SUSTAIN 340B Act

Improved Program Integrity: The bill introduces stricter rules for contract pharmacies and child sites to prevent drug diversion and duplicate discounts (Section 3-E).

Enhanced Transparency: Covered entities must make information regarding their contract pharmacy arrangements available on a Department of Health and Human Services website (Section 3-D).

Protection Against Discrimination: The act prohibits group health plans, insurance issuers, and pharmacy benefit managers from discriminating against 340B entities or pharmacies (Section 11-A).

Patient Financial Assistance: Covered entities are required to ensure their financial assistance policies are transparent and available in plain language (Section 10-A).

Standardized Patient Definitions: The bill establishes specific criteria for what constitutes a "patient" to ensure consistent application of the program (Section 4-A).

Increased Regulatory Burdens: Covered entities and contract pharmacies face new requirements for registration, annual recertification, and maintaining auditable records (Section 3-C).

New Costs for Entities: A user fee program will be established, requiring covered entities to pay quarterly assessments to fund program oversight (Section 12-A).

Strict Audit Protocols: Entities may be subject to more frequent or additional audits by the Secretary or manufacturers to ensure compliance (Section 3-E, Section 4-A).

Eligibility Delays for Child Sites: Newly acquired or constructed child sites may face a delay in their eligibility to participate in the drug discount program (Section 6-A).

Potential Sanctions: Failure to comply with new requirements or corrective action plans could lead to entities being ineligible for the program or facing civil monetary penalties (Section 4-A, Section 8-A).