TAG:
safe harbor
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…
Federal Court Reverses Conviction in AKS Case
CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…
Attorney Discusses Federal Cases Involving EKRA Violations by Labs
IT’S BEEN MORE THAN FIVE YEARS since Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Lab managers and their attorneys quickly recognized that, whereas the Anti-Kickback Statute (AKS) has a safe harbor that permits percentage-based sales commissions to W2 employees, EKRA does…
Anatomic Pathology Referrals Topic of OIG Advisory Opinion 23-06
THANKS TO A RECENTLY-RELEASED ADVISORY OPINION issued this fall by the Office of the Inspector General (OIG) Department of Health and Human Services, there is a new compliance twist involving billing for the technical component (TC) for anatomic pathology procedures. A…
CURRENT ISSUE
Volume XXXIII, No. 9 – July, 2026
Newsmaker Interview with Revvity’s Yves Dubaquie > How Specialty Diagnostic Tests Connect with Lab Customers: In this exclusive Q&A, Revvity’s Yves Dubaquie provides details about the in vitro diagnostics company’s priorities, including developing specialty tests and reviewing its business in China. Dubaquie also explains why clinical laboratories may need to consider hiring more technology-savvy workers in the future as the complexity of instruments grows.
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