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The NDC goes on the J-code line item, not on the 96372 line
First, regarding the applicant's statement that the evidence provided in support of the category of single-use cystoscopes should suffice for a demonstration of substantial clinical improvement, we reiterate that, CMS evaluates transitional pass-through applications using the substantial clinical improvement criterion described at 419.66(c)(2)(i), which requires CMS to determine if the device that has been nominated has demonstrated that it will substantially improve the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body part compared to the benefits of a device or devices in a previously established category or other available treatment. The regulatory provision refers to the device (singular) being compared to a device or devices for purposes of substantial clinical improvement
Elabd C, Centeno CJ, Schultz JR, Lutz G, Ichim T, Silva FJ
Adv Pediatr Infect Dis
AIs most impactful applications are likely to remain largely behind the scenes, improving pattern recognition, trial design, safety monitoring, and decision support rather than replacing clinical judgment, said Dr
