Senate and House Lawmakers Unveil Competing 340B Reform Proposals

For years, debates over the 340B Drug Pricing Program have played out primarily through litigation, agency guidance, and stakeholder advocacy. Congress, by contrast, has largely remained on the sidelines. That may be changing. Within two weeks, lawmakers in both chambers released significant reform proposals that would address some of the program’s most disputed issues, including patient eligibility, contract pharmacies, transparency requirements, and pricing mechanisms.

On June 25, Senate HELP Committee Chairman Bill Cassidy released a discussion draft of the 340B Drug Pricing Integrity and Affordability for Patients Act (“340B for Patients Act”). Less than two weeks later, a bipartisan group of House Energy and Commerce Committee members introduced the Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency in 340B Act (“SECURE 340B Act”). The proposals are notable not only for their timing, but also for their level of detail. At approximately 88 pages and 142 pages, respectively, they reflect extensive legislative development across many of the issues that have defined recent 340B policy discussions. Although the two proposals differ in important ways, both reflect growing bipartisan interest in codifying rules that have been the subject of years of regulatory uncertainty and litigation.

Where the Proposals Align

Both proposals would narrow and formalize the definition of a 340B patient, generally requiring a documented provider-patient relationship and an outpatient encounter within the previous 24 months. Both would also establish statutory frameworks for contract pharmacy arrangements (discussed below), expand transparency requirements, and impose new compliance obligations on covered entities.

The proposals similarly share a focus on demonstrating patient benefit. Each includes patient-affordability provisions aimed at ensuring that 340B savings translate more directly into reduced patient costs.

Where They Differ

The most significant differences for drug manufacturers involve discounting methodology and contract pharmacies. Those differences come against the backdrop of a broader debate over the role of rebates in the 340B Program. Beginning in 2024, several manufacturers sought to replace traditional upfront discounts with rebate-based models that would require covered entities to purchase drugs at a higher price and later receive a rebate equal to the difference between that price and the 340B ceiling price. Those efforts prompted litigation over HRSA’s authority to approve or reject rebate models, an issue that is still under review at the appellate level. The manufacturer rebate initiatives also led HRSA to establish a limited rebate model pilot program in 2025, although that pilot program was subsequently vacated on Administrative Procedure Act grounds and remanded to HHS by a federal district court. HRSA is still contemplating a possible rebate alternative, having issued a request for information on a rebate model earlier this year.

The Senate’s 340B for Patients Act would permit manufacturers to provide 340B pricing through upfront discounts, rebates, or an HHS-administered claims repository. The SECURE 340B Act instead would continue the current requirement of upfront discounts and impose a four-year moratorium on rebates while establishing an independent clearinghouse to validate claims and prevent duplicate discounts. The bill ties continuation of the moratorium to the clearinghouse’s performance, effectively making the future availability of rebates dependent on the success of that data infrastructure.

The proposals also differ sharply on contract pharmacies. The Senate draft would limit disproportionate share hospitals, free-standing cancer hospitals, and rural referral centers to five contract pharmacy arrangements and generally require those pharmacies to be located within the covered entity’s service area. The House bill imposes no such limits and would prohibit manufacturers from restricting access based on a covered entity’s use of contract pharmacies.

The House proposal also addresses a wider range of patient-facing issues, combining financial-assistance requirements with provisions related to medical-debt collection and reporting practices.

Neither proposal addresses another significant issue currently facing the 340B Program: Medicare reimbursement. On July 2, CMS proposed reducing Medicare Part B reimbursement for 340B-acquired drugs from ASP plus 6% to ASP minus 33.4% beginning in CY 2027. The proposal follows an acquisition-cost survey conducted by CMS and revisits a longstanding policy dispute that culminated in the Supreme Court’s 2022 decision, in American Hospital Association v. Becerra, 596 U.S. 724, invalidating the agency’s previous reimbursement cuts. While reimbursement policy is distinct from the reforms contemplated by the Senate and House proposals, the CMS rulemaking underscores that key questions regarding the scope and operation of the 340B Program remain under active consideration across multiple branches of government.

Why It Matters

Manufacturers, covered entities, contract pharmacies, and third-party administrators all face meaningful policy implications under either Congressional proposal. For manufacturers, the principal questions concern rebate models, claims verification, and contract pharmacy access. For covered entities, the proposals would create substantial new reporting, audit, and compliance obligations. Contract pharmacies and TPAs would also need to adapt to new statutory requirements governing participation, data reporting, and compliance oversight.

Perhaps most importantly, the emergence of detailed proposals from both the Senate and House suggests that congressional interest in 340B reform has moved beyond oversight and into active legislative development. The Senate discussion draft can be viewed as a natural outgrowth of Chairman Cassidy’s multi-year investigation of the program and the Senate HELP Committee’s 2025 report, which called for greater transparency, clearer patient-benefit standards, increased oversight of contract pharmacy and TPA arrangements, and more explicit statutory direction for program administration. Whether either proposal will advance in its current form remains uncertain. Taken together, however, they suggest that congressional attention is increasingly focused on establishing clearer statutory rules for a program that has long been shaped by agency guidance, administrative action, and litigation.

Looking Ahead

Chairman Cassidy has requested stakeholder feedback on the Senate discussion draft (with comments due August 28, 2026), while the SECURE 340B Act begins the normal legislative process in the House. As those discussions continue, attention will likely focus on whether Congress can reconcile the competing approaches to rebates, claims administration, and contract pharmacy oversight. For now, the proposals offer an early look at the policy issues that appear to be attracting the greatest congressional attention, including patient eligibility, contract pharmacies, transparency, and program administration.