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While many commenters recognized CMS' efforts to develop an approach to address the removal of 340B units in the inflation rebate calculation, and CMS' efforts to be responsive to prior feedback on proposed methodologies, these commenters believed that CMS should reconsider any methodology that estimates or approximates 340B units and should instead develop a more accurate accounting of 340B claims data to calculate the appropriate number of units of a Part D rebatable drug for which a discount was provided under the 340B Program for the applicable period that begins on October 1, 2025

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The dermal papilla cell experiments confirmed the mechanism