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Omni Healthcare
A Whistleblower Risk for Lab Leaders to Navigate
Our lead briefing details a federal appeals cou…
Ruling Limits Lab Onus on Medical Necessity
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 pr…
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
Labs: Why it Pays to Know Your Customers
WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERI…
Federal Lawsuit Favors Lab Accused of AKS Violations
CEO SUMMARY: This whistleblower lawsuit initially charged a clinical lab with, among other things, violating the Anti-Kickback Statute and EKRA. After the judge ruled to exclude the AKS and EKRA claims, the whistleblower refiled the case and included claims the lab paid commissions for th…
CURRENT ISSUE
Volume XXXIII, No. 8 – June, 2026
Congress Returns to CLIA Reform with Proposed LDT Framework, and the Newly Filed Enhancing CLIA Act seeks to modernize clinical laboratory regulations. A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States.
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