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Monitoring trough levels is important for drugs with narrow therapeutic windows

AOD-9604 is generally well-tolerated with a favorable safety profile based on clinical research involving approximately 900 participants across six studies

Separate billing may be done for other telehealth visits that are not related to the medical necessity

Further, as discussed in the CY 2025 PFS proposed rule (89 FR 61957), in considering whether consistency across CMS programs is critical, we believe that consideration for the completeness of data, as discussed above, should be prioritized over consistency across program timelines