In This Presentation:

Increased Fraud Enforcement Activity; Current Enforcement Climate; Prosecution and Exclusion of Individuals; Inter-relationship with Kickback Allegations; Off-Label Enforcement Activity; Fraud Theory; Off-label Pharma Cases; Off-label Device Cases

Current Enforcement Climate

Recent fraud enforcement: FY ending September 2009, DOJ recovered $2.4b (not including Pfizer settlement), and More than $1b was from healthcare fraud.

Federal Enforcement and Recovery Act of 2009 (FERA); Increased funding for attorneys, investigators, Civil Investigative Demand authority expanded and Substantial liberalization of the False Claims Act.

Creation of Health Care Fraud Prevention and Enforcement

Action Team (HEAT) – May 2009; Obama Executive Order – Fall 2009; National Summit on Health Care Fraud – Winter 2010