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HRSA Issues Guidance on 340B Hospital Off-Site Locations

New guidance from the Health Resources and Services Administration (HRSA) addresses eligibility of hospital off-site locations for 340B Drug Pricing Program discounts.

The guidance, which HRSA issued as an FAQ document on its COVID-19 resource page, states 340B hospitals may begin using 340B drugs for patients seen at off-site locations before the hospitals officially register these clinics in the Office of Pharmacy Affairs Information System.

Under HRSA’s standing policy, 340B hospitals can use 340B drugs for patients seen at off-site, outpatient clinics provided the hospital has registered these clinics. Specifically, HRSA requires a hospital’s off-site, outpatient clinic appear on a reimbursable line of the hospital’s cost report and have associated costs and charges. A hospital can register the off-site clinic once it files the cost report showing the off-site clinic as reimbursable. Due to the requirement that the off-site location appear on a recently filed cost report, there can be a months-long lag time between the time a hospital opens an eligible clinic and when it can officially register the clinic.

HRSA’s new guidance allows hospitals to immediately administer or prescribe 340B drugs to patients of these off-site locations when they become a part of the hospital, as opposed to waiting for cost report filing. This is an important step that will allow hospitals access to 340B discounts at new off-site locations in a timely manner.

HRSA notes in its guidance that hospitals still must meet all other 340B requirements, such as the patient definition, when dispensing drugs at these locations. Hospitals should ensure they keep auditable records for each patient dispensed a 340B drug and clearly document their practice of using 340B drugs for patients of these off-site locations in their policies and procedures.

Although the guidance appears on HRSA’s COVID-19 flexibilities resource page, America’s Essential Hospitals has confirmed this guidance is intended to last beyond the duration of the public health emergency. While hospitals can begin using 340B drugs immediately at eligible off-site locations, they still must officially register these locations so they are listed in OPAIS once they appear as reimbursable on a filed cost report.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.



About the Author

Shahid Zaman is a senior policy analyst at America's Essential Hospitals.

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