TAG:
clia compliance
Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit
IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager w…
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…
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…
COLA Questions UHC on BeaconLBS Accredit Rules
CEO SUMMARY: UnitedHealthcare’s ‘Laboratories of Choice’ network in Florida accepts only labs accredited by the College of American Pathologists and The Joint Commission. In March, COLA wrote to UnitedHealth to question this policy which excludes labs accredited by the five other…
Pathologists Benefit from Hospital Lab Consulting
CEO SUMMARY: Deteriorating finances at many rural hospitals and smaller community hospitals is a growing trend. It is also a new consulting opportunity for local pathologists because financially-strapped hospitals often give their labs inadequate working capital and lack the staff needed …
Rural Hospital Labs and their Lab Directors
FROM TWO DIFFERENT STATES, WE PRESENT INTELLIGENCE BRIEFINGS that have a common element: laboratories in many rural hospitals are struggling. We consider these stories, when taken together, to be persuasive evidence that some significant number of rural hospital laboratories are experiencing ongoing …
Louisiana Pathologists ‘Moonlight’ as Consultants
CEO SUMMARY: Few independent pathology groups have developed robust laboratory consulting businesses. But adopting that strategy has brought important benefits to Delta Pathology Group, LLC, of Shreveport, Louisiana. Not only has providing lab consulting services to cash-strapped hospital…
Lack of Succession Plan Now Hurts Many Labs
CEO SUMMARY: Throughout the past decade, laboratory administrators and pathologists have been reminded about the importance of having a succession plan in their laboratory. Now one veteran lab industry CEO says the lack of a succession plan, unexpected retirements, the d…
California Pathologist Wins Medi-Cal Pay Case
CEO SUMMARY: It was a case that stretched back several years. Medi-Cal officials, wanting to pursue collection of what it deemed overpayments, claimed that the pathologist who was on the license of two defunct lab companies as medical director was personally liable for the $6.37 …
Medi-Cal Hits Pathologist For $6.4 Million Payment
CEO SUMMARY: Once again, government health bureaucrats are overreaching in their efforts to reduce spending and collect money from any source. A California pathologist has been hit with a Medi-Cal demand for $6.4 million in repayments, simply because he served as laboratory director for t…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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