HRSA Seeks Comments on New 340B Rebate Data Forms
Published Date: 6/15/2026
Notice
Summary
HRSA is rolling out a new 340B Rebate Model Pilot Program that changes how drug manufacturers offer discounts to certain health care providers. This means drug companies will submit plans and sales data, while health providers will request rebates differently. If you’re involved in the 340B program, get ready to share info and comment by July 15, 2026—this could impact how discounts and rebates flow, but no new costs are expected.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 2 costs, 1 mixed.
Large reporting burden for covered entities
If you run a covered entity (for example, a hospital, health center, or pharmacy) the Pilot would require you to submit claims-level data to manufacturers. HRSA estimates 15,249 covered entities will each submit 52 responses per year at 5 hours per response, totaling 3,964,740 annual burden hours across all covered entities.
Manufacturers must submit plans and monthly reports
Manufacturers that participate must submit a Pilot Program plan and monthly purchase reports to the 340B Prime Vendor. HRSA estimates 11 manufacturers will each submit one plan (8 hours) and 12 monthly purchase reports per year (2 hours each), totaling 352 burden hours for manufacturers.
Pilot limited to certain negotiated-price manufacturers
HRSA states the Pilot scope is limited to manufacturers with current Medicare Drug Price Negotiation Program Agreements for the initial price applicability years (IPAY) 2026 and 2027. Only those qualifying manufacturers may submit plans to participate.
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