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Evidence Boundary Common current format, but FDA noted no published human pharmacokinetic study has formally characterized subcutaneous AOD-9604

We also disagreed with the RUC that the intensity of CPT code 25447 is unchanged due to increases in the post-operative work

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As stated in the CY 2025 PFS proposed rule (89 FR 61981), we considered the following factors in determining a method and process for providing the rebate information: meeting statutorily provided deadlines in section 1860D-14B(a) of the Act (for example, dates by which to provide the rebate amount owed to the manufacturer)