This year saw substantial activity in FCA settlements and litigated court cases. Although no single case or development dominated the discourse this year, several important court decisions were issued, including two that may warrant Supreme Court attention in 2021. Multiple settlements demonstrated that notwithstanding the investigatory challenges presented by the global pandemic, DOJ and other authorities continue their focus on FCA enforcement.

The year saw significant cases showcasing the government’s enforcement priorities. Enforcement of the Anti-Kickback Statute (AKS) through FCA actions clearly remains an area of focus for DOJ and a significant risk for many companies. The two largest FCA settlements of the year were based on alleged AKS violations. In January, DOJ announced a criminal and civil global resolution with a health information developer accused of soliciting and receiving kickbacks from drug manufacturers in exchange for manipulating its electronic health record program to increase prescriptions for the manufacturers’ opioid drugs. The company agreed to pay $118.6 million to settle FCA liability. In July, DOJ announced the largest FCA settlement of the year — $642 million — against a pharmaceutical company for allegedly funneling physician kickbacks through its speakers program and improperly paying patient copayments thru charitable foundations. DOJ also filed suit against two pharmaceutical manufacturers alleging they conspired with purportedly independent foundations to illegally subsidize Medicare copayments for the drug Copaxone in violation of the AKS.