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Per our finalized policy in the CY 2025 OPPS/ASC final rule with comment period (89 FR 93932 through 93938), for new cell and gene therapy products that are not integral, ancillary, supportive, dependent, or adjunctive to any C-APC primary service, we will continue to add their product specific HCPCS codes, when created, to the C-APC exclusion list

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(5) Taken together, these observations suggest that AOD9604 may act through multiple coordinated mechanisms to support fat metabolism, especially in obesity-related laboratory scenarios robustly

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however, the clinical significance and durability of these effects remain under investigation