Helping You Weather Major Regulatory Changes

by Bob Croce

For The Executive War College

Let’s start today with a little behind the scenes look into the planning of each year’s Executive War College.

Truth be told, as early as late summer each year, I start “pestering” Robert Michel, Master and Commander of our must-attend event for clinical lab and pathology managers, to start building the agenda. As his right-hand man on the business side, I’m always anxious to start selling seats and sponsorships.

However, Robert always pushes back a little, not because he’s a procrastinator, but because completing the agenda closer to the conference gives us the opportunity to address the day’s most-pressing, leading edge challenges. Fast forwarding to today, I must admit now that . . . the boss was right to wait!

There are an unprecedented set of regulatory challenges all smashing into each other right now, and waiting to build an agenda based on the most-current info helps us better prepare you for the looming disruption.

What lies ahead in the coming months is a perfect storm for the clinical lab­oratory industry. It’s a trifecta of regulatory, man­aged care, and compliance developments.

Robert will be doing his own session, entitled, “Regulatory Trifecta Coming Soon to All Labs! Anticipating the Federal LDT Rule, Revisions to CLIA Regulations, and Private Payers’ Z-Code Policies for Genetic Claims,” which will serve as an overview toward us then getting down to the nitty gritty with additional presentations.

Robert Michel, President of the Executive War College

Robert L. Michel will have you covered in his session, “Regulatory Trifecta Coming Soon to All Labs!
Anticipating the Federal LDT Rule, Revisions to CLIA Regulations, and Private Payers’ Z-Code Policies for Genetic Claims.”

As we wrote in the most-recent issue of The Dark Report, this perfect storm includes the following elements:

Element 1

FDA’s LDT rule is currently the head­line story in the lab industry. Speaking about this development and two other FDA initiatives involving diagnostics will be pathologist Tim Stenzel, MD, PhD, former Director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. He will also discuss harmoniza­tion of ISO 13485–Medical Devices and the FDA’s recent memo on reclassifying most high-risk in vitro diagnostics to moderate-risk as a way to ease the regula­tory burden on companies seeking agency review of their diagnostic assays.

Element 2
CLIA Reforms and Updates

On the second development—increased use by private payers of Z-Codes for genetic test claims—the speaker will be pathologist Gabriel Bien-Willner, MD, PhD. He is the Medical Director of the MolDX program at Palmetto GBA, a Medicare Administrative Contractor (MAC). It is the MolDX program that oversees the issuance of Z-Codes for molecular and diagnostic tests.

Element 3
Use of Z-Codes for Test Claims

The third element is coming reforms and updates to the CLIA regu­lations. Speaking on this will be Reynolds Salerno, PhD, Acting Director, Center for Laboratory Systems and Response at the CDC. He will also cover the CDC’s efforts to foster closer connections with clinical labs and their local public health laboratories, as well as the expanding menu of services for labs that his department now offers.

So, batten down your hatches with us at EWC, and we will protect you from this storm.

That’s it for this week. More dispatches to come. Hope to see you and your “krewe” in New Orleans.

(Bob Croce is Executive Publisher/General Manager of The Dark Intelligence Group, the company that brings you the Executive War College. Have a question or comment for Bob, you can reach him at

Executive War College attendees

It was all about connecting with your clinical lab and pathology colleagues
during last year’s Executive War College Grand Reception. Please JOIN US in 2024!

(Here are some recent additions to the EWC ’24 agenda)

Gabriel Bien-Willner, MD, Medical Director, MoIDX Program

Speaker: William Morice
President & CEO,
Mayo Clinic Laboratories,
Rochester, Minnesota

Speaker: Kristie Madden 
Laboratory Manager,
United Indian Health Services
Arcata, CA

Speaker: Suzette Tidmore
Director, Revenue Cycle,
Pathology Consultants of New Mexico,

Las Cruces, NM

Speaker: Jessica Isaac

Executive Director, Pathology Laboratory,
IU Health,

Indianapolis, IN

For ongoing updates, check out our agenda page.

Click below to hear what attendees and sponsors had to say about EWC in 2023