1. (a) Creation of a new HCPCS code for Category B IDE studies that have a treatment arm and a placebo control arm. 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. (1) The Medicare coverage IDE study criteria in § 405.212 of this chapter are met; and
   2. (2) A new or revised code is necessary to preserve the scientific validity of such a study, such as by preventing the unblinding of the study.

2. (b) Payment for Category B IDE Studies. Where CMS creates a new HCPCS code or revises an existing HCPCS code under paragraph (a) of this section, CMS will:

   1. (1) Make a single packaged payment for the HCPCS code that includes payment for the investigational device, placebo control, and routine care items and services of a Category B IDE study, as specified under § 405.201 of this chapter; and
   2. (2) Calculate the single packaged payment rate for the HCPCS code based on the average resources utilized for each study participant, including the frequency with which the investigational device is used in the study population.

[87 FR 72291, Nov. 23, 2022, as amended at 89 FR 94590, Nov. 27, 2024; 90 FR 54086, Nov. 25, 2025]