Notice2024-09750
Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request
Primary source
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Published
May 6, 2024
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The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturer effectuation of the maximum fair price for 2026 and 2027 for the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/.
Full Text
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<title>Federal Register, Volume 89 Issue 88 (Monday, May 6, 2024)</title>
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[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Page 37229]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Program Draft Guidance; Comment Request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announcing an opportunity for the public to comment on CMS' draft
guidance for the second cycle of the Medicare Drug Price Negotiation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
<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 July 2, 2024.
ADDRESSES: Written comments should be sent to
<a href="/cdn-cgi/l/email-protection#175e455645727576637276797359727078637e76637e787957747a64397f7f6439707861"><span class="__cf_email__" data-cfemail="ade4ffecffc8cfccd9c8ccc3c9e3c8cac2d9c4ccd9c4c2c3edcec0de83c5c5de83cac2db">[email protected]</span></a> with the relevant subject line,
``Medicare Drug Price Negotiation Program Draft Guidance.''
FOR FURTHER INFORMATION CONTACT: Elizabeth Daniel,
<a href="/cdn-cgi/l/email-protection#e4a1888d9e858681908cca80858a8d8188a4878997ca8c8c97ca838b92"><span class="__cf_email__" data-cfemail="eda88184978c8f889985c3898c83848881ad8e809ec385859ec38a829b">[email protected]</span></a> 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: <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: 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
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