In a letter, CMS detailed the agency wants to ban Theranos CEO Elizabeth Holmes and President Sunny Balwani from owning or operating any other lab for at least two years, according to Fierce Medical Devices.
Here are six things to know:
1. CMS also is seeking to revoke the license for Theranos' Newark, Calif.-based lab.
2. In the letter, CMS gave Theranos 10 days to provide evidence explaining why CMS shouldn't penalize the California lab, Ms. Holmes or Mr. Balwani.
3. In November, CMS inspected Theranos' California lab and found several major infractions. While Theranos submitted a correction plan in February, CMS was not satisfied with the plan, arguing it was inadequate. In 2015, Theranos failed to sufficiently correct 43 of 45 deficiencies.
https://www.beckershospitalreview.com/hospital-management-administration/feds-want-to-revoke-theranos-lab-license-ban-founder-elizabeth-holmes.htmlinspectors identified.
4. If Theranos does not provide compelling evidence, some of the agency's sanctions could go into effect either right away or within eight days.
5. Other sanctions, including revoking the Newark lab's license, may take nearly two months to go into effect.
6. Although Theranos has the opportunity to appeal CMS' decision, those appeals have a relatively unsuccessful track record. CMS did not lose a single related case from 2001 to 2010.
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