AKS Risk and Sponsored Testing: Structuring a Compliant Program with Data-Driven Firewalls
Session overview
The Anti-Kickback Statute (AKS) requires careful consideration in the context of pharmaceutical-sponsored testing programs, as confirmed by recent DOJ settlements. Maintaining a compliant firewall between sponsored testing and commercial sales is non-negotiable.
This webinar, featured a detailed regulatory analysis from McDonald Hopkins and practical real-world data (RWD) solutions from Prognos Health, which can equip compliance, legal, and commercial teams with the essential elements required to establish a compliant roadmap. We reviewed the key factors from relevant OIG Advisory Opinions and highlighted "red flags" cited in enforcement actions. Prognos demonstrated how utilizing sophisticated Real-World Data tools can support the necessary data separation and attenuation required to mitigate legal and regulatory risk.