Notice2025-08607
Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request
Primary source
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Published
May 15, 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The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the third cycle of the Medicare Drug Price Negotiation Program, the first cycle of renegotiation, and manufacturer effectuation of the maximum fair price for 2026, 2027, and 2028 for the implementation of the Inflation Reduction Act (IRA).
Full Text
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<title>Federal Register, Volume 90 Issue 93 (Thursday, May 15, 2025)</title>
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[Federal Register Volume 90, Number 93 (Thursday, May 15, 2025)]
[Notices]
[Page 20674]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08607]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-4210-N]
Medicare Program; Inflation Reduction Act (IRA) Medicare Drug
Price Negotiation Program Draft Guidance; Comment Request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announcing an opportunity for the public to comment on CMS' draft
guidance for the third cycle of the Medicare Drug Price Negotiation
Program, the first cycle of renegotiation, and manufacturer
effectuation of the maximum fair price for 2026, 2027, and 2028 for the
implementation of the Inflation Reduction Act (IRA).
DATES: Comments must be received by Thursday, June 26, 2025.
ADDRESSES: Written comments should be sent to
<a href="/cdn-cgi/l/email-protection#1b52495a497e797a6f7e7a757f557e7c746f727a6f7274755b78766835737368357c746d"><span class="__cf_email__" data-cfemail="fbb2a9baa99e999a8f9e9a959fb59e9c948f929a8f929495bb989688d5939388d59c948d">[email protected]</span></a> with the relevant subject line,
``Medicare Drug Price Negotiation Program Draft Guidance.'' CMS' draft
guidance and other Inflation Reduction Act-related guidance can be
viewed on the dedicated Inflation Reduction Act section of the CMS
website at <a href="https://www.cms.gov/inflation-reduction-act-and-medicare/">https://www.cms.gov/inflation-reduction-act-and-medicare/</a>.
SUPPLEMENTARY INFORMATION: The Inflation Reduction Act (IRA) (Pub. L.
117-169) was signed into law on August 16, 2022. Sections 11001 and
11002 of the IRA established the Medicare Drug Price Negotiation
Program (hereafter the ``Negotiation Program'') to negotiate maximum
fair prices (MFPs) for certain high expenditure, single source drugs
and biological products. The requirements for this program are
described in sections 1191 through 1198 of the Social Security Act (the
Act) as added by sections 11001 and 11002 of the IRA. The draft
guidance describes how CMS intends to implement the Negotiation Program
for Initial Price Applicability Year (IPAY) 2028 (January 1, 2028 to
December 31, 2028), which includes renegotiation, and specifies the
requirements for manufacturer effectuation of the MFPs for 2026, 2027,
and 2028.
To obtain copies of the Negotiation Program draft guidance and
other IRA-related documents, please access the CMS IRA website by
copying and pasting the following web address into your web browser:
<a href="https://www.cms.gov/inflation-reduction-act-and-medicare">https://www.cms.gov/inflation-reduction-act-and-medicare</a>. If interested
in receiving CMS IRA updates by email, individuals may sign up for CMS'
IRA email updates at <a href="https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/EmailUpdates">https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/EmailUpdates</a>.
Signature Authority
The Administrator of CMS, Dr. Mehmet Oz, having reviewed and
approved this document, authorizes Evell J. Barco Holland, who is the
Federal Register Liaison, to electronically sign this document for
purposes of publication in the Federal Register.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2025-08607 Filed 5-12-25; 4:15 pm]
BILLING CODE 4120-01-P
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