Federal Court Reverses Conviction in AKS Case

By Stephen Beale | From the Volume XXXII, No. 8 – June 2, 2025 Issue

CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…

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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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OIG Issues New Report on Medicare 2023 Lab Spend

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…

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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…

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Physicians Tempted by Lure of In-Office Labs, Payers Balk

By Virchow | From the Volume XXXI, No. 14 – October 14, 2024 Issue

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Behind-the-Scenes Audits Often Hide Cause of Test Claim Denials

By Virchow | From the Volume XXXI, No. 9 – July 1, 2024 Issue

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Final Rule on AI Transparency Can Benefit Clinical Labs

By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue

ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING are becoming ubiquitous in today’s modern hospital systems and clinical laboratories. In response to these developments, federal officials issued a new rule that has major implications on how healthcare providers use artificial intelligence. T…

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Feds Bar Elizabeth Holmes from Government Health Programs

By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue

ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is …

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OIG Reports Its Findings about CDC’s First COVID Test Problems

By Robert Michel | From the Volume XXXI, Number 1 – January 16, 2024 Issue

ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …

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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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