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We noted in the preamble section of that rule that we believe that it is essential to retain the not passed on element in the definition of BFSFs given that the not passed on element is a key factor in distinguishing a price concession from a BFSF because, if a fee that is passed on is excluded from the ASP calculation, then there is a greater risk of the ASP being inappropriately inflated
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We disagree with the commenter suggesting the proposed policy is unnecessary because many ACOs have already moved to a two-sided model
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These effects can be troublesome and may require dose adjustments or treatment discontinuation
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