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ADLT Final Rule Creates Tough Questions for Labs

IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…

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July 25, 2016 Intelligence: Late Breaking Lab News

Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This …

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CMS CLIA Sanction Letter Sent To Theranos Raises Questions

CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab…

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Theranos Now Scrambling To Save What It Can

CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…

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Florida Pathology Group Lost Volume After BeaconLBS Started

CEO SUMMARY: A 22-physician pathology group in Tampa has complied with rules for lab test ordering that UnitedHealthcare and BeaconLBS established, yet has experienced a steep decline in the volume of specimens it receives. Physicians told the pathologists that other labs were not using t…

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Is CMS about to Create New Lab Winners, Losers?

FROM ITS INCEPTION IN 1966, THE MEDICARE PROGRAM WAS DESIGNED to give beneficiaries easy access to healthcare services while allowing any qualified provider to provide those clinical services. That is about to change for…

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New Threat To Community Lab Survival: CMS Clinical Lab Fee Schedule Cuts

This is an excerpt from a 2,000-word article in the July 5 issue of THE DARK REPORT. The original article is available to paid members of the Dark Intelligence Group. CEO SUMMARY: Everyone has read the basic facts, but THE DARK REPORT has gone further …

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July 5, 2016 Intelligence: Late Breaking Lab News

More developments have happened at Theranos, Inc., the beleaguered clinical lab company based in Palo Alto, California. On June 24, Brook Buchanan, Vice President of Communications at Theranos, resigned, giving personal reasons for the decision. Buchanan was hired in November 2015, …

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McKesson, Change Healthcare Decide to Create New Company

ACROSS THE NATION, the hundreds of pathology groups and clinical labs that use McKesson Technology Solutions for their billing and collections, along with labs that use the Advanced Diagnostics Solutions group, should pay attention to a major corporate deal announced…

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PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%

CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…

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