Dear Tribal Leader:
In response to requests from tribal leaders and tribal-serving organizations, and pursuant to Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, I am writing to initiate a Tribal Consultation regarding the Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program – Rebate Model Pilot. The Consultation will be held virtually on Wednesday, September 16, 2026, via Zoom.

On August 3, 2026, HRSA issued a Notice Regarding the 340B Rebate Model Pilot Program in the Federal Register to announce the availability of a revised 340B Rebate Model Pilot Program (Pilot). Consistent with HRSA’s 340B statutory authority, the Pilot provides a rebate mechanism through which qualifying manufacturers may effectuate the 340B ceiling price for certain drugs sold to covered entities.

The Pilot is limited to a select group of drugs and is open to qualifying manufacturers that submit plans meeting specific criteria.

During the consultation, HRSA will discuss how the Rebate Pilot will help:

• balance tribal stakeholder concerns regarding implementation of a rebate model with the agency’s goal of testing rebates in the 340B Program;
• gather data on the effectuation of the ceiling price through use of rebates;
• generate data relevant to other federal health care programs, including the Medicare Drug Price Negotiation Program; and
• improve transparency and inform future policy decisions.

In addition, HRSA welcomes concerns and input from tribes as they work to implement this important initiative.

Participant Information:
What: HRSA Tribal Consultation on the 340B Rebate Model Pilot Program
Date: Wednesday, September 16, 2026
Location: Virtual (Zoom)
Time: 3:00 – 5:00pm ET
Registration link: Consultation Registration – Zoom

If you are unable to attend, you are encouraged to send any written testimony or comments to
tribalconsultation@hrsa.gov by Thursday, October 1, 2026.

For more information, please contact Commander Sharyl Trail, Director of the HRSA Office of
Tribal Affairs at strail@hrsa.gov.

HRSA values its government-to-government relationship with tribal nations and looks forward to
engaging in meaningful consultation to better understand and consider the perspectives and
concerns of tribal partners regarding the proposed pilot program.