America's Essential Hospitals has prepared a comment letter template to assist members in responding to the recent request for information (RFI) on rebate models within the 340B Drug Pricing Program. The template outlines high-level concerns about the operational impacts of rebate models on essential hospitals. It also includes opportunities for members to further describe the full operational, financial, and patient care effects of losing up-front discounts.

On Feb. 13, the Health Resources Services Administration (HRSA) published an RFI on rebate models, soliciting feedback from key stakeholders in the 340B program, including covered entities and pharmaceutical manufacturers. HRSA specifically asks covered entities to describe how a rebate model would affect their operations, including the costs that would be borne by covered entities.

We encourage members to begin preparing their own comments using this template because HRSA has indicated that it is particularly interested in understanding the effects of rebate models on covered entities. This is members' first opportunity to meaningfully inform HRSA's consideration of this iteration of rebate models.

Comments to HRSA are due by April 20.

The association has been actively opposed to rebate models since their inception, so members may also want to refer to previous association letters to HRSA on this issue.

• Our Dec. 1 letter outlining outstanding concerns with the rebate pilot as slated for implementation:
  DeCubellis J. Letter to Thomas J. Engels on Dec. 1, 2025. America's Essential Hospitals. https://essentialhospitals.org/wp-content/uploads/2025/12/12.1.2025-Rebate-Pilot-Outstanding-Questions-Letter.pdf. Accessed Feb. 22, 2026.
• Our comments responding to the July public notice announcing the limited rebate pilot:
  Siegal B. Letter to Thomas J. Engels on Sept. 8, 2025. America's Essential Hospitals. https://essentialhospitals.org/wp-content/uploads/2025/09/340B-Rebate-Model-Pilot-Program-nosig.pdf. Accessed Feb. 22, 2026.
• Our recommendations to Secretary Kennedy regarding forthcoming rebate model guidance:
  Siegal B. Letter to Robert F. Kennedy Jr. on May 28, 2025. America's Essential Hospitals. https://essentialhospitals.org/wp-content/uploads/2025/05/Sec.-Kennedy-HRSA-Rebate-Guidance-Letter-5-28-25.pdf. Accessed Feb. 22, 2026.

This RFI follows a federal court determination that the government had not adequately considered how rebate models would affect covered entities participating in the 340B program. America's Essential Hospitals participated in the lawsuit where a federal court roundly criticized HRSA's process for implementing a rebate model in 2025.

Contact Director of Policy Rob Nelb, MPH, at [email protected] or 202.585.0127 with questions or for more information.