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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

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The use of pineal gland extracts was not a new concept, as there was existing literature on the topic from the late 1800s to the 1970s, and Dr

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