Guidance and Policy Documents

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CMS voluntarily sought comment on the draft guidance for initial price applicability year 2028 and manufacturer effectuation of negotiated MFPs in initial price applicability years 2026, 2027, and 2028.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 After considering the public comments received in response to the draft guidance, CMS issued this final guidance for initial price applicability year 2028 and manufacturer effectuation of negotiated MFPs in initial price applicability years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)

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Public Comments: Medicare Drug Price Negotiation Draft Guidance (PDF) (September 30, 2025)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Draft Guidance for IPAY 2028

Medicare Drug Price Negotiation Draft Guidance (PDF) (May 12, 2025)

Fact Sheet: Medicare Drug Price Negotiation Draft Guidance (PDF) (May 12, 2025) 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.
  • Manufacturers seeking a Small Biotech Exception or a Biosimilar Delay must submit a Small Biotech Exception request or a Biosimilar Delay request in the CMS Health Plan Management System (CMS HPMS) by 11:59 p.m. PDT on December 12, 2025.
  • Primary Manufacturers of drugs selected for negotiation for initial price applicability years 2026 and 2027 may voluntarily submit information to CMS to inform renegotiation drug eligibility and selection. To provide CMS with the voluntary information, a Primary Manufacturer must first email CMS by 11:59 p.m. PDT November 28, 2025 at IRARebateandNegotiation@cms.hhs.gov to indicate its intention to submit the information. CMS will then provide the Primary Manufacturer with access to a specific Box folder and a template of the ICR questions for submission. The Primary Manufacturer must upload its submission to the Box folder by 11:59 p.m. PDT December 12, 2025.
• 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)