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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifiers: CMS-10003, CMS-10146, CMS-R-234 and CMS-222-17]

# AGENCY:

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

# ACTION:

Notice.

# SUMMARY:

                        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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.                    

# DATES:

Comments on the collection(s) of information must be received by the OMB desk officer by October 17, 2024.

# ADDRESSES:

                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to                         *www.reginfo.gov/​public/​do/​PRAMain.*                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.                    

                        To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:                         *https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.*

      ( print page 76114)    

# FOR FURTHER INFORMATION CONTACT:

William Parham at (410) 786-4669.

# SUPPLEMENTARY INFORMATION:

                    Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment:                

                    1.                     *Type of Information Collection Request:*                     Revision of a previously approved collection;                     *Title of Information Collection:*                     Notice of Denial of Medical Coverage (or Payment)—NDMCP;                     *Use:*                     Section 1852(g)(1)(B) of the Social Security Act (the Act) requires Medicare health plans to provide enrollees with a written notice in understandable language of the reasons for the denial and a description of the applicable appeals processes. Regulatory authority for this notice is set forth in subpart M of part 422 at 42 CFR 422.568, 422.572, 417.600(b), and 417.840.                

                    Medicare health plans, including Medicare Advantage plans, cost plans, and Health Care Prepayment Plans (HCPPs), are required to issue form CMS-10003 to Medicare Advantage plan enrollees when a request for either a medical service or payment is denied in whole or in part. The notice explains to the enrollee why the plan denied the service or payment and informs Medicare enrollees of their appeal rights.                     *Form Number:*                     CMS-10003 (OMB control number: 0938-0829);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Private Sector; Business or other for-profits, Not-for-profit institutions;                     *Number of Respondents:*                     970;                     *Total Annual Responses:*                     18,232,560;                     *Total Annual Hours:*                     3,037,544. (For policy questions regarding this collection contact Sabrina Edmonston at (410) 786-3209.)                

                    2.                     *Type of Information Collection Request:*                     Revision of a previously approved collection;                     *Title of Information Collection:*                     Notice of Denial of Medicare Prescription Drug Coverage;                     *Use:*                     Part D plan sponsors are required to issue the Notice of Denial of Medicare Prescription Drug Coverage notice when a request for a prescription drug or payment is denied, in whole or in part. The written notice must include a statement, in understandable language, the reasons for the denial and a description of the appeals process.                

                    The purpose of this notice is to provide information to enrollees when prescription drug coverage has been denied, in whole or in part, by their Part D plans. The notice must be readable, understandable, and state the specific reasons for the denial. The notice must also remind enrollees about their rights and protections related to requests for prescription drug coverage and include an explanation of both the standard and expedited redetermination processes and the rest of the appeal process.                     *Form Number:*                     CMS-10146 (OMB control number: 0938-0976);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Private Sector; Business or other for-profits, Not-for-profit institutions;                     *Number of Respondents:*                     772;                     *Total Annual Responses:*                     2,962,857;                     *Total Annual Hours:*                     740,714. (For policy questions regarding this collection contact Coretta Edmonston at (410) 786-0512.)                

                    3.                     *Type of Information Collection Request:*                     Reinstatement without change of a previously approved collection;                     *Title of Information Collection:*                     Subpart D-Private Contracts and Supporting Regulations;                     *Use:*                     Section 4507 of the Balanced Budget Act of 1997 (BBA 1997) amended section 1802 of the Social Security Act (the Act) to permit certain physicians and practitioners to opt-out of Medicare and to provide—through private contracts—services that Medicare would otherwise cover. Under such contracts, the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. CMS-R-234 allows certain physicians and practitioners to opt out of Medicare and furnish covered services to Medicare beneficiaries through private contracts. Physicians and practitioners use this information collection to comply with the applicable regulations. Physicians and practitioners entering private contracts with beneficiaries must file an affidavit with Medicare in which they agree to opt-out of Medicare for 2 years and to meet certain other criteria. In general, the applicable regulations require that during that 2-year period, physicians and practitioners who have filed affidavits opting out of Medicare must sign private contracts with all Medicare beneficiaries to whom they furnish services that Medicare would otherwise cover (except those who need emergency or urgently needed care). In addition, Medicare Administrative Contractors (MACs) use this information to determine if benefits should be paid or continued.                     *Form Number:*                     CMS-R-234 (OMB control number: 0938-0730);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Business or other for-profit and not-for-profit institutions;                     *Number of Respondents;*                     78,258;                     *Total Annual Responses;*                     78,258;                     *Total Annual Hours:*                     22,780. (For policy questions regarding this collection contact Frank Whelan at 410-786-1302.)                

                    4.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     Rural Health Clinic Cost Report;                     *Use:*                     Under the authority of sections 1815(a) and 1833(e) of the Social Security Act, CMS requires that providers of services participating in the Medicare program submit information to determine costs for health care services rendered to Medicare beneficiaries. CMS requires that providers follow reasonable cost principles under 1861(v)(1)(A) of the Act when completing the Medicare cost report. Regulations at 42 CFR 413.20 and 413.24 require that providers submit acceptable cost reports on an annual basis and maintain sufficient financial records and statistical data, capable of verification by qualified auditors. CMS requires Form CMS-222-17 to determine an RHC's reasonable costs incurred in furnishing medical services to Medicare beneficiaries and reimbursement due to or from an RHC. Each RHC submits the cost report to its contractor for a reimbursement determination. Section 1874A of the Act describes the functions of the contractor.                

                    CMS regulations at 42 CFR 413.24(f)(4)(ii) require each RHC submit an annual cost report to their contractor in American Standard Code for Information Interchange (ASCII) electronic cost report (ECR) format. RHCs submit the ECR file to contractors using a compact disk (CD), flash drive, or the CMS approved Medicare Cost Report E-filing (MCREF) portal.                     *Form Number:*                     CMS-222-17 (OMB control number: 0938-0107);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Private Sector, State, Local, or Tribal Governments, Federal Government, Business or other for-profits, Not-for-profits institutions;                     *Number of Respondents:*                     2,101;                     *Total Annual Responses:*                     2,101;                     *Total Annual Hours:*                     115,555. (For policy questions                           ( print page 76115)                        regarding this collection contact LuAnn Piccione at (410) 786-5423.)                

William N. Parham, III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2024-21063 Filed 9-16-24; 8:45 am]

BILLING CODE 4120-01-P