TAG:
Department of Justice
August 4, 2025, Intelligence: Late-Breaking Lab News
In a filing with the US Securities and Exchange Commission, UnitedHealth Group (UHG) has acknowledged it is under investigation by the US Department of Justice (DOJ). “[UHG] proactively reached out to the Department of Justice after reviewing media reports about investigations into ce…
National Enforcement Trends Will Test Labs
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…
Enjoy the LDT Court Victory, Yet Remain Vigilant
VICTORY IN COURT! FOR AN INDU…
With LDT Rule Vacated, Labs Await FDA Retort
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…
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…
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…
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…
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…
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…
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…
CURRENT ISSUE
Volume XXXII, No. 11 – August 4, 2025
The Dark Report takes a look at new and more complex claims denials by payers, and suggests ways to battle this trend. Also, we offer 6 expert strategies for properly evaluating claims made by AI vendors.
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