Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: August 28, 2020

NEW!

Manufacturer Discount Program: Instructions for Participation

July 18, 2025: The Medicare Part D Manufacturer Discount Program: Instructions for Participation has been added to the Downloads section below. These instructions contain important information for manufacturers that do not already participate in the Manufacturer Discount Program and wish to do so beginning in 2026. Manufacturers that already have a Manufacturer Discount Program agreement in place do not need to take any action.

CMS will begin issuing new Part D “P” numbers on August 1, 2025. Manufacturers may email their requests for new Part D P numbers prior to August 2025, but the P number will not be assigned prior to August 1.

Manufacturer Discount Program 

Effective January 1, 2025, Part D coverage is available only for applicable drugs covered by a Manufacturer Discount Program agreement with CMS. Under the Manufacturer Discount Program, participating manufacturers are required to provide discounts on their applicable drugs in the Initial Coverage and Catastrophic Coverage phases of the Part D benefit. Discounts will be fully phased in after 6 years for those manufacturers determined by CMS to meet the definition of specified manufacturer or specified small manufacturer included in the Inflation Reduction Act.

Beginning in 2026, Manufacturer Discount Program contracting will be done on a rolling basis with quarterly effective dates. For more information, see section 80.1.2 of the Manufacturer Discount Program Final Guidance and the Manufacturer Discount Program: Instructions for Participation, both of which can be found in the Downloads section below. 

Information about the Manufacturer Discount Program, including program guidance, agreements, participating labeler codes, and discount phase-in eligible national drug codes (NDC), is provided in the Downloads section below. Please review the information on this page often as resources are updated regularly. 

Questions about the Manufacturer Discount Program should be sent to PartDManufacturerDiscountProgram@cms.hhs.gov. 

Coverage Gap Discount Program

As required under the Inflation Reduction Act of 2022, the Coverage Gap Discount Program ended on December 31, 2024, and was replaced by the Manufacturer Discount Program. Quarterly invoicing for dates of service prior to 2025 under the Coverage Gap Discount Program will continue in accordance with the CGDP/MDP Calendar 2024-2028 available in the Downloads section below. Archived guidance and other information about the Coverage Gap Discount Program can also be found below in the Downloads. 

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DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.