Insights on 2021 Stark & Anti-Kickback Statute Final Rules

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s long-standing interpretation of the Anti-Kickback Statute (AKS).

Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health care-related agency actions.

The US Supreme Court recently overturned its ruling in Chevron USA, Inc. v. Natural Resources Defense Council, Inc., changing the landscape for federal agency rulemaking and actions, particularly in the health care industry.

Health Care Partner Annie Lee will present at the California Society for Healthcare Attorneys’ (CSHA) 2024 Annual Meeting and Spring Seminar in Olympic Valley, CA, on May 3, 2024.

Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions.

Our Health Care team has a complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.