Medicare Drug Price Negotiation
Medicare Drug Price 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 2027 Policy
Negotiated Prices (Maximum Fair Prices or MFPs) and MFP Explanations for Selected Drugs in the First Negotiation Cycle
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)
The below links contain the MFP explanations for the 10 drugs covered under Medicare Part D that were selected for the first cycle of negotiations; the MFPs will go into effect on January 1, 2026.
The MFP explanations provide information about CMS’ perspective on the data that had the greatest impact on CMS’ determination of offers and consideration of counteroffers consistent with the factors outlined in the IRA. Each MFP explanation includes details that are unique to the negotiation for that particular drug, along with information about the data received, the exchange of offers and counteroffers, and the negotiation meetings. Consistent with the confidentiality policy in CMS’ revised guidance (PDF), the MFP explanations include redactions to protect proprietary information. If you require assistance obtaining or wish to report an issue related to the accessibility of any content included in the MFP explanation files, please email IRARebateandNegotiation@cms.hhs.gov.
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)
Information Collection Requests (ICRs)
- The Small Biotech Exception and Biosimilar Delay approved ICR is available for viewing on OMB's website. Click "all" to see full details. Submissions for the Small Biotech Exception and Biosimilar Delay may be submitted via the CMS Health Plan Management System (CMS HPMS) from November 8, 2024 until 11:59 PST on December 10, 2024. For information regarding access to the CMS HPMS, please visit https://www.cms.gov/about-cms/information-systems/hpms/user-id-process.
- The Negotiation Data Elements and Drug Price Negotiation Process revised ICR can be found in the Federal Register. The full text of the ICR can also be found at CMS' PRA website. The ICR is open for public input for 30 days. Comments are due by December 26, 2024, and can be submitted at this comment submission link.
- The Medicare Transaction Facilitator for 2026 and 2027 initial ICR can be found in the Federal Register. The full text of the ICR can also be found on CMS’ PRA website. The ICR is open for a 60-day comment period. Comments are due by December 27, 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).
Medicare Transaction Facilitator (MTF) Agreements
The draft Medicare Transaction Facilitator (MTF) agreements outline the responsibilities of each party that will be engaged in the Medicare Transaction Facilitator, a core component of implementing the Medicare Drug Price Negotiation Program. CMS anticipates finalizing these draft agreements based on public feedback as well as input from the MTF contractors involved in the development and operations of the MTF system; we anticipate issuing the final Medicare Transaction Facilitator Agreements in Spring 2025. For more information about these agreements, see the FAQs here (PDF).
Draft MTF agreements are available for review and feedback here:
- Manufacturer-CMS Agreement (PDF)
- Manufacturer-MTF Data Module Contractor Agreement (PDF)
- Manufacturer-MTF Payment Module Contractor Agreement (PDF)
- Dispensing Entity-CMS Agreement (PDF)
- Dispensing Entity-MTF Data Module Contractor Agreement (PDF)
Feedback is due to CMS by January 31, 2025, 11:59 pm PST and can be submitted to CMS via email to IRARebateandNegotiation@cms.hhs.gov with the subject line “MTF Agreements Feedback”.
Contract Year 2026 Medicare Advantage and Part D Proposed Rule (CMS-4208-P)
New provisions for Medicare Drug Price Negotiation Program
The Contract Year (CY) 2026 Medicare Advantage and Part D proposed rule includes a provision that would require that Part D sponsors’ network contracts with pharmacies require such pharmacies to be enrolled in the Medicare Drug Price Negotiation Program’s Medicare Transaction Facilitator Data Module. The rule also proposes to shorten the Prescription Drug Event (PDE) submission timeliness requirement for initial PDE records for selected drugs from 30 calendar days to 7 calendar days to help ensure prompt payments by drug manufacturers to dispensing entities to provide access to the MFP. To review or comment on the CY 2026 MA and Part D proposed rule during its 60-day public comment period, visit the Federal Register. Comments must be submitted no later than January 27, 2025.
Page Last Modified:
12/20/2024 04:18 PM