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1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

2. By regular mail. You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention.

Document Identifier/OMB Control Number. ____, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1.

Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N. Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections.

More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-10241 Survey of Retail Prices CMS-10545 Outcome and Assessment Information Set (OASIS) OASIS-D Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection. Survey of Retail Prices.

Use. This information collection request provides for a survey of the average acquisition costs of all covered outpatient drugs purchased by retail community pharmacies. CMS may contract with a vendor to conduct monthly surveys of retail prices for covered outpatient drugs. Such prices represent a nationwide average of consumer purchase prices, net of discounts and rebates.

The contractor shall provide notification when a drug product becomes generally available and that the contract include such terms and conditions as the Secretary shall specify, including a requirement that the vendor monitor the marketplace. CMS has developed a National Average Drug Acquisition Cost (NADAC) for states to consider when developing reimbursement methodology. The NADAC is a pricing benchmark that is based on the national average costs that pharmacies pay to acquire Medicaid covered outpatient drugs. This pricing benchmark is based on drug acquisition costs collected directly from pharmacies through a nationwide survey process.

This survey is conducted on a monthly basis to ensure that the NADAC reference file remains current and up-to-date. Form Number. CMS-10241 (OMB control number 0938-1041). Frequency.

Monthly. Affected Public. Private sector (Business or other for-profits). Number of Respondents.

72,000. Total Annual Responses. 72,000. Total Annual Hours.

36,000. (For policy questions regarding this collection contact. Lisa Shochet at 410-786-5445.) 2. Type of Information Collection Request.

Revision of a currently approved collection. Title of Information Collection. Outcome and Assessment Information Set (OASIS) OASIS-D. Use.

Due to the skin care products related Public Health Emergency, the next version of the Outcome and Assessment Information Set (OASIS), version E planned for implementation January 1, 2021, was delayed. This request is for the Office of Management and Budget (OMB) approval to extend the current OASIS-D expiration date in order for home health agencies to continue data collection required for participation in the Medicare program. The current version of the OASIS-D, data item set was approved by OMB on December 6, 2018 and implemented on January 1, 2019. This request includes updated calculations using 2020 data for wages, number of home health agencies and number of OASIS assessments at each time point.

Form Number. CMS-10545 (OMB control number. 0938-1279). Frequency.

Occasionally. Affected Public. Private Sector (Business or other for-profit and Not-for-profit institutions). Number of Respondents.

11,400. Total Annual Responses. 17,932,166. Total Annual Hours.

9,893,376. (For policy questions regarding this collection contact Joan Proctor at 410-786-0949). Start Signature Dated. May 18, 2021.

William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc. 2021-10796 Filed 5-20-21.

8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &. Medicaid Services, Health and Human Services (HHS). Notice. The Centers for Medicare &.

Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by July 19, 2021.

When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways. 1. Electronically.

You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2. By regular mail.

You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number. CMS-P-0015A, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1. Access CMS' website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N.

Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-R-185—Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory CMS-10166—Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program CMS-10178—Medicaid and Children's Health Insurance (CHIP) Managed Care Payments and Related Information CMS-10184—Payment Error Rate Measurement—State Medicaid and CHIP Eligibility CMS-10417—Medicare Fee-for-Service Prepayment Review of Medical Records CMS-372(S)—Annual Report on Home and Community Based Services Waivers and Supporting Regulations Under the PRA (44 U.S.C.

3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval.

To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request. Extension of currently approved collection.

Title of Information Collection. Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory Programs. Use. The information required is necessary to determine whether a private accreditation organization/State licensure program standards and accreditation/licensure process is at least equal to or more stringent than those of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

If an accreditation organization is approved, the laboratories that it accredits are “deemed” to meet the Start Printed Page 26922CLIA requirements based on this accreditation. Similarly, if a State licensure program is determined to have requirements that are equal to or more stringent than those of CLIA, its laboratories are considered to be exempt from CLIA certification and requirements. The information collected will be used by HHS to. Determine comparability/equivalency of the accreditation organization standards and policies or State licensure program standards and policies to those of the CLIA program.

To ensure the continued comparability/equivalency of the standards. And to fulfill certain statutory reporting requirements. Form Number. CMS-R-185 (OMB control number.

0938-0686). Frequency. Occasionally. Affected Public.

Private Sector—Business or other for-profits and Not-for-profit institutions. Number of Respondents. 9. Total Annual Responses.

9. Total Annual Hours. 5,464. (For policy questions regarding this collection contact Arlene Lopez at 410-786-6782.) 2.

Type of Information Collection Request. Reinstatement without change of a currently approved collection. Title of Information Collection. Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program.

Use. The information collected from the selected States will be used by Federal contractors to conduct Medicaid and CHIP FFS data processing and medical record reviews on which State-specific improper payment rates will be calculated. The quarterly FFS claims and payments will provide the contractor with the actual claims to be sampled. The systems manuals, provider policies, and other supporting documentation will be used by the federal contractor when conducting the FFS data processing and medical record reviews.

Further, the FFS claims and payments sampled for data processing and medical record reviews will serve as the basis for the eligibility reviews. Individuals for whom the state made the FFS claim or payments will have their underlying eligibility reviewed. In addition to the Federal Review Contractor conducting a data processing and medical record review of the FFS claims and payments, the FFS sample selected from the state-submitted universe will also be leveraged to support the PERM eligibility reviews. The Federal Eligibility Review Contractor will review the underlying eligibility of individuals whose FFS claims and payments were sampled as part of the PERM FFS sample.

Form Number. CMS-10166 (OMB control number. 0938-0974). Frequency.

Quarterly. Affected Public. State, Local, or Tribal Governments. Number of Respondents.

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Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each http://mabatar.net/buy-zithromax-for-pets/ proposed extension or reinstatement of an existing collection where to get renova cream of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by January 25, 2022. When commenting, where to get renova cream please reference the document identifier or OMB control number.

To be assured consideration, comments and recommendations must be submitted in any one of the following ways. 1. Electronically. You may send your comments electronically to http://www.regulations.gov.

Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address.

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number. ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following.

1. Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N. Parham at (410) 786-4669.

End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ). CMS-10599 Review Choice Demonstration for Home Health Services CMS-10433 Continuation of Data Collection to Support QHP Certification and other Financial Management and Exchange Operations CMS-10330 Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act CMS-10780 Requirements Related to Surprise Billing. Qualifying Payment Amount, Notice and Consent, and Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in Under the PRA (44 U.S.C.

3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a Start Printed Page 67474 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval.

To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request. Revision of a currently approved collection.

Title of Information Collection. Review Choice Demonstration for Home Health Services. Use. Section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C.

1395b-1(a)(1)(J)) authorizes the Secretary to “develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act (the Act).” Pursuant to this authority, the CMS seeks to develop and implement a Medicare demonstration project, which CMS believes will help assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring among Home Health Agencies (HHA) providing services to Medicare beneficiaries. This revised demonstration helps assist in developing improved procedures for the identification, investigation, and prosecution of potential Medicare fraud. The demonstration helps make sure that payments for home health services are appropriate through either pre-claim or postpayment review, thereby working towards the prevention and identification of potential fraud, waste, and abuse. The protection of Medicare Trust Funds from improper payments.

And the reduction of Medicare appeals. CMS has implemented the demonstration in Illinois, Ohio, North Carolina, Florida, and Texas with the option to expand to other states in the Palmetto/JM jurisdiction. Under this demonstration, CMS offers choices for providers to demonstrate their compliance with CMS' home health policies. Providers in the demonstration states may participate in either 100 percent pre-claim review or 100 percent postpayment review.

These providers will continue to be subject to a review method until the HHA reaches the target affirmation or claim approval rate. Once a HHA reaches the target pre-claim review affirmation or post-payment review claim approval rate, it may choose to be relieved from claim reviews, except for a spot check of their claims to ensure continued compliance. Providers who do not wish to participate in either 100 percent pre-claim or postpayment reviews have the option to furnish home health services and submit the associated claim for payment without undergoing such reviews. However, they will receive a 25 percent payment reduction on all claims submitted for home health services and may be eligible for review by the Recovery Audit Contractors.

The information required under this collection is required by Medicare contractors to determine proper payment or if there is a suspicion of fraud. Under the pre-claim review option, the HHA sends the pre-claim review request along with all required documentation to the Medicare contractor for review prior to submitting the final claim for payment. If a claim is submitted without a pre-claim review decision one file, the Medicare contractor will request the information from the HHA to determine if payment is appropriate. For the postpayment review option, the Medicare contractor will also request the information from the HHA provider who submitted the claim for payment from the Medicare program to determine if payment was appropriate.

Form Number. CMS-10599 (OMB control number. 0938-1311). Frequency.

Frequently, until the HHA reaches the target affirmation or claim approval threshold and then occasionally. Affected Public. Private Sector (Business or other for-profits and Not-for-profits). Number of Respondents.

3,631. Number of Responses. 1,467,243. Total Annual Hours.

744,5143. (For questions regarding this collection contact Jennifer McMullen (410)786-7635.) 2. Type of Information Collection Request. Revision of a currently approved collection.

Title of Information Collection. Continuation of Data Collection to Support QHP Certification and other Financial Management and Exchange Operations. Use. As directed by the rule Establishment of Exchanges and Qualified Health Plans.

Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange is responsible for the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange. A QHP must meet certain necessary minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and non-discrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR 155 and 156, based on the Patient Protection and Affordable Care Act (PPACA), as well as other standards determined by the Exchange.

Issuers can offer individual and small group market plans outside of the Exchanges that are not QHPs. Form Number. CMS-10433 (OMB control number. 0938-1187).

Frequency. Annually. Affected Public. Private sector, State, Local, or Tribal Governments, Business or other for-profits.

Number of Respondents. 2,925. Number of Responses. 2,925.

Total Annual Hours. 71,660. (For questions regarding this collection, contact Nicole Levesque at (617) 565-3138). 3.

Type of Information Collection Request. Extension of a currently approved collection. Title of Information Collection. Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act.

Use. Sections 2712 and 2719A of the Public Health Service Act (PHS Act), as added by the Affordable Care Act, contain rescission notice, and patient protection disclosure requirements that are subject to the Paperwork Reduction Act of 1995. The No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021, amended section 2719A of the PHS Act to sunset when the new emergency services protections under the No Surprises Act take effect. The provisions of section 2719A of the PHS Act will no longer apply with respect to plan years beginning on or after January 1, 2022.

The No Surprises Act re-codified the patient protections related to choice of health care professional under section 2719A of the PHS Act in newly added section 9822 of the Internal Revenue Code, section 722 of the Employee Retirement Income Security Act, and section 2799A-7 of the PHS Act and extended the applicability of these provisions to grandfathered health plans for plan years beginning on or after January 1, 2022. The rescission notice will be used by health plans to provide advance notice to certain individuals that their coverage may be rescinded as a result of fraud or intentional misrepresentation of material fact. The patient protection notification will be used by health plans to inform certain individuals of their right to choose a primary care provider or pediatrician and to use obstetrical/gynecological services without prior authorization. The related provisions are finalized in the 2015 final regulations titled “Final Rules under the Affordable Care Act for Grandfathered Plans, Preexisting Condition Exclusions, Start Printed Page 67475 Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections” (80 FR 72192, November 18, 2015) and 2021 interim final regulations titled “Requirements Related to Surprise Billing.

Part I” (86 FR 36872, July 13, 2021). The 2015 final regulations also require that, if State law prohibits balance billing, or a plan or issuer is contractually responsible for any amounts balanced billed by an out-of-network emergency services provider, a plan or issuer must provide a participant, beneficiary or enrollee adequate and prominent notice of their lack of financial responsibility with respect to amounts balanced billed in order to prevent inadvertent payment by the individual. Plans and issuers will not be required to provide this notice for plan years beginning on or after January 1, 2022. Form Number.

CMS-10330 (OMB control number. 0938-1094). Frequency. On Occasion.

Affected Public. State, Local, or Tribal Governments, Private Sector. Number of Respondents. 2,277.

Total Annual Responses. 15,752. Total Annual Hours. 814.

(For policy questions regarding this collection, contact Usree Bandyopadhyay at (410) 786-6650.) 4. Type of Information Collection Request. Extension of a currently approved collection. Title of Information Collection.

Requirements Related to Surprise Billing. Qualifying Payment Amount, Notice and Consent, Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in. Use. On December 27, 2020, the Consolidated Appropriations Act, 2021 (Pub.

L. 116-260), which included the No Surprises Act, was signed into law. The No Surprises Act provides federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise medical bills arise most frequently. The 2021 interim final regulations “Requirements Related to Surprise Billing.

Part I” (86 FR 36872, 2021 interim final regulations) issued by the Departments of Health and Human Services, the Department of Labor, the Department of Treasury, and the Office of Personnel Management, implement provisions of the No Surprises Act that apply to group health plans, health insurance issuers offering group or individual health insurance coverage, and carriers in the Federal Employees Health Benefits (FEHB) Program that provide protections against balance billing and out-of-network cost sharing with respect to emergency services, non-emergency services furnished by nonparticipating providers at certain participating health care facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services. The 2021 interim final regulations prohibit nonparticipating providers, emergency facilities, and providers of air ambulance services from balance billing participants, beneficiaries, and enrollees in certain situations unless they satisfy certain notice and consent requirements. The No Surprises Act and the 2021 interim final regulations require group health plans and issuers of health insurance coverage to provide information about qualifying payment amounts to nonparticipating providers and facilities and to provide disclosures on patient protections against balance billing to participants, beneficiaries and enrollees. Self-insured plans opting in to a specified state law are required to provide a disclosure to participants.

Certain nonparticipating providers and nonparticipating emergency facilities may provide participants, beneficiaries, and enrollees with notice and obtain their consent to waive balance billing protections, provided certain requirements are met. In addition, certain providers and facilities are required to provide disclosures on patient protections against balance billing to participants, beneficiaries and enrollees. Form Number. CMS-10780 (OMB control number.

0938-1401). Frequency. On Occasion. Affected Public.

Individuals, State, Local, or Tribal Governments, Private Sector. Number of Respondents. 2,494,683. Total Annual Responses.

58,696,352. Total Annual Hours. 4,933,110. (For policy questions regarding this collection, contact Usree Bandyopadhyay at 410-786-6650.) Start Signature Dated.

November 22, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc.

2021-25816 Filed 11-24-21. 8:45 am]BILLING CODE 4120-01-P.

€œThis is our skin care products section right http://mabatar.net/buy-zithromax-for-pets/ here,” said Nurse Kirsten Testoni, while sorting through medical equipment inside the home health supply can you buy renova online room. Metal shelves stacked with supplies take up one of the walls.“Hey Evonne?. € she asked another nurse.

€œYeah?. €â€œDo you have any more of those batteries?. We’re like out of pulse ox’s.”Pulse ox is short for pulse oximeter — those little clamps that go on your finger and measure your blood oxygen levels.

They’re in high demand right now in Petersburg.“You come in with sort of a plan but your day goes from zero to 60,” Testoni said.The Home Health office is located in an apartment across the street from the Petersburg Medical Center. (Photo by Angela Denning/KFSK)Testoni manages a team of eight. Three years ago, there were only two home care nurses in this office.

The additional staff has come from other departments, ERs, clinics, long-term care. Lena Odegaard had worked in all of them. She says she likes home health because she can focus on one patient at a time but it’s also challenging.“There’s just so many elements you can’t control,” she said.

€œWhereas, when you’re in the facility, you can kind of restrict visitors and what people are doing to a point.”Sometimes, there are patients who should go to the hospital but they don’t want to.“We find that quite often in home health, especially during this renova,” said Odegaard. €œSometimes there’s a little bit of a resistance.”Many times the nurses will transport patients to the hospital themselves or they can call an ambulance.Stephanie Romine says home health is different than her many years working in the hospital.“You never know, you can walk in and find someone on the floor,” Romine said. €œYou really don’t know what you’re walking in to a lot of times.”Many hospitals have home health departments but it’s different in a rural town like Petersburg, says Jared Kosin.

He heads the Alaska State Hospital and Nursing Home Association.“You’re going to have almost, in some respects, a more nimble healthcare system because everybody knows everyone,” Kosin said. €œWhen we’re in a crisis like this, can we meet this problem head on before it becomes a bigger problem and requires hospitalization.”During this latest Delta surge in Alaska, it’s been crucial to keep people out of the hospital — not just Petersburg’s local clinics, but also keeping people from getting medevac’d to the bigger hospitals in Anchorage.Plus, it’s a more personal way to receive care. This team in Petersburg is planning on keeping up this level of home health care even when they’re no longer caring for skin care products patients.Home Health Nurse Manager Kirsten Testoni prepares to treat a person with skin care products in their home.

(Photo by Angela Denning/KFSK)Later in the day, Testoni is in her car gearing up to visit a small house where three people are infected with skin care products.She puts on two face masks, goggles, a hair net, a gown, and blue rubber gloves.“Alright…You ready?. Let’s do it,” she said.Natocha Lyons answers the door. She’s 43.

She’s in a black sweatshirt, her blond hair pulled back.“Sorry my house is not cleaned,” Lyons said. €œI don’t have any energy.”In the last week, she’s been to the ER twice.“I was so bad and so weak I couldn’t even get up to go pee at one point. I had to have help from my son,” Lyons said.

Home health drove her back and forth to the hospital. She received oxygen, IV fluids, monoclonal antibody treatment, and steroids.“If it wasn’t for the home health people I wouldn’t have made it because I was too weak to drive myself, I was too weak to even walk, I was too weak to do anything,” she said. €œIt’s been very scary for me.”Testoni checks out her oxygen levels.“Ooo, it was 98!.

That’s the best it’s been since forever!. € said Lyons. €œThe lowest I went was 84.”“Yeah, that’s pretty low,” Testoni said.

Like many Petersburg residents this team has been caring for this month, Lyons isn’t vaccinated. And she hasn’t changed her mind even after two trips to the ER.But Testoni never pushes the issue.“That’s not our role,” she said. €œWe don’t do that.

We are going to take care of people regardless of what their choices are.”Walking back to the car, Testoni says her job isn’t to convince patients of anything. It’s to meet them where they are. And so far, that’s been enough to keep them alive.Start Preamble Centers for Medicare &.

Medicaid Services, Health and Human Services (HHS). Notice. The Centers for Medicare &.

Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Comments must be received by January 25, 2022. When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways.

1. Electronically. You may send your comments electronically to http://www.regulations.gov.

Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments. 2. By regular mail.

You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number.

___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1.

Access CMS' website address at website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N. Parham at (410) 786-4669.

End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ). CMS-10599 Review Choice Demonstration for Home Health Services CMS-10433 Continuation of Data Collection to Support QHP Certification and other Financial Management and Exchange Operations CMS-10330 Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act CMS-10780 Requirements Related to Surprise Billing.

Qualifying Payment Amount, Notice and Consent, and Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a Start Printed Page 67474 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

Information Collection 1. Type of Information Collection Request. Revision of a currently approved collection.

Title of Information Collection. Review Choice Demonstration for Home Health Services. Use.

Section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)) authorizes the Secretary to “develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act (the Act).” Pursuant to this authority, the CMS seeks to develop and implement a Medicare demonstration project, which CMS believes will help assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring among Home Health Agencies (HHA) providing services to Medicare beneficiaries. This revised demonstration helps assist in developing improved procedures for the identification, investigation, and prosecution of potential Medicare fraud.

The demonstration helps make sure that payments for home health services are appropriate through either pre-claim or postpayment review, thereby working towards the prevention and identification of potential fraud, waste, and abuse. The protection of Medicare Trust Funds from improper payments. And the reduction of Medicare appeals.

CMS has implemented the demonstration in Illinois, Ohio, North Carolina, Florida, and Texas with the option to expand to other states in the Palmetto/JM jurisdiction. Under this demonstration, CMS offers choices for providers to demonstrate their compliance with CMS' home health policies. Providers in the demonstration states may participate in either 100 percent pre-claim review or 100 percent postpayment review.

These providers will continue to be subject to a review method until the HHA reaches the target affirmation or claim approval rate. Once a HHA reaches the target pre-claim review affirmation or post-payment review claim approval rate, it may choose to be relieved from claim reviews, except for a spot check of their claims to ensure continued compliance. Providers who do not wish to participate in either 100 percent pre-claim or postpayment reviews have the option to furnish home health services and submit the associated claim for payment without undergoing such reviews.

However, they will receive a 25 percent payment reduction on all claims submitted for home health services and may be eligible for review by the Recovery Audit Contractors. The information required under this collection is required by Medicare contractors to determine proper payment or if there is a suspicion of fraud. Under the pre-claim review option, the HHA sends the pre-claim review request along with all required documentation to the Medicare contractor for review prior to submitting the final claim for payment.

If a claim is submitted without a pre-claim review decision one file, the Medicare contractor will request the information from the HHA to determine if payment is appropriate. For the postpayment review option, the Medicare contractor will also request the information from the HHA provider who submitted the claim for payment from the Medicare program to determine if payment was appropriate. Form Number.

CMS-10599 (OMB control number. 0938-1311). Frequency.

Frequently, until the HHA reaches the target affirmation or claim approval threshold and then occasionally. Affected Public. Private Sector (Business or other for-profits and Not-for-profits).

Number of Respondents. 3,631. Number of Responses.

(For questions regarding this collection contact Jennifer McMullen (410)786-7635.) 2. Type of Information Collection Request. Revision of a currently approved collection.

Title of Information Collection. Continuation of Data Collection to Support QHP Certification and other Financial Management and Exchange Operations. Use.

As directed by the rule Establishment of Exchanges and Qualified Health Plans. Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange is responsible for the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange.

A QHP must meet certain necessary minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and non-discrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR 155 and 156, based on the Patient Protection and Affordable Care Act (PPACA), as well as other standards determined by the Exchange. Issuers can offer individual and small group market plans outside of the Exchanges that are not QHPs.

Form Number. CMS-10433 (OMB control number. 0938-1187).

Private sector, State, Local, or Tribal Governments, Business or other for-profits. Number of Respondents. 2,925.

Number of Responses. 2,925. Total Annual Hours.

71,660. (For questions regarding this collection, contact Nicole Levesque at (617) 565-3138). 3.

Type of Information Collection Request. Extension of a currently approved collection. Title of Information Collection.

Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act. Use. Sections 2712 and 2719A of the Public Health Service Act (PHS Act), as added by the Affordable Care Act, contain rescission notice, and patient protection disclosure requirements that are subject to the Paperwork Reduction Act of 1995.

The No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021, amended section 2719A of the PHS Act to sunset when the new emergency services protections under the No Surprises Act take effect. The provisions of section 2719A of the PHS Act will no longer apply with respect to plan years beginning on or after January 1, 2022. The No Surprises Act re-codified the patient protections related to choice of health care professional under section 2719A of the PHS Act in newly added section 9822 of the Internal Revenue Code, section 722 of the Employee Retirement Income Security Act, and section 2799A-7 of the PHS Act and extended the applicability of these provisions to grandfathered health plans for plan years beginning on or after January 1, 2022.

The rescission notice will be used by health plans to provide advance notice to certain individuals that their coverage may be rescinded as a result of fraud or intentional misrepresentation of material fact. The patient protection notification will be used by health plans to inform certain individuals of their right to choose a primary care provider or pediatrician and to use obstetrical/gynecological services without prior authorization. The related provisions are finalized in the 2015 final regulations titled “Final Rules under the Affordable Care Act for Grandfathered Plans, Preexisting Condition Exclusions, Start Printed Page 67475 Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections” (80 FR 72192, November 18, 2015) and 2021 interim final regulations titled “Requirements Related to Surprise Billing.

Part I” (86 FR 36872, July 13, 2021). The 2015 final regulations also require that, if State law prohibits balance billing, or a plan or issuer is contractually responsible for any amounts balanced billed by an out-of-network emergency services provider, a plan or issuer must provide a participant, beneficiary or enrollee adequate and prominent notice of their lack of financial responsibility with respect to amounts balanced billed in order to prevent inadvertent payment by the individual. Plans and issuers will not be required to provide this notice for plan years beginning on or after January 1, 2022.

Form Number. CMS-10330 (OMB control number. 0938-1094).

State, Local, or Tribal Governments, Private Sector. Number of Respondents. 2,277.