Initial Price Applicability Year 2028
CMS issued draft guidance for the third cycle of negotiations for the Medicare Drug Price Negotiation Program, along with additional information on CMS support for manufacturer effectuation of maximum fair prices (MFPs) in 2026, 2027, and 2028 on May 12, 2025. Public comments on the Draft Medicare Drug Price Negotiation Draft Guidance are due Thursday, June 26 at 11:59 PM Pacific Time (PT). Please submit comments directly to IRARebateandNegotiation@cms.hhs.gov with the subject line “Medicare Drug Price Negotiation Program Draft Guidance”.
Medicare Drug Price Negotiation Draft Guidance (PDF) (May 12, 2025)
Fact Sheet: Medicare Drug Price Negotiation Draft Guidance (PDF) (May 12, 2025)
- Information Collection Requests (ICRs)for IPAY 2028
- The Negotiation Program Drug Selection initial ICR for initial price applicability year 2028 can be found in the Federal Register. The full text of the ICR can also be found at CMS' PRA website. Comments are due by July 14, 2025 and can be submitted here.
Initial Price Applicability Year 2027
CMS issued final guidance for the second cycle of negotiations for the Medicare Drug Price Negotiation Program, along with additional information on CMS support for manufacturer effectuation of maximum fair prices (MFPs) in 2026 and 2027.
CMS voluntarily sought comment on the draft guidance for initial price applicability year 2027 and manufacturer effectuation of negotiated MFPs in initial price applicability years 2026 and 2027. The comment period was open for 60 days and closed on July 2, 2024. After considering the public comments received in response to the draft guidance, CMS issued this final guidance for initial price applicability year 2027 and for manufacturer effectuation of the MFP in 2026 and 2027.
- Final Guidance for IPAY 2027
Medicare Drug Price Negotiation Program Final Guidance (PDF) (October 2, 2024)
Fact Sheet: Medicare Drug Price Negotiation Final Guidance (PDF) (October 2, 2024)
Public Comments: Medicare Drug Price Negotiation Program Draft Guidance (PDF) (submitted no later than July 2, 2024)
Final Maximum Fair Price File Layout and Definitions Document (ZIP) (October 2, 2024)
- Draft Guidance for IPAY 2027
Medicare Drug Price Negotiation Program Draft Guidance (PDF) (May 3, 2024)
Fact Sheet: Medicare Drug Price Negotiation Program Draft Guidance (PDF) (May 3, 2024)
Draft Maximum Fair Price File Layout and Definitions Document (ZIP) (May 3, 2024)
- Information Collection Requests (ICRs) for IPAY 2027
- The Small Biotech Exception and Biosimilar Delay approved ICR is available for viewing on OMB's website. Click "all" to see full details. The submission period for initial price applicability year 2027 closed on December 10, 2024.
- The Negotiation Data Elements and Drug Price Negotiation Process approved ICR is available for viewing on OMB’s website. Click “all” to see full details.
- The Medicare Transaction Facilitator for 2026 and 2027 approved ICR is available for viewing on OMB's website. Click "all" to see full details.
Initial Price Applicability Year 2026
- Revised Guidance for IPAY 2026
Medicare Drug Price Negotiation Revised Guidance (PDF) (June 30, 2023)
Fact Sheet: Medicare Drug Price Negotiation Revised Guidance (PDF) (June 30, 2023)
- Initial Guidance for IPAY 2026
Medicare Drug Price Negotiation Program Initial Guidance (PDF) (March 15, 2023)
Fact Sheet: Medicare Drug Price Negotiation Program Initial Guidance (PDF) (March 15, 2023)
Public Comments: Medicare Drug Price Negotiation Program Initial Guidance (ZIP) (submitted by April 14, 2023)
- Contract Year 2026 Medicare Advantage and Part D Final Rule (CMS-4208-F)
Finalized provisions for Medicare Drug Price Negotiation Program
The Contract Year (CY) 2026 Medicare Advantage (MA) and Part D final rule includes a provision that requires that Part D sponsors’ network contracts with pharmacies require such pharmacies to be enrolled in the Medicare Drug Price Negotiation Program’s Medicare Transaction Facilitator Data Module. The rule also shortens the Prescription Drug Event (PDE) submission timeliness requirement for initial PDE records for selected drugs from 30 calendar days to 7 calendar days to help ensure prompt payments by drug manufacturers to dispensing entities to provide access to the MFP. To review the CY 2026 MA and Part D visit the Federal Register.
- Information Collection Requests (ICRs) for IPAY 2026
The Negotiation Data Elements ICR is available for viewing on OMB’s website. Click “all” to see full details.
The Drug Price Negotiation Process ICR is available for viewing on OMB's website. Click “all” to see full details.
The Small Biotech Exception ICR is available for viewing on OMB's website. Click "all" to see full details.
The Medicare Transaction Facilitator for 2026 and 2027 approved ICR is available for viewing on OMB's website. Click "all" to see full details.
- Early Implementation
Frequently Asked Questions: Medicare Drug Price Negotiation Program for Initial Price Applicability Year 2026 (PDF) (January 5, 2024)
Medicare Drug Price Negotiation Program: Next Steps in Implementation for 2026 (PDF) (January 11, 2023)
Drug Price Negotiation Timeline for 2026 (PDF) (January 11, 2023)