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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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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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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Change Health Cyberattack Breaches PHI Here at TDR!

By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue

CEO SUMMARY: It was Feb. 21 when cybercriminals attacked Change Healthcare’s claims processing systems. On April 22, UnitedHealth Group issued a statement that PHI for “a substantial proportion of people in America” was breached. We believe the PHI of our employees and T…

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UnitedHealth Group Faces DOJ Antitrust Probe

By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue

CEO SUMMARY: Recent events have not been kind to UnitedHealth Group and its subsidiaries UnitedHealthcare and Optum. In February, just as UHG’s Change Healthcare division was hit with a major cyberattack that disrupted billions of dolla…

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Change Healthcare Hit by Major Cyberattack

By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue

CEO SUMMARY: It was a classic ransomware attack against Change Healthcare, the business unit of Optum that is itself a division of UnitedHealth Group. On Feb. 21, this cyberattack shut down critical systems at Change Healthcare, such as those involved in accepting and forwarding prescript…

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January 16, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, Number 1 – January 16, 2024 Issue

If a patient’s genetic test generates results that are actionable, will that patient move forward with treatment? That is one question asked by researchers in a study led by Vanderbilt University Medical Center that was published in the American Journal of Human Genetics. …

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