Theranos Hit With CMS Sanctions; Bans CEO From Lab for Two Years

The Centers for Medicare & Medicaid Services imposed sanctions on Theranos following a litany of quality control failures for the blood testing company.

As part of those sanctions, CEO Elizabeth Holmes is banned from owning or operating a laboratory for at least two years.

CMS also yanked the company’s CLIA certificate, imposed monetary penalties, suspended the lab’s approval to be reimbursed by Medicare and Medicaid and will oversee a directed correction plan for the beleaguered company.

Following a CMS noncompliance determination in March, Theranos rescinded test results from the past two years for its Edison bloodtesting diagnostics. The company issued corrected test results to doctors and patients and also voided results for some tests. In addition to filing a plan of correction, the company suspended further testing. — Tamra Sami