have estimated the revision of policies and procedures would also require 1 hour.

According to the chart above, the total hourly cost for the medical director is $171. For each LTC facility, this would require 1 hour for the medical director during the first year at an estimated cost of $171 (1 hour × $171). The burden for all LTC facilities would be 15,401 hours (1 × 15,401) at an estimated cost of $2,633,571 (171 × 15,401). Therefore, for all 15,401 LTC facilities in the first year, the estimated burden for the policies and procedures requirement would be 61,604 hours (30,802 + 15,401 + 15,401) at a cost of $6,237,405 (2,125,338 + 1,478,496 + 2,633,571).

2. Documentation and Storage Section 483.80(i) also requires LTC facilities to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. The PRA package submitted under OMB Control No.

0938-1363 already provides for the documentation burden for the IP for the LTC facility's prevention and control program (IPCP) under which the requirements in this rule will also be located. We believe the burden for the documentation requirements in this rule should be included in that burden. Therefore, we will not assess any additional burden for the documentation requirements in this rule. The requirements and burden will be submitted to OMB under OMB control number 0938-1363 (expiration date June 30, 2022).

F. ICRs Regarding the Development of Policies and Procedures for PRTFs § 441.151(c), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures Section 441.151(c) requires psychiatric residential treatment facilities (PRTFs) to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The PRTF must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each PRTF to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations for PRTFs do not address prevention and control or vaccinations. Hence, although we believe that at least some PRTFs have already addressed erectile dysfunction treatment vaccination of their staff, we will assess the burden for all 357 PRTFs. We believe these activities would be performed by an RN and an administrator.

According to Table 3, an RN's total hourly cost is $74. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each PRTF, the burden for the RN would be 8 hours at a cost of $592 (8 hours × 74). For all 357 PRTFs, the burden would be 2,856 hours (8 hours × 357) at an estimated cost of $211,344 (592 × 357).

As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator is $122.

Hence, for each PRTF, the burden would be 2 hours at an estimated cost of $244 (2 × 122). For all 357 PRTFs, the total burden would be 714 hours (2 × 357) at an estimated cost of $87,108 (357 × 244). Thus, the total burden for all 357 PRTFs to comply with the policies and procedures requirements in this IFC for policies and procedures is 3,570 hours (2,856 + 714) at an estimated cost of $298,452 (211,344 + 87,108). 2.

Documentation and Storage Section 441.151(c) also requires PRTFs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $74 for each employee. According to Table 3, PRTFs have 30,000 employees.

Hence, the burden for these documentation requirements for all 357 PRTFs would be 2,499 (0.0833 × 30,000) hours at an estimated cost of $184,926 (2,499 × 74). Therefore, the total burden for all 357 PRTFs for this rule would be 6,069 (3,570 + 2,499) hours at an estimated cost of $483,378 (298,452 + 184,926) The requirements and burden will be submitted to OMB under OMB control number 0938-0833 (expiration date May 31, 2022). G. ICRs Regarding the Development of Policies and Procedures for ICFs-IID § 483.430(f), “erectile dysfunction treatment Vaccination of Facility Staff” 1.

Policies and Procedures At § 483.430(f), we require ICFs-IID to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The ICFs-IID must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each ICFs-IID to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 483.470(l) Standard.

control requires that the ICFs-IID must provide a sanitary environment to avoid sources and transmission of s. The facility must also implement successful corrective action in affected problem areas, maintain a record of incidents and corrective actions related to s, and prohibit employees with symptoms or sign of a communicable Start Printed Page 61593 disease from direct contact with clients and their food. Hence, ICFs-IID should already have policies and procedures for prevention and control. We believe these activities would be performed by the RN.

According to Table 3, an RN's total hourly cost is $69. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each ICFs-IID, the burden for the RN would be 8 hours at a cost of $552 (8 hours × 69). For all 5,780 ICFs-IID, the burden would be 46,240 hours (8 hours × 5,780) at an estimated cost of $3,190,560 (552 × 5,780).

As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator is $96.

Hence, for each ICFs-IID, the burden would be 2 hours at an estimated cost of $192 (2 × 96). For all 5,780 ICFs-IID, the total burden would be 11,560 hours (2 × 5,780) at an estimated cost of $1,109,760 (5,780 × 192). Thus, the total burden for all 5,780 ICFs-IID to comply with the requirements for policies and procedures is 57,800 hours (46,240 + 11,560) at an estimated cost of $4,300,320 (3,190,560 + 1,109,760). 2.

Documentation and Storage Section 483.430(f) also requires ICFs-IID to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $69 for each employee. According to Table 3, ICFs-IID have 80,000 employees.

Hence, the burden for these documentation requirements for all 5,780 ICFs-IID would be 6,664 (0.0833 × 80,000) hours at an estimated cost of $459,816 (6,664 × $69). Therefore, the total burden for all 5,780 ICFs-IID for this rule would be 64,464 (57,800 + 6,664) hours at an estimated cost of $4,760,136 (4,300,320 + 459,816). The requirements and burden will be submitted to OMB under OMB control number 0938-1402 (expiration date September 30, 2024). H.

ICRs Regarding the Development of Policies and Procedures for HHAs § 484.70(d), “erectile dysfunction treatment Vaccination of Home Health Agency Staff” 1. Policies and Procedures At § 483.70(d), we require HHAs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The HHA must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each HHA to develop the policies and procedures needed to satisfy all of the requirements in this section.

Current regulations at § 483.70, Condition of participation. prevention and control require each HHA to maintain and document an control program to prevent and control s and communicable diseases. The HHA must follow accepted standards of practice, including the use of standard precautions to prevent the transmission of s and communicable diseases. Thus, all HHA should already have prevent and control policies and procedures, but they likely do not comply with all of the requirements in this IFC.

All HHAs would need to review their current policies and procedures and modify them to comply with all of the requirements in § 483.70(d), as set forth in this IFC. While we believe that many HHAs have already addressed erectile dysfunction treatment vaccination with their staff, we have no reliable means to estimate that number. Therefore, we will assess the burden for these requirements for all 11,649 HHAs. We believe these activities would be performed by the RN and an administrator.

According to Table 3, an RN in home health services total hourly cost is $73. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each HHA, the burden for the RN would be 8 hours at a cost of $584 (8 hours × 73). For all 11,649 HHAs, the burden would be 93,192 hours (8 hours × 11,649) at an estimated cost of $6,803,016 (584 × 11,649).

As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours. According to Table 3, the total hourly cost for the administrator in home health services is $97.

Hence, for each HHA, the burden would be 2 hours at an estimated cost of $194 (2 × 97). For all 11,649 HHAs, the total burden would be 23,298 hours (2 × 11,649) at an estimated cost of $2,259,906 (11,649 × 194). Thus, the total burden for all 11,649 HHAs to comply with the policies and procedures requirements for policies and procedures is 116,490 hours (93,192 + 23,298) at an estimated cost of $9,062,922 (6,803,016 + 2,259,906). 2.

Documentation and Storage Section 483.70(d) also requires HHAs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the agency's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $73 for each employee. According to Table 3, HHAs have 2,110,000 employees.

Hence, the burden for these documentation requirements for all 11,649 HHAs would be 175,763 (0.0833 × 2,110,000) hours at an estimated cost of $12,830,699 (175,763 × 73). Therefore, the total burden for all 11,649 HHAs for this rule would be 292,253 (116,490 + 175,763) hours at an estimated cost of $21,893,621 (9,062,922 + 12,830,699). The requirements and burden will be submitted to OMB under OMB control number 0938-1299 (expiration date June 30, 2024). I.

ICRs Regarding the Development of Policies and Procedures for CORFs § 485.70(n), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures At § 485.70(n), we require CORFs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. Each CORF must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each CORF to develop the policies and procedures needed to satisfy all of the requirements in this section.

This IFC requires CORF staff to receive the erectile dysfunction treatment unless medically contraindicated as determined by a physician, advance practice registered nurse, or physician Start Printed Page 61594 assistant acting within their respective scope of practice as defined by and in accordance with all applicable State and local laws. Based upon our experience with CORFs, we believe some facilities have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated. However, each CORF will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC, especially that their policies and procedures cover all of the organization staff identified in this IFC. Hence, we will base our estimate for this ICR on all 159 CORFs.

The CORF's governing body appoints an administrator who implements and enforces the facility's policies and procedures. Hence, we believe activities associated with this IFC would be performed by the administrator as analyzed below. The governing body would also need to review these policies and procedures, which would be included in its “legal responsibility for establishing and implementing policies regarding the management and operation of the facility.” The administrator would conduct research to either modify or develop policies and procedures. For the administrator, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements.

According to Table 3, the administrator's total hourly cost is $98. Thus, for each CORF, the burden for the administrator would be 8 hours at a cost of $784 (8 × 98). For the administrators in all 159 organizations, the burden would be 1,272 hours (8 × 159) at an estimated cost of $124,656 (784 × 159). The administrator would need to spend time attending governing body meetings to discuss and obtain approval for the policies and procedures.

However, that would be a usual and customary business practice. Therefore, activities for the administrator associated with governing body approval for the policies and procedures are exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). 2. Documentation and Storage Section 485.70(n) also requires CORFs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an administrator 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $98 for each employee. According to Table 3, CORFs have 10,000 employees. Hence, the burden for these documentation requirements for all 159 CORFs would be 833 (0.0833 × 10,000) hours at an estimated cost of $81,634 (833 × 98).

Therefore, the total burden for all 159 CORFs for this rule would be 2,105 (1,272 + 833) hours at an estimated cost of $206,290 (124,656 + 81,634). The requirements and burden will be submitted to OMB under OMB control number 0938-1091 (expiration date November 30, 2022). J. ICRs Regarding the Development of Policies and Procedures for CAHs § 485.640(f), “erectile dysfunction treatment Vaccination of CAH Staff” 1.

Policies and Procedures At § 485.640(f), we require critical access hospitals (CAHs) to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The CAH must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each CAH to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 485.640 Condition of participation.

prevention and control and antibiotic stewardship programs already require CAHs to have an prevention and control program (IPCP) and an preventionist (IP). The IPCP must have methods to prevent and control the transmission of within the hospital and between the hospital and other settings. Thus, all 1,358 CAHs should already have prevention and control policies and procedures. However, each CAH would need to review their current policies and procedures and modify them, if necessary, to ensure compliance with all of the requirements in this IFC, especially that their policies and procedures cover all of the eligible facility staff identified in this IFC.

Based upon our experience with CAHs, we believe many CAHs have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff. Since we have no reliable means to estimate the number of CAHs that may have already addressed erectile dysfunction treatment vaccination of their staff, we will base our estimate for these requirements on all 1,358 CAHs. We believe these activities would be performed by the IP, the director of nursing (DON), and an administrator. The IP would need to research erectile dysfunction treatments, modify the policies and procedures, as necessary, and work with the DON and administrator to develop the policies and procedures and obtain appropriate approval.

For the IP, we estimate these activities would require 8 hours. According to Table 3, the IP's total hourly cost is $79. Thus, for each hospital, the burden for the IP would be 8 hours at a cost of $632 (8 hours × 79). For the IPs in all 1,358 CAHs, the burden would be 10,864 hours (8 hours × 1,358) at an estimated cost of $858,256 (632 × 1,358).

As discussed above, the revision and approval of these policies and procedures would also require activities by the DON and an administrator. We believe these activities would require 2 hours each for the DON and an administrator. According to Table 3, the total adjusted hourly wage for both the DON and an administrator is $122. Hence, for each CAH the burden would be 4 hours (2 × 2) at an estimated cost of $488 (4 × $122).

The total burden for all 1,358 CAHs would be 5,432 hours (4 × 1,358) at an estimated cost of $662,704 (1,358 × 488). Therefore, for all 1,358 CAHs the total burden for the requirements for policies and procedures is 16,296 hours (10,864 + 5,432) at an estimated cost of $1,520,960 ($858,256 + $662,704). 2. Documentation and Storage Section 485.640(f) also requires CAHs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the CAH's policies and procedures for these activities is already accounted for above. Since we were unable to located a reliable number for CAH employees, the documentation burden for CAHs resulting from the documentation requirement in this rule is included in the hospitals' burden above. The requirements and burden for CAHs without DPUs will be submitted to OMB under OMB control number 0938-1043 (expiration date March 31, 2024). The requirements and burden for CAHs with DPUs will be submitted to OMB under OMB control number 0938-0328(expired).

Start Printed Page 61595 K. ICRs Regarding the Development of Policies and Procedures for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (Organizations) § 485.725(f), “erectile dysfunction treatment Vaccination of Organization Staff” 1. Policies and Procedures At § 485.725(f), we require organizations to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and the appropriate documentation is tracked and maintained. The organization must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each organization to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 485.725(a) require organizations to establish an -control committee of representative professional staff with overall responsibility for control. This committee establishes policies and procedures for investigating, controlling, and preventing s in the organization and monitors staff performance to ensure compliance with those policies and procedures. Based upon these requirements and our experience with organizations, we believe some organizations have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated.

However, since we have no reliable means to estimate how many organizations have done this, we will assess the burden for all 2,078 organizations. All organizations would need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC. The types of therapists at each organization vary depending upon the services offered. For the purposes of determining the COI burden, we will assume that the therapist is a physical therapist.

We believe activities associated with this IFC would be performed by a physical therapist and administrator. A physical therapist would need to conduct research on the erectile dysfunction treatments and then develop or modify policies and procedures that comply with the requirements in this IFC. The physical therapist would need to work with an administrator to make the necessary revisions. For the physical therapist, we estimate this would require 8 hours to perform research and revise or develop the policies and procedures to meet these requirements.

According to Table 3, the physical therapist's total hourly cost is $84. Thus, for each organization, the burden for the physical therapist would be 8 hours at a cost of $672 (8 × 84). For the physical therapists in all 2,078 organizations, the burden would be 16,624 hours (8 × 2,078) at an estimated cost of $1,396,416 (672 × 2,078). As discussed above, the revision and approval of these policies and procedures would also require activities by the administrator.

The administrator would need to have meetings with the physical therapist to discuss the revisions and draft any necessary policies and procedures, as well as approve the final policies and procedures. We estimate this would require 2 hours for the administrator. According to Table 3, the total hourly cost for the administrator is $98. The burden for the administrator in each organization would be 2 hours at an estimated cost of $196 (2 × 98).

For the administrators in all 2,078 organizations, the burden would be 4,156 hours (2 × 2,078) at an estimated cost of $407,288 (4,156 × 98). Therefore, for all 2,078 organizations, the total burden for the requirements for policies and procedures is 20,780 hours (16,624 + 4,156) at an estimated cost of $1,803,704 (1,396,416 + 407,288). 2. Documentation and Storage Section 485.725(f) also requires organizations to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the organization's policies and procedures for these activities is already accounted for above. We believe that this would require a physical therapist 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $84 for each employee. According to Table 3, these organizations have 10,000 employees. Hence, the burden for these documentation requirements for all 2,078 organizations would be 833 (0.0833 × 10,000) hours at an estimated cost of $69,972 (833 × 84).

Therefore, the total burden for all 2,078 organizations for this rule would be 21,613 (20,780 + 833) hours at an estimated cost of $1,873,676 (1,803,704 + 69,972). The requirements and burden will be submitted to OMB under OMB control number 0938-0273 (expiration date June 30, 2024). L. ICRs Regarding the Development of Policies and Procedures for CMHCs § 485.904(c), “erectile dysfunction treatment Vaccination of Center Staff” 1.

Policies and Procedures At § 485.904(c), we require CHMCs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. Each facility must maintain documentation of their staff's vaccination status. Also, each facility must have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each CHMC to develop the policies and procedures needed to satisfy all of the requirements in this section.

Based upon our experience with CHMCs, we believe some centers have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated. However, since we do not have a reliable means to estimate how many CMHCs have done so, we will estimate the burden based on all 129 CHMCs. Each CMHC will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC. Based on these requirements and our experience with CHMCs, we believe these activities would be performed by the CHMC administrator and a mental health counselor.

The administrator would conduct research regarding the erectile dysfunction treatments and then either modify or develop the policies and procedures necessary to comply with the requirements in this IFC. The administrator would send any recommendations for changes or additional policies or procedures to the mental health counselor. The administrator and mental health clinician would need to make the necessary revisions and draft any necessary policies and procedures. For the administrator, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements.

According to Table 3, the administrator's total hourly cost is $113. Thus, for each CMHC, the burden for the administrator would be 8 hours at a cost of $904 (8 × 113). The burden for the administrators in all 129 CHMCs would be 1,032 hours (8 × 129) at an estimated cost of $116,616 (904 × 129). As discussed above, the revision and approval of these initial policies and procedures would also require activities Start Printed Page 61596 by the mental health counselor.

The administrator would need to have meetings with the mental health counselor to discuss the revisions and draft any necessary policies and procedures. We estimate this would require 2 hours for the mental health counselor. According to Table 3, the total hourly cost for the mental health counselor is $118. The burden for the mental health counselor in each CHMC would be 2 hours at an estimated cost of $236 (2 × 118).

For the mental health counselors in all 129 CMHCs, the burden would be 258 hours (2 × 129) at an estimated cost of $30,444 (129 × 236). Therefore, for all 129 CMHCs, the total burden for the requirements for policies and procedures is 1,290 hours (1,032 + 258) at an estimated cost of $147,060 (116,616 + 30,444). 2. Documentation and Storage Section 485.904(c) also requires CMHCs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status.

Any burden for modifying the center's policies and procedures for these activities is already accounted for above. We believe that this would require an administrator 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $113 for each employee. According to Table 3, CMHCs have 140,000 employees. Hence, the burden for these documentation requirements for all 129 CMHCs would be 11,662 (0.0833 × 140,000) hours at an estimated cost of $1,317,806 (11,662 × 113).

Therefore, the total burden for all 129 CMHCs for this rule would be 12,952 (1,290 + 11,662) hours at an estimated cost of $1,464,866 (147,060 + 1,317,806). The requirements and burden will be submitted to OMB under OMB control number 0938-1245 (expiration date April 30, 2023). M. ICRs Regarding the Development of Policies and Procedures for HIT Suppliers § 486.525(c), “erectile dysfunction treatment Vaccination of Facility Staff” 1.

Policies and Procedures Section 486.525(c) requires home infusion therapy (HIT) suppliers to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. The HIT supplier must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each HIT supplier to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 486.525 already require that HIT suppliers provide their services in accordance with nationally recognized standards of practice.

Thus, we believe most HIT suppliers should already have prevention and control policies and procedures, including erectile dysfunction treatment vaccination. However, we have no reliable means to estimate how many suppliers have done so. Thus, we will base our burden estimate on all 337 HIT suppliers. All HIT suppliers would need to review their current policies and procedures and develop or modify them to comply with all of the requirements in § 486.525(c) as set forth in this IFC.

We believe these activities would be performed by the RN and an administrator working for the HIT supplier. According to Table 3, an RN working with for a HIT supplier would have a total hourly cost of $73. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each HIT supplier, the burden for the RN would be 8 hours at a cost of $584 (8 hours × 73).

For all 337 HIT suppliers, the burden would be 2,696 hours (8 hours × 337) at an estimated cost of $24,601 (337 × 73). The development and/or revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours.

According to Table 3, the total hourly cost for the administrator working for a HIT supplier is $97. Hence, for each HIT supplier, the burden would be 2 hours at an estimated cost of $194 (2 × 97). For all 337 HIT suppliers, the total burden for the administrator would be 674 hours (2 hours × 337) at an estimated cost of $65,378 (337 × 194). Therefore, for all 337 HIT suppliers, the total burden for the requirements for policies and procedures is 3,370 hours (2,696 + 674) at an estimated cost of $89,979 (24,601 + 65,378).

2. Documentation and Storage Section 486.525(c) also requires HIT suppliers to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the supplier's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $73 for each employee.

According to Table 3, HIT suppliers have 20,000 employees. Hence, the burden for these documentation requirements for all 337 HIT suppliers would be 1,666 (0.0833 × 20,000) hours at an estimated cost of $121,618 (1,666 × 73). Therefore, the total burden for all 337 HIT suppliers for this rule would be 5,036 (3,370 + 1,666) hours at an estimated cost of $211,597 (89,979 + 121,618). The requirements and burden will be submitted to OMB under OMB control number 0938-855B (expiration date March 31, 2024).

N. ICRs Regarding the Development of Policies and Procedures for RHCs and FQHCs § 491.8(d), “erectile dysfunction treatment Vaccination of Staff” 1. Policies and Procedures At § 491.8(d), we require RHCs/FQHCs to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained. Each RHC/FQHC must also have a contingency plan for all staff not fully vaccinated according to this rule.

The ICRs for this section would require each RHC/FQHC to develop the policies and procedures needed to satisfy all of the requirements in this section. This IFC requires clinic or center staff to receive the erectile dysfunction treatment unless medically contraindicated as determined by a physician, advance practice registered nurse, or physician assistant acting within their respective scope of practice as defined by and in accordance with all applicable State and local laws. Based upon experience with RHCs/FQHCs, we believe some clinics or centers have already developed policies and procedures requiring erectile dysfunction treatment vaccination for staff unless medically contraindicated. However, since we do not have a reliable means to estimate how many facilities have already done so, we will base the burden analysis for this estimate on all 15,317 RHC/FQHCs (4,933 RHCs and 10,384 FQHCs).

Each RHC/FQHC will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC, especially that their policies and procedures cover all of the clinic or center staff identified in this IFC. Current regulations require a physician, Start Printed Page 61597 nurse practitioner, and physician assistant to participate in the development, execution, and periodic review of the policies and procedures.[] Moreover, the RHC/FQHC operates under the medical direction of a physician. Based on these requirements and our experience with RHCs/FQHCs, we believe activities associated with this IFC would be performed by the RHC administrator, physician, nurse practitioner, physician assistant, and medical director as analyzed below. The administrator would conduct research to either modify or develop policies and procedures.

The administrator would send any recommendations for changes or additional policies or procedures to the physician, nurse practitioner, and physician assistant. The administrator, physician, nurse practitioner, and physician assistant would need to make the necessary revisions and draft any necessary policies and procedures. The administrator would need to work with the medical director to obtain approval for the policies and procedures to be implemented. For the administrator, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements.

According to Table 3, the administrator's total hourly cost is $108. Thus, for each RHC/FQHC, the burden for the administrator would be 8 hours at a cost of $864 (8 × 108). For the administrators in all 15,317 RHCs/FQHCs, the burden would be 122,536 hours (8 × 15,317) at an estimated cost of $13,233,888 (864 × 15,317). As discussed above, the revision and approval of these initial policies and procedures would also require activities by the physician, nurse practitioner, physician assistant, and medical director.

The administrator would need to have meetings with the physician, nurse practitioner, and physician assistant to discuss the revisions and draft any necessary policies and procedures. The administrator would also need to have meetings with the medical director to obtain approval for the policies and procedures. We estimate this would require 2 hours each for the physician, nurse practitioner, and physician assistant. For the medical director, we estimate 1 hour would be required to perform this function.

According to Table 3, the total hourly cost for the physician is $212. The burden for the physician in each RHC/FQHC would be 2 hours at an estimated cost of $424 (2 × 212). For the physicians in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours (2 × 15,317) at an estimated cost of $6,494,408 (424 × 15,317). The hourly cost for the nurse practitioner is $107.

The burden for the nurse practitioner in each RHC/FQHC would be 2 hours at an estimated cost of $214 (2 × 107). For the nurse practitioners in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours (2 × 15,317) at an estimated cost of $3,277,838 ($214 × 15,317). The hourly cost for the physician assistant is $111. The burden for the physician assistant in each RHC/FQHC would be 2 hours at an estimated cost of $222 (2 × 111).

For the physician assistants in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours (2 × 15,317) at an estimated cost of $3,400,374 (15,317 × 222). The hourly cost for the medical director is $212. The burden for the medical director in each RHC/FQHC would be 1 hour at an estimated cost of $212. For the medical directors in all 15,317 RHCs/FQHCs, the burden would be 15,317 hours (1 × 15,317) at an estimated cost of $3,247,204 (15,317 × 212).

Therefore, for all 15,317 RHCs/FQHCs, the estimated burden associated with the policies and procedures requirement would be 229,755 hours (122,536 + 30,634 + 30,634 + 30,634 + 15,317) at a cost of $29,653,712 (13,233,888 + 6,494,408 + 3,277,838 + 3,400,374 + 3,247,204). 2. Documentation and Storage Section 491.8(d) also requires RHCs/FQHCs to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the clinic's or center's policies and procedures for these activities is already accounted for above.

We believe that this would require an administrator 5 minutes or 0.0833 hours to perform the required documentation at an adjusted hourly wage of $108 for each employee. According to Table 3, RHCs have 40,000 employees and FQHCs have 110,000 employees for a total of 150,000 employees. Hence, the burden for these documentation requirements for all 15,317 RHCs and FQHCs would be 12,495 (0.0833 × 150,000) hours at an estimated cost of $1,349,460 (12,495 × 108). Therefore, the total burden for all 15,317 RHCs and FQHCs for this rule would be 242,250 (229,755 + 12,495) hours at an estimated cost of $31,003,172 (29,653,712 + 1,349,460).

The requirements and burden will be submitted to OMB under OMB control number 0938-0334 (expiration date March 31, 2023). O. ICRs Regarding the Development of Policies and Procedures for ESRD Facilities § 494.30(b), “erectile dysfunction treatment Vaccination of Facility Staff” 1. Policies and Procedures Section 494.30(b) requires the ESRD facilities to develop and implement policies and procedures to ensure their staff are vaccinated for erectile dysfunction treatment and that appropriate documentation of those vaccinations are tracked and maintained.

The ESRD facility must also have a contingency plan for all staff not fully vaccinated according to this rule. The ICRs for this section would require each ESRD facility to develop the policies and procedures needed to satisfy all of the requirements in this section. Current regulations at § 494.30 already require that ESRD facilities follow standard control precautions. Thus, all ESRD facilities should have prevention and control policies and procedures.

We believe that many ESRD facilities have already addressed erectile dysfunction treatment vaccination for their staff. However, we have no reliable means to estimate how many ESRD facilities have done so. Thus, we will base our burden estimate on all 7,893 ESRD facilities. All ESRD facilities would need to review their current policies and procedures and develop or modify them to comply with all of the requirements in § 494.30(b) as set forth in this IFC.

We believe these activities would be performed by the RN and an administrator. According to Table 3, an RN working with for an ESRD facility would have a total hourly cost of $73. Since there are not any current requirements that address erectile dysfunction treatment vaccination, we estimate it would require 8 hours for the RN to research, draft, and work with an administrator to finalize the policies and procedures. Thus, for each ESRD facility, the burden for the RN would be 8 hours at a cost of $584 (8 hours × $73).

For all ESRD facilities, the burden would be 63,144 hours (8 hours × 7,893) at an estimated cost of $4,609,512 (7,893 × 584). The development and/or revision and approval of these policies and procedures would also require activities by an administrator. The administrator would need to work with the RN to develop the policies and procedures, and then review and approve the changes. We estimate this would require 2 hours.

According to Table 3, the total hourly cost for the administrator at an ESRD facility is $97. Hence, for each ESRD, the burden for the administrator would be 2 hours at an estimated cost of $194 (2 × 97). For all ESRD facilities, the total burden would be 15,786 hours Start Printed Page 61598 (2 × 7,893) at an estimated cost of $1,531,242 (7,893 × 194). Thus, the total burden for all ESRD facilities for the policies and procedures requirement would be 78,930 hours (63,144 + 15,786) at an estimated cost of $6,140,754 ($4,609,512 + $1,531,242).

2. Documentation and Storage Section 494.30(b) also requires ESRD facilities to track and securely maintain the required documentation of staff erectile dysfunction treatment vaccination status. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at an adjusted hourly wage of $73 for each employee.

According to Table 3, ESRD facilities have 170,000 employees. Hence, the burden for these documentation requirements for all 7,893 ESRD facilities would be 14,161 (0.0833 × 170,000) hours at an estimated cost of $1,033,753 (14,161 × 73). Therefore, the total burden for all 7,893 ESRD facilities for this rule would be 93,091 (78,930 + 14,161) hours at an estimated cost of $ 7,174,507 (6,140,754 + 1,033,753). The requirements and burden will be submitted to OMB under OMB control number 0938-0386 (expiration date March 31, 2024).

Based upon the above analysis, the total burden for all of the ICRs in this IFC is 1,555,487 hours at an estimated cost of $136,088,221. Start Printed Page 61599 Start Printed Page 61600 Start Printed Page 61601 If you comment on these information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments electronically as specified in the ADDRESSES section of this IFC. Comments must be received on/by January 4, 2022. V.

Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. VI. Regulatory Impact Analysis A.

Statement of Need The erectile dysfunction treatment cialis has precipitated the greatest public health crisis in the U.S. Since the 1918 Influenza cialis. The population of older adults, and LTC facility residents in particular, have been hard hit by the impacts of the cialis. Among those infected, the death rate for older adults age 65 or higher was hundreds of time higher than for those in their 20s during 2020.[] Of the approximately 656,000 Americans estimated to have died from erectile dysfunction treatment through September 10, 2021,[] 30 percent are estimated to have died during or after an LTC facility stay, although these numbers are decreasing as vaccination rates increase in residents and staff as shown in the CDC Data Tracker.

Despite the recent nation-wide surge in s from the Delta variant of erectile dysfunction treatment, uptake of treatments and other measures (masking, screening visitors, and social distancing in particular) to prevent erectile dysfunction treatment, in combination with available therapeutic options to treat, has reduced erectile dysfunction treatment-related patient deaths in all settings. But reductions in erectile dysfunction treatment-related morbidity and mortality depend critically on continued success in vaccination of all health care staff and patients. The May 13, 2021 erectile dysfunction treatment IFC (86 FR 26306) required offering vaccination to residents and staff, but did not mandate vaccination. Recently, however the Departments of Defense and Veterans Affairs staff, and civilian Federal Government employees have become subject to requirements similar to those imposed in this rule.[] This IFC will close a gap in current regulations for all categories of health care provider whose health and safety practices are directly regulated by CMS.

Almost all CMS-regulated providers and suppliers disproportionately serve people who are older, disabled, chronically ill, or who have complex health care needs.[] Because the health care sector has such widespread and direct contact with hundreds of millions of patients, clients, residents, and program participants, the protective scope of this rule is far broader than the health care staff that it directly affects. B. Overall Impact We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L.

96-354), section 1102(b) of the Social Security Act, section 202 of the Start Printed Page 61602 Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C.

804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as “economically significant”).

(2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency. (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared an RIA that, taken together with COI section and other sections of the preamble, presents to the best of our ability the costs and benefits of the rulemaking. This RIA focuses on the overall costs and benefits of the rule, taking into account vaccination uptake to date or anticipated over the next year that is not due to this rule, and estimating the likely additional effects of this rule on both provider staff and the patients with whom they come in contact. We analyze both the costs of the required actions and the payment of those costs.

As intended under these requirements, this RIA's estimates cover only those costs and benefits that are likely to be the effects of this rule. There are also several unknowns that may affect current progress or this rule or both. These include the duration of strong treatment protection with or without a booster shot and the possibility of new cialis variants that reduce the effectiveness of currently authorized and approved treatments. We cannot estimate the effects of each of the possible interactions among them, but throughout the analysis we point out some of the most important assumptions we have made and the possible effects of alternatives to those assumptions.

The providers and suppliers regulated under this rule are diverse in nature, management structure, and size. That said, we believe that the costs faced by regulated entities will be very similar on a “per person vaccinated” basis. Tables 5 and 6 show the full scope of provider and supplier types, facility structures, and staff sizes, taking into account part-time staff (Table 5) and estimated staff turnover (Table 6). As explained earlier in the preamble, this rule includes facility contractors and consulting specialists as well as other persons providing part-time or occasional services to these providers and suppliers and their patients.

In Table 5 we provide a rough estimate of the likely number of full-time employees and other employees and contractors subject to this rule. The “total staff” number in the rightmost column is the number of individual staff directly affected at the time this rule takes effect (adding the number of full-time employees to the number of part-time employees, contractors, and other business persons who have recurring patient or staff interactions). Start Printed Page 61603 This rule presents additional difficulties in estimating both costs and benefits due to the high degree to which all current provider and supplier staff Start Printed Page 61604 have already received information about the benefits and safety of erectile dysfunction treatment vaccination, and the rare serious risks associated with it. Despite this progress, the proportion of fully vaccinated health care staff has approached but not hit the 70 percent with significant variation among states.

Moreover, among the general population more than 600,000 persons a day are currently being vaccinated with the first or second shot and about 100,000 a day have recovered from and are only in very rare cases still infectious. These changes reduce the risk to both health care staff and patients substantially, likely by about 20 million persons a month who are no longer sources of future s.[] This in turn reduces the number of newly infected cases (currently about 100,000 a day and decreasing rapidly). Yet another variable of importance is the increasing number of providers and suppliers that are mandating employee vaccination, and the increasing number of states that are doing so as well. To characterize the baseline scenario of no new regulatory action, from which we estimate the incremental impacts of the interim final rule, we assume that when Phase 1 of this IFC goes into effect, 75 percent of provider staff, 90 percent of LTC facility residents, and 80 percent of all other patients and clients will have been vaccinated, and that these rates will improve over time as a result of both this rule and the other factors previously discussed.[] These numbers leave a large range for the likely effects of this rule over time.

They do indicate, however, that many cases of death or severe illness can be prevented by increasing the number of vaccinated persons, both for those vaccinated and for others they might otherwise infect. As estimated in Table 6, the number of unvaccinated health care workers still remains in the millions despite recent progress. As discussed later in this analysis, we use the concept of the value per statistical life and per statistical case to capture this major potential benefit, as recommended by the Office of the Assistant Secretary for Planning and Evaluation based on standard practices in cost-benefit analysis.[] One additional factor affecting our estimates is remaining life expectancy. Life expectancy varies by age, being about 40 years across an entire population, close to 80 years for a younger population, and a relatively fewer number of years for an older population.

These numbers, of course, are overall averages and mask substantial differences by race and sex (among other factors), including access to affordable health care and prevalence of untreated or insufficiently controlled disease. Individuals with diabetes, for example, are disproportionately African American and disproportionately older, which leads to greater risks from kidney failure and other adverse health effects, including greater susceptibility to the ravages of erectile dysfunction treatment.[] Health care staff of most types of providers and suppliers are of typical working ages. But hospital patients, LTC facility residents, ESRD patients treated for kidney failure, and most other patients are heavily weighted towards older ages and are disproportionately members of African American and Native American minority groups. This means that the morbidity and mortality reductions from this rule when they are adjusted for the age ranges affected disproportionally benefit racial minorities.

In particular, LTC facility residents are near the upper end of the age spectrum. For a statistically average LTC facility resident, the average pre-erectile dysfunction treatment life expectancy if death occurs while in the facility is likely to be on the order of 3 years or fewer but taking into account residents who recover and leave the facility and those enrolled for skilled nursing services we estimate overall life expectancies to be about 5 years.[] We also estimate that vaccination reduces the chance of by about 95 percent, and the risk of death from the cialis to a fraction of 1 percent.[] In Israel, of the first 2.9 million people vaccinated with two doses there were only about 50 s involving severe conditions resulting from the cialis after the 14th day and of these so few deaths that they were not reported in statistical summaries. These data also show that erectile dysfunction treatments are effective for both older and younger recipients. Of those who have received a full primary treatment series, after the 14th day after vaccination only 46 people over the age of 60 became infected and had a severe case, compared to 6 people under the age of 60.

Given that these numbers are compared against 2.9 million recipients of the second dose, both rates are near zero.[] C. Anticipated Costs of the Interim Final Rule With Comment Period We note that our cost estimates assume that all additional vaccination costs for providers and suppliers regulated by this rule are due to this rule. We estimate on this basis because we have no reliable way to estimate how much of these costs might be equally due to independent employer decisions, to other Federal standards, to State and local mandates, or even to individual personal choices. In our cost estimates we cover all providers regulated by CMS for health and safety standards, but we often use LTC facilities for examples because they pose some of the greatest risks for erectile dysfunction treatment morbidity and mortality.

As documented subsequently in this analysis and in a research report on this issue, about 1.5 million individuals work in LTC facilities at any one time.[] A number of these individuals work in multiple LTC facilities which may play additional roles in transmission.[] These individuals are at high risk both to become ill with erectile dysfunction treatment and to transmit the SARS- Start Printed Page 61605 CoV-2 cialis to residents or visitors, or among themselves. Far more than most occupations, LTC facility work requires sustained close contact with multiple persons daily. In Table 6 we present estimates of total numbers of staff individuals regulated under this rule, distinguishing between numbers at the beginning of a year and at any one time during the year, versus the much higher numbers when turnover is considered. In Table 6 we assume that the number departing each year is the same as the number entering each year, which is a reasonable approximation to changes in just a few years, but do not take account of the aging of the population over time.

We note that our estimates do not include a deduction for the overlap among individuals who work in more than one LTC facility. We know that this number is substantial, but have no basis for estimating its precise magnitude and, more importantly, how it may change after this rule goes into effect and facilities change their staffing and hiring patterns. One recent study found about 17% of LTC nursing staff held second jobs, and another recent study found that about 5% held more than one LTC job. The second study, moreover, found that facilities with substantial staff sharing were disproportionally associated with as many as 49% of nursing home erectile dysfunction treatment cases.[] Start Printed Page 61606 These figures are approximations, because none of the data that is routinely collected and published on resident populations or staff counts focus on numbers of individuals residing or working in the facility during the course of a year or over time.

Depending on the average length of stay (that is, turnover) in different facilities, Start Printed Page 61607 an average population at any one time of, for example, 100 persons could be consistent with radically different numbers of individuals, such as 112 individuals in one facility if one person left each month and was replaced by another person, compared to 365 if one person left each day and was replaced that same day by another person. As a specific example, we assume that about 90 percent of existing LTC facility residents and 75 percent of existing staff will have been vaccinated by the date Phase 1 of this IFC takes effect (we use the same or similar assumptions for all provider types). There will be many new persons in each category during the first full year of the regulation, and likely almost all of these will have been vaccinated elsewhere (for simplicity we also assume a base rate 95 percent for this group, almost all of whom will have previously worked in a health care facility requiring vaccination). As presented in the third numeric column of Table 6, the total number of employees or otherwise compensated individuals working in all these different facilities over the course of a year is about 13 million persons, which is almost half again larger than the annual average number of staff shown in the first numeric column.

A recent study, using data from detailed payroll records, found that median turnover rates for all nurse staff in long term care facilities is approximately 90 percent a year, although other estimates are far lower (see subsequent discussion).[] We have not seen figures this high for other provider types but some may approach this level—home health care is well known for high turnover rates.[] Of course, most of these persons will have been vaccinated through other means when they enter the facilities during the next year. That said, it is likely that there will be approximately 2.4 million staff at the beginning or during the first year after this rule is published who will require vaccination (rightmost column of Table 6), possibly preceded in some cases by counseling efforts or employer inducements. While this IFC does not expressly require erectile dysfunction treatment counseling or education, we anticipate that some providers and suppliers will conduct such activities as a part of their procedures for ensuring compliance with the provisions of this rule. Some staff counseling can take place in group settings and some will take place on a one-to-one level.

What works best will depend on the circumstance of the employee and the best method for conveying the information and answering questions. Staff education, using CDC or FDA materials, can also take place in various formats and ways. Individualized counseling, staff meetings, posters, bulletin boards, and e-newsletters are all approaches that can be used. Informal education may also occur as staff go about their daily duties, and some who have been vaccinated may promote vaccination to others.

Facilities may find that reward techniques, among other strategies, may help. For example, monetary or other benefits such as paid days off could be given to staff who agree to vaccination. Even simpler, the employer can bring vaccination providers onsite to vaccinate staff (or both staff and unvaccinated patients). Of importance in such efforts, the value of immunization as a crucial component of keeping patients healthy and well is already conveyed to staff about influenza and pneumococcal treatments.

erectile dysfunction treatment persuasion can build upon that knowledge. The most important inducement will be the fear of job loss, coupled with the examples set by fellow treatment-hesitant workers who are accepting vaccination more or less simultaneously. One hundred percent success is unlikely. The HHS Guidelines for Regulatory Impact Analysis note that “[i]n most cases, the analysis focuses on estimating the incremental compliance costs incurred by the regulated entities, assuming full compliance with the regulation, and government costs.” These guidelines further recommend that “[a]nalysts should consider the uncertainty associated with an assumption of full compliance and provide analysis of alternative assumptions, as appropriate.” [] In preparing this analysis, we have identified several significant sources of uncertainty for these full-compliance estimates, one of which stands out.

If only one health care provider in an area required staff vaccination, then those who refuse vaccination could quit and obtain employment at another location in the same field or type of position.[] But with many employers already mandating vaccination, and with nearly all local (and distant) health care employers requiring vaccination under this rule, we expect that such effects will be minimized (with exceptions for medical or other exemptions as required by law). That said, currently there are endemic staff shortages for almost all categories of employees at almost all kinds of health care providers and supplier and these may be made worse if any substantial number of unvaccinated employees leave health care employment altogether. In this regard, we note that because CMS does not regulate health and safety in physician and dental offices, or in non-health care settings such as assisted living facilities, those entities may provide alternative places of employment for some of the staff currently working for providers and suppliers subject to this IFC who refuse vaccinations. On the other hand, staff shortages might be offset by persons returning to the labor market who were unwilling to work at locations where some other employees are unvaccinated and hence provide some risk, to those who have completed the primary vaccination series for erectile dysfunction treatment.

Despite these uncertainties, we have developed an estimate of staffing disruption costs, primarily to provide a complete cost picture even if this element is particularly uncertain. We note that these costs and benefits are highly dependent on whether, for example, staff vaccination refusals in coming months are closer to 1 percent than to 10 percent, and the extent to which increased confidence in the safety of working in a health care setting leads to offsetting increases in the return of former health care employees to the workforce. Both variables, in turn, may depend in significant ways on the overall labor market and on the ability of telehealth measures to replace in-person staff to patient encounters. The net outcomes of staff turnover over time could easily exceed or offset the administrative and vaccination costs we have estimated.

We welcome comments and information on these issues. The techniques for staff counseling, education, and incentives are so numerous and varied that there is no simple way to estimate likely costs. Staff hesitancy may and likely will change over time as the benefits of vaccination become clear to increasing numbers of individuals working in health care Start Printed Page 61608 settings. For purposes of estimation, we assume that, on average, one hour of staff time or the equivalent will be devoted to counseling or incentives for each unvaccinated staff person, at the same average hourly cost of about $75 estimated for RNs in the Information Collection analysis.

We assume that these efforts occur during paid working hours and that all costs will be borne by the facility. Since we estimate that about 2.4 million employees will need to be vaccinated (or replaced) in the first year (rightmost column of Table 6), most in the first two months after this rule is published, total costs would be about $180 million. This estimate assumes that the 2.4 million will be some mix of existing and replacement staff. For example, if 95% of the existing unvaccinated staff were vaccinated, and 5% of the unvaccinated staff terminated, then in addition to the normal turnover of 2.7 million new hires (second column of Table 6) an additional 114 thousand (.05 × 2,270) persons would need to be hired, with 95% of them already fully vaccinated and the remainder getting vaccinated as a condition of hiring.

For purposes of this estimate we ignore the existence of exemptions. A third major cost component of compliance with this IFC is the vaccination, including both administration and the treatment itself. We estimate that the average cost of a vaccination is what the government pays under Medicare. $20 × 2 = $40 for two doses of a treatment, and $20 × 2 for treatment administration of two doses, for a total of $80 per employee.

For purposes of estimation (and not reflecting any more knowledge than recent press accounts), we further assume that there will be a “booster” shot at the same cost, for a total vaccination cost of $120 per employee. While these treatment costs are currently incurred by the Federal Government, we include them to provide an estimate of total costs, regardless of who pays. In addition, we expect that a significant amount of time—one hour on average—will be used per employee in treatment planning, arrangement, and administration, and related activities for three vaccinations per currently unvaccinated employee. Together with the additional assumption that there will be an hour RN time or the equivalent needed for arranging or administering vaccination, at an average cost for that hour of $75, the total cost for vaccination compliance will be $195 per employee.

We apply that cost to all currently unvaccinated employees. Like counseling and incentives, if 5% of the existing unvaccinated staff leave and are replaced by a slightly higher number of new hires than would otherwise be needed, a roughly equivalent fraction of the new hires will need to be vaccinated before they have patient contact. As a result, we estimate the total costs of vaccination to be approximately $466 million (2,390,000 unvaccinated employees x $195). We note again that these estimates do not reflect the factor that multiple treatment mandates already do or will soon apply to many and perhaps most providers covered by our rule (employers' own self-imposed mandates, State and local mandates, and OSHA ETS, among others).

This means the costs of this rule are overestimated due to this factor, a conservative assumption. Our fourth and final major cost category is staffing and service disruptions. As discussed previously, it is possible there may be disruptions in cases where substantial numbers of health care staff refuse vaccination and are not granted exemptions and are terminated, with consequences for employers, employees, and patients. We do not have a cost estimate for those, since there are so many variables and unknowns, and it is unclear how they might be offset by reductions in current staffing disruptions caused by staff illness and quarantine once vaccination is more widespread.

We believe, however, that the disruptive forces are weaker than the return to normality. As shown in Table 6, it is normal for there to be roughly 2.66 million new hires (column two) in the health care settings we address in this rule, compared to a baseline of roughly 10.4 million staff (column one). These new hires replace a roughly equal number of employees leaving for one reason or another. Health care providers are already in the business of finding and hiring replacement workers on a large scale.

The terminated or self-terminated workers are not going to disappear. They still need to earn a living. Many of the non-clinical staff may will find employment situations in settings that are not subject to vaccination mandates. Cooks, for example, may migrate to restaurant jobs.

But in those cases, a cook who would otherwise have been hired by a restaurant may find a newly vacant health care position requiring vaccination and accept (or more likely already have) vaccination. Similarly, nurses may find jobs in health care settings that are not subject to vaccination mandates, such as most schools or physician offices. But that means that nurses who would otherwise have been hired in schools or physician offices may find jobs in vacant jobs in health care settings requiring vaccination and accept (or more likely already have) vaccination. In a dynamic labor market such behaviors occur continuously on a massive scale.

If net employment opportunities and job-seeking behaviors do not change (and there is no reason to believe they will), these continuous adjustments will leave health care providers and suppliers subject to this rule with their desired staff levels, and former employees who refused vaccination in jobs that do not require vaccination. Because job seeking and worker seeking are already operating on a massive scale in the health care sector, there is no reason to expect any massive new costs in such routine functions as advertising jobs, checking applicant employment history, familiarizing new employees with the nuances of the new employment setting, training, and all the other steps and costs involved in the normal workings of the labor market. As an example of the likely magnitude of hiring costs, one analysis of direct hiring costs for workers in the long-term care sector (including LTC facilities, home health care, and ICFs-IID) found that the direct costs of hiring new workers was on average about $2,500 in 2004.[] Assuming that this amount should be raised to $4,000 based on inflation since then, that a comparable estimate for higher skills health care professions would be $6,000, and that health care workers covered by this rule are half lower skilled and half higher skilled, the recruitment and hiring cost for additional hires equal to 5 percent of the normal annual hiring total of 2.4 million workers would be $600 million (an average of $5,000 × 120,000). (Costs could actually be lower because this study is almost a decade old and internet services have in recent years made recruitment and job application procedures far easier.) An additional cost category may result from erectile dysfunction treatment-related staff shortages, discussed extensively earlier in this IFC.

Although, as noted earlier, erectile dysfunction treatment-related staff shortages are occurring absent the rule due to numerous factors, such as , quarantine and staff illness. Shortages at their most acute prevent facilities from admitting as patients, clients, residents, or participants persons they would normally admit for treatment of diseases or conditions that would in many cases result in death or serious disability. We Start Printed Page 61609 are not aware of any data that would enable a reasonably accurate estimate of the total medical morbidity and mortality involved, but it is certainly massive. While it is true that compliance with this rule may create some short-term disruption of current staffing levels for some providers or suppliers in some places, there is no reason to think that this will be a net minus even in the short term, given the magnitude of normal turnover and the relatively small fraction of that turnover that will be due to vaccination mandates.

Moreover, the benefits of vaccination are not just the lives directly saved, but the resources that vaccination frees up because hospital, LTC facility, and rehabilitation beds are now available and because health care staff themselves are not being incapacitated or killed by erectile dysfunction treatment . The data on cumulative erectile dysfunction treatment cases among health care personnel show 677,000 cases (most of which incapacitated workers at least temporarily), and 2,200 deaths, all of which permanently eliminated those workers as sources of future care.[] Table 7 shows all of the costs that we have estimated. As previously explained, much and perhaps most of these costs would be incurred under other concurrent mandates, including employer-specific decisions, other Federal standards, and some State and local government mandates. Since these efforts overlap in scope, reach, and timing, there is no basis for assigning most of these costs to this rule or any other similar rule.

There are major uncertainties in these estimates. One obvious example is whether treatment efficacy will last more than the approximately 1 year proven to date and whether boosters are needed.[] Some in the scientific community believe that “booster” vaccinations after 6 or 8 months would be desirable to maintain a high level of protection against the predominant Delta version of the cialis. Delta may be overtaken by other cialis mutations, which creates another uncertainty. Booster vaccination or use of treatments whose licenses or EUAs have been amended to address new variants would likely maintain the effectiveness of vaccination for residents and staff.

At this time, as to second (and succeeding) year effects we assume no further major changes in treatment effectiveness. Yet another uncertainty is treatment costs, with a recently announced antiviral pill that could potentially provide substantial reductions in severity of illness and subsequent treatment costs, on a time schedule as yet unknown.[] D. Anticipated Benefits of the Interim Final Rule With Comment Period There will be more than 180 million staff, patients, and residents employed or treated each year in the facilities covered by this rule. In our analysis of first-year benefits of this rule we focus first on prevention of death among staff of facilities as well as on reduction in disease severity.

Second, we focus on resulting benefits from avoiding by unvaccinated staff among patients served in these facilities, who are likely to benefit more substantially because patients receiving health care in such facilities are disproportionately older than working age adults and are therefore more susceptible to severe illness or death from erectile dysfunction treatment. A third group of beneficiaries are staff family members and caregivers and many other persons outside the health care settings who staff might subsequently infect if not vaccinated. We focus initially on LTC facilities because their residents and patients have been among the most severely affected by erectile dysfunction treatment as well as illustrating all the estimating issues involved, but the same estimates, uncertainties, and calculations apply to all types of providers and suppliers in varying degrees. HHS's Guidelines for Regulatory Impact Analysis outline a standard approach to valuing the health benefits of regulatory actions.

The approach for valuing mortality risk reductions is based on the value per statistical life (VSL), which estimates individuals' willingness to pay (WTP) to avoid fatal risks. The approach to valuing morbidity risk reductions is based on measures of the WTP to avoid non-fatal risks when specific estimates are available, and based on measures of the duration and severity of the illness, including quality of life consequences, when suitable WTP estimates are not available.[] Based on this approach, the Office of the Assistant Secretary for Planning and Evaluation published a report that develops an approach for valuing erectile dysfunction treatment mortality and morbidity risk reductions. Start Printed Page 61610 In addition to the avoided death and human suffering, one of the major benefits of vaccination is that it lowers the cost of treating the disease among those who would might otherwise be infected and have serious morbidity consequences. The largest part of those costs is for hospitalization.

As discussed later in the analysis we provide data on the average costs of hospitalization of these patients (it is, however, unclear as to how much that cost will change over time due to improving treatment options). There is a potential offset to benefits that we have not estimated because we believe it is at this time not relevant in the U.S. If treatment supplies did not meet all demands for vaccination, giving priority to some persons over others necessarily meant that some persons would become infected who would not have been infected had the priorities been reversed. In this case, however, the priority for older adults (virtually all of whom have risk factors) who comprise the majority of hospital inpatients and the vast majority of LTC facility residents has already been established and is largely met.

This rule provides a priority for staff at a far lower risk of mortality and severe disease that benefits both groups.[] It achieves this benefit because by preventing the spread of erectile dysfunction treatment from provider and supplier staff, it actually provides a higher mortality and morbidity reduction for patients at far higher risk than the staff who become vaccinated.[] The HHS “Guidelines for Regulatory Impact Analysis” explain in some detail the concept of Quality Adjusted Life Years (QALYs).[] QALYs, when multiplied by a monetary estimate such as the Value of a Statistical Life Year (VSLY), are estimates of the value that people are willing to pay for life-prolonging and life-improving health care interventions of any kind (see sections 3.2 and 3.3 of the HHS Guidelines for a detailed explanation). The QALY and VSLY amounts used in any estimate of overall benefits are not meant to be precise, but instead are rough statistical measures that allow an overall estimate of benefits expressed in dollars. Under a common approach to benefit calculation, we can use a Value of a Statistical Life (VSL) to estimate the dollar value of the life-saving benefits of a policy intervention, for a person who more broadly represent a mixture of ages. We use the VSL of approximately $11.5 million in 2021 as described in the HHS Guidelines, adjusted for changes in real income and inflated to 2020 dollars using the Consumer Price Index.[] Using LTC facilities as an example, and assuming that the average rate of death from erectile dysfunction treatment (following erectile dysfunction ) at typical LTC facility resident ages and conditions is 5 percent, and the average rate of death after vaccination is essentially zero, the expected value of each resident who would, in the absence of this rule, otherwise be infected with erectile dysfunction is about $575,000 ($11.5 million × .05).

For staff, who are generally of working ages in roughly the same proportions as the population at large, the typical rate of death for the full course of two treatments (or possibly three with a booster) is roughly 1 percent of the older adult rate, and the expected value for each employee receiving the same vaccinations is about $57,500 ($11.5 million × .005).[] For community residents who unvaccinated staff might infect, the resulting calculation is similar (actually somewhat lower because the risk of death from erectile dysfunction treatment is even lower for those below employment ages). Under a second approach to benefit calculation, we can estimate the monetized value of extending the life of LTC facility residents, which is based on expectations of life expectancy and the value per life-year. As explained in the HHS Guidelines, the average individual in studies underlying the VSL estimates is approximately 40 years of age, allowing us to calculate a value per life-year of approximately $590,000 and $970,000 for 3 and 7 percent discount rates respectively. This estimate of a value per life-year corresponds to 1 year at perfect health.

(These amounts might reasonably be halved for average LTC facility residents, since non-institutionalized U.S. Adults aged 80-89 years report average health-related quality of life (HRQL) scores of 0.753, and this figure is likely to be lower for LTC facility residents.[] ) Assuming that the average life expectancy of long term care residents is 5 years, the monetized benefits of saving one statistical life would be about $3.0 million ($590,000 x annually for 5 years) at a 3 percent discount rate and about $4.8 million ($970,000 x annually for 5 years) at a 7 percent discount rate. Assuming that the average rate of death from erectile dysfunction treatment (erectile dysfunction ) at LTC facility resident ages and conditions is 5 percent, and the average rate of death after vaccination is essentially zero, the expected life-extending value of each resident who would otherwise be infected is $150 thousand at a 3 percent discount rate and $240 thousand at a 7 percent discount rate. A similar calculation can be made for staff and for the community residents they might infect, who will gain many more years of life but whose risk of death is far smaller since their age distribution is so much younger.

Deaths from erectile dysfunction treatment in unvaccinated LTC facility residents during 2020 were about 130,000, or close to one tenth of the average LTC facility resident census of 1.4 million, a huge contrast to the handful of deaths in the vaccination results from Israel.[] We do not have sufficient data so as to accurately estimate annual resident inflows and outflows over time, but it is clear that over two million new residents and over 700,000 new employees make the total number of individuals involved during the year far higher than point in time or average counts. Moreover, these counts do not include family members and other visitors, whose total visits certainly number in the millions. Most of the preceding calculations address residential long-term care. Long term care residents are a major group within LTC facilities and are generally in the LTC facility because their needs are more substantial and they need assistance with the activities of daily living, such as cooking, bathing, and dressing.

These long-term stays are Start Printed Page 61611 primarily funded by the Medicaid program (also, through long term care insurance or self-financed), and the custodial care services these residents receive are not normally covered by Medicare or any other health insurance.[] A second major group within the same facilities receives short-term skilled nursing care services. These services are rehabilitative and generally last only days, weeks, or months. They usually follow a hospital stay and are primarily funded by the Medicare program or other health insurance. The importance of these distinctions is that the numbers of residents and typical ages in each category regulated under this rule in each category are different.

The average number of persons in facilities for long term care over the course of a year is about 1.2 million residents (as is the point-in-time number), and the total number of persons over the course of a year is about 1.6 million. The average number in skilled nursing care at any one time is about 2 thousand persons, because the average length of stay is weeks rather than years and the median length of stay is days rather than weeks.[] The annual turnover in this group is such that about 2.3 million residents are served each year. There is some overlap between these two populations and the same person may be admitted on more than one occasion. For purposes of this analysis (these are rough estimates because there are no data routinely published on patient and resident turnover or providing unduplicated counts of persons served), we assume that the expected longevity for each group is identical on average, and that a total of 3.9 million different persons are served each year.

The employee staff are a third group and the direct target of these rules. Since both long-term and short-term residents are for the most part served in the same facilities, their care is managed and provided by the same facility staff. These nursing facilities have about 950,000 full-time equivalent employees at any one time and another 100,000 visiting staff or the equivalent, all covered by this rule. For these persons, the average age is about 45, which creates two offsetting effects.

They have more years of life expectancy than residents, but their risk of death from erectile dysfunction treatment is far lower. For purposes of this analysis, we assume that vaccination against erectile dysfunction treatment is effective for at least 1 year and use a 1-year period as our primary framework for calculation of potential benefits, not as a specific prediction but as a likely scenario that avoids forecasting major and unexpected changes that are either strongly adverse or strongly beneficial. If we were adding up totals for benefits we would assume that the risk of death after erectile dysfunction treatment is likely only one-half of one percent (one tenth of the resident rate) or less for the unvaccinated members of this group, reflecting the far lower mortality rates for persons who are almost all in the 18 to 65 year old age ranges compared to the far older residents.[] We assume that the total number of individual employees is 50 percent higher than the full-time equivalent but that only half that number are primarily employed at only one nursing facility, two offsetting assumptions about the number of employees working at each facility (many employees are part-time consultants or the equivalent who serve multiple nursing facilities on a part-time basis). We further assume that employee turnover is 80 percent a year, lower than the results for nurses previously cited.

Accordingly, we estimate that 80 percent of 950,000, or 760,000, are new employees each year and must be offered vaccination (again, most are already vaccinated), for a total of 1,710,000 eligible employees over the course of a year. (This number would likely drop in future years as employers decide to hire only persons previously vaccinated and as treatment uptake increases due to Federal, State, local, or employer requirements, as well as individual choice.) We have some data on the costs of treating serious illness among the unvaccinated who become infected, are hospitalized, and survive. Among those age 65 years or above, or with severe risk factors, over 30 percent of those known to be infected required hospitalization in the first year of the cialis.[] That fraction is far lower now as treatments have improved and as vaccinations have greatly reduced severity of the disease. Among adults aged 21 years to 64 years, about 10 percent of those infected once required hospitalization, but that fraction is now far lower for the same reasons.

For our estimates, we assume a 10 percent hospitalization rate among people aged 65 years or older in LTC facilities, reflecting both that their conditions are significantly worse than those of similarly aged adults living independently, and that pre-hospitalization treatments have improved. For staff we assume one fifth of this rate, or 2 percent. Using LTC facilities as our main example, the LTC facility candidates for vaccination in the first year covered by this rule, about three-fourths are age 65 years or above. Hence, the age-weighted hospitalization rate that we project is about 8 percent.

Among those hospitalized at any age, the average cost is about $20,000.[] To put these cost, benefit, and volume numbers in perspective, vaccinating one hundred previously unvaccinated LTC facility residents who would otherwise become infected with erectile dysfunction and have a erectile dysfunction treatment illness would cost approximately $18,000 ($183 × 100) in vaccination costs. Using the VSL approach to estimation would produce life-saving benefits of about $400,000 for these 100 people ($20,000 × 100 × .05), again assuming the death rate for those ill from erectile dysfunction treatment of this age and condition is one in twenty. Reductions in health care costs from hospitalization would produce another $160,000 ($20,000 × 100 × .08) in benefits for this group assuming that 8 percent would otherwise be hospitalized. However, this comparison should be taken as necessarily hypothetical and contingent due to the analytic, data, and uncertainty challenges discussed throughout this regulatory impact assessment.

Patient benefits are simply a consequence of fewer s among staff. Vaccinating one hundred previously unvaccinated LTC facility employees would be higher than for staff. Life-saving benefits to employees would be about $5,300,000 ($10,600,000 VSL × 100 × .005) for 100 people assuming that the death rate for these far younger 100 people is 1 in 500 hundred. Reductions in health care costs from hospitalizations of employees would produce another $20,000 ($20,000 × 100 × .01).

Start Printed Page 61612 There remain difficult questions of estimating (1) likely numbers of individuals in staff and patient categories who are likely to be unvaccinated when the rule goes into effect and (2) numbers of staff likely to be willing to accept vaccination in the coming months and years.[] Both sets of numbers vary substantially by provider and supplier type. LTC facility and home health care patients are on average both the oldest and most health-impaired of those in settings covered by this rule. At the other extreme, rural and other community-care oriented health centers serve the full age spectrum and a lower fraction of severely health-impaired. We do know that the life-saving benefits for staff are probably small but significant.

During the entire period of erectile dysfunction treatment s, since March 2020, there have been over 2,000 health care staff deaths recorded by the CDC through October 3, 2021.[] Of these, the great majority were in the year 2020. Even during the recent Delta variant surge, health care staff deaths decreased to lower levels. Specifically, during the last 6 months, April through September 2021, total staff deaths were 202, an average of 34 per month and no clear trend (the last 4 weeks, all in September, 2021 produced fewer than 20 deaths). This is not surprising as the most effective precautions other than vaccination—masks, social distancing, and ventilation—have been essentially universal in the health care sector during all of 2021.

Even more importantly, vaccination rates are considerably higher than in the population at large (although still well below optimal levels). Yet, using the last 6 months of CDC Data Tracker information, on an annual basis more than 400 deaths could be expected. These data, moreover, are almost all among unvaccinated persons and are probably undercounted in current data. A major caution about these estimates.

None of the sources of enrollment information for these programs regularly collect and publish information on client or staff turnover during a year. These data have not previously been found useful in program management for individual agencies or programs, or when needed have been addressed through one-time research projects. The estimates in this analysis are based on inferences from scattered data on average length of stay, mortality, job vacancies, news accounts, and other sources that by happenstance are available for one type of facility or type of resident or another. Nor do we have data on the number of persons in these settings who will be vaccinated through other means during the remainder of the year.

All these data and estimation limitations apply to even the short-term impacts of this rule, and major uncertainties remain as to the future course of the cialis, including but not limited to treatment effectiveness in preventing “breakthrough” disease transmission from those vaccinated, the long-term effectiveness of vaccination, the emergence of treatment options, and the potential for some new disease variant even more dangerous than Delta. Another unknown is what currently unvaccinated employees would do when the vaccination deadline is reached, and how rapidly those quitting rather than being vaccinated could be replaced. Even a small fraction of recalcitrant unvaccinated employees could disrupt facility operations. On the other hand, there have been significant reductions in provider and supplier staffing needs in some categories.

For example, LTC facility admissions have declined in the last year, as families and caregivers sought to avoid the risks of exposing a care recipient to unvaccinated residents and staff in LTC facilities. The new vaccination requirement may reduce such fears and bring higher numbers of residents to these facilities and the essential services they provide. Again, we have no way to estimate such behavioral changes. Regardless, we believe it is clear that reductions in patient/resident fatalities through avoiding staff-generated s are both likely to be a significantly larger benefit from staff vaccination than direct benefits to staff.

Staff vaccination will also provide significant community benefits when staff are not at work. Hence, total lives saved under this rule may well reach several hundred a month or perhaps several thousand a month for all three groups in total. Patient and resident benefits are especially likely to be many times higher because the risks of death and serious disease complications are so many times higher among older persons and people with multiple chronic conditions. As indicated by the preceding analysis, predicting the full range of benefits and costs in either the short run or the next full year with any degree of estimating precision is all but impossible.

As the minimum benefit level needed for benefits to exceed costs, however, we estimate that either saving 120 lives, or preventing 600 hundred hospitalizations for serious illness, or any combination of these two magnitudes, would produce benefits that exceed our estimate of costs over the next year. There have been about 200 staff deaths in the last 6 months and this is a likely undercount for this one category of persons alone, and potential life-saving benefits to more than 150 million mostly elderly patients and residents (about 10 percent of whom are likely to remain unvaccinated) who are exposed to provider staff probably would be many times higher. We note, however, as discussed in the preceding section on costs, much of these benefits could be as well attributed to other concurrent and parallel vaccination mandates and campaigns. E.

Other Effects 1. Sources of Payment The initial costs of this rule fall almost entirely on health care providers and suppliers and are extremely small in comparison to the $4 trillion a year spent on health care, mostly through these same entities. In particular, the costs of the treatments are paid by the Federal Government and treatment costs are about two-thirds of the total costs we have estimated. Moreover, through the treatment cost savings to the hospitals and other care providers resulting from the vaccinations that will be made due to this rule, significant savings would accrue to payers.

It is likely that half or more of these savings would primarily accrue to Medicare given the age or disability status of most clients and Medicare's role as primary payer, but there would also be substantial savings to Medicaid, private insurance paid by employers and employees, and private out-of-pocket payers including patients and residents. In some rare cases funds under the CARES Act and the American Rescue Plan Act of 2021 might be available at State or local discretion, but it is hard to foresee any substantial budgetary impact on any insurance plan or service provider that would justify or require such assistance. 2. Regulatory Flexibility Act The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities.

Under the RFA, “small entities” include small businesses, nonprofit organizations, and small governmental jurisdictions. Individuals and states are not included in the definition of a small entity. For Start Printed Page 61613 purposes of the RFA, we estimate that most health care facilities are small entities as that term is used in the RFA because they are either nonprofit organizations or meet the SBA definition of a small business (having revenues of less than $8.0 million to $41.5 million in any 1 year). HHS uses an increase in costs or decrease in revenues of more than 3 to 5 percent as its measure of “significant economic impact.” The HHS standard for “substantial number” is 5 percent or more of those that will be significantly impacted, but never fewer than 20.

As estimated previously, the total costs of this rule for 1 year are about $1.3 billion, most of which is directly proportional to number of employees. Spread over 10.4 million full-time equivalent employees, this is about $125 per employee. Assuming a fully loaded average wage per employee of $90,000, the first-year cost does not approach the 3 percent threshold. Moreover, since much of these costs (in particular, the treatment costs paid by the Federal Government) will not fall on providers or suppliers, the financial strain on these facilities should be negligible.

Finally, as previously discussed, there are other concurrent mandates and much of these costs could as well be attributed to those efforts. Therefore, the Department has determined that this IFC will not have a significant economic impact on a substantial number of small entities and that a final RIA is not required. Finally, this IFC was not preceded by a general notice of proposed rulemaking and the RFA requirement for a final regulatory flexibility analysis does not apply to final rules not preceded by a proposed rule. Regardless, this RIA and the main preamble, taken together, would meet the requirements for either an Initial or Final Regulatory Flexibility Analysis.

3. Small Rural Hospitals Section 1102(b) of the Act requires us to prepare an RIA if a proposed rule may have a significant impact on the operations of a substantial number of small rural hospitals. For purposes of this requirement, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. Because this rule has only the small impact per employee calculated for RFA purposes, the Department has determined that this IFC will not have a significant impact on the operations of a substantial number of small rural hospitals.

This IFC is also exempt because that provision of law only applies to final rules for which a proposed rule was published. That said, early indications are that rural hospitals are having greater problems with employee vaccination refusals than urban hospitals, and we welcome comments on ways to ameliorate this problem. 4. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates will impose spending costs on State, local, or tribal governments, or by the private sector, require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation.

In 2021, that threshold is approximately $158 million. This rule contains no State, local, or tribal governmental mandates, but does contain mandates on private sector entities that exceed this amount. However, this IFC was not preceded by a notice of proposed rulemaking, and therefore the requirements of UMRA do not apply. The analysis in this RIA and the preamble as a whole would, however, meet the requirements of UMRA.

5. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule would pre-empt some State laws that prohibit employers from requiring their employees to be vaccinated for erectile dysfunction treatment. Consistent with the Executive Order, we find that State and local laws that forbid employers in the State or locality from imposing treatment requirements on employees directly conflict with this exercise of our statutory health and safety authority to require vaccinations for staff of the providers and suppliers subject to this rule.

Similarly, to the extent that State-run facilities that receive Medicare and Medicaid funding are prohibited by State or local law from imposing treatment mandates on their employees, there is direct conflict between the provisions of this rule (requiring such mandates) and the State or local law (forbidding them). As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader grounds for exemptions than provided for by Federal law and are inconsistent with this IFC. In these cases, consistent with the Supremacy Clause of the Constitution, the agency intends that this rule preempts State and local laws to the extent the State and local laws conflict with this rule. The agency has considered other alternatives (for example, relying entirely on measures such as voluntary vaccination, source control alone, and social distancing) and has concluded that the mandate established by this rule is the minimum regulatory action necessary to achieve the objectives of the statute.

Given the contagion rates of the existing strains of erectile dysfunction and their disproportionate impacts on Medicare and Medicaid beneficiaries, we believe that vaccination of almost all staff of covered providers and suppliers is necessary to promote and protect patient health and safety. The agency has examined case studies from other employers and concludes that treatment mandates are vastly more effective than other measures at achieving ideal vaccination rates and the resulting patient protections from morbidity and mortality. Given the emergency situation with respect to the Delta variant detailed more fully above, time did not permit usual consultation procedures with the States, and such consultation would therefore be impracticable. We are, however, inviting State and local comments on the substance as well as legal issues presented by this rule, and on how we can fulfill the statutory requirements for health and safety protections of patients if we were to exempt any providers or suppliers based on State or local opposition to this rule.

F. Alternatives Considered As discussed earlier in the preamble, a major substantive alternative that we considered was to limit erectile dysfunction treatment vaccination requirements to full-time employees rather than to all persons who may provide paid or unpaid services, such as visiting specialists or volunteers, who are not on the regular payroll on a weekly or more frequent basis that is, individuals who work in the facility and in some cases infrequently or unpredictably, as well as individuals who are not on the payroll at all. We concluded that covering these persons would be readily manageable without creating major issues for compliance, enforcement, and record-keeping. We did not, however, include some categories of visitors who do not have a business relationship with the provider, such as family member visitors.

There are also many issues such as social isolation and loneliness related to potential discouragement of visiting volunteers or family members. Start Printed Page 61614 We also considered whether it would be appropriate to limit erectile dysfunction treatment vaccination requirements to staff who have not previously been infected by erectile dysfunction. There remain many uncertainties about as to the strength and length of this immunity compared to people who are vaccinated, and—in recognizing that—the CDC recommends that previously infected individuals get vaccinated. Exempting previously infected individuals would have potentially reduced benefits while reducing costs, both roughly in proportion to the number affected.

It would have also, complicated administration and likely require standards that do not now exist for reliably measuring the declining levels of antibodies over time in relation to risk of re. Because of current CDC guidance and understanding of relevant scientific findings, we found that it was not warranted to exempt previously infected individuals. Another option would be to devise a standard with graduated compliance expectations such as 90 percent and then 95 percent and then 100 percent of staff vaccinated and a time period in which to reach each level. A variation of this would be to put providers on a probationary period if they failed to reach 100 percent compliance by the date set in the rule, and were allowed additional time in which to cross that last threshold.

Yet another variation would be to reduce payment to providers and suppliers not meeting the standard after the initial deadline. We recently put a phased system in place for Organ Procurement Organizations (OPOs), so we are not reflexively opposed to such options.[] Nonetheless, there are two major arguments against such a system in the context of this rule. First, to have any usefulness the time periods would have to have a reasonably extensive duration, such as a month each. But that would be almost the same as extending this rule's deadline for an extra several months.

We do not believe that extending the deadline to extend the employment of staff who will simply delay vaccination or final refusal to the last possible moment is in the interest of other staff, patients, and patients who would utilize the provider for needed health care if they did not fear unvaccinated staff. Second, it would not only delay the achievement of both staff and patient safety, but encourage procrastination. For those few staff absolutely unwilling to accept vaccination, it would simply delay the day of final action and the day of hiring a vaccinated replacement. In the case of the OPO rule, an entire organization had to be slowly reformed to achieve compliance.

In the context of this rule, and the lives at stake, there is no obvious ethical or managerial reason to give a relative handful of vaccination-resisting individuals more time until they leave the organization. It would give management more time to find replacements, but it is not at all clear that this would be a fruitful grace period. As for a variation reducing payment to non-performing providers, perhaps by 20 percent per patient over some applicable time period, this would arguably provide something better than an “all of nothing” removal from provider status. It would require legislation but that is not a barrier to meeting E.O.

12866 analysis standards and in some rules may be essential to a valid benefit-cost analysis. The problem with this variation, however, is that for most providers and suppliers is it unlikely to be a realistic choice. Rather than accept lower payment levels, management can simply terminate the unvaccinated employees, a power they have with or without the reduced payment alternative. Moreover, it would be hard to devise a system that treated equally and fairly providers of all sizes—whether with 5 or 50 employees.

We further note that CMS already has and uses discretion in enforcement when inspectors find a violation. Termination of provider status is not normally an immediate consequence, as entities are typically given the opportunity to correct deficiencies. Regardless, we welcome comments on this overall option and its variations, and on the closely-related option of simply adding a month to the compliance deadline in this rule. We considered what standards to apply regarding proof of compliance with exemptions requests base on medical contraindications and religious objections.

We decided to establish minimal compliance burdens for both categories of exemptions. This decision on the evidentiary standards could be revisited should an abuse problem arise on a significant scale. This may open the door to forged documents or false statements, and therefore validation of such claims raises administrative costs. Accordingly, we have allowed for relatively relaxed standards for verification in our administrative provisions and cost estimates but may reconsider in the future.

We considered alternative timelines for implementation but decided that this would not only delay badly needed live-saving compliance, but also provide little real management benefit to providers and suppliers. Staff have had almost a year to consider erectile dysfunction treatment vaccinations that are in their own interests as well as vital to patient protections and the protection of other workers. In this regard we note that one of the claimed barriers to vaccination has recently been removed, now that one treatment is now no longer emergency-authorized, but fully licensed. We believe our requirements provide more than enough time for reasonable counselling and other management measures.

Finally, we considered requiring daily or weekly testing of unvaccinated individuals. We have reviewed scientific evidence on testing and found that vaccination is a more effective control measure. As such, we chose not to require such testing for now but welcome comment. Of course, nothing prevents a provider from exercising testing precautions voluntarily in addition to vaccination.

We note that nothing in this rule removes the obligation on providers and suppliers to meet existing requirements to prevent the spread of , which in practice means that these entities may also conduct regular testing alongside such actions as source control and physical distancing. CMS will continue to review the evidence and stakeholder feedback on this issue. These and some lesser options are presented and discussed in the main preamble. We do not have reliable dollar estimates for either costs or benefits of any alternatives, for the reasons already discussed in the RIA regarding the options we chose.

We welcome comments on these or other options. G. Accounting Statement and Table The Accounting Table summarizes the quantified impact of this rule. It covers only 1 year because there will likely be many developments regarding treatments and vaccinations and their effects in future years and we have no way of knowing which will most likely occur.

A longer period would be even more speculative than the current estimates. Nonetheless, assuming no major unforeseen events that would impinge on our estimates, we would expect lower costs in future years if for no other reason than increases in the fraction of new hires already vaccinated as well as other positive results from the President's plan or individual vaccination decisions. We further note Start Printed Page 61615 that the vaccinations, and hence the benefits and costs, estimated for this rule are more or less simultaneously being created voluntarily by some employers (self-mandates), through the OSHA vaccination rule applicable to employers of 100 or more persons, and by some State or local mandates. There is no simple and non-arbitrary way to disentangle which vaccination benefits and which vaccination costs are due to which source.

As explained in various places within this RIA and the preamble as a whole, there are major uncertainties as to the effects of current variants of erectile dysfunction on future rates, medical costs, and prevention of major illness or mortality. For example, the duration of treatment effectiveness in preventing erectile dysfunction treatment, reducing disease severity, reducing the risk of death, and the effectiveness of the treatment to prevent disease transmission by those vaccinated are not currently known. These uncertainties also impinge on benefits estimates. For those reasons we have not quantified into annual totals either the life-extending or medical cost-reducing benefits of this rule and have used only a 1-year projection for the cost estimates in our Accounting Statement (our first-year estimates are for the last two months of 2021 and the first ten months of 2022).

We also show a large range for the upper and lower bounds of potential costs to emphasize the uncertainty as to several major variables, such as changes in voluntary vaccination levels, longer term effects, and others previously discussed. We welcome comments on all of our assumptions and welcome any additional information that would narrow the ranges of uncertainty or guide us in any important revisions to the requirements established in what is an “interim” final rule. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &.

Medicaid Services, approved this document on October 19, 2021. Start List of Subjects 42 CFR Part 416 Health facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 418 Health facilitiesHospice careMedicareReporting and recordkeeping requirements 42 CFR Part 441 AgedFamily planningGrant programs—healthInfants and childrenMedicaidPenaltiesReporting and recordkeeping requirements 42 CFR Part 460 AgedCitizenship and naturalizationCivil rightsHealthHealth careHealth recordsIncorporation by referenceIndividuals with disabilitiesMedicaidMedicareReligious discriminationReporting and recordkeeping requirements 42 CFR Part 482 Grant program—-healthHospitalsMedicaidMedicareReporting and recordkeeping requirements 42 CFR Part 483 Grant programs—healthHealth facilitiesHealth professionsHealth recordsMedicaidMedicareNursing homesNutritionReporting and recordkeeping requirementsSafety 42 CFR Part 484 Administrative practice and procedureGrant programs—healthHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 485 Grant programs—healthHealth facilitiesMedicaidPrivacyReporting and recordkeeping requirements 42 CFR Part 486 Administrative practice and procedureGrant programs—healthHealth facilitiesHome infusion therapyMedicareReporting and recordkeeping requirementsX-rays 42 CFR Part 491 Grant programs—healthHealth facilitiesMedicaidMedicareReporting and recordkeeping requirementsRural and urban areas 42 CFR Part 494 DiseasesHealth facilitiesIncorporation by referenceMedicareReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1.

The authority citation for part 416 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part2.

Amend § 416.51 by adding paragraph (c) to read as follows. End Amendment Part Conditions for coverage— control. * * * * * (c) Standard. erectile dysfunction treatment vaccination of staff.

The ASC must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following center staff, who provide any care, treatment, or other services for the center and/or its patients.

(i) Center employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the center and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following center staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the center setting and who do not have any direct contact with patients and other staff specified in paragraph (c)(1) of this section. And (ii) Staff who provide support services for the center that are performed exclusively outside of the center setting and who do not have any direct contact with patients and other staff specified in paragraph (c)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment, prior to staff providing any care, treatment, or other services for the center and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (c)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the center has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized or licensed erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the center's erectile dysfunction treatment vaccination requirements based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Part End Part Start Amendment Part3. The authority citation for part 418 continues to read as follow. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh.

End Authority Start Amendment Part4. Amend § 418.60 by adding paragraph (d) to read as follows. End Amendment Part Condition of participation. control.

* * * * * (d) Standard. erectile dysfunction treatment Vaccination of facility staff. The hospice must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. Start Printed Page 61617 (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following hospice staff, who provide any care, treatment, or other services for the hospice and/or its patients. (i) Hospice employees. (ii) Licensed practitioners.

(iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the hospice and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following hospice staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where hospice services are provided to patients and who do not have any direct contact with patients, patient families and caregivers, and other staff specified in paragraph (d)(1) of this section.

And (ii) Staff who provide support services for the hospice that are performed exclusively outside of the settings where hospice services are provided to patients and who do not have any direct contact with patients, patient families and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the hospice and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (d)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law.

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospice has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the hospice's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part5. The authority citation for part 441 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302. End Authority Start Amendment Part6. Amend § 441.151 by adding paragraph (c) to read as follows.

End Amendment Part General requirements. * * * * * (c) erectile dysfunction treatment Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or resident contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its residents. (i) Facility employees. (ii) Licensed practitioners.

(iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its residents, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (c)(1) of this section.

And (ii) Staff who provide support services for the facility that are performed exclusively outside of the center setting and who do not have any direct contact with residents and other staff specified in paragraph (c)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its residents. (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been Start Printed Page 61618 granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring that the facility follows nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment, and which must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (c)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law.

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part7. The authority citation for part 460 continues to read as follow.

End Amendment Part Start Authority 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f). End Authority Start Amendment Part8. Amend § 460.74 by adding paragraph (d) to read as follows.

End Amendment Part control. * * * * * (d) erectile dysfunction treatment Vaccination of PACE organization staff. The PACE organization must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or participant contact, the policies and procedures must apply to the following PACE organization staff, who provide any care, treatment, or other services for the PACE organization and/or its participants. (i) PACE organization employees. (ii) Licensed practitioners providing services on behalf of the PACE organization.

(iii) Students, trainees, and volunteers providing services on behalf of the PACE organization. And (iv) Individuals who provide care, treatment, or other services on behalf of the PACE organization, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following PACE organization staff. (i) Staff who exclusively provide telehealth or telemedicine services for the PACE organization and/or its participants and who do not have any direct contact with participants and other PACE organization staff specified in paragraph (d)(1) of this section.

And (ii) Staff who provide support services for the PACE organization and/or its participants and who do not have any direct contact with participants and other PACE organization staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the PACE organization and/or its participants. (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (d)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law.

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the PACE organization has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements based on recognized clinical contraindications or applicable Federal laws. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as Start Printed Page 61619 defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the PACE organization's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Part End Part Start Amendment Part9. The authority citation for part 482 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted. End Authority Start Amendment Part10. Amend § 482.42 by adding paragraph (g) to read as follows.

End Amendment Part Condition of participation. prevention and control and antibiotic stewardship programs. * * * * * (g) Standard. erectile dysfunction treatment Vaccination of hospital staff.

The hospital must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following hospital staff, who provide any care, treatment, or other services for the hospital and/or its patients.

(i) Hospital employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following hospital staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the hospital setting and who do not have any direct contact with patients and other staff specified in paragraph (g)(1) of this section. And (ii) Staff who provide support services for the hospital that are performed exclusively outside of the hospital setting and who do not have any direct contact with patients and other staff specified in paragraph (g)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (g)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the hospital and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (g)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (g)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospital has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the hospital's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment-.

Start Part End Part Start Amendment Part11. The authority citation for part 483 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.

End Authority Start Amendment Part12. Amend § 483.80 by revising paragraph (d)(3)(v) and adding paragraph (i) to read as follows. End Amendment Part control. (d) * * * (3) * * * (v) The resident or resident representative, has the opportunity to accept or refuse a erectile dysfunction treatment, and change their decision.

And * * * * * Start Printed Page 61620 (i) erectile dysfunction treatment Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

(1) Regardless of clinical responsibility or resident contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its residents. (i) Facility employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers.

And (iv) Individuals who provide care, treatment, or other services for the facility and/or its residents, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (i)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (i)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (i)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its residents. (ii) A process for ensuring that all staff specified in paragraph (i)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

(iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (i)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements.

(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part13. Amend § 483.430 by revising paragraph (f) to read as follows. End Amendment Part Condition of participation.

Facility staffing. * * * * * (f) Standard. erectile dysfunction treatment Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment.

For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or client contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its clients. (i) Facility employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its clients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following facility staff.

(i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, Start Printed Page 61621 treatment, or other services for the facility and/or its clients.

(ii) A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (f)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part14. Amend § 483.460 by revising paragraph (a)(4)(v) to read as follows.

End Amendment Part Condition of participation. Health care services. * * * * * (a) * * * (4) * * * (v) The client, or client's representative, has the opportunity to accept or refuse a erectile dysfunction treatment, and change their decision. * * * * * Start Part End Part Start Amendment Part15.

The authority citation for part 484 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part16.

Amend § 484.70 by adding paragraph (d) to read as follows. End Amendment Part Condition of participation. prevention and control. * * * * * (d) Standard.

erectile dysfunction treatment Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

(1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients. (i) HHA employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers.

And (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. And (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the HHA and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

(iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (d)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements.

Start Printed Page 61622 (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Part End Part Start Amendment Part17. The authority citation for part 485 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395(hh).

End Authority Start Amendment Part18. Amend § 485.58 by revising paragraph (d)(4) to read as follows. End Amendment Part Condition of participation. Comprehensive rehabilitation program.

* * * * * (d) * * * (4) The services must be furnished by personnel that meet the qualifications of § 485.70 and the number of qualified personnel must be adequate for the volume and diversity of services offered. Personnel that do not meet the qualifications specified in § 485.70(a) through (m) may be used by the facility in assisting qualified staff. When a qualified individual is assisted by these personnel, the qualified individual must be on the premises, and must instruct these personnel in appropriate patient care service techniques and retain responsibility for their activities. * * * * * Start Amendment Part19.

Amend § 485.70 by adding paragraph (n) to read as follows. End Amendment Part Personnel qualifications. * * * * * (n) The CORF must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment.

The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its patients. (i) Facility employees. (ii) Licensed practitioners.

(iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (n)(1) of this section.

And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (n)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (n)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (n)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (n)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law.

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions Start Printed Page 61623 and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment.

And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part20. Amend § 485.640 by adding paragraph (f) to read as follows. End Amendment Part Condition of participation.

prevention and control and antibiotic stewardship programs. * * * * * (f) Standard. erectile dysfunction treatment Vaccination of CAH staff. The CAH must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment.

For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following CAH staff, who provide any care, treatment, or other services for the CAH and/or its patients. (i) CAH employees.

(ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the CAH and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following CAH staff.

(i) Staff who exclusively provide telehealth or telemedicine services outside of the CAH setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section. And (ii) Staff who provide support services for the CAH that are performed exclusively outside of the CAH setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the CAH and/or its patients.

(ii) A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of all staff specified in paragraph (f)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

(vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the CAH has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements based on recognized clinical contraindications or applicable Federal laws. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the CAH's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications.

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part21. Amend § 485.725 by adding paragraph (f) to read as follows.

End Amendment Part Condition of participation. control. * * * * * (f) Standard. erectile dysfunction treatment vaccination of organization staff.

The organization that provides outpatient physical therapy must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following organization staff, who provide any care, treatment, or other services for the organization and/or its patients.

(i) Organization employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the organization and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following organization staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the organization setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section. And (ii) Staff who provide support services for the organization that are performed exclusively outside of the organization setting and who do not have any direct contact with patients and other staff Start Printed Page 61624 specified in paragraph (f)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the organization and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (f)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the organization has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.

And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the organization's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. Start Amendment Part22.

Amend § 485.904 by adding paragraph (c) to read as follows. End Amendment Part Condition of participation. Personnel qualifications. * * * * * (c) Standard.

erectile dysfunction treatment vaccination of center staff. The CMHC must develop and implement policies and procedures to ensure that all center staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment.

(1) Regardless of clinical responsibility or client contact, the policies and procedures must apply to the following center staff, who provide any care, treatment, or other services for the center and/or its clients. (i) Center employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers.

And (iv) Individuals who provide care, treatment, or other services for the center and/or its clients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following center staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the center setting and who do not have any direct contact with clients and other staff specified in paragraph (c)(1) of this section. And (ii) Staff who provide support services for the center that are performed exclusively outside of the center setting and who do not have any direct contact with clients and other staff specified in paragraph (c)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components. (i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the CMHC and/or its clients. (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment.

(iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (c)(1) of this section. (v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the CMHC has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements.

(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions Start Printed Page 61625 from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the CMHC's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Part End Part Start Amendment Part23. The authority citation for part 486 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.

End Authority Start Amendment Part24. Amend § 486.525 by adding paragraph (c) to read as follows. End Amendment Part Required services. * * * * * (c) erectile dysfunction treatment Vaccination of facility staff.

The qualified home infusion therapy supplier must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following qualified home infusion therapy supplier staff, who provide any care, treatment, or other services for the qualified home infusion therapy supplier and/or its patients.

(i) Qualified home infusion therapy supplier employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the qualified home infusion therapy supplier and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following qualified home infusion therapy supplier staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home infusion therapy services are provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (c)(1) of this section. And (ii) Staff who provide support services for the qualified home infusion therapy supplier that are performed exclusively outside of the settings where home infusion therapy services are provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (c)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the qualified home infusion therapy supplier and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring that the facility follows nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment, and which must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (c)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the qualified home infusion therapy supplier has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the qualified home infusion therapy supplier's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Part Start Printed Page 61626 End Part Start Amendment Part25. The authority citation for part 491 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 263a and 1302.

End Authority Start Amendment Part26. Amend § 491.8 by adding paragraph (d) to read as follows. End Amendment Part Staffing and staff responsibilities. * * * * * (d) erectile dysfunction treatment vaccination of staff.

The RHC/FQHC must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following clinic or center staff, who provide any care, treatment, or other services for the clinic or center and/or its patients.

(i) RHC/FQHC employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the clinic or center and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following clinic or center staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the clinic or center setting and who do not have any direct contact with patients and other staff specified in paragraph (d)(1) of this section. And (ii) Staff who provide support services for the clinic or center that are performed exclusively outside of the clinic or center setting and who do not have any direct contact with patients and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the clinic or center and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring that the clinic or center follows nationally recognized prevention and control guidelines intended to mitigate the transmission and spread of erectile dysfunction treatment, and which must include the implementation of additional precautions for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (d)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains.

(A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the clinic's or center's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment.

Start Part End Part Start Amendment Part27. The authority citation for part 494 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. L302 and l395hh.

End Authority Start Amendment Part28. Amend § 494.30 by— End Amendment Part Start Amendment Parta. Redesignating paragraphs (b) and (c) as paragraphs (c) and (d) respectively, and End Amendment Part Start Amendment Partb. Adding a new paragraph (b).

End Amendment Part The addition reads as follows. Condition. control. * * * * * (b) erectile dysfunction treatment Vaccination of facility staff.

The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for erectile dysfunction treatment. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for erectile dysfunction treatment. The completion of a primary vaccination series for erectile dysfunction treatment is defined here as the administration of a single-dose treatment, or the administration of all required doses of a multi-dose treatment. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its patients.

(i) Facility employees. (ii) Licensed practitioners. (iii) Students, trainees, and volunteers. And (iv) Individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following facility staff. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with Start Printed Page 61627 patients and other staff specified in paragraph (b)(1) of this section. And (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (b)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components.

(i) A process for ensuring all staff specified in paragraph (b)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose erectile dysfunction treatment, or the first dose of the primary vaccination series for a multi-dose erectile dysfunction treatment prior to staff providing any care, treatment, or other services for the facility and/or its patients. (ii) A process for ensuring that all staff specified in paragraph (b)(1) of this section are fully vaccinated for erectile dysfunction treatment, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of erectile dysfunction treatment, for all staff who are not fully vaccinated for erectile dysfunction treatment. (iv) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status for all staff specified in paragraph (b)(1) of this section.

(v) A process for tracking and securely documenting the erectile dysfunction treatment vaccination status of any staff who have obtained any booster doses as recommended by the CDC. (vi) A process by which staff may request an exemption from the staff erectile dysfunction treatment vaccination requirements based on an applicable Federal law. (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff erectile dysfunction treatment vaccination requirements. (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to erectile dysfunction treatments and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized erectile dysfunction treatments are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.

And (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's erectile dysfunction treatment vaccination requirements for staff based on the recognized clinical contraindications. (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom erectile dysfunction treatment vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to erectile dysfunction treatment, and individuals who received monoclonal antibodies or convalescent plasma for erectile dysfunction treatment. And (x) Contingency plans for staff who are not fully vaccinated for erectile dysfunction treatment. * * * * * Start Signature Xavier Becerra, Secretary, Department of Health and Human Services.

End Signature End Supplemental Information BILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-C[FR Doc. 2021-23831 Filed 11-4-21. 8:45 am]BILLING CODE 4120-01-P.

What side effects may I notice from Cialis?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in hearing
• chest pain
• fast, irregular heartbeat

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• back pain
• dizziness
• flushing
• headache
• indigestion
• muscle aches
• stuffy or runny nose

This list may not describe all possible side effects.

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This historic support – the largest ever credit – is helping families and children struggling to recover financially from the erectile dysfunction treatment cialis. The full benefit is now $300 per month, or $3,600 for the year, and any family with children 17 or under who are tax dependents and have a valid Social Security number (regardless of the parents’ immigration status) can access it. Many families cialis lilly automatically received this benefit. Those who haven't received the benefits can easily and quickly apply for them.

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These funds can be used in any way to cialis lilly support the wellbeing of children — child care, education supports, housing and more. Mixed status families can access this needed support as long as their children hold valid Social Security numbers and are 17 or under. DACA youth are also eligible. Although parents are not required to have a cialis lilly social security number, they must have an Individual Taxpayer Identification Number to claim the credit for their eligible children.

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Eligible families began getting payments in monthly installments in mid-July and will continue receiving those payments through December 2021. When families cialis lilly file their taxes in 2022, they will get the remaining CTC benefit they didn’t get through the monthly installments. The payments will come directly to you. If you have a bank account, you can sign up for direct deposit of your CTC monthly payments.

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Follow the bureau on Twitter. @WB_DOL. 5 Cosas que Debe Saber Sobre el Crédito Tributario por Hijos Analilia Mejía Este verano, la Ley del Plan de Rescate Estadounidense (American Rescue Plan) de la Administración Biden-Harris aumentó la cantidad del Crédito Tributario por Hijos (CTC) 2021, brindando el apoyo crediticio más grande de la historia para auxiliar a familias con niños luchando para recuperarse financieramente de la pandemia de erectile dysfunction treatment. Ahora, el beneficio total es de $300 por mes, o $3,600 por año, y puede recibirlo cualquier familia con hijos de 17 años o menos que sean dependientes a efectos de impuestos y tengan un número valido de Seguro Social (independientemente del estado migratorio de los padres).

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No se requiere un ingreso mínimo para obtener el crédito para el año fiscal 2021. Incluso las familias que reportaron poco o ningún ingreso pueden ser elegibles para el total de $300 al mes. Estos fondos se pueden utilizar de cualquier manera en apoyo al bienestar de los niños. Cuidado infantil, apoyo educativo, vivienda y más.

Las familias de estatus mixto pueden acceder a este apoyo necesario siempre que sus hijos tengan números validos de Seguro Social y 17 años o menos. Los jóvenes de DACA también son elegibles. Aunque los padres no están obligados a tener un número de Seguro Social, si deben tener un Número de Identificación de Contribuyente Individual para reclamar el crédito para sus hijos elegibles. El apoyo es significativo, con muchas familias elegibles para la cantidad anual completa de $3,600.

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Cuando las familias presenten sus impuestos en 2022, obtendrán el beneficio restante del CTC que no recibieron por cuotas mensuales. Los pagos le llegarán directamente a usted. Si tiene una cuenta bancaria puede registrarse para que sus pagos mensuales del CTC se ingresen por depósito directo. Si no es el caso, provea la dirección postal a la que desea que se envíen los pagos.

No permita que su hijo y familia dejen de recibir este apoyo sin precedentes. Para reclamar su crédito, visite https://www.getctc.org/es. Para más información, incluida elegibilidad y cómo aplicar, únase a @WB_DOL para una charla por Twitter el 28 de octubre, de 1 a 2 p.m. Hora del Este, usando #CTCchat.

Analilia Mejia es la subdirectora de la Oficina de Mujeres del Departamento de Trabajo de EE.UU. Siga la oficina en Twitter. @WB_DOL..

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This historic support – the largest ever credit – is helping families and children struggling to recover financially from the erectile dysfunction treatment cialis. The full benefit is now $300 per month, or $3,600 for the year, and any family with children 17 or under who are tax dependents and have a valid Social Security number (regardless of the parents’ immigration status) can access it. Many families automatically received this benefit how to buy cialis online.

Those who haven't received the benefits can easily and quickly apply for them. Accessing this benefit is fast and simple. Here’s what how to buy cialis online families interested in applying for the credit need to know.

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5 Cosas que Debe Saber Sobre el Crédito Tributario por Hijos Analilia Mejía Este verano, la Ley del Plan de Rescate Estadounidense (American Rescue Plan) de la Administración Biden-Harris aumentó la cantidad del Crédito Tributario por Hijos (CTC) 2021, brindando el apoyo crediticio más grande de la historia para auxiliar a familias con niños luchando para recuperarse financieramente de la pandemia de erectile dysfunction treatment. Ahora, el beneficio total es de $300 por mes, o $3,600 por año, y puede recibirlo cualquier familia con hijos de 17 años o menos que sean dependientes a efectos de impuestos y tengan un número valido de Seguro Social (independientemente del estado migratorio de los padres). Muchas familias ya han recibido este beneficio automáticamente.

Aquellos que no han hecho pueden solicitarlo fácilmente. Acceder a este beneficio es rápido y sencillo. Esto es lo que deben saber las familias interesadas en solicitar el crédito.

No se requiere un ingreso mínimo para obtener el crédito para el año fiscal 2021. Incluso las familias que reportaron poco o ningún ingreso pueden ser elegibles para el total de $300 al mes. Estos fondos se pueden utilizar de cualquier manera en apoyo al bienestar de los niños.

Cuidado infantil, apoyo educativo, vivienda y más. Las familias de estatus mixto pueden acceder a este apoyo necesario siempre que sus hijos tengan números validos de Seguro Social y 17 años o menos. Los jóvenes de DACA también son elegibles.

Aunque los padres no están obligados a tener un número de Seguro Social, si deben tener un Número de Identificación de Contribuyente Individual para reclamar el crédito para sus hijos elegibles. El apoyo es significativo, con muchas familias elegibles para la cantidad anual completa de $3,600. Padres que ganan poco o nada, parejas casadas que ganan $150,000 por año o menos, o cabezas de familia que ganan hasta $112,500 son elegibles para recibir el beneficio completo del CTC.

Incluso familias con ingresos más altos pueden ser elegibles para cantidades menores. Todavía hay tiempo para que las familias reciban este apoyo. Las familias elegibles comenzaron a mediados de julio a recibir los pagos en cuotas mensuales y continuarán recibiéndolos hasta diciembre de 2021.

Cuando las familias presenten sus impuestos en 2022, obtendrán el beneficio restante del CTC que no recibieron por cuotas mensuales. Los pagos le llegarán directamente a usted. Si tiene una cuenta bancaria puede registrarse para que sus pagos mensuales del CTC se ingresen por depósito directo.

Si no es el caso, provea la dirección postal a la que desea que se envíen los pagos. No permita que su hijo y familia dejen de recibir este apoyo sin precedentes. Para reclamar su crédito, visite https://www.getctc.org/es.

Para más información, incluida elegibilidad y cómo aplicar, únase a @WB_DOL para una charla por Twitter el 28 de octubre, de 1 a 2 p.m. Hora del Este, usando #CTCchat. Analilia Mejia es la subdirectora de la Oficina de Mujeres del Departamento de Trabajo de EE.UU.

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Gallup. "14% of Americans Say They Use CBD Products," Aug. 7, 2019. Journal of the American Medical Association. "Effect of Cannabidiol and Tetrahydrocannabinol on Driving Performance." Johannes G.

Ramaekers, PhD, professor of psychopharmacology and behavioral toxicology, University of Maastricht, Netherlands. Brain Behavior. "The influence of THC:CBD oromucosal spray on driving ability in patients with multiple sclerosis-related spasticity." Paul Armentano, deputy director, NORML. Adrian Devitt-Lee, chief science writer, Project CBD. AAA.

"Fatal Crashes Involving Drivers Who Test Positive for Marijuana Increase After State Legalizes Drug." National Highway Traffic Safety Administration. "NHTSA Releases Two New Studies on Impaired Driving on U.S. Roads."By Robert Preidt HealthDay Reporter WEDNESDAY, Dec. 2, 2020 (HealthDay News) -- Menopause symptoms can interfere with women's jobs, Japanese researchers report. For the study, the investigators looked at nearly 600 working women, aged 45 to 65, in Japan.

Of those, 61% were postmenopausal. Women with a higher number of menopause symptoms had poorer work performance, according to the authors of the study published online recently in Menopause, journal of the North American Menopause Society (NAMS). But having a job with lower amounts of stress and maintaining a healthy lifestyle helped reduce women's menopause symptoms, the researchers found. And, women with numerous menopause symptoms were more likely to be inactive, and to have chronic health conditions and job-related stress, they noted. The findings provide insight into how to help maintain postmenopausal women's productivity at work, according to Keiko Hashimoto of Tohoku University, in Miyagi, and colleagues.

For example, employers could improve working conditions for women with hot flashes by lowering room temperatures and adapting dress codes to permit lighter-weight, short-sleeved clothing. Another idea is for employers to offer stress management classes that would benefit all employees, including women struggling with mood changes due to fluctuating levels of estrogen. The study authors noted that women are often reluctant to discuss menopause symptoms with their supervisors, so employers may be less likely to make such workplace changes. "This study highlights a link between menopause symptom burden and lower work performance. Notably, women in this study who had more menopause-related symptoms also tended to be caregivers and to have chronic diseases," said Dr.

Stephanie Faubion, medical director of NAMS. "Although workplace modifications are one potential tactic to address this issue, appropriate treatment of menopause-related symptoms and counseling regarding caregiver stress may lead to improved overall health as well as improved work performance," Faubion said in a society news release. This study isn't the only one to assess how menopause symptoms affect job performance, but it is the first to specifically examine the number of menopause symptoms and their effect on productivity. More information There's more on menopause at the U.S. Office on Women's Health.

SOURCE. North American Menopause Society, news release, Nov. 30, 2020By Robert Preidt HealthDay Reporter WEDNESDAY, Dec. 2, 2020 (HealthDay News) -- Lesbian, gay and bisexual (LGB) adults are less likely to take cholesterol-lowering statins to prevent heart disease than heterosexual adults, even though they have a higher heart disease risk, according to a new study. Researchers conducted an online survey of more than 1,500 Facebook users, aged 40 and older, and found that nearly one-third were taking statins.

Of the 12% of respondents who identified as LGB, less than 21% were taking statins for primary prevention, compared with nearly 44% of non-LGB adults. Primary prevention is when a person takes statins to prevent heart disease. There were no significant differences between LGB and non-LGB adults in the use of statins for secondary prevention (the use of statins by someone with heart disease), according to the study published Dec. 2 in the Journal of the American Heart Association. "There could be many reasons for the difference we observed," said study author Yi Guo, assistant professor of health outcomes and biomedical informatics at the University of Florida College of Medicine.

"LGB individuals may not go to the doctor as often, which leads to lower chances of being recommended statins for cardiovascular disease prevention," he said in a journal news release. It's also possible that LGB adults may be less aware of their increased heart disease risk -- in part because they're more likely to smoke, drink alcohol, use drugs and be obese -- and the protective effect of statins. "We were surprised to see such a big difference in primary prevention, with less than half of the rate as the non-LGB population. This highlights the urgent need for tailored interventions and campaigns that promote the awareness of statin use and cardiovascular health in the LGB population,' Guo said. "Health care providers should address their own biases and understand the complexities of LGB patients, making sure to provide guideline-directed recommendations in a culturally competent way," said study co-author Jiang Bian, associate professor of health outcomes and biomedical informatics at the UF College of Medicine.

"What we have found is very much in line with the American Heart Association's statement for LBGTQ adults," Bian said in the release. "First, more research is needed to better understand the cardiovascular disease health risks and outcomes in the LGB population. Second, educational programs are needed to educate health professionals on these unique health risks and outcomes in the LGB population and the appropriate way to communicate with LGB people," he said. More information The U.S. Food and Drug Administration has more on statins.Dec.

1, 2020 -- An influential government committee has recommended that health care workers and people who reside in long-term care facilities get the first doses of erectile dysfunction treatments when they become available. In a 13-to-1 vote, the Advisory Committee for Immunization Practices (ACIP) said health care workers and residents of nursing homes and other residential care facilities should be first in line to get erectile dysfunction treatments. Health care workers include any paid staff or volunteers who work in health care settings. Long-term care facility residents include adults who live in facilities that provide medical or personal care to people who cannot live independently. The vote follows months of deliberation by the committee to determine the most effective and fairest way to distribute scarce early doses.

It follows similar recommendations made by the National Academies of Sciences in October. The ACIP is made up of 15 voting members, eight nonvoting members from other government agencies, and 30 nonvoting members of other organizations that have expertise and interest in vaccination. The committee has met frequently this year to prepare for the erectile dysfunction treatment rollout. If the recommendation is approved by CDC Director Robert Redfield, MD, it will be passed on to states, which have already been working with the agency to create their distribution plans. This recommendation is not binding, though states usually follow the ACIP’s guidance.

The ACIP prioritized health care workers for vaccination because of a “multiplier effect” -- keeping them healthy ensures the health of others. The CDC says there are roughly 21 million health care workers in the U.S. More than 3 million Americans are residents in skilled nursing or assisted living facilities or other group care homes. In making its recommendation, the committee prioritized saving lives over using the treatment to slow disease transmission. €œI think everyone pretty much across the board agrees that with a limited number of doses, the best approach is to try to protect as many of the high-risk people as possible.

That places health care workers at the very top,” says Josh Michaud, PhD, associate director of global health policy for the Kaiser Family Foundation in Washington, D.C. “If you wanted to quash transmission, you would target your vaccination programs to those who do the most transmission in the United States, which is sort of young adults,” he says. It is generally expected that treatment acceptance will be high among health care workers, a group that will also be closely watched for any side effects related to the treatments. The CDC has developed a voluntary cellphone-based system called V-Safe that will monitor health care workers via regular text messages and phone calls. But survey results presented at a previous ACIP meeting revealed significant worry about the treatments even among this group.

In a CDC survey of health care workers, 63% of them said they would get the treatment. A separate survey by the American Nurses Foundation found only 34% of nurses said they would get the treatment if their employer doesn’t require them to do it, 36% said they would not get a erectile dysfunction treatment, and 31% said they were unsure. CVS and Walgreens have signed agreements with the federal government to give treatments to residents of long-term care facilities, agreeing to make three visits per facility to dole out shots. Initial doses of a treatment could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday. Once a treatment is approved, things will move quickly.

Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, says most jurisdictions expect to be able to vaccinate all their health care workers within about 3 weeks of treatment approval. After the first treatment deliveries, 5 million to 10 million more doses could be delivered each week on a rolling basis. The FDA is scheduled to make a decision about Pfizer’s emergency use authorization for its erectile dysfunction treatment after an advisory panel meets on Dec. 10 to review the company’s application. The ACIP will meet and vote again on recommendations for specific products after they are approved by the FDA.

Those recommendations trigger financial reimbursements by the federal government’s health plans like Medicare and Medicaid. Ultimately, the governors of each state will decide how early doses of the treatments are distributed. €œIn the final say, it will be our nation’s governors in implementing the distribution plans to tell us … where to ship, and they will decide who the treatment is given to. We hope our recommendations will carry weight with them, but at the end of the day, they will make that decision,” Health and Human Services Secretary Alex Azar said in an Operation Warp Speed news briefing last week. He said the treatment would be distributed to states according to a formula based on each state’s adult population.

Gen. Gus Perna, chief operating officer of Operation Warp Speed, said in a Nov. 23 news briefing that he was planning for at least 6.4 million treatment doses to go to states in the first push. Operation Warp Speed has not yet released the list of the doses that will be allocated to each state. For a short time, supplies of treatment won’t cover everyone even in the groups flagged for first priority.

So states will have to decide which workers and residents most need the treatment. On Tuesday, the CDC further recommended that health care workers who have direct contact with patients and can’t telework be first of the first. They also suggested that residents in nursing homes get priority over residents of other kinds of residential facilities because they tend to be older and more physically frail. One major issue to be ironed out is what to do for health care workers who are pregnant or nursing. The CDC says 75% of health care workers are women, and as many as 330,000 may be pregnant when a treatment becomes available.

While erectile dysfunction treatment poses a greater risk to pregnant women, the CDC says it has no data on mRNA treatments, like the type made by Pfizer and Moderna, in pregnancy. The agency says it’s awaiting information from the clinical trials for review. On Monday, California Gov. Gavin Newsom announced that his state expected to receive 327,000 doses of Pfizer’s treatment in mid-December. The state has more than 2 million health care workers, meaning that the first doses will fall far short of meeting the full demand even for people who get first priority.

According to a graphic released by Operation Warp Speed, Pfizer will distribute its own treatments, which require ultracold storage. The Moderna treatment will be distributed by McKesson, which has a longstanding contract with the CDC and distributed treatments during the H1N1 flu epidemic. McKesson also distributes seasonal flu treatments to states. Both Pfizer’s and Moderna’s treatments require two doses per person. Pfizer’s treatment needs a booster 3 weeks after the first dose.

Moderna’s second dose is given 4 weeks later. In the Nov. 23 news briefing, Azar, the HHS secretary, said he expected to have enough treatment to vaccinate those who are most vulnerable by the end of December. WebMD Health News Sources Josh Michaud, PhD, associate director of global health policy, Kaiser Family Foundation, Washington, D.C. Live webcast, CDC, Advisory Committee for Immunization Practices emergency meeting, Dec.

1, 2020. News briefing, Operation Warp Speed, Nov. 23, 2020. © 2020 WebMD, LLC. All rights reserved.By Steven Reinberg HealthDay Reporter TUESDAY, Dec.

1, 2020 (HealthDay News) -- Special training may help erectile dysfunction treatment patients regain their sense of smell after suffering parosmia, a new British study suggests. Parosmia is a condition where people have strange and often unpleasant smell distortions. Instead of smelling a lemon, for example, you may smell rotting cabbage, or chocolate may smell like gasoline. Parosmia has been linked to erectile dysfunction treatment and other cialises and head injuries. "Some degree of smell loss is thought to affect up to one-quarter of the general population," said researcher Carl Philpott, from the Norwich Medical School at the University of East Anglia.

"Smell loss is also a prominent symptom of erectile dysfunction treatment, and we know that the cialis is leaving many people with long-term smell loss, or smell distortions such as parosmia," he said in a university news release. Smell training involves sniffing at least four different odors twice a day every day for several months. "It aims to help recovery based on neuroplasticity -- the brain's ability to reorganize itself to compensate for a change or injury," Philpott said. The researchers worked with more than 140 people who had lost or had changes in their sense of smell. The study patients were given a variety of smell training kits -- including different odors, like eucalyptus, lemon, rose, cinnamon, chocolate, coffee, lavender, honey, strawberry and thyme.

"We found that the presence of parosmia and worse smell performance on testing of odor identification and discrimination was associated with clinically significant recovery in smell function for people experiencing post-viral smell disorders," Philpott said. "This means that smell training can help the smell pathways to start to regenerate and recover." The investigators also found that older people were more likely to start to recover their sense of smell. Also, the biggest improvements were seen among those who had lost the most amount of smell function. The research was carried out before the cialis, but the researchers believe their findings could help people who lost their sense of smell due to erectile dysfunction treatment. The report was published online recently in the journal The Laryngoscope.

More information For more on the loss of smell, head to the U.S. National Institutes of Health. SOURCE. University of East Anglia, news release, Nov. 28, 2020The tree of life describes the evolution of life and seeks to define the relationships between species.

Likewise, the tree of cell types aims to organize cells in the brain into groups and describe their relationships to each other.Scientists have long pondered just what the brain's tree of cell types looks like. Now, an international collaboration led by Dr. Andreas Tolias from Baylor College of Medicine, Dr. Philipp Berens from the University of Tübingen in Germany and Dr. Rickard Sandberg from the Karolinska Institute in Stockholm, Sweden, has published an article in Nature that provides one of the most detailed and complete characterizations of the diversity of neural types in the brain so far.Uncovering the shape of the tree of cortical cell types with Patch-seq Neuroscientists mostly use three fundamental features to describe neurons.

Their anatomy, or how they look under a microscope. Their physiology, or how they respond when stimulated. And, more recently, the genes they express, which are known as their transcriptome.For this study, the research team used an experimentally challenging technique that they developed several years ago, called Patch-seq. This technique allowed them to collect a large multimodal database including genetic, anatomical and physiological information from single cells in the mouse motor cortex."Gathering all these three fundamental features from the same set of neurons was the key that enabled us to get a much deeper understanding of how neurons in the motor cortex are related to each other and a clearer view of how the tree of cell types looks like," said co-first author Dr. Federico Scala, postdoctoral associate in Tolias lab at Baylor.Dr.

Dmitry Kobak, also co-first author and a research scientist in Berens lab, described that while the broad genetic families of neurons had distinct anatomical and physiological properties, within each family the neurons exhibited extensive anatomical and physiological diversity. Importantly, all the three basic neuronal characteristics (anatomy, physiology and transcriptome) were correlated, which enabled the team to find interesting links between them."Our data supports the view that the tree of cortical cell types may look more like a banana tree with few big leaves rather than an olive tree with many small ones. This view provides a simpler model to describe the diversity of neurons we find in the brain. We believe that this simpler view will lead to a more principled understanding of why we have so many cell types in the brain to begin with and what they are used for," said Tolias, Brown Foundation Endowed Chair of Neuroscience and director of the Center for Neuroscience and Artificial Intelligence at Baylor.In this metaphor, neurons follow a hierarchy consisting of distinct, non-overlapping branches at the level of families, the large leaves of the banana tree. Within each family, neurons show continuous changes in their genetic, anatomical and physiological features, and all three features within a family are correlated.

In parallel, work published simultaneously in Cell, scientists from the Allen Institute of Brain Science in Seattle obtained very similar results from mouse visual cortex underscoring that this view of cell types may be a general building principle of brain circuits. Story Source. Materials provided by Baylor College of Medicine. Original written by Graciela Gutierrez. Note.

Content may be edited for style and length..

Gallup. "14% of Americans Say They Use CBD Products," Aug. 7, 2019.

Journal of the American Medical Association. "Effect of Cannabidiol and Tetrahydrocannabinol on Driving Performance." Johannes G. Ramaekers, PhD, professor of psychopharmacology and behavioral toxicology, University of Maastricht, Netherlands.

Brain Behavior. "The influence of THC:CBD oromucosal spray on driving ability in patients with multiple sclerosis-related spasticity." Paul Armentano, deputy director, NORML. Adrian Devitt-Lee, chief science writer, Project CBD.

AAA. "Fatal Crashes Involving Drivers Who Test Positive for Marijuana Increase After State Legalizes Drug." National Highway Traffic Safety Administration. "NHTSA Releases Two New Studies on Impaired Driving on U.S.

Roads."By Robert Preidt HealthDay Reporter WEDNESDAY, Dec. 2, 2020 (HealthDay News) -- Menopause symptoms can interfere with women's jobs, Japanese researchers report. For the study, the investigators looked at nearly 600 working women, aged 45 to 65, in Japan.

Of those, 61% were postmenopausal. Women with a higher number of menopause symptoms had poorer work performance, according to the authors of the study published online recently in Menopause, journal of the North American Menopause Society (NAMS). But having a job with lower amounts of stress and maintaining a healthy lifestyle helped reduce women's menopause symptoms, the researchers found.

And, women with numerous menopause symptoms were more likely to be inactive, and to have chronic health conditions and job-related stress, they noted. The findings provide insight into how to help maintain postmenopausal women's productivity at work, according to Keiko Hashimoto of Tohoku University, in Miyagi, and colleagues. For example, employers could improve working conditions for women with hot flashes by lowering room temperatures and adapting dress codes to permit lighter-weight, short-sleeved clothing.

Another idea is for employers to offer stress management classes that would benefit all employees, including women struggling with mood changes due to fluctuating levels of estrogen. The study authors noted that women are often reluctant to discuss menopause symptoms with their supervisors, so employers may be less likely to make such workplace changes. "This study highlights a link between menopause symptom burden and lower work performance.

Notably, women in this study who had more menopause-related symptoms also tended to be caregivers and to have chronic diseases," said Dr. Stephanie Faubion, medical director of NAMS. "Although workplace modifications are one potential tactic to address this issue, appropriate treatment of menopause-related symptoms and counseling regarding caregiver stress may lead to improved overall health as well as improved work performance," Faubion said in a society news release.

This study isn't the only one to assess how menopause symptoms affect job performance, but it is the first to specifically examine the number of menopause symptoms and their effect on productivity. More information There's more on menopause at the U.S. Office on Women's Health.

SOURCE. North American Menopause Society, news release, Nov. 30, 2020By Robert Preidt HealthDay Reporter WEDNESDAY, Dec.

2, 2020 (HealthDay News) -- Lesbian, gay and bisexual (LGB) adults are less likely to take cholesterol-lowering statins to prevent heart disease than heterosexual adults, even though they have a higher heart disease risk, according to a new study. Researchers conducted an online survey of more than 1,500 Facebook users, aged 40 and older, and found that nearly one-third were taking statins. Of the 12% of respondents who identified as LGB, less than 21% were taking statins for primary prevention, compared with nearly 44% of non-LGB adults.

Primary prevention is when a person takes statins to prevent heart disease. There were no significant differences between LGB and non-LGB adults in the use of statins for secondary prevention (the use of statins by someone with heart disease), according to the study published Dec. 2 in the Journal of the American Heart Association.

"There could be many reasons for the difference we observed," said study author Yi Guo, assistant professor of health outcomes and biomedical informatics at the University of Florida College of Medicine. "LGB individuals may not go to the doctor as often, which leads to lower chances of being recommended statins for cardiovascular disease prevention," he said in a journal news release. It's also possible that LGB adults may be less aware of their increased heart disease risk -- in part because they're more likely to smoke, drink alcohol, use drugs and be obese -- and the protective effect of statins.

"We were surprised to see such a big difference in primary prevention, with less than half of the rate as the non-LGB population. This highlights the urgent need for tailored interventions and campaigns that promote the awareness of statin use and cardiovascular health in the LGB population,' Guo said. "Health care providers should address their own biases and understand the complexities of LGB patients, making sure to provide guideline-directed recommendations in a culturally competent way," said study co-author Jiang Bian, associate professor of health outcomes and biomedical informatics at the UF College of Medicine.

"What we have found is very much in line with the American Heart Association's statement for LBGTQ adults," Bian said in the release. "First, more research is needed to better understand the cardiovascular disease health risks and outcomes in the LGB population. Second, educational programs are needed to educate health professionals on these unique health risks and outcomes in the LGB population and the appropriate way to communicate with LGB people," he said.

More information The U.S. Food and Drug Administration has more on statins.Dec. 1, 2020 -- An influential government committee has recommended that health care workers and people who reside in long-term care facilities get the first doses of erectile dysfunction treatments when they become available.

In a 13-to-1 vote, the Advisory Committee for Immunization Practices (ACIP) said health care workers and residents of nursing homes and other residential care facilities should be first in line to get erectile dysfunction treatments. Health care workers include any paid staff or volunteers who work in health care settings. Long-term care facility residents include adults who live in facilities that provide medical or personal care to people who cannot live independently.

The vote follows months of deliberation by the committee to determine the most effective and fairest way to distribute scarce early doses. It follows similar recommendations made by the National Academies of Sciences in October. The ACIP is made up of 15 voting members, eight nonvoting members from other government agencies, and 30 nonvoting members of other organizations that have expertise and interest in vaccination.

The committee has met frequently this year to prepare for the erectile dysfunction treatment rollout. If the recommendation is approved by CDC Director Robert Redfield, MD, it will be passed on to states, which have already been working with the agency to create their distribution plans. This recommendation is not binding, though states usually follow the ACIP’s guidance.

The ACIP prioritized health care workers for vaccination because of a “multiplier effect” -- keeping them healthy ensures the health of others. The CDC says there are roughly 21 million health care workers in the U.S. More than 3 million Americans are residents in skilled nursing or assisted living facilities or other group care homes.

In making its recommendation, the committee prioritized saving lives over using the treatment to slow disease transmission. €œI think everyone pretty much across the board agrees that with a limited number of doses, the best approach is to try to protect as many of the high-risk people as possible. That places health care workers at the very top,” says Josh Michaud, PhD, associate director of global health policy for the Kaiser Family Foundation in Washington, D.C.

“If you wanted to quash transmission, you would target your vaccination programs to those who do the most transmission in the United States, which is sort of young adults,” he says. It is generally expected that treatment acceptance will be high among health care workers, a group that will also be closely watched for any side effects related to the treatments. The CDC has developed a voluntary cellphone-based system called V-Safe that will monitor health care workers via regular text messages and phone calls.

But survey results presented at a previous ACIP meeting revealed significant worry about the treatments even among this group. In a CDC survey of health care workers, 63% of them said they would get the treatment. A separate survey by the American Nurses Foundation found only 34% of nurses said they would get the treatment if their employer doesn’t require them to do it, 36% said they would not get a erectile dysfunction treatment, and 31% said they were unsure.

CVS and Walgreens have signed agreements with the federal government to give treatments to residents of long-term care facilities, agreeing to make three visits per facility to dole out shots. Initial doses of a treatment could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday. Once a treatment is approved, things will move quickly.

Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, says most jurisdictions expect to be able to vaccinate all their health care workers within about 3 weeks of treatment approval. After the first treatment deliveries, 5 million to 10 million more doses could be delivered each week on a rolling basis. The FDA is scheduled to make a decision about Pfizer’s emergency use authorization for its erectile dysfunction treatment after an advisory panel meets on Dec.

10 to review the company’s application. The ACIP will meet and vote again on recommendations for specific products after they are approved by the FDA. Those recommendations trigger financial reimbursements by the federal government’s health plans like Medicare and Medicaid.

Ultimately, the governors of each state will decide how early doses of the treatments are distributed. €œIn the final say, it will be our nation’s governors in implementing the distribution plans to tell us … where to ship, and they will decide who the treatment is given to. We hope our recommendations will carry weight with them, but at the end of the day, they will make that decision,” Health and Human Services Secretary Alex Azar said in an Operation Warp Speed news briefing last week.

He said the treatment would be distributed to states according to a formula based on each state’s adult population. Gen. Gus Perna, chief operating officer of Operation Warp Speed, said in a Nov.

23 news briefing that he was planning for at least 6.4 million treatment doses to go to states in the first push. Operation Warp Speed has not yet released the list of the doses that will be allocated to each state. For a short time, supplies of treatment won’t cover everyone even in the groups flagged for first priority.

So states will have to decide which workers and residents most need the treatment. On Tuesday, the CDC further recommended that health care workers who have direct contact with patients and can’t telework be first of the first. They also suggested that residents in nursing homes get priority over residents of other kinds of residential facilities because they tend to be older and more physically frail.

One major issue to be ironed out is what to do for health care workers who are pregnant or nursing. The CDC says 75% of health care workers are women, and as many as 330,000 may be pregnant when a treatment becomes available. While erectile dysfunction treatment poses a greater risk to pregnant women, the CDC says it has no data on mRNA treatments, like the type made by Pfizer and Moderna, in pregnancy.

The agency says it’s awaiting information from the clinical trials for review. On Monday, California Gov. Gavin Newsom announced that his state expected to receive 327,000 doses of Pfizer’s treatment in mid-December.

The state has more than 2 million health care workers, meaning that the first doses will fall far short of meeting the full demand even for people who get first priority. According to a graphic released by Operation Warp Speed, Pfizer will distribute its own treatments, which require ultracold storage. The Moderna treatment will be distributed by McKesson, which has a longstanding contract with the CDC and distributed treatments during the H1N1 flu epidemic.

McKesson also distributes seasonal flu treatments to states. Both Pfizer’s and Moderna’s treatments require two doses per person. Pfizer’s treatment needs a booster 3 weeks after the first dose.

Moderna’s second dose is given 4 weeks later. In the Nov. 23 news briefing, Azar, the HHS secretary, said he expected to have enough treatment to vaccinate those who are most vulnerable by the end of December.

WebMD Health News Sources Josh Michaud, PhD, associate director of global health policy, Kaiser Family Foundation, Washington, D.C. Live webcast, CDC, Advisory Committee for Immunization Practices emergency meeting, Dec. 1, 2020.

News briefing, Operation Warp Speed, Nov. 23, 2020. © 2020 WebMD, LLC.

All rights reserved.By Steven Reinberg HealthDay Reporter TUESDAY, Dec. 1, 2020 (HealthDay News) -- Special training may help erectile dysfunction treatment patients regain their sense of smell after suffering parosmia, a new British study suggests. Parosmia is a condition where people have strange and often unpleasant smell distortions.

Instead of smelling a lemon, for example, you may smell rotting cabbage, or chocolate may smell like gasoline. Parosmia has been linked to erectile dysfunction treatment and other cialises and head injuries. "Some degree of smell loss is thought to affect up to one-quarter of the general population," said researcher Carl Philpott, from the Norwich Medical School at the University of East Anglia.

"Smell loss is also a prominent symptom of erectile dysfunction treatment, and we know that the cialis is leaving many people with long-term smell loss, or smell distortions such as parosmia," he said in a university news release. Smell training involves sniffing at least four different odors twice a day every day for several months. "It aims to help recovery based on neuroplasticity -- the brain's ability to reorganize itself to compensate for a change or injury," Philpott said.

The researchers worked with more than 140 people who had lost or had changes in their sense of smell. The study patients were given a variety of smell training kits -- including different odors, like eucalyptus, lemon, rose, cinnamon, chocolate, coffee, lavender, honey, strawberry and thyme. "We found that the presence of parosmia and worse smell performance on testing of odor identification and discrimination was associated with clinically significant recovery in smell function for people experiencing post-viral smell disorders," Philpott said.

"This means that smell training can help the smell pathways to start to regenerate and recover." The investigators also found that older people were more likely to start to recover their sense of smell. Also, the biggest improvements were seen among those who had lost the most amount of smell function. The research was carried out before the cialis, but the researchers believe their findings could help people who lost their sense of smell due to erectile dysfunction treatment.

The report was published online recently in the journal The Laryngoscope. More information For more on the loss of smell, head to the U.S. National Institutes of Health.

SOURCE. University of East Anglia, news release, Nov. 28, 2020The tree of life describes the evolution of life and seeks to define the relationships between species.

Likewise, the tree of cell types aims to organize cells in the brain into groups and describe their relationships to each other.Scientists have long pondered just what the brain's tree of cell types looks like. Now, an international collaboration led by Dr. Andreas Tolias from Baylor College of Medicine, Dr.

Philipp Berens from the University of Tübingen in Germany and Dr. Rickard Sandberg from the Karolinska Institute in Stockholm, Sweden, has published an article in Nature that provides one of the most detailed and complete characterizations of the diversity of neural types in the brain so far.Uncovering the shape of the tree of cortical cell types with Patch-seq Neuroscientists mostly use three fundamental features to describe neurons. Their anatomy, or how they look under a microscope.

Their physiology, or how they respond when stimulated. And, more recently, the genes they express, which are known as their transcriptome.For this study, the research team used an experimentally challenging technique that they developed several years ago, called Patch-seq. This technique allowed them to collect a large multimodal database including genetic, anatomical and physiological information from single cells in the mouse motor cortex."Gathering all these three fundamental features from the same set of neurons was the key that enabled us to get a much deeper understanding of how neurons in the motor cortex are related to each other and a clearer view of how the tree of cell types looks like," said co-first author Dr.

Federico Scala, postdoctoral associate in Tolias lab at Baylor.Dr. Dmitry Kobak, also co-first author and a research scientist in Berens lab, described that while the broad genetic families of neurons had distinct anatomical and physiological properties, within each family the neurons exhibited extensive anatomical and physiological diversity. Importantly, all the three basic neuronal characteristics (anatomy, physiology and transcriptome) were correlated, which enabled the team to find interesting links between them."Our data supports the view that the tree of cortical cell types may look more like a banana tree with few big leaves rather than an olive tree with many small ones.

This view provides a simpler model to describe the diversity of neurons we find in the brain. We believe that this simpler view will lead to a more principled understanding of why we have so many cell types in the brain to begin with and what they are used for," said Tolias, Brown Foundation Endowed Chair of Neuroscience and director of the Center for Neuroscience and Artificial Intelligence at Baylor.In this metaphor, neurons follow a hierarchy consisting of distinct, non-overlapping branches at the level of families, the large leaves of the banana tree. Within each family, neurons show continuous changes in their genetic, anatomical and physiological features, and all three features within a family are correlated.

In parallel, work published simultaneously in Cell, scientists from the Allen Institute of Brain Science in Seattle obtained very similar results from mouse visual cortex underscoring that this view of cell types may be a general building principle of brain circuits. Story Source. Materials provided by Baylor College of Medicine.

Original written by Graciela Gutierrez. Note. Content may be edited for style and length..

When is cialis going generic in us

Credit. IStock Share Fast Facts New @HopkinsMedicine study finds African-American women with common form of hair loss at increased risk of uterine fibroids - Click to Tweet New study in @JAMADerm shows most common form of alopecia (hair loss) in African-American women associated with higher risks of uterine fibroids - Click to Tweet In a study of medical records gathered on hundreds of thousands of African-American women, Johns Hopkins researchers say they have evidence that women with a common form of hair loss have an increased chance of developing uterine leiomyomas, or fibroids.In a report on the research, published in the December 27 issue of JAMA Dermatology, the researchers call on physicians who treat women with central centrifugal cicatricial alopecia (CCCA) to make patients aware that they may be at increased risk for fibroids and should be screened for the condition, particularly if they have symptoms such as heavy bleeding and pain. CCCA predominantly affects black women and is the most common form of permanent alopecia in this population. The excess scar tissue that forms as a result of this type of hair loss may also explain the higher risk for uterine fibroids, which are characterized by fibrous growths in the lining of the womb. Crystal Aguh, M.D., assistant professor of dermatology at the Johns Hopkins University School of Medicine, says the scarring associated with CCCA is similar to the scarring associated with excess fibrous tissue elsewhere in the body, a situation that may explain why women with this type of hair loss are at a higher risk for fibroids.People of African descent, she notes, are more prone to develop other disorders of abnormal scarring, termed fibroproliferative disorders, such as keloids (a type of raised scar after trauma), scleroderma (an autoimmune disorder marked by thickening of the skin as well as internal organs), some types of lupus and clogged arteries.

During a four-year period from 2013-2017, the researchers analyzed patient data from the Johns Hopkins electronic medical record system (Epic) of 487,104 black women ages 18 and over. The prevalence of those with fibroids was compared in patients with and without CCCA. Overall, the researchers found that 13.9 percent of women with CCCA also had a history of uterine fibroids compared to only 3.3 percent of black women without the condition. In absolute numbers, out of the 486,000 women who were reviewed, 16,212 had fibroids.Within that population, 447 had CCCA, of which 62 had fibroids. The findings translate to a fivefold increased risk of uterine fibroids in women with CCCA, compared to age, sex and race matched controls.

Aguh cautions that their study does not suggest any cause and effect relationship, or prove a common cause for both conditions. €œThe cause of the link between the two conditions remains unclear,” she says. However, the association was strong enough, she adds, to recommend that physicians and patients be made aware of it. Women with this type of scarring alopecia should be screened not only for fibroids, but also for other disorders associated with excess fibrous tissue, Aguh says. An estimated 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids by age 50, according to the NIH, and while CCCA is likely underdiagnosed, some estimates report a prevalence of rates as high as 17 percent of black women having this condition.

The other authors on this paper were Ginette A. Okoye, M.D. Of Johns Hopkins and Yemisi Dina of Meharry Medical College.Credit. The New England Journal of Medicine Share Fast Facts This study clears up how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types. - Click to Tweet The number of mutations in a tumor’s DNA is a good predictor of whether it will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors.

- Click to Tweet The “mutational burden,” or the number of mutations present in a tumor’s DNA, is a good predictor of whether that cancer type will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors, a new study led by Johns Hopkins Kimmel Cancer Center researchers shows. The finding, published in the Dec. 21 New England Journal of Medicine, could be used to guide future clinical trials for these drugs. Checkpoint inhibitors are a relatively new class of drug that helps the immune system recognize cancer by interfering with mechanisms cancer cells use to hide from immune cells. As a result, the drugs cause the immune system to fight cancer in the same way that it would fight an .

These medicines have had remarkable success in treating some types of cancers that historically have had poor prognoses, such as advanced melanoma and lung cancer. However, these therapies have had little effect on other deadly cancer types, such as pancreatic cancer and glioblastoma. The mutational burden of certain tumor types has previously been proposed as an explanation for why certain cancers respond better than others to immune checkpoint inhibitors says study leader Mark Yarchoan, M.D., chief medical oncology fellow. Work by Dung Le, M.D., associate professor of oncology, and other researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Cancer Institute for Cancer Immunotherapy showed that colon cancers that carry a high number of mutations are more likely to respond to checkpoint inhibitors than those that have fewer mutations. However, exactly how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types was unclear.

To investigate this question, Yarchoan and colleagues Alexander Hopkins, Ph.D., research fellow, and Elizabeth Jaffee, M.D., co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care and associate director of the Bloomberg~Kimmel Institute, combed the medical literature for the results of clinical trials using checkpoint inhibitors on various different types of cancer. They combined these findings with data on the mutational burden of thousands of tumor samples from patients with different tumor types. Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation. The higher a cancer type’s mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half of the differences in how well cancers responded to immune checkpoint inhibitors could be explained by the mutational burden of that cancer.

€œThe idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive. It’s one of those things that doesn’t sound right when you hear it,” says Hopkins. €œBut with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.” Although this finding held true for the vast majority of cancer types they studied, there were some outliers in their analysis, says Yarchoan. For example, Merkel cell cancer, a rare and highly aggressive skin cancer, tends to have a moderate number of mutations yet responds extremely well to checkpoint inhibitors. However, he explains, this cancer type is often caused by a cialis, which seems to encourage a strong immune response despite the cancer’s lower mutational burden.

In contrast, the most common type of colorectal cancer has moderate mutational burden, yet responds poorly to checkpoint inhibitors for reasons that are still unclear. Yarchoan notes that these findings could help guide clinical trials to test checkpoint inhibitors on cancer types for which these drugs haven’t yet been tried. Future studies might also focus on finding ways to prompt cancers with low mutational burdens to behave like those with higher mutational burdens so that they will respond better to these therapies. He and his colleagues plan to extend this line of research by investigating whether mutational burden might be a good predictor of whether cancers in individual patients might respond well to this class of immunotherapy drugs. €œThe end goal is precision medicine—moving beyond what’s true for big groups of patients to see whether we can use this information to help any given patient,” he says.

Yarchoan receives funding from the Norman &. Ruth Rales Foundation and the Conquer Cancer Foundation. Through a licensing agreement with Aduro Biotech, Jaffee has the potential to receive royalties in the future..

Credit can u buy cialis online how to buy cialis online. IStock Share Fast Facts New @HopkinsMedicine study finds African-American women with common form of hair loss at increased risk of uterine fibroids - Click to Tweet New study in @JAMADerm shows most common form of alopecia (hair loss) in African-American women associated with higher risks of uterine fibroids - Click to Tweet In a study of medical records gathered on hundreds of thousands of African-American women, Johns Hopkins researchers say they have evidence that women with a common form of hair loss have an increased chance of developing uterine leiomyomas, or fibroids.In a report on the research, published in the December 27 issue of JAMA Dermatology, the researchers call on physicians who treat women with central centrifugal cicatricial alopecia (CCCA) to make patients aware that they may be at increased risk for fibroids and should be screened for the condition, particularly if they have symptoms such as heavy bleeding and pain. CCCA predominantly affects black how to buy cialis online women and is the most common form of permanent alopecia in this population. The excess scar tissue that forms as a result of this type of hair loss may also explain the higher risk for uterine fibroids, which are characterized by fibrous growths in the lining of the womb. Crystal Aguh, M.D., assistant professor of dermatology at the Johns Hopkins University School of Medicine, says the scarring associated with CCCA is similar to the scarring associated with excess fibrous tissue elsewhere in the body, a situation that may explain why women with this type of hair loss are how to buy cialis online at a higher risk for fibroids.People of African descent, she notes, are more prone to develop other disorders of abnormal scarring, termed fibroproliferative disorders, such as keloids (a type of raised scar after trauma), scleroderma (an autoimmune disorder marked by thickening of the skin as well as internal organs), some types of lupus and clogged arteries.

During a four-year period from 2013-2017, the researchers analyzed patient data from the Johns Hopkins electronic medical record system (Epic) of 487,104 black women ages 18 and over. The prevalence of those how to buy cialis online with fibroids was compared in patients with and without CCCA. Overall, the researchers found that 13.9 percent of women with CCCA also had a history of uterine fibroids compared to only 3.3 percent of black women without the condition. In absolute numbers, out of the 486,000 women who were reviewed, 16,212 had fibroids.Within that population, 447 had CCCA, of which 62 had fibroids. The findings translate how to buy cialis online to a fivefold increased risk of uterine fibroids in women with CCCA, compared to age, sex and race matched controls.

Aguh cautions that their study does not suggest any cause and effect relationship, or prove a common cause for both conditions. €œThe cause of the link between the two conditions remains unclear,” she says how to buy cialis online. However, the association was strong enough, she adds, to recommend that physicians and patients be made aware of it. Women with this type of scarring alopecia should be how to buy cialis online screened not only for fibroids, but also for other disorders associated with excess fibrous tissue, Aguh says. An estimated 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids by age 50, according to the NIH, and while CCCA is likely underdiagnosed, some estimates report a prevalence of rates as high as 17 percent of black women having this condition.

The other authors on this paper were Ginette how to buy cialis online A. Okoye, M.D. Of Johns Hopkins and Yemisi Dina of Meharry Medical College.Credit. The New England Journal of Medicine Share Fast Facts This study clears up how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors how to buy cialis online across many different cancer types. - Click to Tweet The number of mutations in a tumor’s DNA is a good predictor of whether it will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors.

- Click to how to buy cialis online Tweet The “mutational burden,” or the number of mutations present in a tumor’s DNA, is a good predictor of whether that cancer type will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors, a new study led by Johns Hopkins Kimmel Cancer Center researchers shows. The finding, published in the Dec. 21 New England Journal of Medicine, could be used to guide future clinical trials for these how to buy cialis online drugs. Checkpoint inhibitors are a relatively new class of drug that helps the immune system recognize cancer by interfering with mechanisms cancer cells use to hide from immune cells. As a result, the drugs cause the immune system to fight cancer in the same http://myphysicianmd.com/?p=4 way that it would fight an .

These medicines have had remarkable success in treating some types of cancers that historically have had poor prognoses, how to buy cialis online such as advanced melanoma and lung cancer. However, these therapies have had little effect on other deadly cancer types, such as pancreatic cancer and glioblastoma. The mutational burden of certain tumor types has previously been proposed as an explanation for why certain cancers respond better than others to immune checkpoint inhibitors how to buy cialis online says study leader Mark Yarchoan, M.D., chief medical oncology fellow. Work by Dung Le, M.D., associate professor of oncology, and other researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Cancer Institute for Cancer Immunotherapy showed that colon cancers that carry a high number of mutations are more likely to respond to checkpoint inhibitors than those that have fewer mutations. However, exactly how big an how to buy cialis online effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types was unclear.

To investigate this question, Yarchoan and colleagues Alexander Hopkins, Ph.D., research fellow, and Elizabeth Jaffee, M.D., co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care and associate director of the Bloomberg~Kimmel Institute, combed the medical literature for the results of clinical trials using checkpoint inhibitors on various different types of cancer. They combined these findings with data on the mutational how to buy cialis online burden of thousands of tumor samples from patients with different tumor types. Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation. The higher a cancer type’s mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half how to buy cialis online of the differences in how well cancers responded to immune checkpoint inhibitors could be explained by the mutational burden of that cancer.

€œThe idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive. It’s one of how to buy cialis online those things that doesn’t sound right when you hear it,” says Hopkins. €œBut with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.” Although this finding held true for the vast majority of cancer types they studied, there were some outliers in their analysis, says Yarchoan. For example, Merkel cell cancer, a rare and highly aggressive skin cancer, tends to have a moderate number of mutations how to buy cialis online yet responds extremely well to checkpoint inhibitors. However, he explains, this cancer type is often caused by a cialis, which seems to encourage a strong immune response despite the cancer’s lower mutational burden.

In contrast, the most common type of colorectal cancer has moderate mutational burden, yet responds poorly to checkpoint inhibitors for reasons that are still unclear. Yarchoan notes that these findings could help guide clinical trials to test checkpoint inhibitors on cancer types for which these how to buy cialis online drugs haven’t yet been tried. Future studies might also focus on finding ways to prompt cancers with low mutational burdens to behave like those with higher mutational burdens so that they will respond better to these therapies. He and his colleagues plan to extend this line of research by investigating whether mutational burden how to buy cialis online might be a good predictor of whether cancers in individual patients might respond well to this class of immunotherapy drugs. €œThe end goal is precision medicine—moving beyond what’s true for big groups of patients to see whether we can use this information to help any given patient,” he says.

Yarchoan receives funding from the Norman & how to buy cialis online. Ruth Rales Foundation and the Conquer Cancer Foundation. Through a licensing agreement with Aduro Biotech, Jaffee has the potential to receive royalties in the future..