[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Notices]
[Page 42723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1800-N]


Inflation Reduction Act (IRA) Revised Program 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' revised guidance for the Medicare 
Drug Price Negotiation Program for the implementation of the Inflation 
Reduction Act. CMS will be releasing additional Inflation Reduction 
Act-related guidance; all can be viewed on the dedicated Inflation 
Reduction Act section of the CMS website.

ADDRESSES: Inquiries related to the revised guidance should be sent to 
[email protected] with the relevant subject line, 
``Medicare Drug Price Negotiation Program 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), signed into law on August 16, 
2022, 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 Inflation Reduction 
Act.
    To obtain copies of the revised guidance and the responses to 
comments from the initial guidance, as well as 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.

    Dated: June 28, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-14097 Filed 6-30-23; 8:45 am]
BILLING CODE 4120-01-P