AHA comments on CMS proposal to codify Medicare Drug Price Negotiation Program regulations

The AHA Aug. 17 provided comments to the Centers for Medicare & Medicaid Services on its proposed rule to codify in regulation the Medicare Drug Price Negotiation Program. The AHA recommended CMS require drug manufacturers to make the maximum fair price available through a point-of-sale mechanism and eliminate any option permitting manufacturers to meet their obligations through retrospective rebates or post-sale reconciliations. The AHA expressed concerns that permitting retrospective MFP effectuation could set a foundation for broader manufacturer efforts to move the federal 340B program away from upfront discounts and toward a rebate-based model. The AHA also urged CMS to ensure that any future guidance or rulemaking regarding MFP availability maintains clear national standards and avoids permitting manufacturer-specific approaches that could create inconsistency across products and markets.