Initial Price Applicability Year 2028
CMS issued final 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 September 30, 2025.
CMS voluntarily sought comment on the draft guidance for initial price applicability year 2028 and manufacturer effectuation of negotiated MFPs in initial price applicability years 2026, 2027, and 2028. The comment period was open for 45 days and closed on June 26, 2025. After considering the public comments received in response to the draft guidance, CMS issued this final guidance for initial price applicability year 2028 and manufacturer effectuation of negotiated MFPs in initial price applicability years 2026, 2027, and 2028.
- Final Guidance for IPAY 2028
Medicare Drug Price Negotiation Final Guidance (PDF) (September 30, 2025)
Technical Correction to Medicare Drug Price Negotiation Program Final Guidance for Initial Price Applicability Year 2028 (December 16, 2025): CMS posted a corrected version of the Medicare Drug Price Negotiation Program Final Guidance for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028 (Final Guidance) on December 16, 2025. The updated version addresses a numerical error in the Final Guidance in footnote 93 on page 172. The footnote in the Final Guidance issued on September 30, 2025 read “The inflation-adjusted threshold for initial price applicability year 2027 was $206,680,981.” The correct number for the threshold is $206,680,891, and a technical correction to incorporate this number appears in footnote 93 of the corrected version of the Final Guidance.
Fact Sheet: Medicare Drug Price Negotiation Final Guidance (PDF) (September 30, 2025)
Public Comments: Medicare Drug Price Negotiation Draft Guidance (PDF) (September 30, 2025)
Final Maximum Fair Price File Layout and Definitions Document (ZIP) (September 30, 2025)
- Draft Guidance for IPAY 2028
Medicare Drug Price Negotiation Draft Guidance (PDF) (May 12, 2025)
Fact Sheet: Medicare Drug Price Negotiation Draft Guidance (PDF) (May 12, 2025)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 approved ICR for initial price applicability year 2028 is available on OMB’s website. Click “all” to see the full details. The submission periods for the initial price applicability year 2028 to request a Small Biotech Exception or a Biosimilar Delay, and for Primary Manufacturers of drugs selected for negotiation for initial price applicability years 2026 and 2027 to voluntarily submit information to CMS to inform renegotiation drug eligibility and selection have all closed.
- The revised Drug Price Negotiation ICR can be found in the Federal Register and is available for a 30-day comment period. The full text of the ICR can be found on the CMS PRA website. Comments are due by December 24, 2025 and can be submitted at the comment submission link 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)