Overview
- Senate HELP members say they are close to introducing 340B legislation and want a markup before year-end.
- A working draft would require manufacturers to honor discounts for covered entities using contract pharmacies and mandate annual HHS registration of those sites.
- The proposal would tighten eligibility for off-site clinics by requiring child sites to be wholly owned as well as clinically and financially integrated with parent providers.
- HRSA announced a voluntary pilot starting Jan. 1, 2026, allowing manufacturers of 10 high-cost medicines to replace upfront discounts with after-the-fact rebates, a shift hospitals warn could strain finances.
- Debate continues over program impact as the CBO links current design to higher-cost prescribing and consolidation, drugmakers challenge contract-pharmacy use in court, and patient advocates press for transparency and savings reaching patients.