The United States Court of Appeals for the First Circuit has issued a significant ruling in United States v. Regeneron Pharmaceuticals, Inc., No. 23-2086, affirming that to establish liability under the False Claims Act (FCA) predicated on a violation of the Anti-Kickback Statute (AKS), the government must demonstrate that the alleged kickback was a “but-for” cause of the claim submitted to a federal healthcare program. This decision aligns the First Circuit with the Sixth and Eighth Circuits, which have adopted a similar stringent causation standard. The First, Sixth, and Eighth Circuit decisions contrast with the Third Circuit’s more lenient approach, thereby deepening an existing circuit split.
The FCA imposes civil liability on anyone who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment” by the government.[1] A 2010 amendment to the AKS provides that a claim “resulting from” a violation of the AKS constitutes a false claim under the FCA.[2] The issue in Regeneron was the level of causation required to satisfy the “resulting from” language.
In Regeneron, the government alleged that the pharmaceutical company violated the AKS by funding copayments for certain patients prescribed its drug Eylea, thereby inducing physicians to submit claims to Medicare for the drug. The government argued that Medicare claims for those patients who received copay...
Member of the group DJ DOC, Lee Ha-neul has announced a counter-suit against singer Jubi Train and the representative of his agency BASS Camp Studio. On the 21st, BASS Camp Studio issued an offici...