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lab risk & compliance

Federal Lawsuit Favors Lab Accused of AKS Violations

CEO SUMMARY: This whistleblower lawsuit initially charged a clinical lab with, among other things, violating the Anti-Kickback Statute and EKRA. After the judge ruled to exclude the AKS and EKRA claims, the whistleblower refiled the case and included claims the lab paid commissions for th…

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Multi-year Prison Sentence for Genetic Test Fraud

CEO SUMMARY: In recent years, federal prosecutors are filing ever greater numbers of civil actions and criminal indictments against individuals accused of healthcare fraud and abuse. This includes prosecutions of doctors alleged to have received illegal kickbacks from lab companies in exc…

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Owens & Minor Sues Anthem BCBS of Virginia

CEO SUMMARY: For years, clinical laboratories and pathology groups have expressed frustration with the lack of transparency by health plans in how they handle claims, set prices, and establish coverage guidelines. Now, because of recent federal laws and rules concerning health data transp…

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Two Different LDT Lawsuits Combined in Federal Court

CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …

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Internet Tracking Lawsuits Target Quest and Labcorp

CEO SUMMARY: Here is the clinical lab industry’s first intelligence briefing on how class action attorneys are filing lawsuits against healthcare providers—including clinical laboratories. The allegations are that providers are using internet tracking tools, such as those offered by M…

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Federal Cases against Labs Result in Convictions

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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Hospital Lab Outreach: Still a Valuable Asset!

CEO SUMMARY: Hospital lab administrators everywhere are watching press releases announcing the latest agreement of a major health system selling its laboratory outreach business to one of the billion-dollar lab corporations. The pace of these sales is accelerating. These deals confirm the…

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Federal Court Issues Ban on FTC’s Noncompete Rule

BY NOW, MOST CLINICAL LAB MANAGERS AND PATHOLOGY PRACTICE ADMINISTROATORS ARE AWARE of the Federal T…

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HHS Issues Final Rule to Deal with Information Blocking

ANY HEALTHCARE PROVIDER DETERMINED TO HAVE COMMITTED “INFORMATION BLOCKING” can now be asse…

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Language in Draft House Bill Directs FDA to Suspend LDT Rule

THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory deve…

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