Momentum Builds for 340B Reform with New Congressional Focus

For years, the 340B Drug Pricing Program has faced scrutiny over its rapid expansion and the growing disconnect between revenue generation and genuine patient care. With inquiries circulating, it is clear Congress is concerned about the trajectory of the program. Now, lawmakers in both the House and the Senate are taking concrete steps toward structural reform.

U.S. Senator Bill Cassidy (R-La.), Chairman of the Senate HELP Committee, recently released a legislative discussion draft for the 340B Drug Pricing Integrity and Affordability for Patients Act, aiming to overhaul the program. The draft bill builds on the recent Senate investigations into third-party vendors and hospital revenue practices. Shortly after, Representatives Scott Peters (D-CA) and Dr. John Joyce (R-PA) introduced the bipartisan SECURE 340B Act in the House.

Both proposals target the program’s historical lack of oversight and aim to enact transparency measures that restore the original intent of 340B.

Defining the Patient Over the Entity

A core issue plaguing 340B has been a lack of regulatory and definitional certainty regarding who qualifies as a patient. Both the Senate and the House bills prioritize establishing a clear, statutory definition of a 340B patient to ensure the program explicitly serves eligible individuals rather than boosting the revenue of covered entities. to date have shown that some 340B hospitals have directed resources to wealthy areas while services in low-income communities.

Ground-Level Policy Details

Administrative tweaks to 340B have historically served as surface-level, temporary attempts at necessary structural reform. New legislative pushes, however, are a significant move to codify the long-overdue accountability measures:

• Direct Patient Savings: The Senate draft establishes a new sliding fee scale for low-income patients served by hospital covered entities, ensuring participants cannot price patients out of vital medications.
• Clearinghouse & Duplicate Discounts: The House SECURE 340B Act directs the Health Resources and Services Administration (HRSA) to use an independent, conflict-free clearinghouse to securely manage prescription-level data, verify claims, and block duplicate discounts. The Senate draft also operationalizes existing requirements to similarly block duplicate discounts.
• Rebate Models & Contract Pharmacies: The House bill pauses manufacturer rebate models for four years while the new patient definition is formalized. Concurrently, the Senate draft limits practices by middlemen and contract pharmacies that siphon revenue away from patients.
• Transparency & Oversight: Both bills mandate clear reporting on how 340B revenue is generated and utilized, while strengthening HRSA’s regulatory authority. The Senate draft further reforms the 340B Prime Vendor Program to give entities true choice and target anti-competitive behavior.

Addressing 340B’s Unchecked Growth

With 340B drug purchases reaching a record of over $100 billion in 2025 — a 23% increase from 2024 — the Congressional Budget Office notes that misaligned incentives continue to drive up costs for taxpayers and patients.

The introduction of these comprehensive proposals signals that Congress is recognizing that accountability is needed. The Senate HELP Committee is seeking stakeholder feedback on its draft through August 28, 2026, while the House bill leverages bipartisan calls for reform to lay the groundwork for structural changes — what may collectively land as the largest shift toward accountability in the 340B program’s history.