[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Page 37229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09750]



[[Page 37229]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1800-NC3]


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Program Draft Guidance; Comment Request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announcing an opportunity for the public to comment on CMS' draft 
guidance for the second cycle of the Medicare Drug Price Negotiation 
Program and manufacturer effectuation of the maximum fair price for 
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/.

DATES: Comments must be received by July 2, 2024.

ADDRESSES: Written comments should be sent to 
[email protected] with the relevant subject line, 
``Medicare Drug Price Negotiation Program Draft Guidance.''

FOR FURTHER INFORMATION CONTACT: Elizabeth Daniel, 
[email protected] or (667) 290-8793.

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 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 The draft guidance 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) 2027 (January 1, 2027 to 
December 31, 2027), and specifies the requirements for manufacturer 
effectuation of the MFPs for 2026 and 2027.
    To obtain copies of the Negotiation Program draft guidance and 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.

    Dated: April 30, 2024.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-09750 Filed 5-3-24; 8:45 am]
BILLING CODE 4120-01-P