Jelmyto

Overview

Upper Tract Urothelial Cancer (UTUC) is a rare malignancy occurring in the lining of the upper urinary tract, involving the renal pelvis and ureters. Accurate documentation, coding, and billing are essential for ensuring proper reimbursement, compliance, and optimal patient management.

Patients with either newly diagnosed or recurrent upper tract urothelial tumors are first evaluated for endoscopic manageability. Based on that assessment, treatment options are as follows:

  • If the tumor is endoscopically manageable
    • Visible disease is resected or ablated through endoscopic procedures.
    • Post-resection, chemoablation is used:
      • JELMYTO is administered once weekly for six weeks.
      • This approach is designed to treat any residual disease that may remain after visible tumor resection.
  • If the tumor is unresectable via endoscopic means
    • Chemoablation is initiated directly without resection.
    • The goal in this case is to spare the kidney by treating the unresectable disease in a non-surgical manner using JELMYTO.
  • Open treatment options
    • Radical nephrectomy
    • Partial nephrectomy
    • Nephroureterectomy
    • Partial or total ureterectomy

Physician Office Coding

Billing, coding, and reimbursement for JELMYTO® (mitomycin) for pyelocalyceal solution.

Retrograde approach using cystoscope

Code Description
52005 Cystourethroscopy, with ureteral catheterization
74420* Urography, retrograde, with or without KUB
J9281 Mitomycin pyelocalyceal instillation, 1 mg
J9281-JW JW modifier for wastage

* If performed


Antegrade approach via nephrostomy tube

Code Description
50391 Instillation of therapeutic agent into renal pelvis and/or ureter through established nephrostomy tube
50431* Injection procedure for antegrade nephrostogram and/or ureterogram…; existing access
74420* Urography, retrograde, with or without KUB
J9281 Mitomycin pyelocalyceal instillation, 1 mg
J9281-JW JW modifier for wastage

* If performed

Code Description
C65.1Malignant neoplasm of right renal pelvis
C65.2Malignant neoplasm of left renal pelvis
C66.9Malignant neoplasm of unspecified ureter
C66.1Malignant neoplasm of right ureter
C66.2Malignant neoplasm of left ureter
C68.9Malignant neoplasm of urinary organ, unspecified
  • Document the amount administered and the amount discarded/wasted (separate line or note).
  • Include route of administration (retrograde ureteral catheter vs nephrostomy tube) and any applicable imaging performed.
  • JW modifier: use J9281-JW to report discarded drug (wastage) when applicable.
  • Dose math reminder: JELMYTO is 4 mg/mL once reconstituted; bill units based on mg instilled and report the remainder with JW when allowed.
  • Ancillary codes: additional imaging/ancillary services may apply depending on what is performed and payer rules.
  • Payer variation: verify payer coverage rules, diagnosis limitations, and site-of-service requirements prior to treatment.

Facility Coding

Facility billing varies by site of care (ASC vs HOPD) and payer. Confirm payer-specific requirements prior to treatment.

ASC (Ambulatory Surgical Center) — Medicare fee-for-service (when applicable)

  • J9281 — Mitomycin pyelocalyceal instillation, 1 mg
  • J9281-JW — JW modifier for wastage
  • C9789 — Instillation of anti-neoplastic pharmacologic/biologic agent into renal pelvis, any method, including all imaging guidance, including volumetric measurement if performed (Medicare FFS HOPD/ASC context)

HOPD (Hospital Outpatient Department) — Medicare fee-for-service (when applicable)

  • J9281 — Mitomycin pyelocalyceal instillation, 1 mg
  • J9281-JW — JW modifier for wastage
  • C9789 — Instillation of anti-neoplastic pharmacologic/biologic agent into renal pelvis, any method, including all imaging guidance, including volumetric measurement if performed

Note: Payer policies vary. Confirm whether C9789 is appropriate for the specific payer and setting; contracts and fee schedules should be verified to ensure adequate reimbursement.

Code Description
C65.9Malignant neoplasm of unspecified renal pelvis
C65.1Malignant neoplasm of right renal pelvis
C65.2Malignant neoplasm of left renal pelvis
C66.9Malignant neoplasm of unspecified ureter
C66.1Malignant neoplasm of right ureter
C66.2Malignant neoplasm of left ureter
C68.9Malignant neoplasm of urinary organ, unspecified

UB-04 (CMS-1450) – common required elements (HOPD)

  • Revenue code (FL 42): report per hospital billing policy for drug/detail lines and procedure/services.
  • Drug detail (FL 43): include N4 + 11-digit NDC + unit qualifier + unit quantity.
  • HCPCS/procedure/units (FL 44–46): include J9281 (and JW line as applicable), plus procedure code for instillation as appropriate; report service units.
  • Diagnosis (FL 66): report ICD-10-CM for LG-UTUC being treated.
  • Remarks (FL 80): include drug name, quantity administered, route (ureteral catheter vs nephrostomy tube), and NDC as needed; some payers require the route and/or separate attachment.

Units & wastage (facility reminder)

  • Reconstituted concentration is 4 mg/mL. Bill J9281 units based on mg instilled (4 mg per mL).
  • For remaining mg not instilled, report wastage using J9281 with JW when allowed.
  • Include amount administered and amount wasted in documentation/claim detail when required.
  • Site of care matters: billing rules differ for Physician Office vs ASC vs HOPD, and by payer.
  • C9789 context: confirm payer applicability (often tied to Medicare fee-for-service HOPD/ASC context).
  • Contract verification: for Medicare Advantage / Commercial / Managed Medicaid, verify fee schedules and whether drug is separately reimbursed for your site of service.
  • Payer policy checks: confirm diagnosis limitations, prior auth requirements, and claim form preferences (some payers may require additional attachments or route/basis of measurement).

EOBs

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