CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive overhaul of the CLIA regulations in other areas, including
Tag: clia lab
This is an excerpt from a 5,000-word article in the January 22, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: UnitedHealth made national news when it filed a $100 million lawsuit against
CEO SUMMARY: UnitedHealth made national news when it filed a $100 million lawsuit against Next Health and other defendants in Dallas in January 2017. The insurer alleged fraud involving clinical laboratory tests. That lawsuit is just the latest chapter in an almost decade-long string of legal proceedings involving the healthcare businesses some of the defendants have
CEO SUMMARY: Clinical labs must assess their responsibilities to report lab test market prices to CMS as part of the Protecting Access to Medicare Act. A panel of three experts took up this topic at a recent webinar hosted by THE DARK REPORT. On June 23, the federal Centers for Medicaid & Medicare Services published
CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to discuss: a) her company’s new business strategy; b) an
This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group.
SKEPTICS WHO WEREN’T EXPECTING MUCH from Theranos CEO Elizabeth Holmes at the recent American Association of Clinical Chemistry’s annual meeting were proved right: Instead of delivering scientific
This is an excerpt from a 1,900-word article in the July 25 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group.
BY NOW, MANY LAB PROFESSIONALS KNOW that the Centers for Medicare and Medicaid (CMS) sent a letter to Theranos in early July that imposed multiple CLIA
CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab company’s founder and CEO Elizabeth Holmes from the operating a clinical laboratory for
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a clinical lab testing business strategy and back to
IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company.
During March and April, The Wall Street Journal published a series of articles that revealed the extent of the problems Theranos had with CLIA inspections of its clinical laboratory in Newark, California. The Journal published its analysis of the CLIA inspection report and the serious deficiencies identified during lab inspections that happened last fall and earlier this year.