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Search Results for: COVID-19

CAP Introduces Features to Aid CLIA Inspections

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Clinical labs are changing in multiple ways and the College of American Pathologists regularly revises its CLIA accreditation processes in response to these changes. One such change is the growth in the number of integrated delivery networks that operate multiple hospitals and multiple medical clinics, creating a multi-site clinical lab service. To meet …

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New Class of IVD Firms Wants to Serve in Near-Patient Settings

TDR Insider / By Robert Michel

This is an excerpt of a 3,644-word article in the September 27, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Our second installment in this series describes an emerging new class of in vitro diagnostics (IVD) companies. These companies have analyzers and …

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Executive War College to Show New Opportunities for Labs

Clinical Laboratory / By Robert Michel

CEO SUMMARY: Yes, the pandemic continues and hospitals are running short of beds in many communities. At the same time, 225 million Americans are either vaccinated or have some immunity to COVID-19. Based on the early registrations to attend the 27th annual Executive War College, it appears vaccinated individuals are ready to travel to a …

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New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings

In Vitro Diagnostics / By Robert Michel

CEO SUMMARY: Our second installment in this series describes an emerging new class of in vitro diagnostics (IVD) companies. These companies have analyzers and tests designed specifically to be simple to run, generate results in minutes, use small sample sizes, and cost less than even high-volume routine tests run in core labs. These new IVD competitors …

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MedPAC Reports to Congress on Issues in Lab Test Price Survey

Laboratory Compliance / By Robert Michel

IN THE HALLS OF CONGRESS, A GOOD NEWS/BAD NEWS STORY is unfolding around the multi-year cuts to the prices Medicare pays for clinical laboratory tests. First the good news. In its latest semi-annual report to Congress, the Medicare Payment Advisory Commission (MedPAC) confirms much of what the clinical laboratory industry has been saying about Medicare’s new lab test payment …

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September 27, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmes—the disgraced ex-Founder and CEO of Theranos—continues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anecodotes and facts about her personal life and the way she made business …

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Are Live Lab Industry Conferences Returning?

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

For several months, many of you have used conversations and email to encourage us to conduct a live Executive War College before the end of 2021. It was because of this support that we arranged a hotel in a state that has supported a return to more normal activities. Thus, our conference will take place …

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Lab Briefs

Clinical Laboratory / By Robert Michel

DOJ Obtains $140 Mil. Settlement in Drug Testing Case Last Friday, the U.S. Department of Justice (DOJ) announced a settlement totaling $136,025,077 with multiple defendants accused of using illegal inducements to encourage physicians to refer urine drug tests to the defendants. The judgement was issued by the U.S. District Court for the District of South …

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2020 Rankings of the World’s Largest IVD Corporations

In Vitro Diagnostics / By Robert Michel

IN VITRO DIAGNOSTICS (IVD) MANUFACTURING continues to be dominated by a handful of companies, all of which sell their products worldwide. As the rankings below demonstrate, for 2020, just 11 companies accounted for 82.7% of international IVD sales. The COVID-19 pandemic and the need for unprecedented numbers of SARS-CoV-2 tests—both molecular and serological—gave these IVD …

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Insurers Get Aggressive with Years-Old Audits, Searching for Lab Overpayments

TDR Insider / By Robert Michel

This is an excerpt of a 1,971-word article in the July 26, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Not only are health insurers looking back to find lab overpayments and funds paid erroneously, but payers also are requiring documentation for …

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