On March 12, Rep. Doris Matsui (D-Calif.) introduced the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2024 (340B PATIENTS Act, H.R. 7635), which would codify covered entities’ ability to use contract pharmacy arrangements to dispense covered outpatient drugs. The legislation, which is supported by the AAMC, the American Hospital Association, 340B Health, and others, would impose civil monetary penalties on pharmaceutical manufacturers found to violate these statutory protections.
Since 2020, an increasing number of pharmaceutical manufacturers have imposed restrictions on covered entities’ ability to use community-based contract pharmacies to distribute 340B-disounted drugs to patients, resulting in financial losses for these safety-net providers. In 2021, the Health Resources and Services Administration issued letters to six pharmaceutical manufacturers informing them that such restrictions are in “direct violation of 340B statute,” prompting legal action by the pharmaceutical industry [refer to Washington Highlights, May 21, 2021]. The AAMC indicated its support for legislatively clarifying and codifying protections for contract pharmacy arrangements in its response to a June 2023 request for information issued by the Senate Gang of Six [refer to Washington Highlights, July 28, 2023].
- Washington Highlights