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Safety Measurements Any adverse event during the course of the study was monitored and reported to the study staff at week 6 (visit 5) or week 12 (visit 8) in the clinic or directly to the principal investigator throughout the study

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Similar to the FY 2019 IPPS/LTCH PPS final rule regarding removal of eCQM measures, while there is no change in information collection burden related to those proposed provisions, we believe that costs are multifaceted and include not only the burden associated with reporting but also the costs associated with implementing and maintaining program measures in hospitals' EHR systems for all of the eCQMs available for use in the Medicare Promoting Interoperability Program (83 FR 41771)