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When submitting the plans, clinical study sponsors should include enrollment goals for diverse participation and the rationale for selecting those goals

with acute adverse effects including nausea, lightheadedness, sleep disturbances, rapid heart rate, and headaches

(6) Service Period Clinical Labor Time in the Facility Setting Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs

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