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
Manufacturers that do not participate in the Coverage Gap Discount Program but wish to participate in the Manufacturer Discount Program beginning in 2025 must start the process by obtaining a pending contract number (“P number”) from CMS. Information about how a manufacturer can request a P number is provided in the Downloads section below.
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
-
Request For P Number-2025 (PDF) -
Manufacturer Discount Program – Instructions for Submitting Required Ownership Information (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-December-2023-Labeler-Code-File (ZIP) -
BIN_PCN_2023 (updated 10.3.2023) (ZIP) -
Manufacturer Coverage Gap Discount Guidance (v.052017) (ZIP) -
Medicare Part D Contract Plan BIN PCN Files (ZIP) -
Labeler Code Update Calendar_Final (PDF) -
CGDP Master Calendar 2019-2024 (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)