[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Notices]
[Pages 9293-9294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1800-NC]


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

DATES: Comments must be received by March 11, 2023.

ADDRESSES: Written comments should be sent to 
[email protected] with the relevant subject line, 
either ``Medicare Part B Inflation Rebate Comments'' or ``Medicare Part 
D Inflation Rebate Comments.''

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 (herein 
referred to as ``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

[[Page 9294]]

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.
    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/.
    To obtain copies of 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: 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 purposes of 
publication in the Federal Register.

    Dated: February 8, 2023.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-02974 Filed 2-9-23; 4:15 pm]
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