Using Sophisticated Schemes, Fraudsters Hit the Next Level

By Jillia Schlingman | From the Volume XXXII, No. 10 – July 14, 2025 Issue

Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history. Cli…

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National Enforcement Trends Will Test Labs

By R. Lewis Dark | From the Volume XXXII, No. 10 – July 14, 2025 Issue

This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Perhaps you saw news coverage recently when the US military dropped a dozen or so “bunker buster” bombs into underground Ir…

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Enjoy the LDT Court Victory, Yet Remain Vigilant

By R. Lewis Dark | From the Volume XXXII, No. 6 – April 21, 2025 Issue

  VICTORY IN COURT! FOR AN INDU…

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With LDT Rule Vacated, Labs Await FDA Retort

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…

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OPKO Settles Allegations of Fraudulent Billing

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….

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Federal Lawsuit Favors Lab Accused of AKS Violations

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

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…

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Multi-year Prison Sentence for Genetic Test Fraud

By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue

CEO SUMMARY: In recent years, federal prosecutors are filing ever greater numbers of civil actions and criminal indictments against individuals accused of healthcare fraud and abuse. This includes prosecutions of doctors alleged to have received illegal kickbacks from lab companies in exc…

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Review of Genetic Testing Companies During 2024

By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue

CEO SUMMARY: Investors in genetic testing companies are taking it on the chin these days. During 2024, a number of the nation’s largest firms providing genetic test services reported significant losses. Other genetic testing companies are dealing with class action lawsuits claiming that…

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Federal Cases against Labs Result in Convictions

By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue

CEO SUMMARY: Over the past 24 months, federal prosecutors have announced a steady parade of criminal convictions, guilty pleas, and settlement agreements involving fraud and clinical laboratory testing. Not only are these cases numerous, but some resolve legal actions initiated by the fed…

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Federal Prosecution of Lab Test Fraud & Abuse

By R. Lewis Dark | From the Volume XXXI, No. 14 – October 14, 2024 Issue

SOMETHING NEW AND DIFFERENT IS HAPPENING WITH THE ENFORCEMENT OF FRAUD AND ABUSE LAWS by the federal Department of Justice (DOJ). The number of cases being filed has increased over recent years. In turn, that means an increase in press releases announcing criminal convictions, guilty…

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