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| Theranos' Palo Alto, CA, headquarters--Courtesy of Theranos |
Theranos has seemed like all talk and no action lately regarding alleged deficiencies at its California blood testing lab. But now, the company is making moves. Theranos sent a plan to the Centers for Medicare and Medicaid Services (CMS) to address issues cited by regulators last month after an earlier inspection of the facility unearthed some serious problems.
CMS staff "is currently reviewing" Theranos' proposed plan, CMS spokesman Aaron Albright told Bloomberg in an email. Theranos also confirmed the filing but is staying quiet on details, the news outlet reports.
Last month, the CMS came down on Theranos for "deficient practices" at its Newark, CA-based testing lab "that pose immediate jeopardy to patient health and safety." Regulators said that during a November inspection of the lab, they found 5 major infractions that run afoul of federal law.
The CMS described one infraction as "likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public." The agency gave Theranos 10 days to make a game plan to fix the problem, but last week granted the company a one-week extension to get all its ducks in a row.
The CMS' findings sparked immediate backlash from some of Theranos' partners, one of whom was already pumping the brakes on its relationship with the company. Last week, Walgreens Boots Alliance ($WBA), one of Theranos' main partners, said that it was giving the company 30 days to fix the problems at its California lab. If Theranos does not comply, Walgreens will pull the plug on the partnership, the retail giant said.
Pennsylvania insurer Capital BlueCross is also running for the hills. The company said last month that it would suspend Theranos lab draws at its Harrisburg, PA-area retail store "until further notice" upon hearing news of the CMS inspection.
"While we support Theranos' vision of providing greater transparency and reduced pricing for lab work, our highest priority at Capital BlueCross is ensuring quality of care for our customers," Capital BlueCross said at the time.
Theranos is remaining stoic in light of the pressure, though. The company continues to defend its testing practices amid regulatory pushback. Last year, articles showed that the company stopped collecting tiny vials of blood for all but one of its more than 200 tests after the FDA found that "nanotainers" made and used by the company to collect samples were uncleared medical devices. Another report showed that Theranos' lab tool only handled a small portion of tests sold to consumers.
"We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards," Theranos said last month.
- read the Bloomberg story