HRSA approves 10 drugmakers for revised 340B rebate pilot program covering 21 drugs

The Health Resources and Services Administration approved a revised 340B rebate pilot program starting January 1, 2027, allowing 10 drugmakers, including AbbVie, Merck, and Pfizer, to transition upfront discounts on 21 drugs to back-end rebates. While the Trump administration supports the pilot to curb program fraud and waste, hospital groups strongly oppose the changes, warning that drugmakers may improperly deny valid rebates that typically save safety-net providers 25% to 50%.

Timeline and scope of the pilot

• ▪A federal judge blocked the Health Resources and Services Administration's first attempt to launch a 340B rebate pilot in 2025 following a lawsuit filed by hospital groups.
• ▪The Health Resources and Services Administration approved a revised 340B rebate pilot program allowing 10 drugmakers to shift drug discounts to back-end rebates starting January 1.
• ▪The Health Resources and Services Administration's revised 340B rebate pilot program is scheduled to run for at least one year, with a performance evaluation expected by April 30, 2028.
• ▪The revised Health Resources and Services Administration 340B rebate pilot program covers 21 drugs, an increase from the 14 drugs approved in the 2025 pilot.

Participating drugmakers and covered medications

• ▪The 10 drugmakers approved for the revised 340B rebate pilot program include AbbVie, Merck, Pfizer, Amgen, AstraZeneca, Bristol Myers, Boehringer Ingelheim, Astellas Pharma, GlaxoSmithKline, and Teva.
• ▪Johnson & Johnson and Novo Nordisk had 340B rebate plans approved in 2025 but were excluded from the revised 2026 pilot program list.
• ▪The 21 approved drugs in the pilot program include AbbVie's Imbruvica, Amgen's Enbrel, AstraZeneca's Farxiga, Bristol Myers' Eliquis, Merck's Januvia, and Boehringer Ingelheim's Jardiance.

Rules for requesting and paying rebates

• ▪To receive 340B rebates, providers must purchase drugs through wholesaler accounts, dispense them to eligible patients, and submit claim numbers, prescriber IDs, and provider IDs to the Beacon platform.
• ▪Approved drugmakers must pay verified 340B rebates within 10 days or risk having their rebate model approvals revoked by the Health Resources and Services Administration.
• ▪Under the pilot rules, drugmakers cannot deny rebates directly based on diversion or duplicate discount concerns and must instead report these issues to regulators.

Hospital opposition and concerns

• ▪Hospital groups vehemently oppose the 340B payment structure changes, arguing that drugmakers' concerns regarding fraud and waste in the discount program are overblown.
• ▪Hospitals express concern that drugmakers will deny valid 340B rebates to avoid paying discounts that typically range from 25% to 50% off list prices.

Eliquis sales revenue

• ▪Eliquis is the top-selling drug for Bristol Myers, accounting for more than 30% of the drugmaker's total United States revenue in 2025.
• ▪Bristol Myers' blood thinner Eliquis, which is subject to the 340B rebate pilot, generated $10.2 billion in United States sales in 2025.

Debatable claims

• ▪Expanding the 340B rebate pilot to 21 drugs goes too far
• ▪Shifting 340B discounts to back-end rebates is justified to prevent program fraud
• ▪Regulators, rather than drugmakers, are the appropriate authority to police 340B compliance