TDR Insider Archives

Economic and Tech Changes Drive Lab Concerns

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. Meanwhile, attendees considered potential tariff impacts on their lab supplies and how to navigate the threat of […]

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With LDT Rule Vacated, Labs Await FDA Response

TDR Insider / Robert Michel

In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form is likely. In part one of our report about the decision,

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The Role of Price Transparency During Pathology Contract Talks

TDR Insider / Robert Michel

Pathology groups have a much better opportunity to turn the tables on payers and other third parties during contract negotiations if they come armed with the data and other information recommended by two well-respected pathology experts. In this final installment of our four-part series, the price transparency approach is explained. Also discussed is the importance

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Medical Robotics Developer Believes It’s Time to Transform Phlebotomy

TDR Insider / Robert Michel

Phlebotomy and collection of veinous blood is one important procedure in clinical laboratory testing that continues to be primarily a manual process. That is about to change. Netherlands-based Vitestro has obtained a CE mark in the European Union for its novel autonomous robotic phlebotomy device (ARPD), which is already in operation in a hospital in

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Why Labs Should Comply with the FDA’s Final Rule on LDTs

TDR Insider / Robert Michel

On April 29, 2024, the Food and Drug Administration released its final rule on regulation of laboratory developed tests (LDTs). Since then, clinical laboratories have grappled with questions surrounding compliance, while hoping that courts will step in and prevent the rule from taking effect. Now, with a new administration in power and what seem to

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OIG Issues New Report on Medicare 2023 Lab Spending

TDR Insider / Robert Michel

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

TDR Insider / Robert Michel

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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Two Different LDT Lawsuits Are Combined in Federal Court

TDR Insider / Robert Michel

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

TDR Insider / Robert Michel

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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