TAG:
EKRA
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…
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…
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…
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…
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…
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 …
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…
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…
Judge Vacates Provision in No Surprises Act
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
CEO SUMMARY: It …
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 XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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