- Thomson Reuters
Theranos CEO Elizabeth Holmes and the company’s president, Sunny Balwani, may be barred from the blood-testing business for two years, according to a report by The Wall Street Journal.
In a March 18 letter uploaded by The Journal (PDF), the Centers for Medicare and Medicaid Services said it plans to revoke Theranos’ California lab’s license based on its failure to comply with the agency’s safety and performance standards.
A second letter, not yet released to the public, details the potential two-year suspension of Balwani and Holmes, which would, if put into place, bar them from owning or operating any lab, according to The Journal.
Theranos spokeswoman Brooke Buchanan confirmed to Business Insider that the company did receive the March 18 letter and responded in the 10-day time period. “Theranos has not received these sanctions,” she said.
Barbara Cammarata, a lawyer at Sidley Austin LLP, told The Journal that the penalties are some of the most severe that CMS can dish out. “They’re in a lot of trouble,” she said.
The sanctions outlined in the March 18 letter were based on two main problems.
First, the finding of “immediate jeopardy” and Theranos’ “failure to meet all CLIA condition-level requirements,” and, second, the failure by the lab’s owner and director to “comply with certificate requirements and performance standards” outlined during the survey that the agency conducted in December 2015.
Here are the specific sanctions (which Buchanan emphasized Theranos has not been given but rather warned about):
- Revoking the California lab’s CLIA license after 60 days. Barring the lab from participating in the Medicare program. Cancelling of the lab’s approval to receive Medicare payments. Limiting Theranos’ hematology CLIA certification after eight days. Possibly fining the lab $10,000 per day for each day it isn’t compliant with CMS. Forcing the lab to provide CMS with a list of all the physicians and clients who’ve used the lab since January 2014.