Illustration: Megan Robinson / Axios
HHS submitted 340B rebate guidance this week to the Office of Management and Budget, in a sign the Trump administration is considering further changes to the drug pricing program.
Why it matters: Drugmakers, safety net providers and other stakeholders are awaiting more guidance on whether manufacturers could implement a rebate system as an alternative to upfront discounts on covered drugs.
- OMB has 90 days to review the guidance, which hasn't been made public.
Catch up quick: Johnson & Johnson, Eli Lilly and Sanofi all tried to implement rebate models in 2024 that would have no longer given upfront 340B discounts but instead would reimburse providers after the drugs are purchased and they submit documentation.
- The Biden administration's Health Resources Services Administration blocked J&J and Lilly from making the change without approval from the agency.
- The matter was tied up in subsequent litigation, with a May court decision backing the idea that HRSA should have final say.
- That leaves open the possibility that pharmaceutical companies could still potentially issue rebate models.
Between the lines: The Trump administration's proposed budget says the 340B program should be moved under CMS rather than remain under HRSA.
- Under a reorganization plan, HRSA will be moved under the newly formed Administration for a Healthy America.
