6/24/2026 – Despite Substantial Stakeholder Concern, HRSA Sticks to Low Estimated Burden for a Rebate Model

Overview

HRSA continues to move forward with implementing a rebate model pilot, as evidenced by the agency’s submission of a new information collection request (ICR) to the White House Office Management and Budget (OMB) on June 15, 2026. In the ICR, HRSA acknowledges that covered entities outlined significant burdens associated with the model but restated that it will only take covered entities on average 5 hours per week to submit data to manufacturers.

The ICR states that covered entities’ comments on a proposed ICR earlier this year were “consistent” in sharing that the burden would necessitate “additional staffing, new or modified information technology systems, increased data tracking and reconciliation efforts, and ongoing, auditing and reporting activities.” Further, HRSA noted that commenters raised concerns about the “complexity of claims-level data submission, potential for errors, and the need to manage denials and disputes, all of which would increase burden.”

Although the agency acknowledged stakeholders’ higher estimates of burden in response to the proposed ICR, HRSA concluded the estimates “reflect overall operational impacts” rather than the “incremental time” required to complete individual reporting responses. HRSA further justified its estimate by explaining that the pilot is for only a “limited set of drugs” and “is designed to utilize a targeted and limited set of claims-level data elements necessary to administer rebate eligibility and prevent duplicate discounts and diversion.” HRSA added that the “standardized data elements are commonly available and already generated, maintained, and transmitted by covered entities or their vendors.” 

Consistent with the proposed ICR, the new ICR states that the rebate model pilot will be limited to manufacturers with drugs subject to Medicare Part D price caps for 2026 and 2027. The ICR clarifies that the model will only apply to the manufacturers’ price-capped drugs, rather than any drugs made by the manufacturers

Background

HRSA planned to implement a rebate model starting January 1, 2026; however, a group of covered entities successfully sued the agency to stop the rebate model from taking effect. The court ruled that HRSA had failed to adequately consider a rebate model’s impact on covered entities and to provide a reasonable explanation for changing its longstanding policy of requiring manufacturers to provide 340B ceiling prices as upfront discounts.

In February, HRSA published a request for information (RFI) and a proposed ICR regarding a potential new rebate model. The agency received thousands of comments in response to the RFI and 180 comments on the proposed ICR, with the overwhelming majority of unique comments opposing the proposed pilot. At the end of May, HRSA sent a prerule document titled “Notice Regarding 340B Rebate Model Pilot Program” to OMB for review. While the document’s content is unknown, this action suggested that the agency is continuing to advance a rebate model.

Looking Ahead

While the new ICR was published less than two months after the close of the comment period for the proposed ICR, any new pilot is likely still many months away from taking effect. After federal courts struck down HRSA’s first pilot, the agency agreed to set the effective date for any new pilot no earlier than 90 days following approval of drug manufacturer applications for the pilot. Additionally, any new rebate model will likely be legally challenged again by covered entities, which could delay or stop implementation of the model.

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Powers will continue to monitor developments regarding 340B rebates. Please contact Powers’ drug pricing team, or your lead Powers attorney, if you have any questions.