[authors: Elizabeth S. Elson, Anil Shankar, Judith A. Waltz, Brandon O. Young]
In recent months, increased scrutiny from U.S. Congress, the Government Accountability Office (GAO), and pharmaceutical manufacturers has led the Health Resources and Services Administration (HRSA) to increase its enforcement efforts with respect to covered entities participating in the 340B Drug Pricing Program (340B program). As a result, participating 340B-covered entities (including disproportionate share hospitals, federally qualified health centers and look-alikes, and others as discussed below) should be aware of the recent changes to the enforcement environment, including recertification requirements, and should review their policies and procedures to ensure ongoing compliance with 340B program requirements.