Sponsors (2)
Official title: To amend the Public Health Service Act to reform the 340B drug pricing program, and for other purposes.
Introduced September 10, 2025 by Buddy Carter · Last progress September 10, 2025
The bill strengthens 340B transparency, targeting, and patient affordability protections while imposing substantial new reporting, compliance, and penalty risks that could disproportionately strain smaller safety‑net providers and raise privacy and financial exposure concerns.
Hospitals, clinics, manufacturers, and policymakers will have much more transparent, standardized site- and program-level data on 340B discounts, margins, grant/contract sources, and spending uses, improving oversight and enabling research, policy targeting, and public accountability.
Low-income, uninsured, and Medicaid/Medicare patients will gain clearer, enforceable access to 340B discounts and lower point-of-sale costs (including $0 or capped copays and protections against PBM/insurer interference), preserving affordability and access to medicines for underserved populations.
Hospitals and other covered entities that comply will face clearer enforcement standards, audits, and deterrents (civil monetary penalties, OIG authority) that strengthen program integrity and reduce diversion or improper 340B use.
Hospitals, clinics, contract pharmacies, and covered entities will face large new administrative, IT, reporting, and compliance burdens (claim-level reporting, grant documentation, registrations, audits) that raise operating costs and require staff/time investments.
Smaller safety‑net providers and rural or resource‑constrained hospitals are at elevated risk of losing 340B participation (deregistration, audit findings, repayment obligations) or diverting clinical resources to compliance, which could reduce services and access for low‑income patients.
Collecting and publishing detailed claim-, patient-, grant-, and contract-level information increases patient privacy and re‑identification risks and exposes proprietary or commercially sensitive information about hospitals and subgrantees to manufacturers and the public.
Based on analysis of 38 sections of legislative text.
Overhauls 340B program rules—adds public site-level reporting, audits, child-site/contract-pharmacy limits, patient sliding-fee caps, a claims clearinghouse, and penalties for noncompliance.
Establishes new transparency, audit, registration, and patient-affordability rules for the 340B drug discount program. It requires covered entities to report site-level costs and margins, register child sites and contract pharmacies, adopt sliding-fee scales for low-income patients, submit contracts and grant scope documentation, create a claims data clearinghouse, limit certain contract pharmacy arrangements and third-party payments, and authorizes civil monetary penalties and HHS audits and enforcement. Most provisions impose new reporting, recordkeeping, audit, and compliance obligations on hospitals, nonhospital covered entities, contract pharmacies, TPAs, State Medicaid programs, and manufacturers; create a publicly searchable data publication; and preempt conflicting state or local laws. Many HHS rulemaking and implementation deadlines are short (60–365 days) and the Act generally takes effect one year after enactment unless otherwise specified.