TAG:
clia
NILA: CLIA Proposal Doesn’t Address Flaws
CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive o…
Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …
After Two Decades, CMS Wants to Update CLIA Lab Regulations
IN THE FIRST EFFORT OF ITS kIND in more than two decades, the federal Centers for Medicare and Medicaid Services has published a request for information (RFI) in the Federal Register as a first step to revise the CLIA rules it promulgated in 1992. Over the years, CMS has made some m…
Allegations of Lab Test Fraud Involve Multiple Defendants
CEO SUMMARY: UnitedHealth made national news when it filed a $100 million lawsuit against Next Health and other defendants in Dallas in January 2017. The insurer alleged fraud involving clinical laboratory tests. That lawsuit is just the latest chapter in an almost decade-long string of …
Allegations in UHC health insurance fraud case involve multiple defendants
This is an excerpt from a 5,000-word article in the January 22, 2018, 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. …
Beckman Coulter Sues Quidel for Right to Sell BNP Assay
THERE IS AN INTERESTING COURT FIGHT UNFOLDING between Beckman Coulter Corporation and Quidel over the rights to sell a B-type natriuretic peptide (BNP) assay. The lawsuit is a consequence of Abbott Laboratories’ acquisition of Alere, Inc….
In Florida, More Tests Added to UHC’s Decision-Support Program
IN THE FIRST BROAD EXPANSION OF ITS pilot decision-support program for clinical lab testing in Florida, UnitedHealthcare (UHC) will add genetic and molecular tests, drug tests, and pathology procedures, among other assays starting in two months. On March 1, UHC will expand its labor…
Lab Executives Declare Concerns about Fee Cuts
CEO SUMMARY: Members of Joint Venture Hospital Laboratories in Michigan anticipate that the 2018 Clinical Laboratory Fee Schedule rates being implemented under PAMA will lower payment from Medicare to less than the cost of running tests, especially for rural and critical access hospitals….
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 …
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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