TAG:
clinical laboratories
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…
High-Complexity Mobile Labs for COVID-19 Testing
CEO SUMMARY: Demand for high-complexity mobile coronavirus testing facilities is high, according to the CEO of a start-up company building 25 clinical labs in mobile trailers that can do hundreds of tests per eight-hour day. Employers, schools, event organizers, and other entities all…
UnitedHealth Sets More Billing Rules for Labs, Pathologists
SUBMITTING CLINICAL LABORATORY AND PATHOLOGY TEST CLAIMS to UnitedHealthcare (UHC) will be more complex after the nation’s largest health insurer announced three significant changes in its claims processing procedures. The three changes involve: • Requests for refunds from anatomic pa…
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 …
Coming Soon: a Different Clinical Lab Industry
“Keep your eye on the ball” is an idiom that originated with baseball. The idea is that every player on the field should, at all times, know where the ball 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…
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…
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…
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…
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 …
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…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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