Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
AN ONCOLOGY RESEARCH LAB demonstrates the usefulness of SARS-CoV-2 variant sequencing as hospitals, health systems, schools, and municipalities are interested in identifying infection sources and tracking the virus’ spread. Also, the conviction for manslaughter and mail fraud of a VA pathologist is a lesson for all anatomic pathology groups to heed, a lawyer explains.
VARIANT SEQUENCING FOR COVID-19 is the next big opportunity for clinical labs and pathology groups. It is currently being undertaken by large labs and academic medical centers, but local labs could be next. Also, The Dark Report reports on a highly successful collaboration on a COVID test between a university and a commercial company.
THE DARK REPORT HAS DiSCOVERED that 3 major health systems with 372 hospitals have switched to a different CLIA accreditation organization over the past 18 months. All the details are examined here, including reasons why a health system might make such a switch. Also in this issue is an exclusive newsmaker interview with the CEO of a new company that is challenging the 70-year-standard Coulter Principle technology in hematology.
There are several surprises in The Dark Report’s annual list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social life, and economic activities since March, at least one major health insurer pushed ahead with two major policies governing how labs can submit claims. In another big story, for the first time in decades, the federal Anti-Kickback Statute and the Stark Law were revised with new final rules. Also, Medicare lab test spending increased in 2019 despite PAMA cuts.
IN A SURPRISING AND INSPIRING story, a Maine lab executive shares how his lab began preparations for COVID-19 in December 2019. Another lab’s story of pivoting from pathology testing to COVID-19 testing is equally instructional. And in other news, one CPT code has been used so often and for such high payments, it’s earned the title “fraudomatic” from an expert observer.
UNWELCOME CHANGES to how labs do business are forcing labs to cope with high demand for COVID-19 testing while dealing with government and private payers interfering with normal operating procedures. Medicare has new requirements and payment rates for COVID-19 tests. Also reported here are UnitedHealthcare’s new Laboratory Test Registry Protocol, and California’s new COVID-19 testing laboratory that is diverting lab instruments, supplies, and test kits away from hospital and independent labs in the state.Â
INDUSTRY LEADERS SHARE THEIR CONCERNS over CMS’ planned cuts to COVID-19 test payments and discuss their proposed strategies for COVID testing. Also, a pathology group reports lessons learned the hard way when it opened a brand-new clinical lab in the midst of the worst of the pandemic.
THE DARK REPORT HAS ANALYSIS showing potential reasons why the Department of Justice has generated its largest lab fraud crackdown in history. $6B in allegedly fraudulent claims and 345 defendants may well be the result of an explosion in molecular test claims in 2019. Also, another competitor has entered the lab marketplace, this time with portable COVID-19 testing labs in trailers.
THE DARK REPORT IS VIEWING THE FUTURE of the lab industry, and it’s clear that things will be different post-pandemic. Four trends will take shape in the coming months and years which lab professionals must bear in mind as they wrestle with everything the pandemic has wrought. Also, lab industry entrepreneurs are leveraging the pandemic situation in ways that lab managers must be aware of in order to secure their organization’s own position in the industry.
THE DARK REPORT lines up its top lab industry experts to analyze a surprising development: The department of Health and Human Services’ welcome announcement that the Food and Drug Administration does not need to issue an Emergency Use Authorization for laboratory-developed tests. This announcement is significant because EUAs for LDTs have been a long-running irritant to labs. But lab managers will want to consider whether liability issues make a voluntary EUA advisable, based on TDR’s analysis.
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Volume XXXII, No. 13 – September 15, 2025
The Dark Report examines a new bill that would reform PAMA and avoid reimbursement rate cuts scheduled for January 2026. Clinical laboratory leaders are urged to make their voices heard in Congress. Also, an expert describes how labs can fix pre-analytical errors and avoid disaster.
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