In 2018, a Missouri neurosurgeon was found guilty and ordered to pay almost $5.5 million for violating the AKS by submitting claims for the use of spinal implants that were distributed by a company wholly owned by his fiancée, on the grounds that commissions on the purchase of particular devices and stock offers from the device manufacturer used by the neurosurgeon were unlawful kickbacks. On July 27, 2022, the US Court of Appeals for the Eighth Circuit remanded the case for a new trial because the jury was not properly instructed on the requirement of but-for causation. This ruling established a circuit split on the appropriate standard for establishing causation in FCA cases related to AKS violations.
As amended by the ACA in 2010, the AKS provides 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].” In its 2018 ruling in U.S. v. Medco Health Solutions Inc., the US Court of Appeals for the Third Circuit interpreted the “resulting from” requirement by applying a middle-ground approach between IN THIS ISSUE NOTABLE ENFORCEMENT RESOLUTIONS AND ACTIVITY 1 OIG ADVISORY OPINIONS 5 CMS REGULATORY UPDATES 7 OTHER NOTABLE DEVELOPMENTS 9 MWE.COM HEALTHCARE REGULATORY CHECK-UP 2 requiring a direct causal link and no link at all that requires some evidence showing a link between the...
Who: Plaintiff John Gay filed a class action lawsuit against SeaWorld Parks & Entertainment Inc. Why: Gay claims SeaWorld sent emails that contained misleading subject lines to Washington r...