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++ For ACOs that select preliminary prospective assignment with ( retrospective reconciliation, limit the distribution of the standardized written beneficiary information notification to beneficiaries who are more likely to be assigned to the ACO, when compared to the beneficiaries who must receive the written notification under current regulations (section III.G.8.b of this final rule)

\n\n\n\n The compounds multimechanistic nature also makes it challenging to evaluate through conventional clinical trial frameworks, which are typically designed around single-mechanism drugs with well-defined target receptors and predictable dose-response relationships

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