CEO SUMMARY: A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision provides a new defense against whistleblower litigation. The case in question centered on […]
Ruling Limits Lab Onus on Medical Necessity
Judge notes the case involved a well-known whistleblower who has sued labs in the past
- By Janette Wider
- > From the Volume XXXIII, No. 4 - March 23, 2026 Issue
- Tags: anti kickback statute, BioReference Laboratories, Bloomberg Law, CARES Act, Danielle Tangore JD, false claims act, FCA, Florida Today, lab risk & compliance, MD Spine Solutions, Millenium Laboratories, Millennium Health, North Brevard County Hospital District, Omni Healthcare, OPKO Health, Parrish Medical Center, pcr testing, qui tam litigation, Relator, Robinson+Cole, safe harbor, stark law, urinary tract testing, US Court of Appeals for the First Circuit, US Oncology, UTI, whistleblower
