In 2020, the Health Resources & Services Administration (HRSA) waived its requirement that off-site, outpatient hospital facilities be listed as reimbursable on the hospital’s most recently filed Medicare Cost Report, and registered on the Office of Pharmacy Affairs Information System (OPAIS), prior to participating in the 340B program. This allowed hospitals to use 340B for patients of outpatient facilities that were not yet on the most recently filed Medicare Cost Report. As a result, many hospitals were able to recognize up to 18+ months of additional savings. HRSA encouraged hospitals to document situations in which the waiver was utilized and ensure that auditable records were available for any 340B drugs dispensed to patients.
On October 26, 2023, HRSA released a notice (“Notice”) confirming that this waiver has ended. In order to continue purchasing 340B drugs, offsite, outpatient hospital facilities must (1) be listed on the hospital’s most recently filed Medicare Cost Report and registered on OPAIS by the next 340B Program quarterly registration period, or (2) the hospital must notify HRSA within 90 days of the publication of the Notice that they have initiated the process of listing the outpatient facility on the hospital’s Medicare Cost Report and registering it in OPAIS. Following this 90-day grace period, non-compliant hospitals may be subject to audit and compliance action. In addition, 340B hospitals should update their policies and procedures, and hospitals that utilized the waiver should ensure that auditable records are available for any 340B drugs dispensed to patients.
Should you have any questions regarding the above, please contact the author or the Garfunkel Wild attorney with whom you regularly work, or contact us at info@garfunkelwild.com.
On October 26, 2023, HRSA released a notice (“Notice”) confirming that this waiver has ended. In order to continue purchasing 340B drugs, offsite, outpatient hospital facilities must (1) be listed on the hospital’s most recently filed Medicare Cost Report and registered on OPAIS by the next 340B Program quarterly registration period, or (2) the hospital must notify HRSA within 90 days of the publication of the Notice that they have initiated the process of listing the outpatient facility on the hospital’s Medicare Cost Report and registering it in OPAIS. Following this 90-day grace period, non-compliant hospitals may be subject to audit and compliance action. In addition, 340B hospitals should update their policies and procedures, and hospitals that utilized the waiver should ensure that auditable records are available for any 340B drugs dispensed to patients.
Should you have any questions regarding the above, please contact the author or the Garfunkel Wild attorney with whom you regularly work, or contact us at info@garfunkelwild.com.