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We therefore do not believe the Emergency Care Access & Timeliness eCQM would suffer from low case volumes, and we further believe that we have appropriately considered low case volumes as required by the REHQR statute when selecting this measure

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Similarly, over-the-counter tests to detect SARS-CoV-2, diabetes digital behavioral therapeutic devices, prognostic tests to assess chronic kidney disease progression, non-medicated topical formulations to treat erectile dysfunction, and active noise attenuation systems for infant incubators were also classified as class II devices with special controls