Issue: Volume XXIII No. 7 - May 23, 2016

Do Regulators Really Protect Patients, Consumers?

IMAGINE, FOR A MOMENT, THAT ONE OF YOUR LOVED ONES had gone to Theranos during the past two years to get lab tests. Assume that your loved one was being tested for significant biomarkers that directly affected the care provided to your family member for significant health issues and that your loved one’s physician had …

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Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?

CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions against Theranos, including revocation of the Theranos CLIA certificate. An expanded scientific advisory …

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Theranos CEO Elizabeth Holmes to Show Scientific Data at AACC Conference

CEO SUMMARY: Theranos Founder and CEO Elizabeth Holmes will be in Philadelphia to present to the American Association of Clinical Chemistry (AACC) data about the technology developed at Theranos. Conference organizers said Holmes would answer ques- tions to clarify the science, accuracy, and reliability of the lab company’s technologies and its effect on patient care …

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UnitedHealth Sues 5 Tox Labs, Says It Was Defrauded of $50M

FLORIDA IS ONCE AGAIN GROUND ZERO for a major case of lab testing fraud. UnitedHealthcare has filed suit against five toxicology laboratory companies, three general partners in those companies, eight urinalysis referral sources, and other entities, claiming the defendants defrauded the health insurer of more than $50 million. Filed last month in U.S. District Court …

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Lab, Emergency Department at Cleveland Clinic Collaborate to Reduce Hemolysis Rates

CEO SUMMARY: Two years ago, the rate of hemolysis in blood drawn in the Cleveland Clinic’s Emergency Department was about nine times higher than the ASCP recommended rate of 2%. With a two-year cooperative agreement and funding from the federal Centers for Disease Control and Prevention, the ED and clinical lab staff developed a quality …

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Payers Asking for Repayment When Labs Waive Fees

CEO SUMMARY: Health insurers appear to have stepped up their efforts to warn clinical laboratories not to waive patients’ fees in return for specimen referrals. Consultants also say that payers are increasing enforcement efforts. There are cases where, when insurers discover labs have not collected fees from patients, they have hit labs with automatic payment …

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May 23, 2016 Intelligence: Late Breaking Lab News

Patients of Health Diagnostic Laboratories who were tested between 2009 and 2014 are now being dunned by a collection agency! Creditors in the HDL bankruptcy case have engaged a Florida collection agency to go after 9,000 accounts. As reported by The Wall Street Journal, the amount of these bills totals $50 million, according to bankruptcy court documents. …

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