[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65359-65360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10147 and CMS-10905]


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 October 8, 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-10147 Medicare Drug Coverage and Your Rights
CMS-10905 Service Level Data Collection for Initial Determinations and 
Appeals

    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 Collections

    1. Type of Information Collection Request: Revision of a currently 
approved information collection; Title of Information Collection: 
Medicare Drug Coverage and Your Rights; Use: Section 423.562(a)(3) and 
an associated regulatory provision at Sec.  423.128(b)(7)(iii) require 
that Part D plan sponsors' network pharmacies provide Part D enrollees 
with a printed copy of our standardized pharmacy notice ``Medicare Drug 
Coverage and Your Rights'' (hereafter, ``notice'') if an enrollee's 
prescription cannot be filled.
    The purpose of this notice is to provide enrollees with information 
about how to contact their Part D plans to request a coverage 
determination, including a request for an exception to the Part D 
plan's formulary. The notice reminds enrollees about certain rights

[[Page 65360]]

and protections related to their Medicare prescription drug benefits, 
including the right to receive a written explanation from the drug plan 
about why a prescription drug is not covered. Through delivery of this 
standardized notice, a Part D plan sponsor's network pharmacies are in 
the best position to inform enrollees at point of sale about how to 
contact their Part D plan if the prescription cannot be filled. Form 
Number: CMS-10147 (OMB control number: 0938-0975); Frequency: Yearly; 
Affected Public: Private Sector, Business or other for-profits, Not 
for-profits; Number of Respondents: 72,900; Number of Responses: 
55,215,940; Total Annual Hours: 919,898. (For policy questions 
regarding this collection contact Sabrina Edmonston at 410-786-3209 or 
[email protected]).
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Service 
Level Data Collection for Initial Determinations and Appeals; Use: The 
Part C and D Reporting Requirements, as set forth in Sec. Sec.  
422.516(a) and 423.514(a), provide CMS with the ability to collect more 
granular data related to all plan activities regarding adjudicating 
requests for coverage and plan procedures related to making service 
utilization decisions. This includes collecting more timely data with 
greater frequency or closer in real-time. The proposed data elements 
listed in the Technical Specifications document in this proposed PRA 
would provide key data to CMS on the utilization of benefits, enhance 
audit activities to ensure plans are operating in accordance with CMS 
guidelines, and ensure appropriate access to covered services and 
benefits.
    CMS staff will use this information to monitor health plans and to 
hold them accountable for their performance. CMS users include group 
managers, division managers, branch managers, account managers, and 
researchers. Health plans can use this information to measure and 
benchmark their performance. CMS receives inquiries from the industry 
and other interested stakeholders about beneficiary access to the 
items, services, and drugs, including service level data for initial 
determinations and appeals, and other factors pertaining to use of 
government funds, as well the performance of MA plans. Form Number: 
CMS-10905 (OMB control number: 0938-New); Frequency: Quarterly; 
Affected Public: Private Sector, Business or other for-profits, Not 
for-profits and Federal Government State, Local; Number of Respondents: 
728; Number of Responses: 2,912; Total Annual Hours: 728. (For policy 
questions regarding this collection contact Sabrina Edmonston at 410-
786-3209 or [email protected]).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-17773 Filed 8-8-24; 8:45 am]
BILLING CODE 4120-01-P