[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76113-76115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21063]


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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 Information Collection Activities: Submission for OMB 
Review; Comment Request

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

ACTION: Notice.

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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.

[[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

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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