TAG:
clia lab
NILA: CLIA Proposal Doesn’t Address Flaws
By Joseph Burns | From the Volume XXV No. 3 – February 12, 2018 Issue
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 o…
Allegations in UHC health insurance fraud case involve multiple defendants
By Mary Van Doren | From the Volume XXV No. 2 – January 22, 2018 Issue
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. …
Allegations of Lab Test Fraud Involve Multiple Defendants
By Pamela Scherer McLeod | From the Volume XXV No. 2 – January 22, 2018 Issue
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 …
Labs Have Heavy Burden to Report Lab Price Data
By Joseph Burns | From the Volume XXIII No. 15 – November 7, 2016 Issue
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 &…
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
By Robert Michel | From the Volume XXIII No. 11 – August 15, 2016 Issue
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 d…
Score for Theranos after AACC: Fail.
By Mary Van Doren | From the Volume XXIII No. 11 – August 15, 2016 Issue
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. …
CMS CLIA Sanction Letter Sent To Theranos Raises Questions
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
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…
What will the future hold for Theranos?
By R. Lewis Dark | From the Volume XXIII No. 10 – July 25, 2016 Issue
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. …
Theranos Now Scrambling To Save What It Can
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
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 c…
Theranos Saga Just Keeps Getting More Intriguing
By Mary Van Doren | From the Volume XXIII No. 6 – May 2, 2016 Issue
This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group. …
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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