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OIG Issues New Report on Medicare 2023 Lab Spending

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WITHIN THE LATEST REPORT ON MEDICARE PART A CLINICAL LABORATORY SPENDING during 2023 is information about the financial impact that price cuts to the Clinical Laboratory Fee Schedule (CLFS) have had on clinical laboratories. As mandated by the Protecting Access to Medicare Act of 2014 (PAMA), the report is prepared annually by the Office of […]

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Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome

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On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final rule. Both chatbots answered that a favorable ruling for

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Top 10 Lab Stories for 2024 Do Reflect Important Trends

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Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the final rule. However, another Top 10 Lab Industry Story centers around the

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Two Different LDT Lawsuits Are Combined in Federal Court

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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 District of Texas, which will continue to oversee the now-unified case as it moves forward. Both plaintiffs make similar

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Internet Tracking Lawsuits Are Targeting Quest and Labcorp

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QUEST DIAGNOSTICS AND LABCORP, THE TWO GIANTS OF THE U.S. CLINICAL LABORATORY BUSINESS, are among many companies across a wide range of industries facing class-action lawsuits over their use of tracking technologies designed to facilitate online advertising. This type of class action lawsuit is increasingly common. Such cases often claim that the healthcare providers’ use

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Four Independent Health Systems Launch ‘Longitude Health’

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For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Longitude Health joins Risant Health as the newest attempt to bring together different health systems and foster collaboration and innovation in ways that directly lead to better patient care at lower cost. If

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Lab Innovators in Europe Have Solutions for the USA

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Rapid advances in a wide range of technologies over the past 15 years are enabling entrepreneurs to create transformative products for use by clinical laboratories and anatomic pathology groups. The Dark Report recently toured Europe to visit several such innovative companies. One clever invention is an “autonomous blood drawing system” that automatically performs venipunctures and

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Uncertainty in the Market for Digital Path Products

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These are uncertain times for many companies offering a range of digital pathology (DP) products to the nation’s pathologists. Sales lag behind projections that caused investors to pour money into numerous DP start-ups. One reason DP companies are not meeting sales goals is the inherent caution common with pathologists when it is time to make

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Identifying Current Lab Trends from Labcorp and Quest Experience

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Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. With coast-to-coast operations, they are often first to experience and respond to new trends—whether its more

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What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule

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Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This compliance will require substantial staff time and costs that may outweigh the benefit to the lab

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