The number of health care fraud settlements between the U.S. Department of Justice and drug and device manufacturers jumped sharply in 2019, reflecting DOJ’s continued focus on fraud and abuse in the life sciences sector. More than two-thirds of settlements involved Anti-Kickback Statute violations, either directly or as the predicate for a False Claims Act resolution. This prevalence reflects DOJ’s continued shift away from enforcement premised on commercial speech and toward the financial relationships between drug and device manufacturers on the one hand, and those who purchase, prescribe or pay for their products on the other. We expect this focus on kickbacks and financial fraud to continue in 2020 as DOJ targets the activities that it believes contribute to high drug and medical device prices.

Drug and Device Settlements Doubled in 2019