Theranos is appealing the government sanctions that have barred its CEO, Elizabeth Holmes, from running a blood-testing lab for two years.
The sanctions from Centers for Medicare and Medicaid Services, which has oversight of labs like Theranos’, came after the company failed its California lab inspection. The California lab doesn’t currently test patients, but the company’s Arizona lab is still up and running.
The sanctions from July also included revoking the California lab’s Clinical Laboratory Improvement Amendments license (the regulatory standards that apply to all clinical labs) after 60 days, prohibiting the lab from participating in the Medicare program and canceling the lab’s approval to receive Medicare payments.
Now, Theranos plans to appeal those sanctions.
“Theranos has made substantial progress toward correcting the deficiencies CMS identified, including appointing new laboratory leadership; enhancing Theranos’ clinical policies and procedures; and revamping training programs,” the company said in a release.
Earlier this month, Theranos debuted a new blood-testing system at the American Association for Clinical Chemistry’s annual conference – its first medical conference appearance – that included a machine that takes the sample of blood and processes it so it can give a diagnosis or tell you your cholesterol level. Theranos is calling the device the “miniLab.”
Here’s the release:
“Theranos, a health technology company, said today that it has filed a notice of intent to appeal the sanctions that the Centers for Medicare and Medicaid Services (CMS) imposed last month on the company’s Newark, California, lab.
“Theranos is not conducting patient testing at its Newark facility. In addition, since CMS originally announced the imposition of sanctions, Theranos has made substantial progress toward correcting the deficiencies CMS identified, including appointing new laboratory leadership; enhancing Theranos’ clinical policies and procedures; and revamping training programs.
“While the appeal is pending, Theranos intends to continue communicating with CMS regarding the possibility of reaching a mutually agreeable resolution to this matter.”