HRSA is testing a change that could require Tribal health clinics to pay more upfront for certain prescription drugs, then claim their 340B discount afterward. This is the agency’s second attempt, since a federal district court vacated HRSA’s earlier pilot notice on February 10, 2026, and HRSA withdrew it before issuing a revised version in August.
340B is a federal program that lets eligible health providers buy outpatient drugs at reduced prices. HRSA, the federal Health Resources and Services Administration, runs the program.
For example, suppose a clinic’s 340B price for a medicine is $60, while its price without that discount is $100. The clinic ordinarily pays $60 when it buys the medicine. Under the pilot, it could pay $100 first, submit information about the drug it provided, and receive the $40 difference later as a rebate.
The pilot could apply to certain drugs selected for Medicare price negotiation in 2026 and 2027. Being on that list doesn’t automatically put a drug in the pilot; HRSA must approve the manufacturer’s plan. The eligible drugs include medicines for:
- Diabetes and weight management, such as Jardiance, Ozempic, and Wegovy.
- Heart conditions and blood clots, such as Entresto and Eliquis.
- Asthma and chronic lung disease, such as Breo Ellipta and Trelegy Ellipta.
- Cancer, such as Ibrance and Xtandi.
For an affected clinic, the question is how it pays the higher purchase price while waiting for the rebate, and how much work it takes to obtain it. HRSA’s rules would give clinics at least 45 days after dispensing to submit the required data. A manufacturer would then have 10 calendar days after a complete submission to pay the rebate or provide a documented denial. If information is missing, that 10-day clock starts over when the submission is completed. HRSA’s pilot notice; Medicare’s selected drug lists.
The National Council of Urban Indian Health (NCUIH) estimates that under the rebate model, the cash outlay for urban Indian organization 340B participants could rise by as much as $342,716 a year for clinics that, in NCUIH’s words, “operate with limited cash reserves and narrow margins that leave little capacity to absorb delayed rebate payments.” NCUIH has shared an information sheet explaining its position that Indian health care providers should be exempted from the pilot. A link to the information sheet is below.
HRSA is consulting Tribal leaders today, September 16, from 3–5 p.m. ET, about how the pilot would affect Tribal health programs and whether its payment and reporting procedures are workable. Written comments are due October 1. The consultation invitation includes the registration link and address for comments. Approved manufacturer plans are scheduled to take effect January 1, 2027.
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’re unable to attend, you’re 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.
Additional Resource
NCUIH: The Need to Exempt Indian Health Care Providers from HRSA’s 340B Rebate Model Pilot
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