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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…

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Healthcare Fraud Cases Include Decades-Long Cases of Deceit

Healthcare fraud cases continue to receive harsh penalties from the federal government as indicated in the case of a California clinical laboratory owner and her husband who attempted to defraud the government of millions of dollars. Lourdes Navarro and husband Imran Shams attempted to defraud ins…

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How Private Payers Audit Labs for Possible Claims Fraud

EDITOR’S NOT…

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OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’

CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fra…

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Lab Execs Allegedly Lied to FDA about Faulty Tests

CEO SUMMARY: Three former executives of a lab testing company face criminal charges. Federal prosecutors claim that the three plaintiffs who previously worked at Magellan Diagnostics flagrantly hid…

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May 8, 2023, Intelligence: Late-Breaking Lab News

Responding to the need to expand access to training for diagnostic testing professionals, the CDC’s Division of Laboratory Systems has launched OneLab TEST (Timely Education and Support of Testers)….

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

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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Attorney Advises Labs to Track Genetic Test LCDs

CEO SUMMARY: Skyrocketing numbers of genetic test referrals and telehealth claims since 2016 are getting the full attention of both federal prosecutors and auditors from Medicare and private health insurers. The DOJ has filed criminal cases against a growing number of telehealth pro…

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Feds Target Genetic Test and Telemedicine Fraud

MEDICARE FRAUD TOTALING $562 MILLION in genetic and cardiovascular tests is at the heart of recent federal criminal cases involving telemedicine that names clinical laboratory owners, physicians, and healthcare marketers as defendants.  A host of indictm…

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September 19, 2022 Intelligence: Late-Breaking Lab News

Déjà vu? Lawmakers in Congress question whether public health officials have done enough to stay ahead of monkeypox, including the availability of diagnostic tests. Concerns about such testing came up during a Sept. 14 hearing before the Senate’s Health, Education, Labor, and Pensions Committee. …

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