As in the previous fiscal year, we expect the federal government to direct much of its fraud and abuse law enforcement activities at the health care industry. The federal government has many civil, criminal, and administrative tools to address fraud and abuse against the health care industry, generally, and clinical laboratories, specifically. The most important of these tools include the False Claims Act (FCA), 31 U.S.C. §§ 3729-3733; Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a; Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b); Eliminating Kickbacks in Recovery Act (EKRA), 18 U.S.C. § 220; Physician Self-Referral Law (“Stark Law”), 42 U.S.C. § 1395nn; and Exclusion Statute, 42 U.S.C. § 1320a-7. Although this article does not cover these laws in any real detail, please refer to our Compliance for Clinical Labs with Federal Fraud and Abuse Laws video for a broad overview of clinical laboratory federal fraud and abuse laws compliance considerations.
The FCA is the federal government’s primary civil tool in combatting false claims. From October 1, 2020 through September 30, 2021, the Department of Justice’s (DOJ’s) settlements and judgements from civil cases involving false claims and fraud exceeded $5.6 billion, which is the second largest annual total in FCA history. Approximately 90% of these settlements and judgments relate to the health care industry, which has historically been a leading source of the DOJ’s FCA settlements and judgments.
The Fraud Section of...
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