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In response to comments, CMS stated in section 40.1.2 of the revised Medicare Part D Drug Inflation Rebate Guidance that Part D rebatable drugs first approved or licensed on or before October 1, 2021, that were not marketed until after that date and thus did not have AMP in the statutorily defined payment amount benchmark period (that is, January 1, 2021, through September 30, 2021) would be treated in the same manner as subsequently approved drugs for purposes of establishing the payment amount benchmark period, benchmark period CPI-U, first applicable period, and first applicable period CPI-U

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As finalized with the CY 2024 PFS final rule (88 FR 79195 through 79200), 425.652(a)(9) introductory text was amended to specify, among other changes, that for each performance year during the term of the agreement period, the ACO's benchmark is adjusted for changes in values used in benchmark calculations as a result of issuance of a revised initial determination under 425.315 (among other factors)