For AI Regulation, Look to Data Laws, FDA Action

By Scott Wallask | From the Volume XXXII, No. 10 – July 14, 2025 Issue

CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…

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Regional Health Systems Are New Dominant Players in M&A

By Scott Wallask | From the Volume XXXII, No. 9 – June 23, 2025 Issue

READERS OF THE DARK REPORT UNDERSTAND HOW INTERTWINED THEIR CLINICAL LAB BUSINESS is with healthcare system mergers and acquisitions (M&A). Thus, financial service firm Morgan Stanley’s recent report on M&A activity in the healthcare industry will be of inte…

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How Medicaid Cuts May Affect Clinical Labs

By Mark Terry | From the Volume XXXII, No. 9 – June 23, 2025 Issue

CEO Summary: As lawmakers debate the merits of President Donald Trump’s budget bill, it appears that Medicaid changes are on the horizon. For medical laboratories, three immediate areas to monitor include potentially decreased Medicaid recipients, federal cuts to Medicai…

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June 2, 2025, Intelligence: Late-Breaking Lab News

By Scott Wallask | From the Volume XXXII, No. 8 – June 2, 2025 Issue

Our sibling publication, G2 Intelligence, reported in May about a new Department of Justice (DOJ) memorandum that indicated prosecutors will seek to exercise fairness when deciding how to pursue fraud cases against clinical laboratories and other organizations. The DOJ emphasiz…

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Economic, Tech Changes Drive Lab Concerns

By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue

CEO SUMMARY: Uncertainty around tariffs, future regulations, and artificial intelligence (AI) defined the mood at the 2025 Executive War College, where nearly 1,000 lab leaders gathered. Speakers warned of how stagnant healthcare spending could trickle down to labs. Meanwh…

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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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Managing Denials and Appeals of Clinical Lab, Path Claims

By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue

CEO SUMMARY: Based on a study of denials and appeals involving about 20 million lab test claims, the team at XiFin Inc. presents here their findings. They also provide recommendations on steps labs can take to reduce denials and win a greater proportion of appeals. IN RECENT…

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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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Federal Prosecution of Lab Test Fraud & Abuse

By R. Lewis Dark | From the Volume XXXI, No. 14 – October 14, 2024 Issue

SOMETHING NEW AND DIFFERENT IS HAPPENING WITH THE ENFORCEMENT OF FRAUD AND ABUSE LAWS by the federal Department of Justice (DOJ). The number of cases being filed has increased over recent years. In turn, that means an increase in press releases announcing criminal convictions, guilty…

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