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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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This method can be particularly beneficial for individuals with absorption issues or those who may not be getting enough B12 through diet alone

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