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All current CMS policies regarding eCQM data submission requirementsincluding file format, zero denominator declarations, case thresholds, submission deadlines, and EHR certification requirements outlined at 419.46(j) and finalized in the CY 2022 or CY 2025 OPPS/ASC final rules (86 FR 63867 through 63870 and 89 FR 94418 through 94420, respectively) would apply to the Emergency Care Access & Timeliness eCQM for both the voluntary and mandatory data submission periods

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And on product safety: FY 2025 saw 317 drug-recall events , most classified as Class II (moderate risk but still serious), per the RAPS report