HRSA has launched a new one-year 340B rebate pilot program. This pilot will apply only to the ten drugs subject to 2026 Medicare price negotiations, which together account for about 20% of all Medicare Part D sales. Importantly, rebates will apply to all units of those drugs — not just Medicare claims.
- How it works: Health centers must purchase these drugs at full price up front and then request a rebate after dispensing. Manufacturers can either pay rebates on each claim as it comes in or wait until a full “package size” of claims is reached before issuing payment.
- Manufacturer obligations: To participate, drug companies must cover all costs of the rebate model (including health center administrative expenses), limit data requirements to 11 HRSA-specified fields, allow 45 days post-dispense to request a rebate, and pay approved rebates within 10 calendar days.
- Timeline: Manufacturers must decide whether to participate this fall, and HRSA will begin announcing approvals in October 2025. The pilot is expected to launch in early 2026 and run for at least one year.
Why this matters for health centers:
While the pilot creates a new pathway for accessing 340B pricing, it also poses serious cash flow challenges. Health centers will have to carry the cost of purchasing these drugs at full price until rebates are paid. If manufacturers choose to delay payment until package-size thresholds are met, those cash flow pressures could be significant.