Fraud and Abuse Issues In Off-label Marketing

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

Please see full presentation below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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