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The skin, subcutaneous tissue, and fascia were sequentially incised, and a pencil-tipped guide rod was inserted and placed on the surface of the intervertebral space

The applicant seems to suggest that because we determined that the Uretero1 TM device demonstrated substantial clinical improvement despite providing a study which did not include the nominated device as a comparator, that we must similarly determine that the type of evidence submitted for the VersaVue TM Single-Use Flexible Cystoscope represents substantial clinical improvement

In the CY 2026 OPPS/ASC proposed rule, we proposed to continue assigning CPT code 0786T to status indicator E1 to indicate that it is still pending the FDA approval

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Supports normal neurological function

doi:10.1002/jimd.12009