Understanding the Legal Landscape
Any health care provider facing a federal subpoena regarding this issue should understand the likely legal theories the DOJ will pursue and the defensive strategies available. Based on the announcement’s emphasis on “health care fraud” and a recent memorandum published by the DOJ’s Civil Division, several federal statutes appear relevant, including the False Claims Act (FCA), the Food, Drug & Cosmetic Act (FD&C Act), and the criminal health care fraud statute.
The government is likely to allege that providers submitted false claims to federal health care programs, such as Medicaid or TRICARE. The FCA targets anyone who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval.” Claims can be considered factually false (billing for services not rendered) or legally false (failing to comply with material requirements). The DOJ could also attempt to apply FD&C Act misbranding provisions to physicians prescribing Food & Drug Administration (FDA)-approved medications for off-label uses, although such claims would be relatively novel and would represent a potentially problematic expansion of traditional enforcement. More significantly, under the criminal health care fraud statute, criminal charges may be pursued for schemes to defraud health care benefit programs (which include commercial health plans), requiring proof of willful intent beyond a reasonable doubt.
Defensive Strategies
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