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, Selected Drugs, and Public Input Opportunities

Negotiated Prices for Selected Drugs in the First Negotiation Cycle

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. Potential updates to the list include the addition of drugs covered under Medicare Part D or Part B selected for negotiation in future years. 

File for Negotiated Prices, also known as Maximum Fair Prices in Statute (ZIP)

This file contains information on the negotiated prices under the Medicare Drug Price Negotiation Program, which the statute refers to as Maximum Fair Prices (MFPs), for 10 drugs covered under Medicare Part D that will go into effect beginning January 1, 2026, based on negotiations and agreements reached between CMS and participating drug companies. The file contains the single negotiated price for a 30-day equivalent supply of each selected drug, NDC-9 per unit price, and NDC-11 per package price. The file also contains other important information regarding updates to the NDCs and MFPs. 

The file is updated annually each year subsequent to the first initial price applicability year of the price applicability period for each selected drug, at a minimum, to show the inflation-adjusted negotiated price for the selected drug. Additional updates are made on a recurring basis to account for the application of the negotiated price to new NDC-11s of selected drugs or when an NDC-11 should no longer have the negotiated price applied. Lastly, additional updates are made to account for when a drug is no longer selected. CMS will publish the file in both .xlsx and .csv file formats.

Fact Sheet: Negotiated Prices for Initial Price Applicability Year 2026 (PDF)

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

CMS issued final guidance for the second cycle of negotiations for the Medicare Drug Price Negotiation Program, along with additional information on CMS support for manufacturer effectuation of MFPs in 2026 and 2027. 

CMS voluntarily sought comment on the draft guidance for initial price applicability year 2027 and manufacturer effectuation of negotiated MFPs in initial price applicability years 2026 and 2027. The comment period was open for 60 days and closed on July 2, 2024.  After considering the public comments received in response to the draft guidance, CMS issued this final guidance for initial price applicability year 2027 and for manufacturer effectuation of the MFP in 2026 and 2027.

Medicare Drug Price Negotiation Program Final Guidance (PDF) (October 2, 2024)

Fact Sheet: Medicare Drug Price Negotiation Final Guidance (PDF) (October 2, 2024)

Public Comments: Medicare Drug Price Negotiation Program Draft Guidance (PDF) (submitted no later than July 2, 2024)

Final Maximum Fair Price File Layout and Definitions Document (ZIP) (October 2, 2024)

Initial Price Applicability Year 2027 Draft Guidance Documents

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

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

Draft 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' PRA website. CMS considered the comments received during the 60-day comment period that closed on July 2, 2024. The Small Biotech Exception and Biosimilar Delay ICR is open for a 30-day comment period.  Comments are due on November 1, 2024, and can be submitted at this comment submission link.
  • The Negotiation Data Elements and Drug Price Negotiation Process initial ICR can be found in the Federal Register. The full text of the ICR can also be found at CMS' PRA website. The 60-day comment period closed on September 3, 2024. After considering the comments received, CMS plans to publish the ICR for a second 30-day comment period.  

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:
10/02/2024 04:10 PM