IRA Provision: The Medicare Drug Price Negotiation Program

The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet and initial guidance for the implementation of the Medicare Drug Price Negotiation Program. The guidance provides great detail about CMS’s intended implementation of the negotiations process and solicits stakeholder feedback on specific issues:

  • Terms and conditions contained in the manufacturer agreement 
  • Content required for the maximum fair price (MFP) explanation
  • Offer and counteroffer process to negotiate with CMS 
  • Application of the MFP for different forms/strengths of a drug
  • Dispute resolution process and compliance
  • And more

Key Considerations

  • Comments are open for only 30 days.
  • This is the first significant opportunity the broader stakeholder community has had to submit substantive and specific input on the implementation of the Medicare Drug Price Negotiation Program.
  • CMS issued the “Identification of Selected Drugs for Initial Price Applicability Year 2026” section of the guidance as “final” to meet the September 1, 2023, statutory deadline to announce the first 10 Part D drugs selected for 2026.

Next Steps for Stakeholders

Comments to CMS are due April 14, 2023, and must be submitted via email (IRARebateandNegotiation@cms.hhs.gov).

Related Documents

CMS Fact Sheet

Medicare Drug Price Negotiation Program

Date of Issuance: March 15, 2023

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