HRSA announced Oct. 1 that it has approved 10 drugmakers to participate in a revised 340B Rebate Model Pilot Program, which will replace the traditional upfront 340B discount with a post-sale rebate structure for a limited set of drugs starting Jan. 1, 2027.
Here are five things to know:
- The approved manufacturers and their selected drugs are:
- AbbVie: Imbruvica, Linzess and Vraylar
- Amgen: Enbrel, Otezla and Otezla XR
- Astellas Pharma: Xtandi
- AstraZeneca: Farxiga
- Bristol Myers Squibb: Eliquis and Pomalyst
- Boehringer Ingelheim: Jardiance, Ofev and Tradjenta
- GlaxoSmithKline: Breo Ellipta and Trelegy Ellipta
- Merck: Januvia, Janumet and Janumet XR
- Pfizer: Ibrance
- Teva: Austedo and Austedo XR
- Under the pilot, covered entities will continue purchasing drugs through their existing 340B wholesaler accounts at wholesale acquisition cost, then submit limited claims data — not purchasing or full encounter-level data — within 45 days of dispense through a manufacturer-funded IT platform.
- Manufacturers must pay or deny each rebate within 10 days of a complete submission. HRSA said rebates cannot be denied over eligibility, diversion or Medicaid duplicate-discount concerns, which must instead be raised through separate audit channels. The agency plans to publish periodic implementation findings, with a final evaluation due by April 2028.
- This is a reworked version of a pilot HRSA first attempted to launch under a different framework, which a federal court in Maine vacated and remanded to the agency to reconsider.
- The AHA, which has pushed Congress to permanently bar rebate models, said in a statement it “remains deeply concerned” HHS is moving forward despite “overwhelming evidence” of new administrative and financial burdens and that it is “considering all available options to prevent this flawed program from going into effect.” The pilot’s Jan. 1 start date lands the same day CMS’s new 340B claims data repository is proposed to become mandatory and a cluster of other Medicare drug pricing changes take effect.
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