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FCA
OPKO Settles Allegations of Fraudulent Billing
By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
Labs: Why it Pays to Know Your Customers
By R. Lewis Dark | From the Volume XXXII, No. 2 – January 27, 2025 Issue
WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERI…
Federal Lawsuit Favors Lab Accused of AKS Violations
By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue
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…
Federal Cases against Labs Result in Convictions
By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue
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 Healthcare Fraud Enforcement Turns to Emerging Areas
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
CEO SUMMARY: Healthcare compliance attorneys say the Department of Justice (DOJ) is turning its focus to fraudulent activity related to COVID-19 testing. But that’s not the only area attracting greater scrutiny by the DOJ. Fraud stemming from opioid treatment has snared clinical l…
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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