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While we did not question whether the ureteroscope itself is integral to the service furnished, we questioned whether the MEMS pressure sensor, the mechanism which the applicant asserts is the distinguishing feature of the LithoVue TM Elite Ureteroscope, is integral to the service furnished in accordance with 419.66(b)(3), because pressure monitoring during ureteroscopy procedures appears to be purely additive and not necessary to furnish the ureteroscopy

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information can be located at As we gain more experience with this policy, we may revisit this issue in future rulemaking if we determine that ( it is necessary to further refine the regulations to prevent gaming