Notice2023-02974
Inflation Reduction Act (IRA) Initial Program Guidance; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 13, 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 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/.
Full Text
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<title>Federal Register, Volume 88 Issue 29 (Monday, February 13, 2023)</title>
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[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Notices]
[Pages 9293-9294]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 March 11, 2023.
ADDRESSES: Written comments should be sent to
<a href="/cdn-cgi/l/email-protection#6e273c2f3c0b0c0f1a0b0f000a200b09011a070f1a0701002e0d031d4006061d40090118"><span class="__cf_email__" data-cfemail="10594251427572716475717e745e75777f64797164797f7e50737d633e7878633e777f66">[email protected]</span></a> 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 <a href="https://www.cms.gov/inflation-reduction-act-and-medicare/">https://www.cms.gov/inflation-reduction-act-and-medicare/</a>.
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: <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 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]
BILLING CODE 4120-01-P
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