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Top 10 2014 Biggest News Stories

Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…

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Attorneys Outline Issues in FDA’s LDT Guidance

CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify…

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Labs Share Successes in Delivering More Value

CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…

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Where Are Pathologists When You Need Them?

WHAT’S WRONG WITH THIS PICTURE? National health insurer has exclusive national contract with a single billion-dollar lab company. Billion-dollar lab company creates a business division to manage how physicians order lab tests. This lab test order system requires physicians to follow the lab test o…

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Public Comment Started on FDA LDT Regulations

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…

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Florida Ob-Gyns Call for UHC to End BeaconLBS

CEO SUMMARY: In Florida, obstetricians and gynecologists are complaining about the burdensome nature of the new lab test management system introduced by UnitedHealthcare. In addition to calling for an end to the program, some ob-gyns plan not to use the system, a process that could lead U…

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UnitedHealth Answers Queries about Function of BeaconLBS

ANSWERS TO QUESTIONS SUBMITTED to UnitedHealthcare about the insurer’s laboratory benefit management program now coming into operation in Florida were provided by the company’s public communication officer. These answers are reproduced below: Q: Will BeaconLBS proces…

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LabCorp, Quest Diagnostics Report Improved Q-3 Revenue

THIRD QUARTER EARNINGS at each of the nation’s two biggest public lab companies showed improved growth in revenue and specimen volume, as compared to recent years. Laboratory Corporation of America was first to release its financial report for the quarter ending September 30, 2014…

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Theranos Pursues Different Business Plan in Arizona

CEO SUMMARY: Since its big public debut in late 2013, Theranos has been the subject of keen interest and much skepticism among pathologists and clinical laboratory professionals. Theranos is expanding its presence in Phoenix, Arizona. However, as it does, it looks more like a conventional…

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Doctors at Johns Hopkins Improve Lab Test Utilization

CEO SUMMARY: Efforts to help physicians improve their utilization of clinical lab tests paid big dividends at the Johns Hopkins Bayview Medical Center in Baltimore, Maryland. Working collaboratively, physicians and the clinical lab team identified overused or needless cardiac biomarker te…

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