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We note that because section 1847A of the Act provides for payment limit calculations that differ between single-source drugs (as defined in section 1847A(c)(6)(D) of the Act and 414.902) and multiple source drugs (as defined in section 1847A(c)(6)(C) of the Act and 414.902), we are proposing different ways to determine payment limits for each, in cases in which only negative or zero manufacturer's ASP data is reported, to reflect these differences

The weekly and monthly formulations of the drug are available at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available

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[243] Under policies finalized in the CY 2023 PFS final rule, the 18-month exclusion period for Leqembi would begin on April 1, 2023, which marks the first day of the calendar quarter after the drug's first date of sale as reported to CMS in January 2023