Issue: Volume XXIX, No. 8 - June 6, 2022

Halfway Through 2022, More Changes Come at Labs

APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year.  For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges come and go, as well as changes to the No Surprises Act’s out-of-network billing procedures. At the same …

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Atrium, Advocate Aurora Merge into $27b System

CEO SUMMARY: Integrated delivery networks continue to consolidate in the U.S., with the latest example being the merger of Atrium Health and Advocate Aurora Health. The deal forms a 67-hospital system across two distinct geographic areas in the Southeast and upper Midwest. IDN mergers raise the value of longitudinal test records for patients, with IDNs …

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Passage of FDA Regulation of LDTs Inches Closer in the Senate

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. FDA Would Approve LDTs The bipartisan Verifying Accurate Leading-Edge IVCT Development (VALID) …

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Amazon to Close Employee COVID-19 Testing Lab in Ky.

IN A MOVE THAT MAY SURPRISE SOME OBSERVERS, Amazon announced it will close its COVID-19 employee testing laboratory in Hebron, Ky., which is just across the Ohio River from Cincinnati.  This is the second large COVID-19 clinical laboratory to publicly announce it will cease operations instead of transitioning to conduct other non-COVID testing for either …

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DOJ Charges Execs over Alleged Lab Kickbacks to Obtain Restitution

CEO SUMMARY: Multiple executives and sales representatives at True Health Diagnostics and Boston Heart Diagnostics have been named as defendants in a civil suit filed by the U.S. Department of Justice. The complaint centers on alleged kickbacks in return for clinical laboratory test referrals. The companies and employees involved have been associated with allegations, a …

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Lab Vendors Adjusting to Changing Sales Practices

CEO SUMMARY: Important changes are happening in how lab managers research and buy new lab analyzers, automation, test kits, and consumables. Today, a large proportion of a lab buyer’s research and interaction involving new products is done digitally. This includes virtual sales calls, say two IVD lab marketing experts.  WHEN IT COMES TO MARKETING AND …

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June 6, 2022 Intelligence: Late-Breaking Lab News

Monkeypox is the latest disease showing up in the United States. That means hospital laboratories will want to be ready to diagnose monkeypox cases that show up in their emergency departments. An official from the Centers for Disease Control and Prevention (CDC) says it is exploring the possibility of expanding capacity for monkeypox testing if …

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