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The Federal Prosecutor As Regulator
The Department of Justice (DOJ) proclaimed 2012 as yet another health care fraud record-breaker. Of $4.9 billion in total False Claims Act (FCA) recoveries, over $3 billion was recovered in health care fraud actions. DOJ also opened 885 new civil, and over 1,100 new criminal, health care fraud investigations, and convicted 826 defendants of health care fraud-related crimes.'
In the heavily regulated health care sector, the line between human error and a knowing “false claim” can be indistinct, aided and abetted by prosecutors' reliance on the FCA-defined concepts of “reckless disregard” and “deliberate ignorance” as proxies for proof of actual knowledge. See 31 U.S.C. ' 3729(b)(1). Nowhere is this line more blurry than in the area of current Good Manufacturing Practices (cGMP) for pharmaceutical and medical device manufacturers.”'
Background: cGMPs for Pharma and Med Device Manufacturers
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