Part D Information for Pharmaceutical Manufacturers

IMPORTANT: Manufacturers must submit labeler code requests in HPMS no later than November 1, 2024, to have the requested changes included in the Manufacturer Discount Program January 2025 participating labeler code list and NDC list. For more details about labeler code changes, see the Frequently Asked Questions in the Downloads section below. 

This page provides important information related to the Part D Coverage Gap Discount Program and the Part D Manufacturer Discount Program created under the Inflation Reduction Act of 2022 that will replace the Coverage Gap Discount Program beginning in 2025. 

Manufacturer Discount Program 

Effective January 1, 2025, Part D coverage will be 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.

The statutory deadline for entering into a Manufacturer Discount Program agreement for 2025 was March 1, 2024. At this time, CMS is not currently processing requests for new P numbers for manufacturers of Part D drugs. CMS will be updating instructions for manufacturers to request a P number and enter into an agreement for 2026 or a future year and will release the instructions in early 2025.

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. Resources are updated regularly. 

Questions about the 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 will end on December 31, 2024. Beginning January 1, 2025, discounts on certain applicable Part D drugs will be provided under the Manufacturer Discount Program, which is described above.

The Medicare Coverage Gap Discount Program makes manufacturer discounts available to eligible Medicare beneficiaries receiving applicable drugs while in the coverage gap benefit phase. In order to participate in the Coverage Gap Discount Program, manufacturers must sign an agreement with CMS to provide the discount on all of its applicable drugs (i.e., prescription drugs approved or licensed under a New Drug Application or Biologic License Application). Beginning in 2011, only those applicable drugs that are covered under a signed manufacturer agreement with CMS can be covered under Part D.

CMS has provided in the Download section of this page information about the Coverage Gap Discount Program contracting process, the list of participating manufacturers, and FDA Labeler Codes with the associated manufacturer names.