[Federal Register Volume 89, Number 112 (Monday, June 10, 2024)]
[Notices]
[Pages 48901-48902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12583]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10003, CMS-10146 and CMS-R-240]


Agency Information Collection Activities: Proposed Collection; 
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 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.

DATES: Comments must be received by August 9, 2024.

ADDRESSES: 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, 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.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY 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-10003 Notice of Denial of Medical Coverage (or Payment)--NDMCP
CMS-10146 Notice of Denial of Medicare Prescription Drug Coverage
CMS-R-240 Prospective Payments for Hospital Outpatient Services and 
Supporting Regulations in 42 CFR 413.65

    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.

[[Page 48902]]

Information Collection

    1. Type of Information Collection Request: Revision with change 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 with change 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 of a 
previously approved collection; Title of Information Collection: 
Prospective Payments for Hospital Outpatient Services and Supporting 
Regulations in 42 CFR 413.65; Use: Section 1833(t) of the Act, as added 
by section 4523 of the Balanced Budget Act of 1997 (the BBA) requires 
the Secretary to establish a prospective payment system (PPS) for 
hospital outpatient services. Successful implementation of an 
outpatient PPS requires that CMS distinguish facilities or 
organizations that function as departments of hospitals from those that 
are freestanding, so that CMS can determine which services should be 
paid under the OPPS, the clinical laboratory fee schedule, or other 
payment provisions applicable to services furnished to hospital 
outpatients. Information from the reports required under sections 
413.65(b)(3) and (c) is needed to make these determinations. In 
addition, section 1866(b)(2) of the Act authorizes hospitals and other 
providers to impose deductible and coinsurance charges for facility 
services but does not allow such charges by facilities or organizations 
which are not provider-based. Implementation of this provision requires 
that CMS have information from the required reports, so it can 
determine which facilities are provider-based. Form Number: CMS-R-240 
(OMB control number: 0938-0798); Frequency: Occasionally; Affected 
Public: Private Sector (Business or other for-profits, Not-for-Profit 
Institutions); Number of Respondents: 2032; Total Annual Responses: 
15,138,400; Total Annual Hours: 683,670. (For policy questions 
regarding this collection contact Emily Lipkin at 410-786-3633.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-12583 Filed 6-7-24; 8:45 am]
BILLING CODE 4120-01-P