Medicare Program; Inflation Reduction Act of 2022 (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the Medicare Drug Price Negotiation Program ...
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
ACTION:
Notice.
SUMMARY:
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the Medicare Drug Price Negotiation Program regarding manufacturer effectuation of the maximum fair price in 2028 for the implementation of the Inflation Reduction Act of 2022 (IRA) (Pub. L. 117-169). CMS' draft guidance and other IRA-related guidance can be viewed on the CMS website at
https://www.cms.gov/priorities/medicare-prescription-drug-affordability/medicare-prescription-drug-affordability.
DATES:
Comments must be received by September 18, 2026.
ADDRESSES:
Written comments should be sent to
IRARebateandNegotiation@cms.hhs.gov
with the subject line, “Medicare Drug Price Negotiation Program Draft Guidance”.
The Inflation Reduction Act of 2022 (IRA) 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 The draft guidance specifies the requirements for manufacturer effectuation of the MFPs in 2028.
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Dr. Mehmet Oz, having reviewed and approved this document, authorizes Chyana Woodyard, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the
Federal Register
.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.