Administrative War College will address the perfect storm for clinical laboratories and genetic testing companies involving FDA’s proposed LDT rule, payers requiring Z codes for genetic testing claims, and revisions to CLIA regulations

Administrative War College will address the perfect storm for clinical laboratories and genetic testing companies involving FDA’s proposed LDT rule, payers requiring Z codes for genetic testing claims, and revisions to CLIA regulations

Top laboratory experts, innovators and laboratory leaders gather in New Orleans April 30-May 1, 2024 to address the top three challenges facing the nation’s clinical laboratories, genetic testing companies and anatomic pathology laboratories will be the main talking point.th yearly Executive War College of Diagnostics, Clinical Laboratory and Pathology Management. The event was held at the Hyatt Regency just minutes from the historic French Quarter, and registration numbers indicated it was the largest event in its history.

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Tim Stanzel, MD; Gabriel Bien-Willner, MD, PhD; Reynolds Salerno, PhD; Lle White (Photo: Business Wire)

Robert L. Michel, producer of “The Perfect Storm,” said the perfect storm is three disruptive forces arriving at the same time to hit the medical laboratory market. administrative war college and editor-in-chief dark report https://www.darkreport.com. One is the rule proposed by the U.S. Food and Drug Administration (FDA) https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectness-laboratory – Develop tests to standardize Laboratory Developed Tests (LDT). The second is that private payers require genetic test statements to include Z codes. The third is a major rewrite and update of the CLIA regulations that all laboratories must comply with. Each would wreak havoc on clinical laboratories in nearly every country.

Michelle continued, To help lab leaders and pathologists prepare for this perfect storm, we have assembled a unique trio of speakers. For the first time in the history of medical laboratory testing, we are sending top experts to each of these three disruptive forces at the same time and in the same place. Each will speak at the same plenary session, followed by an open forum, described below.

The perfect storm is FDA’s LDT rule, private payer Z code requirements, and CLIA regulatory revisions

To prepare clinical laboratories and genetic testing companies for the perfect storm of three forces, this unique trio of expert speakers includes:

• Tim Stenzel, MD https://www.linkedin.com/in/timothy-stenzel-md-phd-20204521/CEO of Gray Haven, LLC, retired former director of FDA’s Office of In Vitro Devices: He will discuss FDA’s pending FDA rules, harmonization of ISO 13485 (Medical Devices), and FDA’s memorandum on reclassification of IVD tests.

• Gabriel Bien-Willner, MD, PhD https://www.linkedin.com/in/gabriel-bien-willner-52a332117/Chief Medical Officer, Palmetto GBA MolDx/Z-Code Program: He will discuss developments involving MolDx and Z-Code programs, as well as differences in the use of Z-Code in genetic testing guidelines and claims processing by federal health plans and private payers.

• Dr. Reynolds Salerno https://www.cdc.gov/cliac/members/salerno.htmlDirector, Division of Laboratory Systems (DLS), CDC (CLIA) regulations. An important point to note here is the proposal to define laboratory test data, including genetic sequence data, as samples that must be processed under CLIA regulations.

• Lebai https://www.xifin.com/about-us/#lale-white, CEO of XiFin, Inc.: She will discuss how three forces of the perfect storm will play a role in broader changes in the U.S. health care system and clinical laboratory testing markets.

Already 29 nowth Stronger than ever this year,administrative war collegeis the largest and most respected clinical laboratory management and operations event in the United States, attracting senior laboratory managers, managers, and pathologists from around the world who come together to learn from thought leaders, experts, and analysts , communicate and collaborate to develop the right strategy for their lab. That’s why major laboratory industry companies actively support this unique gathering, including organizations such as XiFin, Inc., Leica BioSystems, TELCOR, Beckman Coulter, Cleveland Clinic, ARUP Laboratories, COLA and the College of American Pathologists.