Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Volume XXX, No. 11 - July 31, 2023

Online Exclusive: Robert Michel Discusses Three Notable Items from AACC Meeting

ROBERT MICHEL, EDITOR-IN-CHIEF OF THE DARK REPORT, attended July’s American Association for Clinical Chemistry (AACC) Annual Scientific Meeting in Anaheim, California. In this video from the exhibit hall, Michel noted three important changes at the conference.   Among Michel’s observations were the following: Name change. “This is the last year that this is the AACC …

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OIG Says Billing Code 81408 Is at Risk of ‘Improper’ Payment

Clinical laboratories may have heard billing code 81408 referred to as “fraudomatic,” and now the Office of Inspector General (OIG) has attached a remarkable number to this problem: $888 million over four years. Payers now have an even greater reason to inspect 81408 claims from genetic testing labs. Reaffirming past reporting here and elsewhere, a …

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‘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 groups. We named it “Virchow” in recognition of Rudolf Virchow (1821-1905), the famed German physician who shaped modern pathology and laboratory medicine. Lab leaders need …

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OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’

CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fraudulent Medicare payments. A new report from the Office of Inspector General attaches a remarkable number to this threat: $888 million over four years. Payers …

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Digital Pathology Rollout Was ‘Big Bang’ at University of Louisville

CEO SUMMARY: It took less than one year to achieve full implementation of whole slide imaging and digital pathology at the University of Louisville’s Department of Pathology. One decision was to scan slides in a central location to promote efficient workflows. Integrating digital pathology with the pathology LIS and artificial intelligence software proved to be …

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2022 Ranking of the World’s Top 12 IVD Corporations

WHILE THE TOP FOUR IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS kept their collective hold on the market compared to 2021, the big surprise was that Thermo Fisher Scientific’s Lab Products Division jumped up two positions to become the largest global IVD corporation, based on The Dark Report’s 2022 ranking of the Top 12 IVD Companies. (See …

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Hospital Lab Outreach Selloffs Continue with Labcorp as Buyer

OVER THE LAST FEW MONTHS, Labcorp has shaken up the hospital laboratory market in the Pacific Northwest, particularly as it concerns lab outreach services. On July 11, the Burlington, North Carolina-based company announced a deal with nonprofit Legacy Health, a six-hospital health system in Portland, Oregon. Under the arrangement, Labcorp will acquire select assets of …

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With Z-codes, Will Other Payers Follow UnitedHealthcare’s Lead?

EDITOR’S NOTE: Our new column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. Genetic testing laboratories …

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Competency Assessments Prove To Be a Nagging CLIA Deficiency

CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to watch out for and how to avoid citations. Among the hotspots: ensuring technical consultants and technical supervisors are qualified. Editor’s note: This is the first installment in an …

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July 31, 2023, Intelligence: Late-Breaking Lab News

Regulatory relief is on the way for clinical laboratories accredited by The Joint Commission. An overhaul of the Laboratory Accreditation Program’s standards, which goes into effect Aug. 27, will reduce the number of Elements of Performance (EPs) under the lab standards. A review of the changes shows that 79 EPs have either been revised or …

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