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January 19, 2021 Intelligence: Late-Breaking Lab News

Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 mo…

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Top 10 2020 Lab Stories Are about More than Just COVID-19

This is an excerpt of a 3,689-word article in the December 28, 2020 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There are several surprises in The Dark R…

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2020’s Top 10 Lab Stories Are Without Precedent!

CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…

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OIG Says Medicare Spending On Testing Increased in 2019

CEO SUMMARY: Newly-released data indicates that Medicare officials are falling far short of their goal to decrease the total amount of money spent annually on Part B clinical laboratory tests. That is one finding by the federal Office of the Inspector General in its report of Medica…

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THE DARK REPORT’s Ranking of 2019’s Top 10 IVD Companies

One trend continues to reshape the in vitro diagnostics (IVD) industry year after year: acquisitions.  Since the 1990s, the biggest IVD companies have frequently used acquisitions to boost their revenue and keep shareholders happy. But acquisition…

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Why Labs Operate in a ‘Duality’ during Pandemic

HAS IT OCCURRED TO MANY OF YOU THAT YOUR CLINICAL LABORATORIES today must operate in what I will describe as an operational “duality”?  On one side, your lab must deal with COVID-19 testing. This is true whether your lab performs molecular SARS-CoV-2…

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One Genetic Test CPT Code Earns ‘Fraudomatic’ Title

CEO SUMMARY: Several genetic testing companies have noticed that some of the nation’s Medicare Administrative Contractors (MAC) pay about $2,000 for test claims billed with CPT code 81408. From 2018 through and 2019, the number of 81408 claims rose dramatically at just two of thes…

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CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates

CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS).  The first letters were sent on Aug. 12 and le…

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December 7, 2020 Intelligence: Late-Breaking Lab News

Supply chain issues associated with the SARS-CoV-2 pandemic are about to disrupt testing for other infectious diseases, ranging from strep throat and pneumonia to sexually-transmitted diseases (STDs). That was one important finding from the American Society for Microbiology’s (ASM) November …

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California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?

CEO SUMMARY: California dropped a bomb on the state’s existing network of hospital labs and independent clinical labs when, on Oct. 30, it announced it had built and opened a new laboratory facility in Valencia designed to perform 150,000 COVID-19 tests per day. Now, existing labs…

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