Because of the new drug law, 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.

Drugs Selected for the First Cycle of Negotiation

Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation. The negotiations with participating drug companies will occur in 2023 and 2024, and any negotiated prices will become effective beginning in 2026. 

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

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

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

Selected Drug List for Initial Price Applicability Year 2026

The list of 10 drugs covered under Medicare Part D selected for negotiation for initial price applicability year 2026 based on Total Expenditures under Part D and other criteria as required by the law.  The list will be updated over time as needed.

Public Input Opportunities

Patient-Focused Listening Sessions 

CMS will host a series of patient-focused Listening Sessions this fall as part of the Medicare Drug Price Negotiation Program. The virtual public Listening Sessions will provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first cycle of negotiations.

Speaker Registration and Information

Public Submission of Information about Selected Drugs and Their Therapeutic Alternatives                                                                                

CMS encourages the public to submit written input, if interested, in response to the 2023 CMS request for information about selected drugs and evidence about alternative treatments. Submissions can include data on the selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical need and impacts on specific populations as well as the patient/caregiver experience. Information can be submitted between September 1 and October 2, 2023.

Form for Public Submission of Information about Selected Drugs and Their      Therapeutic Alternatives

Guide: Information about How to Submit

Guidance for the First Cycle of Negotiation

Frequently Asked Questions: Medicare Drug Price Negotiation Program for Initial Price Applicability Year 2026 (October 16, 2023)

Medicare Drug Price Negotiation Revised Guidance (June 30, 2023)

Fact Sheet: Medicare Drug Price Negotiation Revised Guidance (June 30, 2023)

Public Comments: Medicare Drug Price Negotiation Program Initial Guidance (submitted by April 14, 2023)

Medicare Drug Price Negotiation Program Initial Guidance (March 15, 2023)

Fact Sheet: Medicare Drug Price Negotiation Program Initial Guidance (March 15, 2023)

Medicare Drug Price Negotiation Program: Next Steps in Implementation for 2026 (January 11, 2023)

Drug Price Negotiation Timeline for 2026 (January 11, 2023)

Information Collection Requests (ICRs)

The Negotiation Data Elements ICR is now final and the information collection request form is available for viewing on OMB’s website. Click “all” to see full details.

The Drug Price Negotiation Process ICR is now final and the information collection request form is available for viewing on OMB's website.  Click “all” to see full details. 

Medicare Drug Price Negotiation Agreement

Drug manufacturers and other interested parties may now review the Medicare Drug Price Negotiation Program Agreement and the Instructions for this Agreement. A manufacturer of a selected drug for initial price applicability year 2026 may sign the Agreement beginning September 1, 2023. The Agreement will be executed in the CMS Health Plan Management System (HPMS).