HRSA takes first step to restart the 340B rebate pilot
Issue
HRSA posted a revised 340B rebate pilot application package in the Federal Register on June 15, and comments were due July 15. A June 22 correction expects 11 manufacturer plans, up from about 8 to 9 in the first round a court vacated.
OMB finished its review in late July, but HRSA has not published the full policy.
Key points
- HRSA is bringing back the rebate pilot a court vacated in February, and its revised package expects 11 manufacturers, up from about 8 to 9.
- Comments were due July 15, 2026, so covered entities that opposed the first round had 13 days to respond.
- A 90-day wait after approvals puts the earliest realistic start in late 2026 or 2027, so model the cash-flow impact now.
Sources for this story
HRSA / Federal RegisterPart of
- 340B drug pricing
HRSA's rebate model pilot
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FQHC Talent. (2026, June 15). HRSA takes first step to restart the 340B rebate pilot. Source: HRSA / Federal Register. Retrieved November 11, 2026, from https://www.fqhctalent.com/intel/hrsa-340b-rebate-pilot-2-revival-icr-june-2026