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dark report
Top 10 Lab Stories of 2017 Dominated by Part B Cuts
CEO SUMMARY: In hindsight, 2017 is likely to be remembered as a milestone year that launched several disruptive developments that will reshape the lab industry moving forward. For the clinical laboratory sector this year, CMS confirmed its intent to slash Part B clinical laboratory test price…
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 …
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…
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…
Tougher Times Ahead as Labs React to Fee Cuts
CEO SUMMARY: Just as Nero is reputed to have fiddled while Rome burned, officials at CMS seem to be doing their own fiddling as their planned deep price cuts to Medicare Part B lab tests could begin driving lab companies out of business. In recent weeks, the owners of two lab companies de…
New source of lab test abuse surfaces in the form of HOPDs and MSOs
This is an excerpt from a 2,350-word article in the Oct. 30, 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: …
Labs Begin Applying Lean to Cut Costs, Add Value
CEO SUMMARY: In more than 40 presentations by 55 speakers, two big themes dominated the 11th annual Lab Quality Confab in New Orleans last week. One theme is the urgent need to cut clinical laboratory costs. The second theme is the need for both clinical labs and anatomic pathology groups…
Lab Scheme Recruits Hospitals To Bill as In-Network Providers
CEO SUMMARY: Management companies using a new generation of potentially fraudulent schemes are targeting hospitals and health systems for arrangements that use questionable means to increase lab test volume and revenue. The management companies often use the term “hospital outpatient de…
LabCorp, Quest Open PSCs in Retail Stores
CEO SUMMARY: In the past year, both national laboratory companies have increased the number of patient service centers they operate in retail pharmacies and grocery stores. But these PSCs are not serving direct access testing (DAT) customers. Rather, early evidence indicates that patients…
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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