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In response to comments, we 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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Payne CK, Terai A and Komatsu K: Research criteria versus clinical criteria for interstitial cystitis