First Circuit Clarifies Clinical Laboratory Safe Harbor: Laboratories May Rely on Physicians’ Medical Necessity Determinations in FCA Cases

Key Takeaways - First Circuit strengthens False Claims Act defenses for clinical laboratories. In United States ex rel. Omni Healthcare Inc. v. MD Spine Solutions LLC, the court held that laboratories may generally rely on physicians’ medical necessity determinations when submitting Medicare claims, absent evidence the laboratory knew the order was improper.... By: Arnall Golden Gregory LLP