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OIG Issues New Report on Medicare 2023 Lab Spend

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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Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome

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 …

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Using AI to Predict Outcomes in FDA LDT Lawsuits

Given the popular sentiment that artificial intelligence (A…

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Top 10 Lab Stories for 2024 Reflect Important Trends

CEO SUMMARY: 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…

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129,624 Genetic Tests in the United States

REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…

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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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Hurdles Continue When Labs Request Genetic Test Coverage

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Assessing the Clinical Service & Revenue Issues of the LDT Rule

BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…

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Unpacking the Surprises in the FDA LDT Rule

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…

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September 3, 2024, Intelligence: Late-Breaking Lab News

To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Tex…

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