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Theranos was fined $30,000 by CMS. Meanwhile, it will pay $4.65 million to Arizona residents for blood testing services that it performed between 2013 and 2016. 

S.794 would require Medicare contractors to hold public meetings and disclose the rationale and evidence underlying an LCD at the start of the process.

The agency said it is giving labs 60 additional days to report private payor rates but is still expecting to launch the new clinical lab fee schedule in 2018.

ACLA said the goal of the delay is to redefine "applicable laboratories" and give labs and CMS more time to collect data that will inform market-based pricing.

The court ruled against CMS' motion to dismiss the case, which seeks to have Arriva's Medicare billing privileges reinstated.

Genelex is hoping that a recently published randomized-controlled trial will help it get on better footing with Medicare.

At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.

The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs. 

The firm is developing a personalized medicine program that involves genetic testing for drug compatibility and tolerance.

There was a lot of growth in the precision medicine field in the past year, and some experts believe the FDA's decision to hold off on regulating LDTs could spur more innovation.

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