Arnold Ventures submitted comments to the Centers for Medicare and Medicaid Services (CMS) on the draft guidance on manufacturer effectuation of the Maximum Fair Price (MFP) in 2028 under the Medicare Drug Price Negotiation Program. The letter outlines AV’s recommendations for portions of the draft guidance.
In particular, Arnold Ventures makes two recommendations to CMS in the letter related to the retrospective refund amount to effectuate the MFP and the standardized default refund amount for drugs payable under Part B. Arnold Ventures strongly recommends that CMS continue the policy of placing brand-name drugs and their therapeutically equivalent generic drugs in the same billing code, even when the brand-name drug is a selected drug with an MFP in order to promote generic competition and reduce Part B spending in the long term. Arnold Ventures also recommends that CMS, in estimating provider acquisition costs in the Standard Default Rebate Amount formula, use the Wholesale Acquisition Cost (WAC) as opposed to the Average Sales Price (ASP) to better compensate providers for the difference between their acquisition cost and the MFP.