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CMS Investigations

The health technology startup, Theranos, face another major challenge, as the Democrats have demanded the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) to submit their investigation details on the project. In the letters that were sent to FDA Commissioner Robert Califf and CMS Acting Administrator Andrew Slavitt, the representatives stated, “Given Theranos’ disregard for patient safety and its failure to immediately address concerns by federal regulators, we write to request more information about how regulators are working with Theranos to address these failures.”

FDA and CMS have discovered several frauds in health care, which urged the government to start an investigation. The investigation team, which consists of House Energy and Commerce Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO), began their investigation in June 2016.

This is not the first time “Theranos” is being targeted by the authorities. An inspection organized by CMS in November 2015 uncovered illegal test results from Edison test system. This was followed by the removal of Clinical Laboratory Improvement Amendments (CLIA) certification of Theranos, which happened last month. Furthermore, CEO Elizabeth Holmes and many other operators and owners lost their right to run a laboratory for the next two years.

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FDA Approvals

The agency also clarified that the “nanaotainer” blood collection devices used in the facilities require a Class II medical device clearance. However, for the further inspection of facilities in Northern California regions, two Form 483s were also issued by the agency.

The Democratic representatives asked clarification on whether the FDA has completed a thorough inspection on the Arizona site. They also enquired whether the company has submitted their products for FDA approval and whether FDA has enforced regulations for Theranos products.

A brief report on the post inspection response of the company where they failed to produce “a credible allegation of compliance and acceptable evidence of correction for the cited deficiencies” was also asked to be submitted. Both CMS and FDA are required to submit their reports by August 10, 2016.

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