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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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In the CY 2026 OPPS/ASC proposed rule, we stated that if we were to finalize the proposal to collect the proposed market-based information (specifically, the median payer-specific ( negotiated charges negotiated between a hospital and all its MAOs, by MS-DRG) on the cost report, the data would become publicly accessible on the HCRIS dataset in a de-identified manner and would be usable for analysis by third parties