Anti-Kickback Enforcement and Legislation Developments: What Drug, Medical Device and Biologics Companies Must Know

Within the past three years, investigation and enforcement activity under the federal False Claims Act1 (FCA) and the federal Anti-Kickback Statute2 (AKS) relating to payments made by medical device companies to their customers, typically physicians, has increased dramatically. The September 2007 highly-publicized orthopedic implant case, involving $311 million in total civil settlements, is just one example of investigations and prosecutions in the medical device industry (1 MELR 436, 10/10/07).