R. Lewis Dark
Articles by R. Lewis Dark
Two Forces Push for More FDA Oversight of LDTs
CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administrati…
Is Lab and IVD Consolidation Ready to Hit the Wall?
IN HUMAN HISTORY, ALL ERAS COME TO AN END. The majority of the time, the end of an era is disruptive and a new status quo emerges, with different winners and losers. Today, there is growing evidence that one era in c…
Provider Price Transparency Trend Has New Twist
IT’S NOT JUST PATIENTS WHO ARE TYPICALLY UNABLE TO SEE PRICES FOR THEIR MEDICAL CARE IN ADVANCE OF SERVICE. Guess who else is unhappy that they cannot access the prices charged by hospitals, physicians, and other pro…
‘Virchow’ Is Your New Source of Managed Care Insights
WE ARE UNVEILING A VALUABLE INTELLIGENCE RESOURCE FOR YOU. It is a new commentary focused exclusively on managed care contracting for diagnostic services provided by clinical laboratories and anatomic pathology gr…
Stressful Weeks Ahead for Labs Thanks to Z-codes
We are not alone in recognizing that UnitedHealthcare’s…
Expect More Z-code Requirements for Genetic Tests
GENETIC TESTING COMPANIES ARE STILL REACTING TO LAST MONTH’S NEWS that one of the nation’s largest health insurers—UnitedHealthcare (UHC)—will require Z-codes for molecular test claims submitte…
For Labs, a Little Angel and Devil Sit Behind Z-Codes
Much lies underneath the surface of UnitedHealthcare’s (UHC) new policy mandating Z-code use for molecular tests covered under its commercial health plans. It’s a developme…
Healthcare Megatrends and a Famous Book
PREDICTING THE FUTURE IS A RISKY BUSINESS. SKEPTICS ARE ALWAYS AROUND TO CALL ATTENTION TO PROPHETS WHO GET IT WRONG. One prophet whose predictions were on target was author John Naisbitt. Those of us around in…
What’s Next in 2023 for Clinical Laboratories?
AS YOU OPEN THIS ISSUE OF THE DARK REPORT, in New Orleans, about 900 senior lab administrators, executives, and pathologists will be gathered at the 28th annual Executive War College on …
Come One, Come All to the Executive War College
THIS IS FOR ALL OF YOU LONG-TIME READERS WHO EVERY SPRING SEE NEWS about the Executive War College on Diagnostics, Laboratory, and Pathology Management, tell yourself that you need to attend, but then you…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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