The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged on the meaning of the phrase “resulting from” within the 2010 amendment to the AKS, which provided that a claim that includes items or services “resulting from” a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. The meaning of “resulting from” for purposes of establishing such FCA liability has been hotly debated by courts. The First Circuit now joins the Sixth and Eighth Circuits in adopting this stricter but-for standard, while the Third Circuit has opted for a much looser approach.

This case, United States of America v. Regeneron Pharmaceuticals, Inc., centered on whether Medicare claims for the drug Eylea, which were allegedly influenced by AKS violations through copayment coverages, constituted false or fraudulent claims under the FCA.  On the question of causation under the AKS, Regeneron claimed that the 2010 amendment imposed a “but-for” causation standard and urged the court to adopt the standards applied by the Eight and Sixth Circuits.  Regeneron argued that the government “b[ore] the burden of proving that an AKS violation . . . actually caused [a] physician to provide different medical treatment (and thus caused the false claims).” United States v. Regeneron Pharms., Inc., No. 20-11217, 2023 WL 6296393, at *10 (D. Mass. Sept. 27, 2023).  The government, on the other hand, urged the court to adopt the Third Circuit’s view that the AKS only requires proof of a causal link between a claim submitted to the government and medical care that was provided in violation of the AKS. Id.

The First Circuit’s adoption of the but-for causation standard is expected to have broad implications on the FCA landscape, potentially narrowing the field of actionable claims under the FCA, impacting both the government’s and whistleblowers’ ability to pursue damages for AKS violations that result in false claims to federal healthcare programs.

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