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Exposure to ambient moisture (e.g., from repeatedly opening a vial in a humid environment, or from a vial seal failure) introduces water that can degrade the peptide

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In the CY 2021 PFS final rule (85 FR 84744 through 84747),we established at § 425.512(c) that, for performance year 2021 and subsequent performance years, including the applicable quality data reporting period for the performance year, we use an alternative approach to calculating the quality score, as described at § 425.512(c), for ACOs affected by EUCs, instead of using the approach as described at § 425.512(a)