Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is the largest generic drug manufacturer in the United States. The settlement resolved two alleged kickback schemes: Medicare Cost-Sharing Scheme and Copay Assistance Foundations First, Teva has agreed to resolve...

The reach of the Anti-Kickback Statute and the False Claims Act is broad.  As a result, AKS liability is a real and significant risk for healthcare companies and providers. Healthcare companies and providers have to resolve such claims because of the potential consequence of exclusion from “federal health care programs,” which is essentially a death sentence for any covered company that received federal reimbursement. In...

The Justice Department continues to pile up healthcare enforcement actions — false claims, anti-kickback, and fraud.  DOJ is on its way to a record year. In a recent enforcement action, Modernizing Medicine (“ModMed”), an electronic health record (“EHR”) vendor, agreed to pay $45 million for AKS and False Claims Act violations for receiving bribes in exchange for referrals and causing users to falsely report information...