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Around the world, road crashes claim over 1.3 million lives annually, causing injuries to millions more with widespread social disruption and massive public health costs

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CMS will create a new HCPCS code, or revise an existing HCPCS code, to describe a Category B IDE study, which will include both the treatment and placebo control arms, related device(s) of the study, as well as routine care items and services, as specified under 405.201 of this chapter, when CMS determines that: (1) The Medicare coverage IDE study criteria in 405.212 of this chapter are met