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

December 2020

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 tests or simply handles specimens that you refer to other labs for testing. …

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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 these federal contractors: Novitas Solutions and First Coast Service Options. This …

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Surprise! Many Fewer Cases of Flu in US, Canada, Europe

IN NORTH AMERICA, THE INFLUENZA SEASON IS NOW UNDERWAY.  But it is starting off much slower than in past years. What makes this significant is that the number of influenza cases as reported by Europe and countries in the southern hemisphere also has been much lower than in a typical year.  In the United Kingdom, …

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Memphis Path Lab Pivots to COVID, Pooled Testing

CEO SUMMARY: When routine testing volume declined sharply last winter and spring, one of the nation’s largest anatomic pathology groups added testing for COVID-19 and boosted revenue significantly. Since then, the laboratory has become the first in the nation to gain an Emergency Use Authorization (EUA) to do pooled testing with 20 samples in one …

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State of California’s COVID Lab Producing Inconclusive Results

Inconclusive COVID-19 test results and delays in reporting results continue to plague the state of California’s brand new clinical laboratory, located in Valencia. That’s according to reports by several news outlets in the Golden State.  On Nov. 20, CBS13 reported that the “state’s new billion-dollar PerkinElmer lab is returning a high number of inconclusive test …

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NorDx Lab Started to Prepare for COVID-19 Testing in 2019

CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned his lab team to assume the worst and energized them to …

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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 letters have been sent to other labs each month.  Recently, CMS reported it had sent cease-and-desist letters to …

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Feds Revise Stark Law, Anti-Kickback Statute

CEO SUMMARY: It is essential that all clinical laboratories and anatomic pathology groups understand major changes in two new federal rules that take effect next month. Revisions to the Physician Self-Referral Law (also known as the Stark Law) and the Anti-Kickback Statue will have wide-ranging effects on how clinical labs engage in value-based and care-coordination …

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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 survey of 134 microbiology labs around the country. More than half of the responding labs …

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