Healthcare Regulatory Check-Up | August 2022 - McDermott Will & Emery


This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit decided that the phrase “resulting from” in the Anti-Kickback Statute (AKS) creates a but-for causal requirement between an antikickback violation and the items or services included in the claim to the government. This decision established a circuit split regarding the appropriate standard for establishing causation in False Claims Act (FCA) cases related to AKS violations. In another notable case, the US Court of Appeals for the Second Circuit upheld an unfavorable Office of Inspector General (OIG) advisory opinion and subsequent district court ruling related to a pharmaceutical manufacturer’s proposed copay assistance program. The Second Circuit held that “corrupt” intent is not required to establish an AKS violation. This issue also reviews several criminal and civil enforcement actions related to AKS violations and false claims allegations.

In addition to examining a recent OIG advisory opinion, we provide a summary of key healthcare-related provisions of the Inflation Reduction Act, which allows the Centers for Medicare & Medicaid Services (CMS) to negotiate drug prices under Medicare for the first time, and the Joint Commission’s new health equity standards for accreditations. Finally we take a look at recent CMS activity, including its 2023 proposed and final rules for its various prospective payment systems, along with a recent proposed rule updating CMS’s interpretation of the nondiscrimination provisions of Section 1557 of the Affordable Care Act (ACA).