ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act (FCA) through a variety of priority enforcement areas. Especially pertinent to the life sciences industry are drug, device, and biologics pricing (e.g., discounts, rebates, formulary/service fees, and related activities), kickbacks related to drugs and device, and electronic health record manipulation. While the industry is familiar with FCA enforcement in these areas, this announcement further validates our prediction for the administration's increased and creative enforcement priorities out of DOJ and HHS, citing a mandate to seek new leads and leverage resources through "enhanced data mining."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
