Sponsors (6)
The bill strengthens 340B program oversight, transparency, and patient access protections while imposing substantial new reporting, audit, and compliance requirements (and fees) that risk raising administrative costs and disrupting access for some providers and patients—particularly small, rural, or resource‑constrained safety‑net providers.
Low‑income, uninsured, Medicaid, and chronically ill patients retain and in many cases gain clearer, more consistent access to 340B‑discounted outpatient drugs and point‑of‑care financial assistance (including use of contract pharmacies, mail/delivery, and documented referral pathways).
The 340B program would get substantially stronger oversight and integrity protections through new funding, OIG audits, HHS enforcement authority, a centralized data clearinghouse, and expanded audit/recertification powers, improving accountability and deterring improper use of discounts.
Patients and the public gain greater transparency: covered entities must publish plain‑language financial assistance policies, and the bill requires public/reporting and studies that make 340B usage, prescription counts, and patient financial mixes visible to policymakers and researchers.
Hospitals, clinics, and contract pharmacies will face large, widespread new administrative, reporting, recertification, record‑retention, and compliance burdens—requiring staff time, systems changes, and ongoing costs that could divert resources from patient care.
Stricter eligibility rules, documentation requirements, audit authority, and possible deregistration create a real risk that some patients (including Medicaid and other low‑income patients, people receiving infusion/home therapies, or patients at newly acquired/remote sites) could lose access to 340B‑priced drugs or face new barriers to filling prescriptions.
Smaller, rural, or resource‑constrained safety‑net providers and nonprofit hospitals are disproportionately exposed to fees, audit risk, data‑reporting burdens, and potential loss of participation—threatening their financial viability and the services they provide to vulnerable populations.
Based on analysis of 15 sections of legislative text.
Tightens 340B program oversight: new transparency, reporting, audits, nondiscrimination rules, a data clearinghouse, user fees, and penalties to prevent duplicate discounts.
Official title: Amend the Public Health Service Act with respect to the drug discount program, and for other purposes.
Introduced August 5, 2026 by Jerry Moran · Last progress August 5, 2026
Strengthens oversight, reporting, and auditing of the 340B drug discount program, requires covered entities to publish patient financial assistance policies, creates a nationwide 340B data clearinghouse, imposes nondiscrimination rules on plans and PBMs, and establishes a user-fee to fund program administration. It also tightens rules for child sites and contract pharmacies, mandates multiple studies and GAO reports, increases HHS audit authority and civil monetary penalties, and authorizes additional funding for implementation and OIG oversight.