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ARTICLE · 28 FEBRUARY 2025

Circuit Split Deepens On Anti-Kickback Statute's Causation Standard

Lowenstein Sandler LLP
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Introduction: In its recent decision in United States v. Regeneron Pharmaceuticals, Inc., the United States Court of Appeals for the First Circuit deepened an existing federal circuit court split regarding the causation.

United StatesCriminal Law

Introduction: In its recent decision in United States v. Regeneron Pharmaceuticals, Inc., the United States Court of Appeals for the First Circuit deepened an existing federal circuit court split regarding the causation standard to apply under the False Claims Act (FCA) for violations of the federal Anti-Kickback Statute (AKS).1 The split is likely to invite the Supreme Court to weigh in on the issue sooner rather than later.

The FCA and AKS: The FCA is a powerful instrument in federal health care fraud enforcement. It imposes liability on individuals and companies that defraud the government by submitting "false or fraudulent" claims for payment by the government, such as reimbursement claims for medical goods and services covered, in whole or in part, by Medicare or Medicaid.2 The AKS, in turn, prohibits, among other things, individuals and companies from knowingly and willfully inducing someone through incentives, such as cash payments or in-kind services, to

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