TAG:
the clinical laboratory
FDA Clears Waived CBC For Near-Patient Testing
CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees…
Value-based healthcare launches new conflicting interests for hospital labs, independents
This is an excerpt from a 2,400-word article in the Nov. 20, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: Her…
Paths of Hospital Labs, Independent Labs Diverge
CEO SUMMARY: With each passing year, the primary role of hospital and health system labs evolves in a different direction than that of independent lab companies. This trend is a response to the creation of integrated delivery networks paid on value and how they are scored on their ability…
Looming CMS lab fee schedule cuts unite AMA, AHA and labs in opposition
This is an excerpt from a 1,237-word article in the Oct. 8, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: In what m…
XIFIN CEO White Analyzes Medicare 2018 Fee Cuts
CEO SUMMARY: If the draft lab rates that CMS published Sept. 22 for the Clinical Laboratory Fee Schedule for 2018 go into effect Jan. 1 as proposed, then clinical labs will see a cut of 28% in what they get paid for the top 20 most common tests, according to a recent analysis. The rates t…
AMA, AHA Join Labs to Request Delay, Fix
CEO SUMMARY: In what may be a first for the clinical lab industry, the American Medical Association and the American Hospital Association joined with 20 other healthcare associations to ask CMS Administrator Seema Verma to address the problems with the CMS proposal involving Medicare Part B f…
For Top 20 Tests, CMS to Cut Payment by 28% in 2018-2020
ON SEPT. 22, MEDICARE OFFICIALS RELEASED THE DRAFT PRICES for the 2018 Clinical Laboratory Fee Schedule. The bad news for the lab industry is that the fee cuts are deeper than the federal Centers for Medicare and Medicaid Services had predicted earlier. The price cuts to clinical la…
Positive Patient ID System Catches Patients Cheating on Toxicology Tests
CEO SUMMARY: The urine drug testing industry is challenged every day to detect the large number of patients trying to cheat on their drug tests. GenoTox Laboratories of Austin, Texas, developed a DNA-authentication method for urine samples that allows the lab to detect when patients have …
Drug Testing Labs in Texas, California Deal With Fraud Charges
CEO SUMMARY: Two toxicology lab companies accused of fraud are fighting to stay in business. In the case of Medicus Laboratories of Dallas, it is asking a federal judge to issue a temporary restraining order to prevent state and federal lab regulators from pulling its CLIA license. At Pro…
Proove Biosciences, Medicus Face Serious Fraud Charges
This is an excerpt from a 1,400-word article in the Sept. 18, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. …
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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