Mitomycin Pyelocalyceal Solution (Jelmyto) (CPB 0972, reviewed 2025-08-13)

IMMEDIATE (as of 2025-08-13): 1) Billing team must implement mandatory precertification workflow for Jelmyto (J9281) claims by updating billing system to flag all requests and route to prior authorization department. Contact number: (866) 752-7021; Fax: (888) 267-3277. 2) Establish approval pathway documentation requiring: (a) confirmation of pyelocalyceal administration route only, (b) treatment schedule (weekly for 6 weeks for initiation), (c) diagnosis confirmation (non-metastatic, low-grade, low-volume 5-15mm upper tract urothelial cancer), and (d) complete response documentation at 3-month mark before approving continuation doses (maximum 11 additional monthly doses). 3) Update billing system to deny all claims for Jelmyto indications outside approved criteria (high-grade disease, metastatic disease, other indications) as experimental/investigational. 4) Providers and clinical staff must document volumetric measurements using pyelography and sodium bicarbonate pre-treatment protocol (3.9g total) on all treatment encounters. 5) Ensure encounter forms and EMR templates reflect that only CPT 50391 and 52005 are billable for administration, with J9281 for the drug itself, and C9789 as alternative instillation code. Failure to obtain precertification will result in claim denial; claims submitted for non-approved indications will be rejected.