CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own request for summary judgment; and most recently ACLA filed its rebuttal to the
Tag: medical laboratory tests
CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could conduct comprehensive blood tests from drops of blood collected via
CEO SUMMARY: Researchers at the Mayo Clinic showed that only 12% of patients referred to Mayo physicians for a second opinion got a confirmation that their original diagnosis was complete and correct. In 21% of the cases, the diagnosis was completely changed. Among patients who got additional work ups for a second opinion, some 80%
THROUGHOUT THE WORLD, THE UNITED STATES IS ENVIED for the quality and ready access to medical laboratory tests that it delivers to physicians and their patients. Yes, there are criticisms that healthcare costs too much in this country compared with costs in other nations. But few countries offer both convenient access to testing services and
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
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.
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.
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.
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.
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.