December 2015

December 7, 2015 Intelligence: Late Breaking Lab News

Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accreditation, ISO 15189 accreditation, and CLIA requirements. In their statement about the benefits of the new arrangement, the […]

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Washington Post: Theranos Approached Military in 2012

Clinical Laboratory / Joseph Burns

SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices. One example is the disclosure by The Wall Street Journal in November that Theranos had an agreement with Safeway to put blood collection

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UnitedHealthcare Comments on Labs’ Use of “Fee Waivers”

Laboratory Compliance / Joseph Burns

PATHOLOGISTS AND LAB SCIENTISTS are familiar with the well-known scientific principle that, “for every action, there is a reaction.” This principle also holds true for the managed care contracting practices of the two national laboratory companies. One action that is the subject of this story is the award, in 2007 by UnitedHealthcare, of a 10-year,

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Letter to Florida Doctor Offers to Waive Lab Test Fees

Laboratory Compliance / Joseph Burns

CEO SUMMARY: Florida’s highly-competitive market for lab testing services is again seeing some lab companies use “Waiver of Charges to Managed Care Patients” agreements with physicians in situations where the lab is an out-of-network provider. This means the lab will do free testing—waiving charges to the health plan and the patient—in order to keep the

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True Health Diagnostics Sued by Cleveland Clinic Foundation, Cleveland HeartLab

Clinical Laboratory / Joseph Burns

IT’S GETTING DOWN AND DIRTY in the cardiology testing sector of the lab industry. No less than the Cleveland Clinic Foundation, along with Cleveland HeartLab, have filed a patent infringement lawsuit against a start-up lab in Texas. The defendant is True Health Diagnostics LLC, of Frisco, Texas. In an amended complaint filed November 30 in

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Aurora Diagnostics Buys Toledo Pathology Group

Pathology Trends / Joseph Burns

CEO SUMMARY: Consultants in Laboratory Medicine of Greater Toledo was sold to Aurora Diagnostics last month. CLM’s president said that, as an ancillary service, pathology has little appeal to hospital administrators who want to cut costs as quickly as possible, and all hospital-based services are targets for cost reduction. Therefore, CLM sought a partner that

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Coming Next Year for Labs: PAMA, FDA, LDTs, and More

Laboratory Compliance / Robert Michel

CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observers expect that each government program will cost labs substantial amounts of money—from fee

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State of Clinical Lab Industry Likely to Be Mixed in 2016

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: Over the next 24 months, it will be essential for every clinical laboratory and anatomic pathology group to develop clinical and financial strategies that meet the changing needs of health insurers, hospitals and health systems, physicians, and patients. THE DARK REPORT provides its assessment of key macro trends for 2016, along with comments

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Opportunities Ahead for Labs That Prepare

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

AT THE END OF EVERY YEAR, IT’S ALWAYS SMART BUSINESS FOR EVERY LAB to peer into the future specifically to identify the best clinical and financial opportunities. With the New Year just a few weeks away, this issue of THE DARK REPORT is designed to help you and your management team prepare for what’s coming

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Low 2013 Molecular Rates May Bankrupt Some Labs

The Dark Report / R. Lewis Dark

CEO SUMMARY: Many of the recently issued reimbursement rates for molecular diagnostic tests are inadequate and in fact are lower than the cost of running the tests, lab experts say. Smaller laboratories that specialize in developing and selling molecular tests could be forced to close. As many as 20 or more molecular labs operate in California

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