Having passed the halfway point of 2019, recent reporting on Department of Justice (DOJ) settlement amounts under the False Claims Act (FCA) points to a slight increase from the same period in 2018.
Thus far, DOJ has accounted for over $750 million in FCA settlements—predominantly from health care and pharmaceutical entities. Also, as in past years, alleged violations under both the Anti-Kickback Statute and the Stark Law account for the lion’s share of settlement dollars. One of the largest settlements was with Insys Therapeutics, Inc., for $225 million as a result of DOJ enforcement actions related to the company’s alleged kickback and other unlawful marketing practices of Subsys, a powerful and highly addictive opioid painkiller.
DOJ continues to pursue a robust enforcement policy in the healthcare and pharmaceutical arena, with no signs of decline in activity, so perhaps this is an appropriate time to issue a reminder regarding DOJ’s guidance pertaining to the assessment of corporate compliance programs, set out in our client alert, “DOJ Criminal Division Releases Guidance on Evaluation of Corporate Compliance Programs.”
The FisherBroyles Pharmacy and Health Care Law team is pleased to keep you updated on events of interest to those in the healthcare, medical device, and pharmaceutical industries. For a review of your existing compliance program or the creation of a new one, please contact any member of the listed attorneys.