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[242] In public comments on the CY 2024 proposed rule, the manufacturer of Leqembi explained that Leqembi's Phase III confirmatory trial was already fully enrolled and complete prior to FDA granting accelerated approval, and as such, there was no RCT in which to enroll Medicare beneficiaries

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of this proposed rule, while we evaluate our broader policies in this space for future rulemaking, we are proposing to codify in regulations at 414.904(e)(6) that, for radiopharmaceuticals furnished in a setting other than the hospital outpatient department, MACs shall determine payment limits for radiopharmaceuticals based on any methodology used to determine payment limits for radiopharmaceuticals in place on or prior to November 2003

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