HRSA Quietly Restarts the 340B Rebate Model Pilot — Revised Application Package in the Federal Register, Comments Due July 15

⚠️ UPDATE (July 30, 2026): OMB/OIRA completed its review of HRSA's rebate pilot proposal in late July after reclassifying it as 'economically significant' (the ≥$100M-impact tier under EO 12866) — the last procedural gate before Federal Register publication, which can now come any day. OMB held 17 stakeholder meetings on the pending notice; HRSA has not yet published the full policy.

Original item: Four months after a federal court vacated the first 340B Rebate Model Pilot (AHA v. Kennedy, February 2026), HRSA has taken the first formal step toward Rebate Pilot 2.0: an Information Collection Request for a revised '340B Rebate Model Pilot Program Application, Implementation, and Evaluation' published in the Federal Register June 15, 2026, with public comments due July 15, 2026.

A June 22 correction notice revised the estimated responses to include 11 manufacturer Pilot Program Plan submissions — signaling HRSA anticipates MORE manufacturers in the revived pilot than the ~8-9 approved in the vacated first round. Guardrails from the February joint vacatur motion still bind: any new rebate program requires fresh public notice-and-comment and an effective date no earlier than 90 days after manufacturer-application approvals, sliding the earliest realistic go-live toward late 2026 or 2027.

Strategic implication for FQHCs: a rebate model converts upfront 340B discounts into after-the-fact rebates — a working-capital hit covered entities (including NACHC) fought in round one. The July 15 comment window is the 13-day action item.