
2020 was a tumultuous year for virtually everyone and everything, and the 340B Program was no exception. As we outlined in previous articles, many drug manufacturers have decided that the Health Resources and Services Administration’s Office of Pharmacy Affairs (“HRSA OPA”) guidance on contract pharmacy[1] arrangements is no longer binding. Accordingly, many drug manufacturers have curtailed selling 340B-priced drugs based on contract pharmacy encounters, causing a significant disruption in operations and loss in revenue for all types of 340B covered entities. Finally, in keeping with the “roller coaster” nature of the year, the Department of Health and Human Services (“HHS”), the agency that generally oversees HRSA OPA, issued an Advisory Opinion on December 30, 2020[2] stating the law requires manufacturers offer 340B pricing on appropriate drugs dispensed by contract pharmacies.