42 C.F.R. § 419.47

Coding and Payment for Category B Investigational Device Exemption (IDE) Studies

§ 419.47 Coding and Payment for Category B Investigational Device Exemption (IDE) Studies

(a) Creation of a new HCPCS code for Category B IDE Studies. 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 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:

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