CMS Proposes Regulations Codifying Medicare Drug Price Negotiation Program
The Centers for Medicare & Medicaid Services has issued a proposed rule to codify regulations for the Medicare Drug Price Negotiation Program established under the Inflation Reduction Act. The American Hospital Association submitted comments on August 17, 2026, urging CMS to require manufacturers to make negotiated maximum fair prices available at point-of-sale rather than through retrospective rebates. AHA expressed concern that allowing retrospective price adjustments could encourage manufacturers to shift the 340B drug discount program from upfront discounts to rebates. The proposal affects how Medicare Part D beneficiaries and covered entities access negotiated drug prices.
Though focused on Medicare Part D, the pricing mechanism CMS adopts could establish precedent for Medicaid rebate structures and threaten the upfront discount model that safety-net hospitals and FQHCs rely on under 340B, which serves many Medicaid beneficiaries.
Pharmacy
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