After nearly two months of uncertainty and legal challenges to the initial 340B rebate model pilot program, HRSA is now seeking public input on a future pilot program through March 19th.
The latest status of the 340B rebate model pilot program, originally slated to begin on January 1, 2026, includes a withdrawal of the program by the Department of Health and Human Services (HHS) and now a public comment period set to begin this week and run through March 19th.
HHS is seeking input from all stakeholders across the 340B spectrum – covered entities, manufacturers, wholesalers, state Medicaid agencies, pharmacies, the federal government, and all others. This input is being requested to assist HHS’s Health Resources and Services Administration (HRSA) in deciding whether it should use its statutory authority to implement a rebate model and what a rebate model framework should be.
A summary of the key input being sought is below. See the full Request for Information here and review the additional guidance provided for specific input.
- Administrative, operational, financial, and medication access concerns related to rebate models.
- Reliance interests in continuing to obtain the 340B ceiling prices through upfront discounts and whether such reliance interests are reasonable in light of the Secretary of HHS’s express statutory authority to provide for discounts via “rebate or discount.”
- Potential cash-flow impacts; and
- 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, as well as consistency with the Medicare Drug Price Negotiation Program nonduplication provision.
The importance of weighing in and providing your unique covered entity’s situation, concerns, and limitations in the event of a future rebate model pilot program cannot be emphasized enough. Blue & Co.’s pharmacy team has had numerous conversations with covered entities and has heard specific concerns regarding cash-flow limitations, insufficient funds and staffing to manage the expected oversight of such a program, and issues with the calculation of charity care equations, among other significant concerns. We encourage each covered entity to review the specific details being requested by HHS and to take time before the March 19th deadline to share your story.
Contact Us
Blue & Co., LLC, will continue to update covered entities on developments regarding potential pilot programs and can assist with questions or needs as your organization prepares to provide public comments and to implement future pilots. If you have any questions, please do not hesitate to reach out to one of our 340B ACE-certified advisors.
Kyle Smith, CPA, 340B ACE, Director
Jason Prokopik, PharmD, 340B ACE, Senior Manager
Alyssa Kramer, PharmD, 340B ACE, Manager
Kelly Kuhn, 340B ACE, Senior Pharmacy Consultant
