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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…

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Multi-year Prison Sentence for Genetic Test Fraud

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

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

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

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!

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

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

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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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…

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

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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