Article
The rulings
On Feb. 10, the US District Court for the District of Maine vacated HRSA’s voluntary 340B rebate pilot, which was set to begin Jan. 1 for drugs selected for Medicare price negotiation, finding the agency had not followed Administrative Procedure Act requirements. Manufacturers must continue to provide upfront discounts.
On March 3, the US District Court for the District of Columbia ruled for more than 40 hospitals and health systems led by Albany Med Health System. The court vacated HRSA’s October 2023 notice requiring off-campus child sites to appear on a hospital’s most recent Medicare cost report and be registered in the program database before using 340B drugs. It found the requirement contrary to the statute and beyond HRSA’s authority.
What changes, and what does not
For hospitals opening new outpatient sites, the child site decision removes a waiting period tied to cost report timing, so eligible sites may be able to use 340B pricing sooner. Every other program rule still applies, including patient definition, diversion and duplicate discount requirements. Legal advisers recommend continuing to register sites for transparency and audit readiness. Whether HRSA will appeal is not yet known.
The Maine ruling does not end the rebate debate. HRSA issued a request for information on rebates in February, with comments due April 20, and the AHA has reported that the agency may pursue a broader model through 2027. Separately, CMS is surveying hospitals’ acquisition costs for outpatient drugs, including 340B drugs bought from July 2024 through June 2025, and the results could inform payment policy as early as 2027.
Action items
- Revisit timing and financial projections for planned outpatient sites in light of the child site ruling.
- Submit comments on the rebate request for information by April 20, with data on cash flow and administrative effects.
- Make sure responses to the CMS acquisition cost survey are accurate and complete, since they may shape future payment rates.
- Keep compliance programs audit-ready; manufacturers may lean more on audits and contract pharmacy limits as HRSA’s front-end reviews narrow.
Archive entry for Mar 16, 2026, added Nov. 11, 2026.