Executive War College to Address, Clinical Laboratories' and Genetic Testing Firms' Perfect Storm, involving FDA's Proposed LDT Rule, Payers Requiring Z-Codes on Genetic Test Claims, and Revisions to CLIA Regulations

Three major challenges poised to confront the nation's 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 29^th annual Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. 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.

"This perfect storm is the simultaneous arrival of three disruptive forces hitting the medical laboratory market," stated Robert L. Michel, producer of Executive War College and Editor-In-Chief of The Dark Report https://www.darkreport.com. One is the Food and Drug Administration's (FDA) proposed rule https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests 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's clinical laboratories.

"To help lab leaders and pathologists prepare for this perfect storm, we've assembled a unique trifecta of speakers," continued Michel. "For the first time in the history of medical laboratory testing?at one time and at one place?we 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."

Perfect Storm Is FDA's LDT Rule, Private Payer Z-Code Requirements, and Revisions to CLIA Regulations

To give clinical labs and genetic testing companies an inside track to prepare for the perfect storm's three power forces, this unique trifecta of expert speakers includes:

• Tim Stenzel, MD https://www.linkedin.com/in/timothy-stenzel-md-phd-20204521/, CEO, Grey Haven, LLC, retired former director of the FDA's Office of In Vitro Devices: He will discuss the FDA's pending FDA rule, harmonization of ISO 13485 (Medical Devices), and the FDA Memo on Reclassification of IVD tests.
• Gabriel Bien-Willner, MD, PhD https://www.linkedin.com/in/gabriel-bien-willner-52a332117/, Chief Medical Officer, Palmetto GBA's MolDx/Z-Code Program: He will address developments involving the MolDx and Z-Code program and the differences in how federal health programs and private payers are using Z-Codes in their genetic testing guidelines and claims processing.
• Reynolds Salerno, PhD https://www.cdc.gov/cliac/members/salerno.html, Director, Division of Laboratory Systems (DLS), U.S. Centers for Disease Control and Prevention (CDC): He will cover major initiatives involving connecting clinical labs with public health labs, the DLS lab resource center, and the progress of the CLIAC Committee in updating and developing major revisions to the regulations of the Clinical Laboratory Improvement Amendments (CLIA). The notable element here is a recommendation to define lab test data (including genetic sequence data) as a sample that must be handled in compliance with CLIA regulations.

• Lâle White https://www.xifin.com/about-us/#lale-white, CEO, XiFin, Inc.: She will discuss how the three forces of the perfect storm will play out within the wider changes happening to the U.S. healthcare system and the clinical laboratory testing marketplace.

Now in its 29^th year and stronger than ever, Executive War College is the nation's largest, most respected gathering on clinical lab management and operations? attracting the attendance of senior lab executives, administrators, and pathologists from all over the world who gather to learn, network, and collaborate with thought leaders, experts, and analysts in developing the right strategies for their labs. It's why major lab 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.

In addition to more than 90 information-packed presentations comprising an enlightening and expansive range of topics, Executive War College 2024 will also feature a 3^rd day with post conference workshops and exhibits that address whole genome sequencing, digital pathology, artificial intelligence, Lean, and revenue cycle management.

"Our expert content is what differentiates the Executive War College and provides true value to our attendees," Michel said. "The event is fine-tuned to provide real-world solutions for laboratories and pathology practices to be successful. We will navigate, propose, and present solutions to the urgent issues that continue to challenge the clinical laboratory industry, including staffing, rising costs, tightening margins, regulations, and more."

A maximum-capacity attendance is expected at this year's 29^th Anniversary Executive War College. To register and for more information on Executive War College 2024, visit http://www.executivewarcollege.com. You may also contact Amanda Curtis at 512-264-7103.

About THE DARK REPORT

Established in 1995, THE DARK REPORT is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely read by leaders in laboratory medicine and diagnostics. The Dark Report produces the famous Executive War College on Diagnostic, Laboratory, and Pathology Management every spring, which showcases innovations by the nation's and globe's leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management.