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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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 Percentage-Based Commissions Ruling

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

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 …

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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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DOJ: EKRA Governs Lab Sales and Marketing Commissions

By Robert Michel | From the Volume XXIX, No. 6 – April 25, 2022 Issue

BY FILING A MOTION IN A U.S. DISTRICT COURT RECENTLY, officials from the federal Department of Justice (DOJ) took steps to oppose an earlier ruling by a federal judge in Hawaii dealing with the way the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) governs how percentage-based commission…

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Judge Vacates Provision in No Surprises Act

By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue

  CEO SUMMARY: It …

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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…

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Labs Should Be Cautious about ‘Surprising’ EKRA Ruling

By Robert Michel | From the Volume XXIX, No. 3 – February 22, 2022 Issue

CONFUSION ABOUT WHEN IT IS LEGAL UNDER TWO FEDERAL LAWS to pay commissions to sales reps based on volume and/or revenue has existed since the passage of the federal Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Now, a district court judge in Hawaii has surprisingly ruled that payments of perc…

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