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American Clinical Laboratory Association

Labs Directly Attack Upcoming PAMA Cuts

CEO SUMMARY: The clinical laboratory industry once again finds itself advocating on Capitol Hill for proposed legislation to deal with an old problem: test reimbursement rate cuts under PAMA. While Congress has delayed scheduled rate cuts for the last several years, PAMA c…

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Quest, Labcorp Discuss PAMA and M&A with Investors

WHILE LAUDING EXCELLENT GROWTH FOR THE SECOND QUARTER, executives at Labcorp and Quest Diagnostics also expressed concern over the Protecting Access to Medicare Act (PAMA), which was passed by Congress in 2014 and which continues to cause uncertainty as full implementation is repeatedly…

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Lab Stakeholders Discuss PAMA Reform

CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …

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With LDT Rule Vacated, Labs Await FDA Retort

CEO SUMMARY: 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…

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Upcoming Executive War College to Cover Important Lab Trends

New developments now changing the landscape in health-care and the clinical laboratory market will be addressed at the upcoming 30th Annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management that happens on April 29-30, 20…

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

CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…

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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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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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Unpacking the Surprises in the FDA LDT Rule

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…

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