TAG:
US Department of Justice
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…
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…
January 23, 2023, Intelligence: Late-Breaking Lab News
New data from the Association of American Medical Colleges (AAMC) offers further evidence of a decreasing talent pool of pathologists in the United States. Active physicians in anatomic and clinical pathology dropped from 13,201 in 2016 to 12,180 in 2021—a 7.7% decrease, according to the AAM…
Balwani Guilty! Sentencing Is Next for Theranos Execs
CEO SUMMARY: The trial of former Theranos President and Chief Operating Officer Ramesh “Sunny” Balwani ended with convictions by a jury on 12 counts of wire fraud and conspiracy. Now all eyes are looking ahead to the sentencing of Balwani and Elizabeth Holmes, the founder and fo…
New Percentage-Based Commissions Ruling
CEO SUMMARY: In denying a motion to dismiss certain charges against a clinical laboratory owner, a federal court in California has declared that the Eliminating Kickbacks in Recovery Act (EKRA) of 2018 applies to payments for marketing to physicians and other referral sources. This …
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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