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May 12, 2023

HRSA Says COVID Flexibility About Dispensing 340B Drugs in Unregistered Hospital Offsite Locations Will End Thursday

HRSA said late last Friday that, when the COVID-19 public health emergency (PHE) ends on May 11, so too will the policy of permitting hospitals to dispense 340B drugs at offsite outpatient clinics not yet registered with the 340B program. HRSA had previously required a hospital off-site outpatient facility to be listed as reimbursable on the hospital’s most recently filed Medicare cost report in order to be registered for the 340B program. However, in the past, hospitals complained that it took a significant amount of time to become 340B-qualified under this policy. During the pandemic, HRSA allowed flexibilities to the policy, allowing hospitals that were unable to register to still dispense 340B drugs to patients of a 340B-covered entity, and only requiring the hospital to maintain records for each patient to which drugs were dispensed. HRSA had previously advised in mid-2020 that the flexibility would stay in place, regardless of the pandemic, but it appears that the agency has walked back this decision and will proceed under the old policy once the PHE ends. 

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