TAG:
Mark Schena
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
Court: Percentage-Based Comp Is Not Illegal in Itself
OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in…
How Federal Court’s Decision Will Affect Lab Marketing
MOST MEDICAL PROVIDERS are buyers of healthcare services. But for clinical laboratories, that equation is turned on its head. Labs are medical providers, but since they rarely provide those services directly to patients, they must properly market them to providers to ensure steady sales…
Attorney Discusses Federal Cases Involving EKRA Violations by Labs
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
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…
Important Court Rulings & Pending New Federal Law
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
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 …
DOJ: EKRA Governs Lab Sales and Marketing Commissions
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…
Labs Should Be Cautious about ‘Surprising’ EKRA Ruling
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…
CURRENT ISSUE
Volume XXXIII, No. 2 – February 9, 2026
Congress has once again delayed cuts to test reimbursement rates under PAMA, this time until Jan. 1, 2027. Laboratory professionals are urged to lobby Congress to pass the RESULTS act to solve the PAMA cuts problem permanently. Also, patient-driven testing is spurring new opportunities.
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