[Federal Register Volume 88, Number 240 (Friday, December 15, 2023)]
[Notices]
[Pages 86904-86905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1800-N2]


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 
Part B and Part D Prescription Drug Inflation Rebate 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.

FOR FURTHER INFORMATION CONTACT: Inquiries related to the revised 
guidance should be sent to <a href="/cdn-cgi/l/email-protection#b1f8e3f0e3d4d3d0c5d4d0dfd5ffd4d6dec5d8d0c5d8dedff1d2dcc29fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="87ced5c6d5e2e5e6f3e2e6e9e3c9e2e0e8f3eee6f3eee8e9c7e4eaf4a9efeff4a9e0e8f1">[email protected]</span></a> with 
the relevant subject line, ``Medicare Inflation Rebate Program 
Guidance.''

SUPPLEMENTARY INFORMATION: The Inflation Reduction Act was signed into 
law on August 16, 2022. Section 11101 of the Inflation Reduction Act 
added a new section 1847A(i) to the Social Security Act (the Act), 
which establishes a requirement for manufacturers to pay Medicare Part 
B rebates for single source drugs and biological products with prices 
that increase faster than the rate of inflation for a calendar quarter 
to the Federal Supplementary Medical Insurance Trust Fund, and provides 
for lower Part B beneficiary cost sharing on these drugs and 
biologicals. Section 11102 of the Inflation Reduction Act added a new 
section 1860D-14B to the Act, which establishes a requirement for 
manufacturers to pay rebates to the Federal Supplementary Medical 
Insurance Trust Fund for certain Part D drugs when prices increase 
faster than the rate of inflation for each 12-month applicable period. 
Collectively, this program to implement these rebates is referred to as 
the Medicare Prescription Drug Inflation Rebate Program, or the 
Inflation Rebate Program.
    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 Vanessa Garcia, who is the Federal Register 
Liaison, to electronically sign this document for

[[Page 86905]]

purposes of publication in the Federal Register.

    Dated: December 12, 2023.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-27551 Filed 12-14-23; 8:45 am]
BILLING CODE 4120-01-P


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