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

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.