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…

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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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Attorney Discusses Federal Cases Involving EKRA Violations by Labs

By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue

IT’S BEEN MORE THAN FIVE YEARS since Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Lab managers and their attorneys quickly recognized that, whereas the Anti-Kickback Statute (AKS) has a safe harbor that permits percentage-based sales commissions to W2 employees, EKRA does…

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Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence

By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue

THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…

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Anatomic Pathology Referrals Topic of OIG Advisory Opinion 23-06

By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue

THANKS TO A RECENTLY-RELEASED ADVISORY OPINION issued this fall by the Office of the Inspector General (OIG) Department of Health and Human Services, there is a new compliance twist involving billing for the technical component (TC) for anatomic pathology procedures. A…

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OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens

By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue

CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…

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Important Court Rulings & Pending New Federal Law 

By R. Lewis Dark | From the Volume XXIX, No. 10 – July 18, 2022 Issue

IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we th…

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New OIG Advisory Opinion Dubious of ‘Fair Market’

By Robert Michel | From the Volume XXIX, No. 10 – July 18, 2022 Issue

CEO SUMMARY: There is a new advisory opinion from the Office of the Inspector General (OIG). It reviewed a proposal in which a clinical lab network would pay fair market value to hospitals for specimen collection based on volume of patients tested. The OIG said this arrangement woul…

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DOJ Charges Execs over Alleged Lab Kickbacks to Obtain Restitution

By Robert Michel | From the Volume XXIX, No. 8 – June 6, 2022 Issue

CEO SUMMARY: Multiple executives and sales representatives at True Health Diagnostics and Boston Heart Diagnostics have been named as defendants in a civil suit filed by the U.S. Department of Justice. The complaint centers on alleged kickbacks in return for clinical laboratory test…

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Innovation Showcased at Executive War College

By Robert Michel | From the Volume XXIX, No. 7 – May 16, 2022 Issue

CEO SUMMARY: This year’s Executive War College on Laboratory and Pathology Management proved to be a high-energy event. A record 900 attendees showed up and responded enthusiastically to visions and predictions of a post-COVID-19 healthcare system that hungers for large volumes of…

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