In about two months, hospitals will start paying full price up front for 21 drugs and waiting for their 340B discounts to come back as rebates, unless a court or Congress stops the change first.
Here are five questions hanging over the pilot:
1. What changes Jan. 1? HRSA approved rebate plans from 10 drugmakers covering 21 drugs for its revised 340B Rebate Model Pilot Program. The drugmakers are AbbVie, Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, GSK, Merck, Pfizer and Teva. Covered entities will keep buying through their 340B wholesaler accounts, but at wholesale acquisition cost. They will then submit limited claims data within 45 days of dispensing through a platform the manufacturers fund. Manufacturers must pay or deny each rebate within 10 days of a complete submission. They cannot deny a rebate over concerns about eligibility, diversion or duplicate discounts; those disputes go through a separate audit process. All 21 drugs come from the Medicare drug price negotiation lists, including Eliquis, Jardiance and Imbruvica.
2. Why do drugmakers want rebates? Drugmakers say the model will stop them from paying both a 340B discount and a Medicare negotiated price on the same drug. In its bid to join the hospitals’ lawsuit, PhRMA said its members could pay $5.2 billion in duplicate discounts in 2027 alone. It also said one manufacturer paid out millions of dollars a week in duplicate discounts in early 2026.
3. Will a court block it again? Hospitals have stopped a version of this pilot before. A federal judge in Maine blocked HRSA’s first version in December 2025, and the government withdrew it in February. On Oct. 9, the AHA, the Maine Hospital Association and four hospitals sued in the same court, arguing that HHS and HRSA ignored their feedback, including warnings that the pilot could cost hospitals more than $1 billion a year. The plaintiffs are Bangor, Maine-based Eastern Maine Medical Center, Gloversville, N.Y.-based Nathan Littauer Hospital & Nursing Home, Grafton, N.D.-based Unity Medical Center and Fordyce, Ark.-based Dallas County Medical Center. They have asked for a temporary restraining order before the Jan. 1 start date. AbbVie, Bristol Myers Squibb, Boehringer Ingelheim and PhRMA have moved to intervene in the case to defend the approved plans.
4. Will Congress delay it? A bipartisan House bill, the 340B Rebate Model Delay Act, would require drugmakers to keep providing upfront 340B discounts through Dec. 31, 2028. It would also bar the use of federal funds to carry out the pilot or a substantially similar program during that period. Reps. Rob Bresnahan, R-Pa., Debbie Dingell, D-Mich., Tracey Mann, R-Kan., and Lois Frankel, D-Fla., introduced the bill, and the AHA has endorsed it. It joins a broader wave of 340B legislation introduced this year.
5. How much is at stake? The 21 drugs represent less than 5.5% of total 340B sales in 2025, according to HRSA, and upfront discounts remain in place for every other drug. Hospitals see a bigger risk: If the model holds up in court, it gives drugmakers a federally approved path to rebates that could eventually cover far more of the program.
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