WASHINGTON, D.C. (September 3, 2026) – The Health Resources and Services Administration (HRSA) will hold a Tribal Consultation on its 340B Rebate Model Pilot Program on Wednesday, September 16, 2026, from 3:00 to 5:00 p.m. ET. The virtual session, held via Zoom and initiated pursuant to Executive Order 13175, was announced in an August 28, 2026, Dear Tribal Leader Letter from RADM Krista Pedley, Acting Associate Administrator, in response to requests from Tribal leaders and Tribal-serving organizations. Tribal stakeholders who are unable to attend are encouraged to submit written testimony or comments directly to HRSA.

The National Council of Urban Indian Health (NCUIH) encourages Tribal representatives to register and engage in this important consultation. Feedback that may be helpful to include could address anticipated cash-flow or operational impacts specific to your organization, how current 340B savings support patient care, administrative or staffing capacity needed to manage rebate claims, and any experience with delayed or denied claims in similar programs.

In the Dear Tribal Leader Letter announcing the Consultation, RADM Krista Pedley, HRSA’s Acting Associate Administrator, wrote that HRSA intends to use the session to discuss how the Rebate Pilot will help the agency balance Tribal stakeholder concerns against its goal of testing a rebate model in the 340B Program, gather data on how the 340B ceiling price is effectuated through rebates, generate data relevant to other federal drug pricing programs including the Medicare Drug Price Negotiation Program, and improve transparency to inform future policy decisions. HRSA framed the session as an opportunity to hear directly from Tribes, describing its intent to “welcome concerns and input” as the agency works to implement the Pilot, and characterizing the Consultation as part of the agency’s broader government-to-government relationship with Tribal Nations.

Background

On August 3, 2026, HRSA published a Federal Register notice launching the 340B Rebate Model Pilot Program, effective January 1, 2027. Under the Pilot, covered entities, including UIOs participating in 340B, would pay full price upfront for a limited set of drugs and receive a rebate from the manufacturer within a 10-day window. HRSA states that this design is expected to keep cash-flow impact minimal for covered entities generally.

NCUIH appreciates HRSA’s engagement on this issue and has shared with the agency that a 10-day rebate window may still pose challenges for Indian Health Care Providers operating on tight margins, particularly if a rebate claim is denied and enters an appeals process, which could further delay payment. NCUIH’s analysis shows that UIO 340B participants’ cash outlay could rise by as much as $342,716.14 annually under this model. Twenty-five of the 41 IHS-funded UIOs currently participate in the 340B program, and many operate with limited cash reserves and narrow margins that leave little capacity to absorb delayed rebate payments.

Tribes and Indian Health Care Providers have engaged in advocacy on HRSA’s 340B Rebate Model Pilot Program since it was announced, and across both iterations of the proposed program. NCUIH has consistently advocated for an exemption for Indian Health Care Providers, including UIOs.

In December 2025, NCUIH sent a letter to HRSA Administrator Thomas J. Engels requesting an exemption for UIOs and Indian Health Care Providers from the Pilot, and published a press release and one-pager on the issue, impact, and policy ask.

In April 2026, NCUIH submitted formal comments to HRSA requesting an exemption for Indian Health Care Providers, including UIOs, consistent with requests developed alongside the HHS Secretary’s Tribal Advisory Committee (STAC) and the CMS Tribal Technical Advisory Group (TTAG). See the TTAG comment letter to HRSA (April 20, 2026).

Participant Information

What: HRSA Tribal Consultation on the 340B Rebate Model Pilot Program
Date: Wednesday, September 16, 2026 Time: 3:00 – 5:00 p.m. ET
Location: Virtual (Zoom) Registration: Register here
Written comment deadline: Thursday, October 1, 2026, to tribalconsultation@hrsa.gov
Questions: Commander Sharyl Trail, Director, HRSA Office of Tribal Affairs, strail@hrsa.gov

Resources

The Need for Exemption for Indian Health Care Providers from 340B Pilot
HRSA Federal Register Notice on the 340B Rebate Model Pilot Program (August 3, 2026)

About NCUIH

The National Council of Urban Indian Health (NCUIH) is a national representative for the 41 Urban Indian Organizations contracting with the Indian Health Service under the Indian Health Care Improvement Act. NCUIH is devoted to the support and development of high quality and accessible health and public health services for American Indian and Alaska Native people living in urban areas.

NCUIH respects and supports Tribal sovereignty and the unique government-to-government relationship between our Tribal Nations and the United States. NCUIH works to support those federal laws, policies, and procedures that respect and uplift Tribal sovereignty and the government-to-government relationship. NCUIH does not support any federal law, policy, or procedure that infringes upon or in any way diminishes Tribal sovereignty or the government-to-government relationship.

NCUIH Contact: Meredith Raimondi, Senior Vice President of Policy and Communications, mraimondi@ncuih.org