Friday, July 8, 2016

TheraNOs

The enfant terrible of unicorns, medical testing firm Theranos, Inc., has had its horn substantially clipped by the Centers for Medicare & Medicaid Services ("CMS").  On July 7, 2016, the CMS announced - on Theranos' own website - that the privately-held company will suffer the following sanctions beginning August 6, 2016:
– Revocation of the [Newark, California] laboratory’s CLIA [Clinical Laboratory Improvement Amendments] certificate which, as dictated by the regulations, includes a prohibition on owners and operators of the lab from owning, operating or directing a lab for at least two years from the date of revocation 
– Limitation of the laboratory’s CLIA certificate for the specialty of hematology 
– A Civil Money Penalty 
– A Directed Portion of 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 
– Cancellation of the laboratory’s approval to receive Medicare and Medicaid payments for all laboratory services
These penalties represent serious blows to Theranos.

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