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
2024年4月19日 - 8:00PM
ビジネスワイヤ(英語)
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 29th 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.
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the full release here:
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Tim Stenzel, MD; Gabriel Bien-Willner,
MD, PhD; Reynolds Salerno, PhD; Lâle White (Photo: Business
Wire)
“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 29th 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 3rd 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 29th
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.
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Amanda Curtis acurtis@darkreport.com