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  • Washington Highlights

    HRSA Issues Notice Regarding 340B Off-Site Facility Policy


    Katherine Gaynor, Hospital Policy and Regulatory Analyst
    For Media Inquiries

    The Health Resources and Services Administration (HRSA) issued a notice on Oct. 26 ending a waiver related to the 340B Drug Pricing Program that allowed for flexibilities during the COVID-19 PHE in registering off-site outpatient facilities, also known as child sites. With these flexibilities, hospitals could offer 340B-covered outpatient drugs to eligible patients at new off-site outpatient facilities before they appeared on their most recently filed Medicare Cost Report (MCR). However, this notice will roll back this flexibility, and hospitals will have 90 days to return to compliance. Under this policy, 340B hospitals must report their off-site outpatient facilities as reimbursable on the covered entity’s most recently filed MCR, along with listing any associated costs and charges for the facility on the report. These sites must also be registered in the Office of Pharmacy Affairs Information System (OPAIS) as a child site of the covered entity.  

    The notice provides a transition period for covered entities to come into compliance. If a hospital has an off-site outpatient facility currently listed on the hospital’s most recently filed MCR but has not yet registered in OPAIS, then the facilities must be registered in the database during the next 340B quarterly registration period (Jan. 1-16, 2024). If the facilities are not registered during this period, the hospital may be subject to audit and compliance action. For facilities that are not listed on the MCR but were opened and began using 340B drugs prior to the publication date of the notice, 340B drugs can still be utilized at this facility if they provide HRSA with a written notification, including the date when the facility will be listed on the MCR, within 90 days of the notice. Sites that fail to comply with these requirements by Jan. 25, 2024, must stop using 340B-covered outpatient drugs.