A bipartisan group of senators has introduced the Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act), a comprehensive legislative proposal that would make significant changes to the 340B Program. The bill seeks to address many of the issues at the center of ongoing disputes among covered entities, manufacturers, pharmacies, and payers while establishing new compliance, reporting, and oversight requirements, in the name of transparency and program integrity.
At its core, the legislation attempts to address three of the most debated issues in the 340B Program: contract pharmacies, patient eligibility, and duplicate discount prevention.
Key Takeaways:
- Contract pharmacies would be codified in federal law. Covered entities would be expressly permitted to utilize contract pharmacies without geographic or numeric limitations. The bill would also require additional oversight among other new requirements. Manufacturers would be required to honor contract pharmacy arrangements and deliver 340B-priced drugs through those arrangements.
- A statutory patient definition would be established. The legislation creates a federal definition of an eligible 340B patient and establishes requirements governing referral prescriptions. Covered entities could continue to use 340B pricing for certain prescriptions written by referred providers, but additional documentation, auditing, and reporting requirements would apply.
- A national clearinghouse would be created to prevent duplicate discounts. The bill would establish an independent third-party clearinghouse designed to support duplicate discount prevention and program integrity efforts. The proposal would also sunset any 340B rebate model program within one year of enactment and transition oversight to the clearinghouse framework.
- Oversight and transparency requirements would expand significantly. Covered entities would be required to submit annual reports detailing their use of 340B savings, patient populations served, charity care activities, contract pharmacy arrangements, and other program information. HRSA would receive additional audit and enforcement authority, including expanded corrective action requirements for noncompliant entities.
- Additional reforms would affect child sites, patient assistance programs, payer relationships, and would introduce new oversight and transparency requirements. Finally, the legislation establishes a User Fee Program that covered entities would pay into, and the funds would be used to pay for administrative and clearinghouse costs.
Join us for a Webinar & Fireside Chat
Draffin Tucker will be hosting a webinar on Tuesday August 11, at 2:00 p.m. Eastern. We are pleased to have Jeff Davis, with Bass, Berry, & Sims, joining us to provide timely insights and discuss the early impacts if this legislation moves forward as introduced. Register to join the webinar here.