HRSA is re-engaging with a revised approach to the 340B drug pricing program. The agency issued a Request for Information (RFI) on February 17, 2026, seeking feedback on the potential implementation of a rebate model. This model would shift from the current system, where hospitals receive discounts at the point of purchase, to a system where they initially pay the full price and then claim rebates from pharmaceutical companies. The U.S. District Court for the District of Columbia, in the case of American Hospital Association v. Kennedy on February 10, vacated and remanded the 2025 pilot program and pharmaceutical company approvals. HRSA is now adopting a strategy of gathering stakeholder input to address procedural weaknesses under the Administrative Procedure Act.

The proposed model targets high-revenue drugs and safety-net healthcare providers. The canceled pilot program was designed around drugs expected to be subject to Medicare price negotiation in 2026, including FDA-approved and marketed products such as Eliquis (apixaban, an anticoagulant), Xarelto (rivaroxaban, an anticoagulant), and Stelara (ustekinumab, an IL-12/IL-23 inhibitor). Eliquis is a key product for Bristol Myers Squibb (BMY) and Pfizer (PFE), while Xarelto and Stelara are key products for Johnson & Johnson (JNJ). These are all marketed products, not those in clinical development. Competing standard treatments include anticoagulants like Pradaxa (dabigatran, a thrombin inhibitor) and immune disease treatments like Skyrizi (risankizumab, an IL-23 inhibitor) and Humira (adalimumab, a TNF inhibitor). The operating costs of the rebate program and changes in net sales will also impact pricing competition within these therapeutic categories.

The key issues revolve around cash flow and data, rather than just the discount rate. Hospitals participating in the 340B program and safety-net clinics will have to purchase high-cost drugs at full price and wait for reimbursement, increasing their working capital burden and the risk of claim errors. Pharmaceutical companies, on the other hand, will be able to control for duplicate discounts and ineligible claims by cross-referencing patient, prescription, and dispensing information, improving their ability to forecast net sales and audit the program. HRSA's reason for seeking feedback until April 20, 2026, is to incorporate the reimbursement period, data elements, dispute resolution processes, and impact on patient access into the rules.

The program, valued at USD 100 billion, will see a shift in its distribution structure. According to HRSA, the 2025 340B program covered outpatient drugs with a total acquisition cost of USD 100 billion, with disproportionate share hospitals accounting for USD 79.2 billion. Therefore, the transition to a rebate model is not just about individual product price adjustments, but about changing the timing of when billions of dollars flow between hospitals and pharmaceutical companies, and who has the authority to verify these transactions. Although the original pilot program was invalidated by the court ruling, the new RFI represents a redesign rather than a policy reversal, and the final scope of implementation and the reimbursement rate will determine hospital liquidity and pharmaceutical company 340B revenue leakage.