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If CMS grants an ECE to the hospital, REH, or ASC, the written decision will specify whether the hospital, REH, or ASC is exempted from one or more reporting requirements or whether CMS has granted the hospital, REH, or ASC an extension of time to comply with one or more reporting requirements

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This allows them to be marketed without pre-approval, although manufacturers are responsible for ensuring product safety and truthful labeling

Its findings are not necessarily applicable to all weight-loss seekers, and individual outcomes vary depending on baseline weight, diet, physical activity, and adherence

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