TAG:
DOJ
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…
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
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…
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…
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. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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