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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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For example, UDCA a closely related bile acid has not improved disease histology in randomized controlled trials and is not recommended in treatment guidelines.33 While TUDCA shows promise in animal NAFLD models, human studies so far have not shown improvements in liver fat, and its role in treating NAFLD remains unproven

Neuroimmune interactions: from the brain to the immune system and vice versa