CMS releases Theranos letter, inspection report with more information

CMS decided Monday to release a previously unpublished 45-page letter to Palo Alto, Calif.-based Theranos and a more lightly redacted version of its inspection report, according to The Wall Street Journal.

The letter was not published publicly because Theranos said it contained trade secrets, and the inspection report was more heavily censored to the public for the same reason. But the agency decided these initial redactions were too extensive, according to the report.

The inspection report finds a number of deficiencies with Theranos' Newark, Calif.-based lab. The information that was previously redacted, but is now included in the latest version shows proprietary Theranos devices often failed to pass the company's own tests, according to the report.

The letter details six sanctions proposed by CMS for the deficiencies found in the inspection. These included banning Theranos founder and CEO Elizabeth Holmes from owning or operating any labs for the next two years, revoking the Newark lab's license and barring it from Medicare, among others, according to the report. These sanctions have not yet been imposed and Theranos is still working to address issues and avoid the sanctions, according to the report.

The information that is still redacted involves a traditional blood testing machine produced by Siemens AG that Theranos used for some of its testing, according to the report.

 

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