Senators introduce bipartisan 340B legislation

A bipartisan group of senators Aug. 5 introduced the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act), a bill aimed at providing statutory clarity for the 340B Drug Pricing Program while establishing new transparency, reporting and program integrity requirements. The bill was introduced by Sens. Jerry Moran, R-Kan.; Tammy Baldwin, D-Wis.; Shelley Moore Capito, R-W.Va.; Tim Kaine, D-Va.; John Boozman, R-Ark.; and John Hickenlooper, D-Colo. 

“The AHA appreciates the leadership of the Senate 340B Bipartisan Working Group,” said Aimee Kuhlman, AHA group vice president of advocacy and grassroots. “We look forward to reviewing their legislation in detail, discussing it with our 340B hospitals, and working with them and other policymakers to ensure the 340B program remains strong for patients, communities, and providers across the country.”

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 also would 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 also would terminate the Department of Health and Human Services’ 340B Rebate Model Pilot Program within one year of enactment and prohibit the expansion of that pilot or any substantially similar rebate model, replacing it instead 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 and a user-fee program beginning in fiscal year 2031 to support the Health Resources and Services Administration’s oversight and program integrity activities.