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Healthcare Fraud › Compliance › Safe Harbors

ArentFox Schiff

Understanding OIG Advisory Opinion 25-09: Compliance Guidelines for Physician-Owned Medical Device Companies

ArentFox Schiff on

On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs)....more

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

Baker Donelson on

Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Mintz

DOJ’s Criminal Division Announces Pilot Program on Voluntary Self-Disclosure for Individuals

Mintz on

Drawing on a carrot and stick approach, Department of Justice (“DOJ” or the “Department”) guidance in 2023 focused heavily on incentivizing companies to voluntarily self-disclose their misconduct. This guidance included the...more

Womble Bond Dickinson

Current Trends and Real-World Best Practices in Healthcare Fraud Compliance

Womble Bond Dickinson on

Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...more

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