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Approved dose 1.75 mg subcutaneous, 45 minutes before sexual activity, per the Vyleesi label

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Oral administration faces hepatic first-pass metabolism, reducing bioavailability to approximately 4050% of subcutaneous routes, but offers convenience for longer-term studies where daily injections create compliance challenges

Response: We continue to believe that the procedures described by CPT codes 38225, 38226, and 38227 describe the various steps required to collect and prepare the genetically modified T-cells, and Medicare does not generally pay separately for each step used to manufacture a drug or biological product