{"id":59235,"date":"2024-04-19T13:03:25","date_gmt":"2024-04-19T11:03:25","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/executive-war-college-to-address-clinical-laboratories-and-genetic-testing-firms-perfect-storm-involving-fdas-proposed-ldt-rule-payers-requiring-z-codes-on-genetic-test-c\/"},"modified":"2024-04-19T13:03:25","modified_gmt":"2024-04-19T11:03:25","slug":"executive-war-college-to-address-clinical-laboratories-and-genetic-testing-firms-perfect-storm-involving-fdas-proposed-ldt-rule-payers-requiring-z-codes-on-genetic-test-c","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/executive-war-college-to-address-clinical-laboratories-and-genetic-testing-firms-perfect-storm-involving-fdas-proposed-ldt-rule-payers-requiring-z-codes-on-genetic-test-c\/","title":{"rendered":"Executive War College to Address, Clinical Laboratories\u2019 and Genetic Testing Firms\u2019 Perfect Storm, involving FDA\u2019s Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to CLIA Regulations"},"content":{"rendered":"
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AUSTIN, Texas–(BUSINESS WIRE)–#CLIA<\/a>–Three major challenges poised to confront the nation\u2019s clinical laboratories, genetic test companies, and anatomic pathology laboratories will be major topics when a top-flight roster of lab experts, innovators, and lab leaders gather in New Orleans April 30-May 1, 2024, for the 29th<\/sup> annual Executive War College on Diagnostics, Clinical Laboratory and Pathology Management<\/i>. The event takes place at the Hyatt Regency Hotel just a few minutes from the historic French Quarter and registrations point to the largest event in its history.<\/p>\n

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\n\u201cThis perfect storm is the simultaneous arrival of three disruptive forces hitting the medical laboratory market,\u201d stated Robert L. Michel, producer of Executive War College<\/i> and Editor-In-Chief of The Dark Report <\/i>https:\/\/www.darkreport.com<\/i><\/a>. One is the Food and Drug Administration\u2019s (FDA) proposed rule https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests<\/a> to regulate laboratory developed tests (LDTs). The second is requirements by private payers that genetic test claims include Z-Codes. The third is a major rewrite and update to the CLIA regulations to which all labs must comply. Each will be disruptive to nearly all the nation\u2019s clinical laboratories.<\/p>\n

\n\u201cTo help lab leaders and pathologists prepare for this perfect<\/span> storm<\/span>, we\u2019ve assembled a unique trifecta of speakers,\u201d continued Michel. \u201cFor the first time in the history of medical laboratory testing\u2014at one time and at one place\u2014we are presenting the leading expert in each of these three disruptive forces. Each will speak at the same plenary session and will later conduct an open forum, as described below.\u201d<\/p>\n

\nPerfect Storm Is FDA\u2019s LDT Rule, Private Payer Z-Code Requirements, and Revisions to CLIA Regulations<\/b><\/p>\n

\nTo give clinical labs and genetic testing companies an inside track to prepare for the perfect storm\u2019s three power forces, this unique trifecta of expert speakers includes:<\/p>\n