On February 10, 2026, in American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 (D. Me.), the U.S. District Court for the District of Maine vacated and remanded to HHS the 340B Rebate Model Pilot Program Application Notice, 90 Fed. Reg. 36,163 (Aug. 1, 2025), the Corrected 340B Rebate Model Pilot Program Application Notice, 90 Fed. Reg. 38,165 (Aug. 7, 2025), and the approvals of applications from drug manufacturers submitted pursuant to those notices (announced between October 30 and November 14, 2025).
HHS is reconsidering whether to implement a 340B Rebate Model Pilot Program consistent with its statutory authority. HRSA is issuing a Request for Information (RFI) to gather input from interested parties regarding the potential use of rebates to effectuate the ceiling price under the 340B Program. For more information on how to submit a response to the RFI by the April 20, 2026 deadline, please visit Request for Information: 340B Rebate Model Pilot Program.
Clarification Regarding Submission of Confidential or Proprietary Information
The questions in this RFI are intended to guide stakeholders in identifying and describing the range of issues and impacts relevant to a potential 340B Rebate Model Pilot Program. Stakeholders are encouraged to respond using estimates, ranges, aggregate, or general descriptions rather than using privileged or confidential trade secrets and commercial or financial information.
If you choose to provide privileged or confidential trade secrets and commercial or financial information that you believe is necessary to comment on the RFI, your comment must be submitted separately to 340BPricing@hrsa.gov so that it is not publicly displayed in its entirety. If you are submitting a comment to the 340BPricing@hrsa.gov inbox, please: 1) put “Confidential RFI Info” in the subject line of your email; 2) clearly mark the specific pages and portions of your submission that you believe contain proprietary or confidential information with the words “Confidential/Proprietary Information Exempt from Public Disclosure” in the header or footer; and 3) clearly and conspicuously identify every line and paragraph on each page containing such information (e.g., marked with double brackets or highlighting). HRSA will ensure that any confidential/proprietary information you identify pursuant to the aforementioned criteria is protected from disclosure to the extent the law permits. You may be asked to submit a redacted version of your comment, with any confidential/proprietary information redacted, for public display.