[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Page 82245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1800-N4]


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 second cycle 
of the Medicare Drug Price Negotiation Program and manufacturer 
effectuation of the maximum fair price in 2026 and 2027 for the 
implementation of the Inflation Reduction Act. This and other Inflation 
Reduction Act-related guidance can be viewed on the dedicated Inflation 
Reduction Act section of the CMS website at https://www.cms.gov/inflation-reduction-act-and-medicare/.

ADDRESSES: Inquiries related to the final guidance should be sent to 
<a href="/cdn-cgi/l/email-protection#377e657665525556435256595379525058435e56435e585977545a44195f5f4419505841"><span class="__cf_email__" data-cfemail="622b3023300700031607030c062c07050d160b03160b0d0c22010f114c0a0a114c050d14">[email protected]</span></a> with the relevant subject line, 
``Medicare Drug Price Negotiation Program Final Guidance.''

SUPPLEMENTARY INFORMATION: The Inflation Reduction Act was signed into 
law on August 16, 2022. Sections 11001 and 11002 of the Inflation 
Reduction Act (IRA) (Pub. L. 117-169) 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 (hereafter ``the Act'') as added by sections 11001 and 
11002 of the IRA. The final guidance summarizes and addresses comments 
received on the draft guidance issued on May 3, 2024 and describes how 
CMS intends to implement the Negotiation Program for Initial Price 
Applicability Year 2027 (January 1, 2027 to December 31, 2027), and 
specifies the requirements for manufacturer effectuation of the MFPs in 
2026 and 2027. To obtain copies of the Negotiation Program final 
guidance and other Inflation Reduction Act-related documents, please 
access the CMS Inflation Reduction Act website by copying and pasting 
the following web address into your web browser: https://www.cms.gov/inflation-reduction-act-and-medicare. If interested in receiving CMS 
Inflation Reduction Act updates by email, individuals may sign up for 
CMS Inflation Reduction Act's email updates at https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/EmailUpdates. The 
Administrator of the Centers for Medicare & Medicaid Services (CMS), 
Chiquita Brooks-LaSure, 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. 2024-23418 Filed 10-9-24; 8:45 am]
BILLING CODE 4120-01-P


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