Part D Information for Pharmaceutical Manufacturers
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
Information about the Manufacturer Discount Program beginning in 2025 is provided in the Downloads section below. The statutory deadline to enter into a Discount Program agreement for 2025 was March 1, 2024. Questions about the program should be sent to PartDManufacturerDiscountProgram@cms.hhs.gov.
Coverage Gap Discount Program
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 on 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.
Please click the selection that best matches your area of interest and check back, as we will continue to update these resources regularly.
Downloads
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Manufacturer Discount Program 2025 Phase-In Eligible NDC9 09062024 (ZIP) -
Manufacturer Discount Program 2025 Participating Labeler Codes 09062024 (ZIP) -
Manufacturer Discount Program Frequently Asked Questions (FAQs) (September 6, 2024) (PDF) -
Manufacturer Discount Program – Final Guidance (PDF) -
Manufacturer Discount Program – Specified and Specified Small Manufacturer Methodology (PDF) -
Manufacturer Discount Program – Manufacturer Agreement (PDF) -
Manufacturer Discount Program – TPA Agreement (PDF) -
Medicare-Coverage-Gap-Discount-Program-September-2024-Labeler-Code-File (ZIP) -
BIN_PCN_2024_040224 (ZIP) -
Manufacturer Coverage Gap Discount Guidance (v.052017) (ZIP) -
Medicare Part D Contract Plan BIN PCN Files 2015-2023 (ZIP) -
Medicare Part D CGDP Calendar - 2023-2028 (PDF) -
Labeler Code Calendar Updates (12.20.2023) (PDF) -
Medicare Coverage Gap Discount Program- Program Invoicing Dates (PDF) -
Medicare Coverage Gap Discount Program-Manufacturer's Agreement (05.2018) (PDF) -
Coverage Gap Discount Program - Timely Payment Determination (PDF) -
Medicare Coverage Gap Discount Program - Part D Sponsor Program Guidance (5/21/10) (ZIP) -
Medicare Coverage Gap Discount Program - Maximum Discount (ZIP) -
Medicare Coverage Gap Discount Program - Dispute Resolution (PDF) -
Coverage Gap Discount Program Appeal Decision Letters (ZIP) -
Medicare Coverage Gap Discount Program Third Party Administrators Agreement (v042017) (PDF)