A little over a month after a federal circuit court blocked the Health Resources and Services Administration’s (HRSA) scheduled implementation of its 340B Rebate Model Pilot Program largely due to procedural deficiencies, HRSA appears to be performing additional diligence in hopes of avoiding similar setbacks in the future. In an announcement on February 13, 2026, HRSA released a request for information (RFI) seeking stakeholder feedback on the potential impact of rebate models in the 340B Program space.1
As part of the RFI, HRSA is inviting stakeholder commentary regarding several rebate-related issues, including medication access concerns, anticipated cash-flow impacts, proposed alternatives and scope-limiting measures to inform the rebate pilot design, among others. Many requests expressly seek submission of detailed data to demonstrate expected impacts and operational costs, signaling HRSA’s intent to conduct a more detailed and granular review of its proposed model this time around. Stakeholder comments to the RFI must be submitted and received no later than March 19, 2026.
Notably, the RFI comes just two days after the White House’s Office of Management and Budget (OMB) completed its regulatory review of HRSA’s new 340B rebate proposal – which also occurred over the span of just a few days. Although no material steps toward implementation are expected until the conclusion of the comment period, the quick advancement of HRSA’s RFI suggests a sense of urgency in advancing a new rebate model proposal.
For additional background information regarding the initial 340B rebate model proposal, please review our earlier publications on this subject, available on our 340B Blog. Given the significant implications for both manufacturers and covered entities, we will continue to closely monitor activity related to the RFI and provide additional updates as necessary. In the meantime, if you have questions or require assistance in developing responsive comments to the RFI, please reach out to your Quarles attorney or:
- Brenda Maloney Shafer: 602-229-5774 / brenda.shafer@quarles.com
- Richard Davis: 414-277-5844 / richard.davis@quarles.com
- Michael French: 312-715-5261 / michael.french@quarles.com
- Jake Pallotta: 317-399-2810 / jake.pallotta@quarles.com
END NOTES
1 340B Rebate Model Pilot Program – Request for Information, Health Resources and Services Administration, available here. Note that the RFI will be formally published in the Federal Register on February 17, 2026.