TAG:

lab industry

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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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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Amazon Targets COVID-19 Testing in its New Lab-Building Venture

This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 t…

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UHC Ready to Implement New Lab Test Registry

CEO SUMMARY: UnitedHealthcare announced that its new Test-Registry Protocol will become effective on Jan. 1, 2021, creating a major billing hurdle for labs and pathology groups. By that date, a lab must register each type of test before it can submit claims for these tests to the nati…

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UHC Issues Details about How Labs Register Tests

CEO SUMMARY: As of January 1, UnitedHealthcare will require all clinical laboratories and anatomic pathology groups to register every type of test before labs can bill for those tests. Not only is the COVID-19 pandemic disrupting normal activity, but the administrative burden UHC is i…

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Amazon Building Labs to Do COVID-19 Testing

CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent lab-testing venture for employees could be a significant concern given that the e-commerce company could disrupt the clinical lab business nationwide. The online retail giant has long had an interest in medic…

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Employers, Others Looking to Build New Clinical Labs

CEO SUMMARY: Employers, universities, municipalities, and other large organizations are interested in building their own clinical laboratories. In addition, entrepreneurs—many with no prior experience in laboratory medicine—want to make money providing COVID-19 testing. Many of th…

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Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?

This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnos…

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It’s a Clinical Lab Moment … But No Advocates!

Nearly every day since the onset of the SARS-C0V-2 outbreak, there have been stories in the national news about clinical laboratory testing for COVID-19. No laboratory professional alive today has seen such an endless stream of news stories about clinical lab testing. This is a once-in-a-lifetime …

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