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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

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

After applying the process outlined in this section of this proposed rule, we next estimate the number of Potentially MIPS Eligible clinicians

We further propose under 425.640(h)(4) that CMS may immediately terminate an ACO's prepaid shared savings under 425.640(h)(1) and (2) without taking any of the pre-termination actions set forth in 425.216