Issue: Volume XXIII No. 8 - June 13, 2016

Why Theranos Is a Big Test for CMS and CLIA

OFFICIALS AT THE FEDERAL CENTERS FOR MEDICARE & MEDICAID SERVICES are at what may be the most important crossroads in the history of clinical laboratory regulation since Congress passed the CLIA 1988 legislation. Will CMS pursue the severe sanctions it disclosed to Theranos, Inc., and force the lab to close? Or will it soften its …

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Walgreens Tells Theranos: ‘Lab Deal Is Terminated’

BREAKING NEWS: As this issue of THE DARK REPORT went to press, it was learned that Walgreens had announced the termination of its lab testing agreement with Theranos, effective immediately. Theranos loses access to about 40 Walgreens pharmacies in Phoenix and is left with about five patient collection centers. The following story summarizes developments involving …

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Quest Makes Second Deal For Inpatient Lab Volume

NEWS OF A HOSPITAL INPATIENT LAB MANAGEMENT AGREEMENT between HealthONE of Denver and Quest Diagnostics Incorporated marks the second time in six months that the public lab company has earned an inpatient lab management pact with a multi-hospital health system. There are two aspects of this development that make it newsworthy for lab administrators and …

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Genetic Testing Lab Finds Payers Respond To Education on Test Utility

CEO SUMMARY: In recent years, insurers have raised the bar and become much tougher when making coverage and reimbursement decisions for molecular assays, genomic, and genetic tests. Yet several lab testing companies are having good success at demonstrating the validity and clinical utility of their assays. Among them is Foundation Medicine, of Cambridge, Mass. In …

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Years of Biobank Experience Pay Off for Mayo Clinic Lab

THANKS TO 10 YEARS OF EXPERIENCE, an existing infrastructure for banking patient specimens, and the unique capabilities of its clinical laboratory organization, Mayo Clinic has been awarded a five-year, $142 million grant from the National Institutes of Health. Last month, NIH announced this grant to Mayo Clinic. It will establish the world’s largest research-cohort biobank …

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June 13, 2016 Intelligence: Late Breaking Lab News

Life insurers are adopting healthcare big data as part of their underwriting process and clinical laboratory test data has an important role. Quest Diagnostics Incorporated participates in this business line. Huffington Post recently published a story on this topic and identified companies that life insurers use to access data about prescription drug histories and lab …

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Quest to Manage Six Labs at HCA HealthONE Hospitals

CEO SUMMARY: For decades, hospitals were reluctant to allow any outside lab company to run their inpatient lab operations because they preferred to maintain control over quality results and turnaround times. That attitude may be changing as health systems face increasing margin compression by moving to value-based reimbursement models and taking on more risk-based contracts. …

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