In February 2026, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) seeking stakeholder input on whether—and how—it should pursue a 340B rebate model. This RFI comes after a preliminary injunction in December 2025 paused implementation of the initially proposed 340B Rebate Model Pilot Program.
The RFI asks covered entities, manufacturers, and other stakeholders to weigh in on using post‑drug purchase rebates to deliver the 340B ceiling price, instead of the program’s current upfront discounted drug pricing model. HRSA is seeking detailed feedback on operational feasibility, administrative burden, financial impacts, data requirements, and the implications for patient access. HRSA’s statement emphasizes the need for evidence‑based input as it evaluates whether a rebate model is consistent with the goals of the 340B program.
Originally issued with a 30‑day comment window, the RFI’s deadline has since been extended to April 20, 2026, following requests from hospital and provider groups for additional response time.
The RFI comes amid shifts in the drug pricing landscape, including the implementation of Maximum Fair Pricing (MFP) provisions for select Medicare Part D drugs on January 1, 2026. Shortly after the launch of the Medicare Drug Price Negotiation Program (MDPNP), Eli Lilly and Novo Nordisk announced new policies requiring covered entities to submit claims data for all 340B dispensations, including in-house pharmacy settings and medical benefit claims, to continue receiving 340B pricing.
While HRSA’s RFI is focused on evaluating a potential rebate model, broader stakeholder engagement across the supply chain reflects increased interest in how 340B claims are identified, tracked, and validated. As a result, covered entities may see continued requests for more detailed claims information in the months to come.
Today, no 340B rebate model is active, and manufacturers are required to continue offering 340B pricing through upfront discounts.
Once the comment period closes, HRSA has indicated it will analyze stakeholder feedback before taking any next steps. That could mean a revised pilot proposal, rebate-model alternatives, or a decision not to pursue a rebate model entirely.
Regardless of the outcome, one theme is clear: data readiness is becoming increasingly critical. Verity’s 340B solutions are designed to help organizations streamline, validate, and operationalize data, supporting covered entities with reliable and accurate 340B purchasing and reporting. Whether the future of 340B involves rebates, expanded claims reporting, or continued manufacturer requirements, Verity is ready to help covered entities respond and adapt.
For more information about HRSA’s RFI, click here to view the full list of questions and submit comments by April 20, 2026.
