Tag: medical laboratory tests

Official Makes Case in Favor of FDA LDT Guidance

IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging

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Feds Show How Labs Took $500 Million from Medicare

CEO SUMMARY: In this second phase of the whistleblower case against three cardiology testing labs and a sales consulting company, federal prosecutors are requesting a jury trial against the individuals named in the court documents filed August 7. Federal investigators alleged that executives at one lab began a fraud scheme in 1999 and then expanded that scheme to other labs over 15 years. The suit claims that the labs made improper payments to referring physicians.

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Theranos, Capital Blue Sign Lab Test Agreement

capital-blue-cross-theranos

CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health insurers. Meanwhile, respected laboratory scientists and physicians are using peer-reviewed medical journals to point out that Theranos has yet to publish details about the performance of its diagnostic technology to enable independent validation.

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Our Editor Describes Visit to Theranos Test Center

CEO SUMMARY: Theranos now operates wellness centers in Walgreens in Palo Alto, California, and Phoenix, Arizona. It con- tinues to claim it is transforming the lab testing experience for patients and physicians. It says it can perform hundreds of lab tests, using a finger stick collection and a micro-specimen vial, and return results in four hours. Last month, our editor visited a Theranos wellness center in a Walgreens pharmacy with a test requisition for four lab tests. He reports here on the experience.

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What’s New at Theranos? Lab Firm Expands in AZ

CEO SUMMARY: Over the past 18 months, Theranos has taken steps to enter the clinical lab marketplace. Across Greater Phoenix, Theranos now has specimen collection centers in about 40 Walgreens pharmacies. It is opening a CLIA lab facility in Scottsdale. Now that it is delivering clinical laboratory testing services on a regular basis, the quality of its laboratory test results and the service it provides to physicians and patients will get close scrutiny from both investors and competing labs.

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Locked Out of Payer Network, NH Hospital Opens Lab Company

CEO SUMMARY: Since Anthem launched its site of service program in New Hampshire in 2010, labs in the state’s hospitals have mostly been excluded from its network and have lost market share. Recently one community hospital developed an unusual strategy to win back those patients. Last year, Frisbie Memorial Hospital in Rochester, opened a stand-alone independent lab company that became a provider in the Anthem network. To date, the independent lab has been gaining patients steadily, hospital officials say.

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