On May 28, 2024, Rep. Larry Bucshon (R-IN) introduced the “340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act.” This legislation is the latest bill introduced in the House attempting to clarify the intent and operations of the 340B drug discount program administered by the Health Resources and Services Administration (HRSA). It also comes one year after the House Energy and Commerce Committee reported out of committee H.R 3290, a bill that if enacted, would require 340B hospitals to annually report total 340B savings, patient demographics and charity care information. The full House has yet to act on that legislation. Rep. Bucshon’s legislation would:

• Establish patient affordability and hospital eligibility requirements;
• Codify a patient definition in statute and clarify which drugs could qualify for 340B discounts;
• Recognize contract pharmacies and add new requirements for manufacturers to ship or facilitate delivery of 340B drugs to contract pharmacies;
• Implement statutory standards for child site eligibility and require covered entities to demonstrate to the Department of Health and Human Services (HHS) Secretary that each child site satisfies new standards prior to participating in the program;
• Impose restrictions on pharmacy benefit managers, contract pharmacies, third-party administrators and for-profit entities; and
• Require grantees to report how they use 340B margins using rules established by HHS that are consistent with reporting requirements that federally qualified health centers use for Uniform Data System reporting.

Because of the 340B program’s growth and efforts by drug manufacturers to place restrictions on 340B covered entities that distribute 340B drugs using contract pharmacies, as well as a lack of transparency, Congress has become concerned about how the program has operated. Some reports suggest that the program is no longer fulfilling its original intent of lowering drug costs for low-income patients and is rather generating additional profits for hospitals and health systems. In addition, there have been a number of lawsuits concerning various aspects of the 340B program. The American Hospital Association and 340B Health argue the Bucshon legislation would limit hospital eligibility for the program and eliminate resources needed to curb drug price hikes. However, the National Association of Community Health Centers and the Alliance to Save America’s 340B Program support the legislation because they believe it would ensure the program benefits patients in underserved communities and recognize the important role of contract pharmacies. The House Energy and Commerce Subcommittee on Oversight and Investigations recently held a hearing to discuss the 340B program focusing on what the definition of a patient should be under the 340B program and the role of contract pharmacies as well as other challenges affecting the program.