OPKO Settles Allegations of Fraudulent Billing

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….

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Review of Genetic Testing Companies During 2024

By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue

CEO SUMMARY: Investors in genetic testing companies are taking it on the chin these days. During 2024, a number of the nation’s largest firms providing genetic test services reported significant losses. Other genetic testing companies are dealing with class action lawsuits claiming that…

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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…

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

By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue

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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Attorney Advises Labs to Track Genetic Test LCDs

By Scott Wallask | From the Volume XXIX, No. 13 – September 19, 2022 Issue

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

By Scott Wallask | From the Volume XXIX, No. 13 – September 19, 2022 Issue

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

By Robert Michel | From the Volume XXIX, No. 13 – September 19, 2022 Issue

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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Halfway Through 2022, More Changes Come at Labs

By R. Lewis Dark | From the Volume XXIX, No. 8 – June 6, 2022 Issue

APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year.  For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges co…

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