Monday, January 11, 2021
On December 30, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) released an Advisory Opinion concluding that providers participating in the 340B Program (“covered entities”) are entitled to purchase covered outpatient drugs at 340B discounted prices even when those drugs are distributed by third-party contracted pharmacies (“contract pharmacies”) on the covered entity’s behalf. The Advisory Opinion responds to drug manufacturers who have recently declined to distribute 340B drugs through contract pharmacies. The Advisory Opinion is available here.
IN DEPTH
Background
Guidance issued by the Health Resources and Services Administration (HRSA) in 1996 provided that 340B covered entities may elect to sign a contract with a pharmacy to dispense drugs purchased at 340B prices to the covered entity’s patients. The 1996 guidance generally limited the contract pharmacy option to those covered entiti