TAG:
DOJ
Elizabeth Holmes Seeks Trump Clemency for Conviction
Elizabeth Holmes, the convicted former CEO of Theranos, is again drawing public attention as she seeks clemency from President Donald Trump, reviving interest in one of the most notorious fraud cases in Silicon Valley and clinical laboratory history. …
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
December 8, 2025, Intelligence: Late-Breaking Lab News
For the next 46 months, a Georgia fraudster will stay behind bars after pleading guilty to charges he violated the Anti-Kickback Statute by arranging for medically unnecessary genetic tests. A judge sentenced Patrick C. Moore, Jr. on Dec. 2. Moore was also ordered to pay $7.2 million in…
Court: Percentage-Based Comp Is Not Illegal in Itself
OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in…
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…
Using Sophisticated Schemes, Fraudsters Hit the Next Level
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…
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…
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
CURRENT ISSUE
Volume XXXIII, No. 3 – March 2, 2026
The Dark Report highlights the six themes that will carry the 2026 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management,, including finance issues and AI. Also, we show how RCM automation helped one lab conquer billing headaches and increase revenue.
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