Regulators also revoked the certification for Theranos’ lab in Newark, Calif., and prohibited the lab from taking Medicaid and Medicare payments for its services. Last November, a CMS inspection revealed five major categories of infractions at the Newark lab. The company submitted a correction plan in February, but CMS concluded it was insufficient.
“We accept full responsibility for the issues at our laboratory in Newark, Calif., and have already worked to undertake comprehensive remedial actions,” Ms. Holmes said in a statement. “Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures.”
CMS also levied a monetary penalty for an unspecified amount against the embattled blood-testing startup.
The sanctions take effect in 60 days.
More articles on Theranos:
Walgreens terminates partnership with Theranos
Theranos faces consumer fraud lawsuit
Theranos recalls tens of thousands of tests: 7 things to know
At Becker's 4th Annual CEO + CFO Roundtable, taking place November 2–5 in Chicago, more than 1,500 hospital and health system executives tackle decisions that determine whether organizations thrive or merely survive: protecting margins under cost pressure, choosing where to grow, renegotiating payer relationships, stabilizing the workforce and proving real ROI on technology. This is where leaders work through them together, face-to-face. Apply for complimentary registration now.