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COVID-19 test

Medicare to Cut Payment for COVID Tests Starting Jan. 1

CEO SUMMARY: Starting Jan. 1, CMS will lower the COVID-19 test payment to $75 when labs with “high-throughput systems” report a COVID-19 test result after 48 hours. This is the federal government working at cross purposes, since other federal agencies are diverting COVID-19 testin…

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New Clinical Lab Opens on March 23 and Prospers

CEO SUMMARY: Timing is everything when launching a new clinical laboratory business. The March 23 grand opening of Incyte Pathology’s clinical lab came in the midst of the collapse of daily routine specimen referrals. But once the lab was operational, Incyte had the capability, the …

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$481 Mil Federal COVID Contract Awarded to Young IVD Company

IN THEIR FIGHT AGAINST THE PANDEMIC, federal officials are boosting the fortunes of some little-known or emerging in vitro diagnostics (IVD) companies. One example is the recent award of a $481 million  COVID-19 test contract to Cue Health Inc., of San Diego. Earlie…

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October 26, 2020 Intelligence: Late-Breaking Lab News

In Houston, an 18-year-old high school student started a mobile laboratory company to provide COVID-19 tests to home-bound patients. As the youngest emergency medical technician in Texas, Taft Foley, III, saw the need for this service. Texas Mobile Medical Labs is the name of his company a…

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Will HHS Ruling on COVID-19 LDTs Be Good or Bad for Lab Reimbursement?

This is an excerpt of a 1,028-word article in the September 14, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an …

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Understanding COVID-19’s Changes to Lab Industry

CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executiv…

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Texas Company Operates 400 COVID-Collection Sites

CEO SUMMARY: In April, the federal Department of Health and Human Services contracted with eTrueNorth to operate COVID drive-through specimen-collection sites under the Community-Based Testing Sites program. The drive-through sites are an extension of non-COVID testing the company has …

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New York Firm to Build CLIA Labs in Shipping Containers

CEO SUMMARY: In many respects, the COVID-19 pandemic is like a gold rush for entrepreneurs. Federal and state governments, colleges, employers, school districts, and other entities need COVID-19 tests and tens of billions of dollars are available to pay for such tests. This modern gol…

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Covid-19 Pandemic May Be Creating New IVD Winners and Losers

WITH THE PANDEMIC NOW IN ITS NINTH MONTH, in vitro diagnostics (IVD) company executives and industry consultants recognize the market for clinical laboratory instruments, tests, and products is changing in fundamental ways. “Evidence accumulates that the pandemic is helping create …

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Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?

WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an emergency use authorization (EUA) for COVID-19 laboratory-developed tests (LDTs), there is a potential downside—difficulty getting reimbursed for the test. On Aug. 19, the Department of Health and Human S…

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