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Comment: The applicant acknowledged that CMS applies a high evidentiary standard for substantial clinical improvement, typically requiring robust clinical data showing improved patient outcomes such as reduced complications, fewer reoperations, faster recovery, or better functional results compared to the current standard of care

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After completing a treatment cycle, taking 2 to 4 weeks off before potentially repeating allows assessment of maintained improvements

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For sports procedures, these include validated functional scores, return-to-sport timing, and complication surveillance