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[52] Given the evidence in these additional studies, we questioned in the CY 2026 OPPS/ASC proposed rule whether the totality of available evidence establishes that the use of a single-use, disposable cystoscope results in substantial clinical improvement when compared to reprocessed cystoscopes, and furthermore, whether the use of the VersaVue TM Single-Use Flexible Cystoscope compared to reusable, reprocessed cystoscopes results in decreased adverse events, including post-procedure encounters and infections

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