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DOJ
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….
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…
CURRENT ISSUE
Volume XXXII, No. 18 – December 29, 2025
The Dark Report reviews its top 10 stories from 2025, from the vacating of the FDA’s LDT rule to the merger of Waters and Becton Dickinson’s biosciences and diagnostics units. Also, a lab outlines its solution to a shortage of histotechnologists, and another story shows how pathologists can become patients’ partners.
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