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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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References Tesamorelin LiverTox: Clinical and Research Information on Drug-Induced Liver Injury National Institutes of Health, NIDDK (2018) Tesamorelin (Subcutaneous route) Drug Information Mayo Clinic / IBM Merative (2025) Effects of tesamorelin (TH9507), a growth hormonereleasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two phase 3 trials J