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Response to FDA’s Gottlieb on Reducing Regulatory Burden
By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …
Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close
By Joseph Burns | From the Volume XX No. 9 – July 8, 2013 Issue
CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…
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Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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