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. 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)

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 voluntarily sought comment on the 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 was open for 60 days and closed on July 2, 2024.  After considering the public comments received in response to the 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. The 60-day comment period closed on July 2, 2024. After considering the comments received, CMS plans to publish the ICR for a second 30-day comment period.  
  • 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:
09/10/2024 06:27 PM