HRSA clarifies policy regarding registration requirements for 340B ‘child sites’

The Health Resources and Services Administration will require hospitals in the 340B Drug Pricing Program to register their off-site outpatient departments, known as child sites, with the 340B Office of Pharmacy Affairs within 90 days in order to access 340B drug pricing, the Health Resources and Services Administration announced Oct. 26. The agency said the 90-day grace period will give 340B hospitals time to register these child sites and list them on the hospital’s Medicare cost report, after which noncomplying hospitals may be subject to audit and compliance action.
HRSA provided flexibility regarding the registration of 340B child sites during the COVID-19 public health emergency, which ended in May. Three days before the end of the PHE, HRSA issued a notice instructing hospitals to stop purchasing 340B drugs at outpatient facilities that are not yet included in the hospital’s Medicare cost report and registered with HRSA. AHA then urged the agency to clarify that 340B hospitals can continue to purchase 340B drugs at off-site clinics that have not yet appeared on their most recent Medicare cost report.