False Claims Act and Anti-Kickback Statute Enforcement on Performance Based Contracts in the Pharmaceutical and Device Industries
The Department of Justice (DOJ) recently argued that certain performance based contracts used by many pharmaceutical companies violate the Anti-Kickback Statute (AKS) and False Claims Act (FCA) in United States, et al., ex rel. Lisitza v. Johnson & Johnson, et al., Civil Action 07-10288-RGS (D. Mass). DOJ's position may make it difficult to offer rebates as they argue that rebates "conditioned on" a buyers "agreement to take specific actions to promote utilization" of drugs "do not qualify as 'discounts' under either the statutory discount exception or the regulatory discount safe harbor." This BNA webinar will address FCA and AKS enforcement actions, emerging risk areas and potential theories of liability involving performance based contracts such as inventory management fees, redistribution fees, distributor performance, disease management, and clinical consulting service agreements. The program will also provide an analysis of the statutory discount exception, the regulatory discount safe-harbor, and recent amendments to both FCA and AKS.