Theranos appeals sanctions imposed by Centers for Medicare and Medicaid Services
In July, CMS banned founder Elizabeth Holmes from blood-testing business for two years, as well as other measures.
Theranos Founder Elizabeth Holmes
Embattled blood testing company Theranos has filed a notice of intent to appeal the sanctions that the Centers for Medicare and Medicaid Services has imposed on their Newark, California lab, the company announced Thursday.
Early last month, CMS banned founder Elizabeth Holmes from the blood testing business for two years and issued a number of other sanctions in response to Theranos' alleged failures including a limitation of the laboratory's CLIA certificate for the specialty of hematology; a civil monetary penalty; a plan of correction; suspension of the laboratory's approval to receive Medicare and Medicaid payments for any services performed for the specialty of hematology; and cancellation of the laboratory's approval to receive Medicare and Medicaid payments for all laboratory services.
[Also: Walgreens to close all Theranos centers, gives embroiled blood-testing firm the boot]
Also in July, the United States House of Representatives' Committee on Energy and Commerce demanded to know what Theranos was doing to address its testing inaccuracies and questionable adherence to federal guidelines.
In a letter to Holmes, the committee cited clinical laboratory failures that led Theranos to void two years of test results from its proprietary Edison blood-testing device as well as tests run on traditional machines from 2014 and 2015, affecting patients who may have received inaccurate or unwarranted medical care on the basis of those results.
[Also: Theranos hit with class action lawsuit over blood testing technology]
Since CMS originally announced the imposition of sanctions, Theranos said in a statement that they have appointed new laboratory leadership; enhanced their clinical policies and procedures; and revamped training programs.
Theranos said it is not conducting any patient testing at its Newark facility, though the company had previously stated they would still provide those services at their Arizona facility.
While the appeal is pending, Theranos said they will keep communicating with CMS in an effort to reach a "mutually agreeable resolution to this matter".
Twitter: @BethJSanborn
