Zusduri (Intravesical Mitomycin) for Bladder Cancer
Coding & Reimbursement

Zusduri is a newly FDA-approved intravesical therapy (June 2025) indicated only for patients with recurrent, low-grade, intermediate-risk non-muscle invasive bladder cancer.

Unlike traditional mitomycin, Zusduri uses reverse thermal gel technology—it is chilled into a liquid for instillation and then warms into a gel inside the bladder, allowing prolonged contact (5–24 hours) with the bladder lining.

Dosing & Administration

• Standard dose: 75 mg mitomycin (56 mL product)

• Schedule: Once weekly × 6 weeks

• Preparation:
  1. Prepared on-site (under chilled conditions) by your pharmacy/clinic staff, or
  2. Prepared by a contracted UroGen partner pharmacy and delivered to your facility chilled for administration.

• Retention time: Prolonged (5–24 hours)

Additional Resources from UroGen

(PRS Vetted and Approved) 

UroGen Support™ Brochure

ZUSDURI Product Fact Sheet

Misc. J-Code Flashcard

Access and Reimbursement Guide

Ordering and Scheduling Guide

Affordability Brochure

Return Goods Resource

ZUSDURI Patient Enrollment Form

Prior Authorization Checklist

Claims Submission Checklist

Letter of Appeals

Letter of Medical Necessity

Annotated 1450 Claims Form

Annotated 1500 Claims Form

Physician Office Coding

Coding & Billing

CPT® Code

• 51720 – Bladder instillation of anticarcinogenic agent (including retention time)

HCPCS Codes

• J9999 – Antineoplastic drugs, not otherwise classified (recommended for Zusduri)

• Some payers may require: 

  • J3490 – Unclassified drugs

  • J3590 – Unclassified biologics

Report Zusduri used and wasted separately (-JW for waste); document NDC, Lot #, Exp
Total Used [xx mL (xx mg), Wasted: xx mL (xx mg); include both mL and mg

Important: Do not use J9280 (Mitomycin, 5 mg) for Zusduri.

ICD-10-CM Codes for Bladder Cancer

Pair C67.x site‑specific malignant neoplasm codes with treatment/encounter Z‑codes as appropriate.

• C67.0 – Malignant neoplasm of trigone of bladder

• C67.1 – Malignant neoplasm of dome of bladder

• C67.2 – Malignant neoplasm of lateral wall of bladder

• C67.3 – Malignant neoplasm of anterior wall of bladder

• C67.4 – Malignant neoplasm of posterior wall of bladder

• C67.5 – Malignant neoplasm of bladder neck

• C67.6 – Malignant neoplasm of ureteric orifice

• C67.7 – Malignant neoplasm of urachus

• C67.8 – Malignant neoplasm of overlapping sites of bladder

• C67.9 – Malignant neoplasm of bladder, unspecified

• Z51.11 – Encounter for antineoplastic chemotherapy (e.g., mitomycin, gemcitabine)
  (List as principal diagnosis)

• Z51.12 – Encounter for antineoplastic immunotherapy (e.g., BCG)
  (List as principal diagnosis)
  

• Z85.51 – Personal history of malignant neoplasm of bladder (use for surveillance when no active disease)

Note: ICD‑10‑CM does not capture grade/stage—keep these in the documentation.

Code to the specific location of the tumor when known. Documentation should reflect bladder cancer stage, grade, and risk category. 

Reimbursement Considerations

• New Drug: Until ASP is available (~2 quarters), reimbursed at 103% of WAC

• Medicare Part B: Paid at 106% of ASP once established

• Documentation Requirements: 

  • Bladder cancer type, stage, risk category, tumor location

  • Amount instilled, amount discarded (modifier -JW)

  • Rationale for choosing Zusduri

• Appeals & Prior Authorization: Often required; expect record requests

• Coverage: Typically follows FDA-approved indications; confirm with payer before administration

Key Takeaways

• Zusduri provides prolonged bladder drug exposure for eligible intermediate-risk patients

• Use CPT 51720 for instillation and J9999 (or payer-specific unlisted code) for the drug

• Detailed documentation is critical for coverage and payment

• Expect WAC-based reimbursement until ASP is established