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We invite public comments on whether the TOPS TM System meets the cost criterion and our proposal to approve new technology add-on payments for the TOPS TM System for FY 2024 subject to the technology receiving FDA marketing authorization as a Breakthrough Device for the indication corresponding to the Breakthrough Device designation by July 1, 2023

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2 mg (2000 mcg) once daily subcutaneously, the FDA-approved regimen, after an optional 1 mg first-week titration