The New Medicare P Code Process
CMS recently published the updated P Code process for the new Medicare Part D Manufacturer Discount Program (the successor to the Coverage Gap Discount Program). The new guidelines will allow manufacturers that are about to launch, or that currently have piggy back agreements (your labeler code on another manufacturer's P Code) the ability to obtain a P Code. The P Code is necessary for participation in Medicare Part D and also has been linked to certain Medicare Part B rebates.
The major change is that starting in the calendar year 2026, manufacturers can gain a P Code on a rolling quarterly basis. This is a welcome replacement of the previously annual P Code process. Per CMS, “an agreement will become effective on the first day of a calendar quarter. A participating manufacturer must enter into the agreement no later than the last day of the first month of a calendar quarter in order for the term to begin on the first day of the next calendar quarter. If a manufacturer enters into the agreement after the last day of the first month of a particular calendar quarter, the initial term will begin on the first day of the second calendar quarter after the calendar quarter in which the manufacturer entered into the agreement.” (emphasis added). This means that a manufacturer would need to enter into an agreement on January 30th for a Q2 effective date. If they do not enter into an agreement by January 30th then the agreement would go into effect Q3. The proposed P Code timing mirrors the timing currently in place for the Medicaid NDRA mandatory effective date.
Per CMS instructions, manufacturers of brand name drugs that want to participate in Part D must obtain a Part D contract P number to initiate the contracting process. Manufacturers that do not currently have a Part D P number should:
- email PartDManufacturerDiscountProgram@cms.hhs.gov with the subject line “[manufacturer name] Request for P Number”
- In the body of the email include:
- Program type: either Part D or Part D with Part B,
- Manufacturer name,
- DUNS number, and
- Primary contact first and last name, email, and phone number.
Manufacturers with Part B-only P numbers that are seeking a Part D P number in order to participate in the Discount Program should email HPMSConsultantAccess@cms.hhs.gov to request that their Part B-only P number be converted to a Part D with Part B P number.
If you have any questions please feel free to contact us and we will be happy to answer your questions and assist with your P Code process.
Published on Aug. 4, 2025 by Scott Hoffman