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[1] The more advanced regulatory activity belongs to the combination product CagriSema (cagrilintide plus semaglutide), which reached Phase 3 and for which a New Drug Application was reported to have been filed with the FDA in late 2025
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doi: 10.1136/bmj.1.5377.212
Similarly, in the absence of sufficient claims data to establish an APC payment rate, in the CY 2021, CY 2022, CY 2023, CY 2024, and CY 2025 OPPS/ASC final rules with comment period (85 FR 85879 through 85880, 86 FR 63469, 87 FR 71760-71761, 88 FR 81553, and 89 FR 93925), we finalized our policy to use our equitable adjustment authority under section 1833(t)(2)(E) of the Act to maintain the CY 2019 payment rate of $4.69 per mm 2 for HCPCS code C2645 for CYs 2021 through 2025