HRSA Issues Request for Information on 340B Rebate Model Pilot Program

On February 17, 2026, the Health Resources and Services Administration (HRSA) published a Request for Information (RFI) in the Federal Register seeking input on the potential implementation of a rebate model under the 340B Drug Pricing Program. The RFI reflects HRSA's continued efforts to evaluate whether and how a rebate-based framework might operate within the 340B Program following litigation that paused an earlier pilot initiative. Comments are due by March 19, 2026.

Background: The 340B Program and the Shift to a Rebate Model

The 340B Drug Pricing Program, established under Section 340B of the Public Health Service Act, requires drug manufacturers to provide discounted pricing on covered outpatient drugs to eligible covered entities. According to the RFI, the program is intended to enable these entities "to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services." Approximately 14,000 covered entities and 800 drug manufacturers currently participate in the program. In 2024, covered entities purchased $81.4 billion of covered outpatient drugs through the program.

Traditionally, the 340B Program has operated as an upfront discount program, where covered entities receive the discounted 340B ceiling price at the time of purchase. However, in 2024, HRSA began receiving inquiries from manufacturers seeking to implement rebate models as an alternative approach. Under a rebate model, a covered entity would order drugs at a higher price and subsequently receive a rebate reflecting the difference between that initial price and the 340B ceiling price. 

Manufacturers cited several reasons for their interest in a rebate model, including: (1) limiting the availability of the maximum fair price (MFP) to 340B covered entities consistent with the Medicare Drug Price Negotiation Program (MDPNP) nonduplication provision; and (2) preventing 340B-Medicaid duplicate discounts and diversion. 

Prior Pilot Program and Litigation

On August 1, 2025, HRSA published a Federal Register notice establishing an application process for a voluntary 340B Rebate Model Pilot Program. The agency received 1,243 public comments from stakeholders, including covered entity and manufacturer trade organizations, individual covered entities, and pharmaceutical manufacturers. 

Covered entities subsequently filed suit on December 1, 2025, to enjoin implementation of the rebate pilot. On December 29, 2025, in accordance with the order by the U.S. District Court for the District of Maine in American Hospital Association et al. v. Kennedy et al., No. 25-cv-600, HRSA paused implementation of the pilot program for all covered entities and the nine manufacturers that had been approved to participate. 

The Current RFI

HRSA is undertaking what it describes as a "methodical and deliberate approach" to assess whether to implement a 340B Rebate Model Pilot Program consistent with its statutory authority. The agency has committed to analyzing comments received before pursuing implementation of any pilot program.

The RFI seeks to evaluate the operational, financial, and patient access impacts of a rebate model on covered entities, manufacturers, and other stakeholders across the drug supply chain. HRSA invites comments on a range of issues, including: (a) administrative, operational, financial, and medication access concerns; (b) reliance interests in continuing to obtain 340B ceiling prices through upfront discounts versus rebates; (c) potential cash-flow impacts; and (d) proposed alternatives and scope-limiting measures to inform pilot design, including safeguards.

Key Areas of Inquiry

The RFI poses detailed questions across seven substantive categories:

Costs to Covered Entities. HRSA requests information on current administrative costs under the upfront 340B discount model, estimated incremental costs under a rebate model (distinguishing between one-time startup costs and ongoing costs), staffing impacts, and systems and infrastructure requirements. The agency also seeks input on specific impacts on patient access to drugs that may result from a rebate model. 

Payment Timing and Cash Flow. The RFI asks covered entities to describe whether payment timing under a rebate model would affect cash flow, including any associated financial risks. HRSA notes that a potential pilot program could require manufacturers to pay or deny all rebates within 10 calendar days of data submission and solicits input on how to structure the program to ensure manufacturer compliance.

Rebate Denials. HRSA seeks input on guardrails that should be incorporated into a pilot program to ensure rebate denials are limited to appropriate circumstances. The agency is considering limiting acceptable grounds for denial and requiring manufacturers to provide covered entities with rationale and specific documentation supporting any denials.

Data Collection. The RFI requests information on how covered entities currently collect, maintain, and retain data related to 340B Program participation, as well as what specific pharmacy and medical claims data elements should comprise a potential rebate program. HRSA also seeks recommendations for ensuring appropriate guardrails to mitigate privacy and security concerns related to patient information and data submission. 

Manufacturer Efforts to Avoid Duplicate Discounts. HRSA asks manufacturers to describe their practices and procedures to avoid paying both 340B discounts and Medicaid rebates on the same drug dispense, including any operational changes implemented since January 1, 2026, related to identifying drug dispenses subject to an MFP under the MDPNP. 

Required Reporting. The agency seeks input on what specific data manufacturers should be required to submit for HRSA's review to ensure compliance with a potential pilot program, what data should be shared publicly, and the appropriate frequency and duration of data collection. 

Program Integrity and Potential Benefits. HRSA asks stakeholders to explain whether and how a rebate model would affect the integrity of the 340B Program, including whether such a model would assist manufacturers in avoiding duplicate discounts, reduce diversion or improper claims, and increase pricing transparency. 

Submitting Comments

Comments should be submitted electronically through the Federal eRulemaking Portal at www.regulations.gov, referencing HHS Docket No. HRSA-2026-03042, by March 19, 2026. HRSA encourages commenters to include supporting facts, research, and evidence, with citations to published materials and active hyperlinks where possible.