On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in connection with an alleged violation of the federal Anti-Kickback Statute.
The decision marks a significant win for companies and individuals in the healthcare industry who perennially face, and therefore seek to limit, potential exposure under the Anti-Kickback Statute. This issue may soon find its way to the Supreme Court of the United States given the increasing prevalence of cases where the government and whistleblowers allege that False Claims Act violations are predicated on violations of the broad but nebulous Anti-Kickback Statute.
The Anti-Kickback Statute prohibits, among other things, soliciting or receiving any remuneration in exchange for referring patients under federal healthcare programs. A 2010 amendment provides that any claim for payment under federal healthcare programs, like Medicare and Medicaid, “resulting from” a violation of the Anti-Kickback Statute is also a false or fraudulent claim for purposes of the False Claims Act, 31 U.S.C. §§ 3729-33. The First Circuit, in United States v. Regeneron Pharmaceuticals, Inc., confronted what it means for a claim to “result from” a violation of the Anti-Kickback Statute. Is it enough that a claim followed an illegal kickback? Or must the government show that the claim would not have been...
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