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Therefore, we believe that this proposal would have no impact on Medicare spending

Direct supervision is required for various types of services, including most incident-to services under 410.26, many diagnostic tests under 410.32, pulmonary rehabilitation services under 410.47, cardiac rehabilitation and intensive cardiac rehabilitation services under 410.49, and certain hospital outpatient services as provided under 410.27(a)(1)(iv)

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CMS further proposes codifying policy that it may consult with the FDA for technical assistance in instances where there is ambiguity as to whether a new product is therapeutically equivalent