R. Lewis Dark
Articles by R. Lewis Dark
2024: Year of Decision for FDA Regulation of LDTs
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
Labs: Be Ready for Data to Dominate Diagnostics
By now, it should be clear to clin…
Forensic Pathologist Shortage Gets News Coverage
Pathologists are making headlines in several states, as well as nationally. But this time, the news is not about the shortage of surgical pathologists. Rather, it’s about the acute shortage of forensic pathologists. For example, ABC News reported last month that “Forensic pathologists…
Why Many Patients Cannot Pay for Their Lab Tests
IT IS WIDELY RECOGNIZED THAT GOVERNMENT AND PRIVATE PAYERS STEADILY NIBBLE AWAY at what they reimburse clinical laboratories and anatomic pathologists. Lowering the prices paid for tests, excluding labs from networks, and declining to grant coverage for new lab tests are just a few of the tactics use…
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…
CURRENT ISSUE
Volume XXXII, No. 14 – October 6, 2025
The Dark Report examines increasing healthcare costs for employers and how clinical labs can help those employers. Also, an in-depth case study shows how one hospital system regained its outreach program after originally ceding it to a national lab company, adding millions to the system’s bottom line.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.