Comment: The applicant submitted a response to our concerns that some components or parts of the aprevo Cervical ACDF System, specifically the aprevo insertion instrument, the integrated fixation screws, and/or the CAM, may be considered a material or supply furnished incident to the service, because, as previously discussed with respect to criteria at 419.66(b)(3), it is unclear how and when these components or parts are used, and whether they can be substituted with other products
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Therefore, consistent with the burden estimates for this measure under OMB control number 0938-1270, we estimate the removal of this measure will decrease burden for voluntary reporting for the CY 2025 reporting period by 383 hours (4,590 ASCs 50 percent of ASCs 0.167 hours per ASC) at a savings of $21,088 (383 hours $55.06/hour) and 765 hours annually (0.167 hours 4,590 ASCs) at a savings of $42,121 (765 hours $55.06/hour) for mandatory reporting beginning with the CY 2026 reporting period
While a simple urine test can check for the presence of protein, a comprehensive evaluation is needed to determine the cause
