HRSA Requests Info on 340B Drug Rebate Pilot Program
Published Date: 2/17/2026
Notice
Summary
HRSA wants to hear from hospitals, drug makers, and others about a new idea to use rebates (money back) to keep drug prices fair under the 340B Program. This could change how discounts work, affecting patients, providers, and manufacturers. Comments are open until March 19, 2026, so folks can share their thoughts before any money or rules change.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
Upfront 340B Discount Could Become Rebate
HRSA is considering a rebate model where a covered entity would order a drug at a higher initial price and then receive a rebate that equals the difference between that higher price and the 340B discounted price, instead of receiving the discounted price up front. HRSA is requesting information about operational, financial, and access impacts of such a rebate model on covered entities, manufacturers, wholesalers, pharmacies, State Medicaid Agencies, and patients.
Proposed 10-Day Rebate Payment Requirement
The notice describes structuring a potential pilot so that all rebates would be paid to the covered entity (or documented as denied) within 10 calendar days of data submission. HRSA asks for input on ways to ensure manufacturers adhere to such a 10-calendar-day requirement.
Administrative, Staffing, and IT Cost Risks
HRSA asks covered entities to estimate incremental administrative and operational costs under a rebate model, distinguishing one-time startup costs from ongoing costs, and to describe potential staffing impacts (additional FTEs or reallocation of provider time). The notice asks for estimated system development or procurement costs and other anticipated costs (legal review, training, consultants).
Rebate Model May Address Duplicate Discounts
HRSA seeks comment on whether a rebate-based model would help manufacturers avoid paying 340B-Medicaid duplicate discounts (including consistency with the Medicare Drug Price Negotiation Program nonduplication provision), reduce diversion or improper claims, and increase pricing transparency across stakeholders.
Pilot Implementation Paused After Court Order
HRSA paused implementation of the 340B Rebate Model Pilot Program for all covered entities and the nine manufacturers approved to participate following the U.S. District Court for the District of Maine order on December 29, 2025. HRSA is now requesting comments to further evaluate potential benefits and costs before deciding on next steps.
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