A recent Massachusetts Federal District Court decision adds to divergent opinions deciding an important health care enforcement question: what causation standard applies to a False Claims Act (FCA) case based on a violation of the Anti-Kickback Statute (AKS)? The AKS states that a claim that includes items or services “resulting from” a violation of the AKS constitutes a “false or fraudulent claim” under the FCA. As we previously discussed, there is a two-to-one circuit split on the causation standard applicable to the AKS’s “resulting from” language: the Sixth and Eighth Circuits endorse a “but-for” causation standard, while the Third Circuit has taken a proximate cause approach.
Massachusetts District Court Joins the Sixth and Eighth Circuits, Adopting “But-For” Causation Standard for AKS-Based FCA Claims
On September 27, 2023, Chief Judge Saylor of the District of Massachusetts issued a decision in United States v. Regeneron Pharmaceuticals, Inc., C.A No. 20-11217-FDS, which adopted a “but-for” standard of causation applicable to the AKS’s “resulting from” language. In so doing, Judge Saylor relied on the text of the statute, similar to the approach of the Sixth and Eight Circuits, which Judge Saylor deemed “persuasive.” Despite applying the higher causation standard, Judge Saylor denied Regeneron’s summary judgment motion, finding that the government presented sufficient evidence to raise a triable issue for the jury.
Regeneron manufactures a drug called Eylea, which...
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