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Friday, Jul 8 2016

Full Issue

CMS Bans Theranos Founder From Lab For 2 Years, Bars Medicare And Medicaid Payments

The blood-testing startup has been facing intense scrutiny during the past eight months over the efficacy of its practices. The decision by the Centers for Medicare & Medicaid Services penalizes the CEO Elizabeth Holmes and also pulls the license for the company's California lab.

United States regulators have banned Elizabeth Holmes, the chief executive of Theranos, from owning or operating a medical laboratory for at least two years, in a major setback for the embattled blood-testing firm and its once widely lauded founder. In a statement late Thursday, Theranos said the regulators also yanked the operating license of its Newark, Calif., laboratory and forbade the laboratory from taking Medicare and Medicaid payments for its services. Regulators will also levy a monetary penalty that Theranos did not specify. (Tejada, 7/8)

The sanctions, which include an unspecified monetary penalty, cap eight months of public scrutiny that began in October when The Wall Street Journal raised questions about the company鈥檚 ability to perform a wide variety of blood tests with just a few drops of blood. Theranos once was a leading light in the technology boom, with the private company valued at $9 billion in 2014. (Siconolfi, 7/8)

Along with the ban on Holmes, CMS has pulled the operating license of the company鈥檚 Newark laboratory and will also levy a fine, Theranos announced in a statement. It鈥檚 not clear yet how much the company, once valued at $9 billion, will have to shell out. 鈥淲hile we are disappointed by CMS鈥 decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance,鈥 Holmes said in the statement, adding that the company accepts 鈥渇ull responsibility for the issues鈥 at the lab. (Thielking, 7/8)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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