The Health Resources and Services Administration (HRSA) on July 31 proposed to pilot the limited use of manufacturer rebate models in the 340B Drug Pricing Program, effective Jan. 1, 2026.
HRSA proposes that manufacturers may use rebates only for drugs selected for negotiation under the Medicare Drug Price Negotiation Program. Covered entities must submit claims to manufacturers within 45 days from dispensing the drug, although manufacturers must have allowances for extenuating circumstances.
To participate, a manufacturer must submit an implementation plan to HRSA by Sept. 15. If approved, manufacturers must pay rebates—which comprise the difference between acquisition cost and 340B ceiling price—within 10 days of claims submission. Additionally, manufacturers must pay covered entities’ technical and administrative costs to ensure data security assurances and customer service components.
HRSA forbids manufacturers from denying claims based on concerns of diversion or duplicate discounts. Further, HRSA restricts manufacturers from requiring covered entities to provide data beyond 11 readily available pharmacy claim fields.
In a statement, America’s Essential Hospitals noted that the program’s administrative burden on hospitals could harm patients and urged HRSA to rethink its approach.
The proposal is open to comment until Aug. 30.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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