Mid-August to mid-September marks the time every year when hospitals need to recertify for 340B. Failure to recertify in time could cost a hospital its ability to participate in 340B. 340B Health Senior Manager of Policy and Compliance Rebecca Swartz joins us to walk listeners through the process.

Why recertification is “exceptionally important”

Swartz says annual recertification is not just important, it’s also one of the central tenets of 340B compliance. All hospital types except critical access hospitals need to make sure they’re meeting the minimum disproportionate share percentage threshold. Hospitals also need to affirm that they are non-profit facilities and that all their registered parent and child sites continue to have reimbursable outpatient costs and charges on their Medicare cost reports.

The cost of losing eligibility is high

Failure to recertify 340B eligibility in a timely manner can lock hospitals out of their access to 340B pricing for a year or more. That could deprive a hospital of crucial resources to provide the care and support its patients need.

Tips for a smooth recertification

Swartz says a key to making the process go smoothly is to start early and make sure hospital officials have the necessary worksheets and other documentation before the recertification process begins. Authorized officials and primary contacts should be on the lookout for returned tasks from HRSA and other messages to ensure their recertification process is complete. Taking screenshots of each step of the process also can help identify and fix discrepancies that might arise.

Resources

1. Annual Hospital Recertification Began August 11
2. 340B Health Webinars
3. HRSA Announces 340B Rebate Pilot Program for up to 10 Drugs in 2026 
4. 340B Health Responds To HRSA 340B Rebate Pilot Program