Issue: Volume XXVII No. 13 - September 14, 2020

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 thatĀ comes from not having to get anĀ emergency use authorization (EUA) forĀ COVID-19 laboratory-developed testsĀ (LDTs), there is a potential …

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Coming Soon: a Different Clinical Lab Industry

ā€œKeep your eye on the ballā€ is an idiom that originated with baseball. TheĀ idea is that every player on the field should, at all times, know where the ballĀ is so that they can be ready to do their job when the ball comes their way. This is excellent advice for clinical lab administrators and pathologistsĀ during …

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Understanding COVID-19’s Changes to Lab Industry

CEO SUMMARY: With the SARS-CoV-2 pandemic about toĀ enter its eighth month in the United States, it remains difficultĀ to predict whether the pandemic will strengthen with the fallĀ influenza season or steadily diminish. What is clear to mostĀ pathologists and clinical laboratory executives is that theĀ COVID-19 pandemic has already changed several aspects ofĀ how laboratories select suppliers, purchase supplies, …

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Franciscan Missionaries Sells Lab Outreach Business to LabCorp

SINCE THE ONSET OF THE PANDEMIC IN LATE FEBRUARY, the nation’s twoĀ largest clinical lab companies haveĀ announced only two acquisitions of hospitalĀ laboratory outreach programs, one inĀ June and one this month. Last week, LabCorp announced itsĀ acquisition of the clinical ambulatory laboratoryĀ business of Franciscan MissionariesĀ of Our Lady Health System (FMOLHS) inĀ Baton Rouge, La. Earlier, on June 23, QuestĀ Diagnostics …

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New York Firm to Build CLIA Labs in Shipping Containers

CEO SUMMARY: In many respects, the COVID-19 pandemicĀ is like a gold rush for entrepreneurs. Federal and stateĀ governments, colleges, employers, school districts, and otherĀ entities need COVID-19 tests and tens of billions of dollarsĀ are available to pay for such tests. This modern gold rush hasĀ encouraged companies such as Amazon and Alphabet/Google toĀ build their own clinical labs. Now …

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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 diagnosticsĀ (IVD) company executives andĀ industry consultants recognize the marketĀ for clinical laboratory instruments, tests, andĀ products is changing in fundamental ways. ā€œEvidence accumulates that the pandemicĀ is helping create new winners andĀ new losers among big and little IVD companies,ā€Ā stated Peter van Overwalle, whoĀ is Head of Marketing and Partner atĀ LiquidSMARTS …

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

WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY thatĀ comes from not having to get anĀ emergency use authorization (EUA) forĀ COVID-19 laboratory-developed testsĀ (LDTs), there is a potential downside—difficulty getting reimbursed for the test.Ā On Aug. 19, the Department ofĀ Health and Human Services (HHS)Ā issued a new directive that said clinicalĀ laboratories are no longer required toĀ obtain an EUA from the Food …

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September 14, 2020 Intelligence: Late-Breaking Lab News

Alphabet, Inc., theĀ parent of Google, isĀ expanding its COVID-19 testing activities. In recentĀ months, Verily Life Sciences—a division of AlphabetĀ devoted to research into lifeĀ sciences—organized a clinicalĀ laboratory for COVID-19 testing. It obtained CLIAĀ certification and is licensedĀ with the State of California.Ā In a blog, Verily’s Head ofĀ Pathology, Deb Hanks, MD,Ā wrote that the lab had ā€œverifiedĀ the performance of theĀ SARS-CoV-2 RT-PCR test …

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