Notice2025-21501
Medicare Program; Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Final Guidance
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
November 28, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
The Centers for Medicare & Medicaid Services (CMS) is announcing the availability of CMS' final guidance for the third cycle of the Medicare Drug Price Negotiation Program (hereafter the "Negotiation Program"), the first cycle of renegotiation, and manufacturer effectuation of the maximum fair price (MFP) in 2026, 2027, and 2028 for the implementation of the Inflation Reduction Act of 2022 (IRA) (Pub. L. 117-169). This and other IRA-related guidance can be viewed on the dedicated IRA section of the CMS website at https:// www.cms.gov/inflation-reduction-act-and-medicare/
Full Text
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<title>Federal Register, Volume 90 Issue 227 (Friday, November 28, 2025)</title>
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[Federal Register Volume 90, Number 227 (Friday, November 28, 2025)]
[Notices]
[Page 54692]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-4210-N2]
Medicare Program; Inflation Reduction Act (IRA) Medicare Drug
Price Negotiation Program Final Guidance
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 the availability of CMS' final guidance for the third cycle
of the Medicare Drug Price Negotiation Program (hereafter the
``Negotiation Program''), the first cycle of renegotiation, and
manufacturer effectuation of the maximum fair price (MFP) in 2026,
2027, and 2028 for the implementation of the Inflation Reduction Act of
2022 (IRA) (Pub. L. 117-169). This and other IRA-related guidance can
be viewed on the dedicated IRA 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>
ADDRESSES: Inquiries related to the final guidance should be sent to
<a href="/cdn-cgi/l/email-protection#9ad3c8dbc8fff8fbeefffbf4fed4fffdf5eef3fbeef3f5f4daf9f7e9b4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="dc958e9d8eb9bebda8b9bdb2b892b9bbb3a8b5bda8b5b3b29cbfb1aff2b4b4aff2bbb3aa">[email protected]</span></a> with the subject line, ``Medicare
Drug Price Negotiation Program Final Guidance.''
FOR FURTHER INFORMATION CONTACT: Elisabeth Daniels, 410-786-0549.
SUPPLEMENTARY INFORMATION: The IRA was signed into law on August 16,
2022. Sections 11001 and 11002 of the IRA established the Negotiation
Program to negotiate 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. On July 4, 2025,
the ``Working Families Tax Cuts Act'' (Pub. L. 119-21) was signed into
law. Section 71203 of the ``Working Families Tax Cuts Act'' expanded
protections for orphan drugs in section 1192(e) of the Act. The final
guidance describes how CMS will 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 in 2026, 2027,
and 2028.
To obtain copies of this Negotiation Program final 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's 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>.
The Administrator of CMS, Dr. Mehmet Oz, having reviewed and
approved this document, authorizes Chyana Woodyard, who is the Federal
Register Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2025-21501 Filed 11-26-25; 8:45 am]
BILLING CODE 4120-01-P
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