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Response: We appreciate commenters' concerns but forcefully reiterate, as stated in the CY 2024 OPPS/ASC final rule with comment period (88 FR 82086, 82116), that this final rule with comment period falls outside the scope of the FCA

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Beyond these clinical studies, Jeuveau was first introduced to the Korean market in 2014 under the name Nabota, and so we have some good data as well about what happens when Jeuveau is used outside of closely controlled scientific studies

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