Notice2023-05411

Inflation Reduction Act (IRA) Initial Program Guidance; Comment Request

Primary source

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Published
March 17, 2023

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' initial 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 at https://www.cms.gov/inflation-reduction-act-and-medicare/.

Full Text

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<title>Federal Register, Volume 88 Issue 52 (Friday, March 17, 2023)</title>
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[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Notices]
[Page 16449]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1800-NC2]


Inflation Reduction Act (IRA) Initial Program 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' initial 
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 at 
<a href="https://www.cms.gov/inflation-reduction-act-and-medicare/">https://www.cms.gov/inflation-reduction-act-and-medicare/</a>.

DATES: Comments must be received by April 14, 2023.

ADDRESSES: Written comments should be sent to 
<a href="/cdn-cgi/l/email-protection#93dac1d2c1f6f1f2e7f6f2fdf7ddf6f4fce7faf2e7fafcfdd3f0fee0bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="f3baa1b2a19691928796929d97bd96949c879a92879a9c9db3909e80dd9b9b80dd949c85">[email&#160;protected]</span></a> 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) 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 Negotiation Program initial 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: <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 Inflation 
Reduction Act updates by email, individuals may sign up for CMS 
Inflation Reduction Act'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 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: March 13, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-05411 Filed 3-15-23; 4:15 pm]
BILLING CODE 4120-01-P


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Indexed from Federal Register on March 17, 2023.

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