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Medicare
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….
Quest Acquires ‘Select Assets’ of Fresenius Medical Care
By Robert Michel | From the Volume XXXII, No. 4 – March 10, 2025 Issue
FRESENIUS MEDICAL CARE AND QUEST DIAGNOSTICS AGREED TO A DEAL in which Quest will provide laboratory testing services for the latter’s dialysis clinics in the United States. Separately, Quest Diagnostics will acquire “select assets” of Spectra Labora…
Negotiating Path Contracts with Hospitals, Third Parties
By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue
PART THREE OF A SERIES TO HELP ANATOMIC PATHOLOGY GROUPS THRIVE AND PROSPER during these challenging times, The Dark Report presents this third installment in a series that identifies clinical, operational, and financial strategies pathology groups…
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…
Multi-year Prison Sentence for Genetic Test Fraud
By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue
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…
Once Again, Congress Acts to Defer Medicare Lab Fee Cuts
By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue
LAST MONTH, CONGRESS ONCE AGAIN DEFERRED MEDICARE REIMBURSEMENT CUTS OF UP TO 15% f…
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…
Physicians Tempted by Lure of In-Office Labs, Payers Balk
By Virchow | From the Volume XXXI, No. 14 – October 14, 2024 Issue
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Federal Prosecution of Lab Test Fraud & Abuse
By R. Lewis Dark | From the Volume XXXI, No. 14 – October 14, 2024 Issue
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…
Assessing the Clinical Service & Revenue Issues of the LDT Rule
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…
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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