Theranos Announces Appeal of CMS Sanctions

Theranos has announced that it is appealing the Centers for Medicare & Medicaid’s threatened sanctions. The announcement also indicated that the company has made “substantial progress toward correcting the deficiencies CMS identified” and will continue to work with the agency while the appeal is pending to try to achieve a “mutually agreeable resolution to the matter.” But it’s not just CMS that is looking to Theranos for corrective action. Earlier this summer, ranking members of U.S. House of Representatives Committee on Energy and Commerce requested a briefing from Theranos to inform the committee about Theranos’ efforts to comply with CMS inspection letters and FDA 483 inspection reports. Those same committee members also sent letters to both the U.S. Food and Drug Administration and CMS expressing concern about how regulators are working with Theranos to address the deficiencies raised. The letter also questions the company’s statements about the number of tests invalidated. Theranos had said in June approximately 70,000 tests—slightly less than 1 percent of 7 million performed—had been invalidated. But the committee members noted prior statements by Theranos about the volume of patients who were tested using its new technologies to call into question those statistics. The committee also questioned an internal investigation undertaken by the company that concluded that no patients had been harmed by the inaccurate tests. “It is unclear whether the corrected blood-test reports issued by Theranos thus far capture the universe of inaccurate blood test results that the company has provided patients,” the House letter to the FDA said.