TAG:
laboratory test
DOJ Delivers $6B Lab Fraud Crackdown
By Mary Van Doren | From the Volume XXVII, No. 14 – October 5, 2020 Issue
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…
Lab Finances to Become More Challenging
By R. Lewis Dark | From the Volume XXVII, No. 14 – October 5, 2020 Issue
When you finish reading our story about how Medicare spending for molecular and genetic tests jumped by as much as 700% in certain states during 2019, you’ll be among the first in the nation to understand why a financial crisis is soon to wash over those clinical laboratories and pathology grou…
Medicare Pays 500% More for Molecular Test Claims
By Robert Michel | From the Volume XXVII, No. 14 – October 5, 2020 Issue
CEO SUMMARY: Rapid growth in what Medicare spent for molecular tests in recent years may lead federal investigators to increase scrutiny of fraudulent billing for clinical laboratory and molecular pathology tests, according to a lab consultant who has tracked such spending in recent y…
DOJ $6B Fraud Crackdown Charges 345 Defendants
By Robert Michel | From the Volume XXVII, No. 14 – October 5, 2020 Issue
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
By Robert Michel | From the Volume XXVII, No. 14 – October 5, 2020 Issue
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…
Will HHS Ruling on COVID-19 LDTs Be Good or Bad for Lab Reimbursement?
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
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 …
Understanding COVID-19’s Changes to Lab Industry
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
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…
Texas Company Operates 400 COVID-Collection Sites
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: In April, the federal Department of Health and Human Services contracted with eTrueNorth to operate COVID drive-through specimen-collection sites under the Community-Based Testing Sites program. The drive-through sites are an extension of non-COVID testing the company has …
New York Firm to Build CLIA Labs in Shipping Containers
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
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…
Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
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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