On February 17th, HRSA published a request for information (“RFI”), asking covered entities to submit comments detailing the burden that a 340B rebate model would incur. This RFI follows HRSA’s withdrawal of the 340B Rebate Pilot program that was set to begin on January 1, 2026. The withdrawal was in response to federal court decisions in hospital lawsuits—specifically American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 (D. Me.)—which found that the process by which HRSA developed and presented the Rebate Model did not comply with federal administrative laws. In that case, the U.S. District Court for the District of Maine found that HRSA’s “anemic” administrative record failed to account for 30 years of industry reliance on upfront discounts or the significant cash-flow and administrative burdens the shift would impose on safety-net providers.
Unlike previous notices, this RFI requires covered entities (CEs) to provide documented evidence of administrative costs, including IT infrastructure, staffing reallocation, and methodology for estimates; directly addressing the court’s criticism of HRSA’s previously “threadbare” administrative record. The RFI seeks comments from industry stakeholders to evaluate the operational, financial, and access issues associated with implementing a rebate model. Comments are due by March 19, 2026.
A summary of the requests includes:
- Administrative, operational, financial, and medication access concerns in connection with rebate models;
- Potential cash-flow impacts due to the payment timing of the rebate compared to current payment arrangements with wholesalers and manufacturers;
- Staffing impacts, including whether additional full-time employees would be required or whether clinical staff would need to shift time to administrative tasks;
- Technological infrastructure adjustments and investments to support the rebate model, including estimates on associated costs (e.g., new software systems);
- Burdens associated with data collection and submission to adhere to the program;
- Inputs on efforts associated with preventing duplicate discounts;
- Organization-specific factors that impact an organization’s ability to participate in the rebate model;
- Input on transparency, specifically for manufacturer denials and timelines regarding adjudication of improper denials;
- Inquiries as to what data manufacturers should be required to submit;
- Proposed alternatives and scope-limiting measures to inform a rebate pilot design, including safeguards to promote the integrity of the 340B Program and avoid duplicate discounts.
While it is somewhat encouraging to see HRSA’s commitment to learning more about the impact of the Rebate model changes, there is a striking disparity in the nature of the information HRSA requests from covered entities compared to the information sought from pharmaceutical manufacturers.
For Covered Entities, the RFI’s tone is granular and defensive. HRSA demands precise, data-driven proof of burden, requiring entities to calculate total transaction counts, full-time employee (FTE) hours, and dollar-for-dollar IT and consulting costs. Covered entities are also expected to provide the specific “methodology and assumptions” used to reach these figures, while simultaneously navigating instructions not to disclose confidential business information. This structure implies that the burden of proof rests entirely on the providers to justify maintaining the current upfront discount model or to quantify the exact cost of the proposed shift.
In contrast, the tone regarding Manufacturers is collaborative. HRSA seeks their input on “minimum data elements” they believe are necessary to identify duplicate discounts and asks for their perspective on “challenges encountered” during previous compliance efforts. Rather than requiring manufacturers to prove a specific financial or operational burden, the RFI asks for their advice on how required reporting should be structured to support their own efforts.
This dynamic effectively reassigns the logistical and evidentiary weight of program changes from manufacturers to covered entities. While manufacturers are invited to define the parameters of a system that serves their interests, covered entities are tasked with the exhaustive work of proving why those very parameters may be unsustainable. By prioritizing manufacturer input on system design while demanding rigorous cost-justification from providers, the RFI creates a lopsided environment where the regulated entities—the providers—must bear the cost of proving that the manufacturer-favored model is a burden.
Advis encourages your covered entity to review the RFI and consider replying. Due to the highly technical data being sought by HRSA, our team is available to help navigate a response with your covered entity. Contact Advis today to further discuss your options to protect the 340B program.
Published February 18, 2026
