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A few commenters highlighted the operational challenges, administrative burden, and potential for increased dispensing fees and reimbursement issues with both point-of-sale modifiers and retrospective 340B identifiers
(a) Estimation Methodology To Remove 340B Units From Rebate Calculations To fulfill the statutory requirement to remove 340B units from rebate calculations beginning on January 1, 2026, CMS is proposing in 428.203(b)(2) a new policy to remove units from the total number of units dispensed of a Part D rebatable drug for each applicable period based on a calculated percentage that reflects the portion of 340B purchasing relative to total sales
doi:10.1056/nejmra0809890 23
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