The SUSTAIN 340B Act comprehensively reforms the federal 340B drug discount program, which allows hospitals, clinics, and other safety-net providers to purchase discounted medications from drug manufacturers to stretch limited resources and serve low-income patients. The bill strengthens program oversight through multiple mechanisms: requiring covered entities to register and annually recertify contract pharmacies, defining eligible patients as those who received care from the covered entity within two years and maintain auditable medical records, imposing regular audits of covered entities and manufacturers, and establishing penalties for noncompliance including corrective action plans and program removal. The legislation also mandates transparency through annual public reporting of patient demographics, drug purchases, charity care, and how entities use program savings, while protecting participating providers from insurance company discrimination and ensuring patients have access to clear financial assistance policies at the point of care. All provisions take effect immediately upon enactment, with the Secretary of Health and Human Services required to establish detailed rulemaking and audit procedures within one year to implement the law's requirements.
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