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If the proposed recalculation methodology to account for the impact of improper payments were to be finalized, we would consistently apply the methodology in recalculating expenditures and payment amounts used in Shared Savings Program financial calculations upon reopening a payment determination pursuant to 425.315(a)

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The 2023 draft guidance is a standalone document outlining FDAs current thinking on the prohibition on wholesaling under Section 503B, separate from the temporary COVID-19 policies that have since been withdrawn