In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address healthcare compliance challenges when expanding into the U.S. market.
Mike and David cover key fraud and abuse laws, including the False Claims Act, the Anti-Kickback Statute, Physician Self-Referral Law (Stark law), and the Civil Monetary Penalties Law, and highlight common mistakes companies make and the severe penalties for non-compliance. As regulatory issues can be incredibly costly and disruptive to a business, Mike and David emphasize the importance of establishing a strong compliance culture from the start.