News: Senators introduce 340B legislation, encouraging transparency and program integrity
A bipartisan group of United States senators introduced the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act). The bill aimed at providing statutory clarity for the 340B Drug Pricing Program while establishing new transparency, reporting, and program integrity requirements.
The bill would codify the use of contract pharmacies and require drug manufacturers to offer 340B pricing regardless of whether drugs are dispensed through a covered entity or contract pharmacy. It would also prohibit manufacturers from imposing conditions on access to 340B pricing or restricting delivery of 340B drugs to contract pharmacy locations. In addition, the bill would establish a statutory definition of a 340B patient and create new documentation, reporting, auditing, and compliance requirements for covered entities.
The bill would also terminate the Department of Health and Human Services’ (HHS) 340B Rebate Model Pilot Program within one year of enactment. It would prohibit the expansion of that pilot or any substantially similar rebate model, instead replacing it with a national data clearinghouse intended to address duplicate discount concerns.
Among other provisions, the bill includes:
- New reporting, registration, and recertification requirements for contract pharmacies and child sites
- Expanded auditing authority
- A user-fee program beginning in fiscal year 2031 to support the Health Resources and Services Administration’s oversight and program integrity activities
Editor’s note: To read the full bill, click here. To read additional coverage from the American Hospital Association, click here.