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.

Drugs Selected for the First Cycle of Negotiation

The Centers for Medicare & Medicaid Services (CMS) announced in August 2023 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 (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)

Selected Drug List for Initial Price Applicability Year 2026 (ZIP)

The list of 10 drugs covered under Medicare Part D selected for negotiation for initial price applicability year 2026 was 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 hosted a series of patient-focused Listening Sessions this fall as part of the Medicare Drug Price Negotiation Program. The virtual public Listening Sessions provided 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.

More Information about the Patient-Focused Listening Sessions 

Guidance for the First Cycle of Negotiation

Frequently Asked Questions: Medicare Drug Price Negotiation Program for Initial Price Applicability Year 2026 (PDF) (January 5, 2024)

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

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

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

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

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

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

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

 

ira information

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. 

The Small Biotech Exception 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 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:
01/05/2024 04:30 PM