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Response: Because we assume the collection of data for eCQMs is already being collected in each HOPD's electronic health record (EHR) system as part of the HOPD's patient workflow, the burden estimates provided in this final rule with comment period include only the time associated with submission of data to CMS

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* These statements have not been evaluated by the Food and Drug Administration (FDA)

For this reason, the NIH has not established a tolerable upper intake level for B12

Similar to breastfeeding, the use of Botox during pregnancy has become more widely accepted and practiced by most headache specialists given the years of data published and clinical experience

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