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April 07, 2014 “Intelligence: Late Breaking Lab News”

In the United Kingdom, the National Health Service’s (NHS) biggest consolidation of clinical laboratory services is expected to take place in May, after the government’s Office of Fair Trading said it will conduct no further investigation into the project. Six health trusts are c…

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Whole Genome Sequencing Is Poised for Clinical Use

CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …

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CMS Gives Deemed Status to A2LA under CLIA Law

CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…

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New Federal Law Changes How CMS Sets Lab Prices

CEO SUMMARY: CMS wanted more power to cut the prices it pays for clinical lab testing. A significant part of the lab industry wanted more transparency and consistency in how CMS established coverage guidelines and prices for new lab tests. Congress appears to have attempted to craft a law…

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Congress’ New SGR Law Has Mixed News for Labs

CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…

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Congress Raises Stakes in Lab Test Pricing Game

EACH OF YOU READERS KNOW that there is always a story behind the story. This is particularly true in Congress and the federal government, where lobbying and influence can often have their own role in shaping how laws and regulations are written. Keep that in mind as you learn more about the new law …

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Anatomic Pathology Business Faces Uncertain Future

CEO SUMMARY: There’s a day of reckoning on the way for the traditional business model of the private pathology group practice. At most risk are smaller pathology groups that typically have five or fewer pathologists. Blame it on the reduced prices that Medicare and private insurers are …

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Clinical Labs Spending Money in New Ways

CEO SUMMARY: In response to the many changes now unfolding in the U.S. healthcare system, labs are investing their scarce capital in different ways. Five trends in lab spending can be identified. They range from expanding the informatics capabilities of a lab organization to acquiring the…

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Eastern Canada’s Latest Lab Errors Get Attention

CEO SUMMARY: Authorities for Eastern Health in Newfoundland and Labrador province in Canada are conducting a root cause analysis after finding discrepancies in breast cancer testing that affected nine patients. Health officials said these cases were discovered as a result of an improved q…

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Quest Gets into Wellness By Acquiring Summit Health

IT IS NO SURPRISE THAT THE NATION’S largest laboratory companies are looking for new revenue opportunities now that fee-for-service payment for lab tests is soon to end. One striking example of this trend was the move last week by Quest Diagnostics Incorporated to acquire …

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