Medicare Drug Price Negotiation

Medicare Drug Price Negotiation

 

IRA negotiation

Because of the prescription drug law, known as the Inflation Reduction Act, Medicare is able to negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs.

More Information about Initial Price Applicability Year 2026 Policy and Public Input Opportunities

Selected Drugs for Negotiation

Selected Drug List (ZIP) 

This list contains 10 drugs covered under Medicare Part D that were selected for the first cycle of negotiation based on Total Expenditures under Part D and other criteria as required by the law; the list will be updated over time. Negotiations with participating drug companies are ongoing, and any negotiated prices for the first cycle of negotiation will become effective beginning in 2026. 

Fact Sheet: Manufacturer Agreements for Selected Drugs for Initial Price Applicability Year 2026 (PDF)

Fact Sheet: Key Information on the Process for the First Round of Negotiations (PDF)

Fact Sheet: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 (PDF)

Guidance for Second Cycle of Negotiation and Manufacturer Effectuation of the Maximum Fair Price

CMS has issued draft guidance for public comment that details requirements and parameters for the second cycle of negotiations for the Medicare Drug Price Negotiation Program, along with additional information on CMS support for manufacturer effectuation of maximum fair prices in 2026 and 2027. 

CMS is voluntarily seeking comment on this draft guidance for initial price applicability year 2027 and manufacturer effectuation of negotiated maximum fair prices in initial price applicability years 2026 and 2027. The comment period is open for 60 days.  Please send comments pertaining to this draft guidance to IRARebateandNegotiation@cms.hhs.gov with the subject line “Medicare Drug Price Negotiation Program Draft Guidance.” Comments received by 11:59 PM Pacific Time (PT) on July 2, 2024 will be considered. After considering the public comments received in response to this draft guidance, CMS will issue final guidance for initial price applicability year 2027 and for manufacturer effectuation of the MFP in 2026 and 2027.

Medicare Drug Price Negotiation Program Draft Guidance (PDF) (May 3, 2024)

Fact Sheet: Medicare Drug Price Negotiation Program Drug Guidance (PDF) (May 3, 2024)

Proposed Maximum Fair Price File Layout and Definitions Document (ZIP) (May 3, 2024)

ira information

Information Collection Requests (ICRs)

The Small Biotech Exception and Biosimilar Delay initial ICR can be found in the Federal Register. The full text of the ICR can also be found at CMS's PRA website. Comments are due by July 2, 2024 and can be submitted at this comment submission link

Medicare Drug Price Negotiation Agreement

Drug manufacturers and other interested parties may review the Medicare Drug Price Negotiation Program Agreement (PDF) and the Instructions for this Agreement (PDF). The Agreement is executed in the CMS Health Plan Management System (HPMS).

Page Last Modified:
05/06/2024 08:36 AM