The authors submitted the comment letter to the Centers for Medicare and Medicaid Services on August 17, 2026.
Richard Frank, Kristi Martin, and Rachel Sachs submitted comments to the Centers for Medicare and Medicaid Services on their proposed rule for the Medicare Drug Price Negotiation Program. The rule largely codifies existing initial price applicability year (IPAY) 2026–2028 guidance, but also proposes substantive changes that would take effect beginning with IPAY 2029.
The authors express general support for the proposed rule. The letter then offers specific comments on six topics and related proposals:
- Modification to the fixed combination drug policy
- Orphan Drug rule
- Codified process for determining “Bona Fide Marketing”
- New method for one-time therapies
- Temporary Floor for Small Biotech Drugs
- Regulatory Impact Analysis (RIA)
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Commentary
Comments on the Medicare Drug Price Negotiation Program proposed rule for IPAY 2029
August 18, 2026