Federal Register #CMS4219N

CMS Seeks Public Comment on Medicare Drug Price Negotiation Program Guidance

The Centers for Medicare & Medicaid Services (CMS), under the Department of Health and Human Services, is seeking public input on its draft guidance for the Medicare Drug Price Negotiation Program, as mandated by the Inflation Reduction Act of 2022. - Government Buyer: - Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services - Purpose: - Request for public comment on draft guidance for the Medicare Drug Price Negotiation Program - Guidance covers requirements for manufacturers to implement maximum fair prices for certain high-expenditure, single source drugs and biological products - OEMs and Vendors: - No specific OEMs, manufacturers, or vendors are named in this notice - Products/Services Requested: - No specific drugs, products, part numbers, or quantities are listed - The request is for feedback on program requirements and processes, not for procurement of goods or services - Unique/Notable Requirements: - Focus on manufacturer compliance with maximum fair price implementation - Public comment period for stakeholders to provide input on the draft guidance - Additional Information: - Draft guidance and related documents are available on the CMS website for review

Description

The Centers for Medicare & Medicaid Services (CMS) is seeking public comments on draft guidance for the Medicare Drug Price Negotiation Program. This program involves manufacturer effectuation of the maximum fair price in 2028 as part of implementing the Inflation Reduction Act of 2022 (IRA). The draft guidance outlines requirements for manufacturers regarding the negotiation program. Interested parties can view the draft guidance and related IRA documents on the CMS website and submit comments by September 18, 2026.

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