Notice2025-23582
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 22, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 243 (Monday, December 22, 2025)</title>
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[Federal Register Volume 90, Number 243 (Monday, December 22, 2025)]
[Notices]
[Pages 59834-59835]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23582]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-262 and CMS-10717]
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 February 20, 2026.
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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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
[[Page 59835]]
following information collections. More detailed information can be
found in each collection's supporting statement and associated
materials (see ADDRESSES).
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 collection; Title of Information Collection: CMS Plan Benefit
Package (PBP) and Formulary CY 2027; Use: Under the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA),
and implementing regulations at 42 CFR, specifically Sec. 422.254 and
Sec. 423.265, Medicare Advantage (MA) and Prescription Drug Plan (PDP)
organizations are required to submit a bid for each plan they intend to
offer in their service area for the upcoming year. In addition to
actuarial pricing, which is addressed in OMB 0938-0944, each bid
submission consists of a description of the plan benefit package and
the plan formulary. MA and PDP organizations use the Plan Benefit
Package (PBP) software to describe their organization's plan benefit
packages, including information on premiums, cost sharing,
authorization rules, and supplemental benefits. They also generate a
formulary to describe their list of drugs, including information on
prior authorization, step therapy, tiering, and quantity limits. CMS
uses the PBP and formulary data to review and approve the plan benefit
packages proposed by each MA and PDP organization.
CMS requires that MA and PDP organizations submit a completed PBP
and formulary as part of the annual bidding process. During this
process, organizations prepare their proposed plan benefit packages for
the upcoming contract year and submit them to CMS for review and
approval. CMS uses this data to review and approve the benefit packages
that the plans will offer to Medicare beneficiaries. This allows CMS to
review the benefit packages in a consistent way across all submitted
bids during with incredibly tight timeframes. This data is also used to
populate data on Medicare Plan Finder, which allows beneficiaries to
access and compare Medicare Advantage and Prescription Drug plans. Form
Number: CMS-R-262 (OMB control number: 0938-0763); Frequency: Yearly;
Affected Public: Private sector, Business or other for-profits, Not-
for-profits institutions; Number of Respondents: 764; Number of
Responses: 8,068; Total Annual Hours: 44,178. (For policy questions
regarding this collection contact Kristy Holtje at 410-786-2209 or
<a href="/cdn-cgi/l/email-protection#452e372c36313c6b2d2a29312f20052628366b2d2d366b222a33"><span class="__cf_email__" data-cfemail="68031a011b1c11460007041c020d280b051b4600001b460f071e">[email protected]</span></a>.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Part C
and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring
Project (TMP) Protocols; Use: CMS is responsible for overseeing the
Medicare Advantage (MA) and Part D programs to ensure that
beneficiaries receive appropriate and timely benefits, services, and
drugs. Under Sections 1857(d) and 1860D-12 of the Social Security Act,
and related regulations at 42 CFR 422.503, 422.504, 422.516, 423.504,
and 423.505, CMS has the authority to inspect, evaluate, and monitor
the benefits provided by Sponsoring organizations. To carry out this
oversight, Sponsoring organizations must provide CMS with access to
relevant records, documentation, and systems. They are also required to
report information on service utilization and other data as requested
by CMS to confirm ongoing compliance with program requirements. CMS
uses the data collected by way of these audit protocols to thoroughly
assess whether Sponsoring organizations are meeting specific federal
requirements.
The information gathered during this program audit will be used by
the Medicare Parts C and D Oversight and Enforcement Group (MOEG)
within the Center for Medicare (CM) to assess Sponsoring organizations'
compliance with Medicare program requirements. MOEG reviews submitted
data and selected samples from that data to ensure appropriate enrollee
access to benefits, services and drugs. Specifically, CMS reviews data
to ensure Part D organizations are administering their formulary and
transition benefit in accordance with their CMS-approved formulary; CMS
reviews coverage requests and appeals to ensure regulatory requirements
are followed when enrollees request services; and, if the audited MA
organization offers a SNP, MOEG's review evaluates whether the SNP is
coordinating care in accordance with CMS requirements. Form Number:
CMS-10717 (OMB control number: 0938-1395); Frequency: Annually;
Affected Public: Private sector, State, Local, or Tribal Governments,
Federal Government, Business or other for-profits, Not-for-Profit
Institutions; Number of Respondents: 30; Total Annual Responses: 30;
Total Annual Hours: 12,045. (For policy questions regarding this
collection contact Caroline Zeman at 410-786-0116 or
<a href="/cdn-cgi/l/email-protection#8ae9ebf8e5e6e3e4efa4f0efe7ebe4cae9e7f9a4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="91f2f0e3fefdf8fff4bfebf4fcf0ffd1f2fce2bff9f9e2bff6fee7">[email protected]</span></a>.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-23582 Filed 12-19-25; 8:45 am]
BILLING CODE 4120-01-P
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