Bass, Berry & Sims attorney Jeff Davis authored an article for the American Health Law Association (AHLA) discussing the Health Resources and Services Administration’s (HRSA) approval of a new 340B Rebate Pilot Program. Under the Pilot Program, drug manufacturers will be allowed to offer 340B-discounted drug prices through rebates for ten approved drugs in 2026. This will replace the existing upfront discount model currently in place for these select drugs.
The drug manufacturers have chosen to use the Beacon Platform to implement the rebate plans. As Jeff outlined in the article, “Starting January 1, 2026, all covered entities must purchase the nine drugs covered by the rebate plans at wholesale acquisition cost (WAC) pricing and then submit a rebate request through the Beacon Platform after dispensing or administering a drug to a 340B-eligible patient.” Since publication of the article, HRSA approved a rebate plan for another manufacturer covering a tenth drug, effective April 1, 2026.
In response to concerns from covered entities that drug manufacturers could deny rebates, Jeff stated that “HRSA advised manufacturers that they may not deny rebates based on concerns about 340B program non-compliance. However, the manufacturer rebate plans indicate they will issue rebates only after validating that a dispense is through an approved contract pharmacy location under the manufacturer’s contract pharmacy, and manufacturers may deny rebates if a covered entity does not submit the rebate request consistent with the manufacturer’s instructions.”
While the Pilot Program has been approved by HRSA, additional rebate models are being challenged in court. Jeff recapped HRSA’s position about expanding the program, saying “HRSA has also said it will assess the Pilot Program and may consider expanding it to other drugs in the future.”
The full article, “HRSA Approves 340B Drug Rebate Plans to Start January 1,” was published by AHLA’s Regulation, Accreditation, and Payment Practice Group on November 13 and is available online (subscription required).