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Proposed 401.305(b)(3)(ii) provides that, if the conditions for proposed 401.305(b)(3)(i) are met, the deadline for reporting and returning the initially identified overpayment and related overpayments that arise from the same or similar cause or reason as the initially identified overpayment will remain suspended until the earlier of the date that the investigation of related overpayments has concluded and the aggregate amount of the initially identified overpayments and related overpayments is calculated, or the date that is 180 days after the date on which the initial identified overpayment was identified

06/18/2026 Appearance Draw Burn Aroma Taste Citrus blast on the retrohale View Details Justin S

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This approach of requiring manufacturers to report such information would be consistent with CMS' understanding of the provisions of section 1860D-14B of the Act requiring CMS to establish the payment amount benchmark period at the dosage form and strength level, and with CMS' authority under sections 1102(a) and 1871(a)(1) of the Act to make rules and regulations as necessary for the efficient administration of programs, including the Medicare Part D Drug Inflation Rebate Program

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