TAG:

laboratories

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…

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New Twist: HHS Exerts Authority Over FDA on LDTs

CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…

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Medicare COVID Test Coding May Become a ‘Logistical Nightmare’

STARTING JAN. 1, 2021, clinical laboratories performing COVID-19 tests using high-throughput systems for Medicare patients must comply with a complex new coding rule when submitting claims for these tests.  The federal Centers for Med…

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Labs, AP Groups Confused about UnitedHealthcare’s Test Registry

CONFUSION CONTINUES among clinical laboratories and anatomic pathology groups about how they should comply with UnitedHealthcare’s new Laboratory Test Registry Program. The program goes into effect on Jan. 1, 2021, but labs and pathology groups must register all tests and testing procedure…

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DOJ Delivers $6B Lab Fraud Crackdown

This is an excerpt of a 1,028-word article in the October 5, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In this latest lab fraud crackdown, Department of Justice cases involving clinical labs or molecular te…

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DOJ $6B Fraud Crackdown Charges 345 Defendants

CEO SUMMARY: Department of Justice cases involving clinical labs or molecular test claims may represent about half (or about $3 billion) of the total fraudulent claims. Those claims stem from genetic testing, urine-drug and other tests, and healthcare services, the DOJ said. In additi…

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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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Franciscan Missionaries Sells Lab Outreach Business to LabCorp

SINCE THE ONSET OF THE PANDEMIC IN LATE FEBRUARY, the nation’s two largest clinical lab companies have announced only two acquisitions of hospital laboratory outreach programs, one in June and one this month. Last week, LabCorp announced its acquisition of the clinical ambu…

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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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Quest Reports 46% Decline in New Cancer Diagnoses in March

ONCE SHELTER-IN-PLACE ORDERS WERE ENACTED IN MARCH because of the COVID-19 pandemic, the number of new diagnoses of cancer declined sharply in the United States. Newly-published data confirms this fact. The data also support the warnings of anatomic pathologists that—because of the pandemi…

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