ZUSDURI (UroGen)
Code Matrix (Download Now)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.
- Standard dose: 75 mg mitomycin (56 mL product)
- Schedule: Once weekly Ă— 6 weeks
- Preparation:
- Prepared on-site (under chilled conditions) by your pharmacy/clinic staff, or
- Prepared by a contracted UroGen partner pharmacy and delivered to your facility chilled for administration.
- Retention time: Prolonged (5–24 hours)
- 51720 – Bladder instillation of anticarcinogenic agent (including retention time)
- J9999 – Antineoplastic drugs, not otherwise classified (recommended for Zusduri)
Some payers may require:
- J3490 – Unclassified drugs
- J3590 – Unclassified biologics
Box 19:
Use Box 19 to document the NDC number, drug name, route of administration, and dosage given.
If billing with a miscellaneous code, record any drug wastage here.
Example: A patient receives 75 mg from an 80 mg vial. The remaining 5 mg should be documented as wastage. Box 19 could be written like: 72493010603 ZUSDURI Instillation ME75 ME5JW
Important: Do not use J9280 (Mitomycin, 5 mg) for Zusduri.
Pair C67.x site-specific malignant neoplasm codes with treatment/encounter Z-codes as appropriate. Code to the specific location when known. Documentation should reflect stage, grade, and risk category.
- 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 (surveillance when no active disease)
Note: ICD-10-CM does not capture grade/stage—keep these in documentation.
- New Drug: Until ASP is available (~2 quarters), reimbursed at 103% of WAC
- Medicare Part B: Paid at 106% of ASP once established
- 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
- Zusduri provides prolonged bladder drug exposure for eligible recurrent, low-grade, intermediate-risk NMIBC 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
Facility Billing for ZUSDURI™
When Zusduri™ (Intravesical Mitomycin) for Bladder Cancer is administered in a hospital outpatient department (HOPD) or an ambulatory surgery center (ASC), billing requirements differ based on site of care.
- CMS-1450 (UB-04)
Use one of the following miscellaneous codes until a permanent J-code is assigned:
- C9399 – Unclassified drugs or biologicals
- J9999 – Not otherwise classified, antineoplastic drugs
- J3490 – Unclassified drugs
- J3590 – Unclassified biologics
- 51720 – Bladder instillation of an anticarcinogenic agent
- C67 – Malignant neoplasm of bladder
- C67.0, C67.1, C67.2, C67.3, C67.4, C67.5, C67.6, C67.7, C67.8, C67.9
- 10-digit: 72493-106-03
- 11-digit: 72493-0106-03
(Single-dose kit: two 40-mg mitomycin vials [80 mg total] + one 60-mL hydrogel vial)
- 0636 – Drugs requiring detailed coding
- 0510 – Non-surgical outpatient clinical service
- FL 42: Enter revenue code (0636 or 0510)
- FL 43: Enter drug details with NDC and amount (e.g., N4 72493010603 ME 80 – Bladder instillation anticarcinogen agent)
- FL 44–46: HCPCS (e.g., C9399) and CPT® 51720
- FL 66: ICD-10 diagnosis code(s)
- FL 80 (Remarks): Document NDC, dose given, wastage. Example: ME75 ME5JW
- CMS-1500
- J9999 – Not otherwise classified, antineoplastic drugs
- J3490 – Unclassified drugs
- J3590 – Unclassified biologics
- 51720 – Bladder instillation of an anticarcinogenic agent
(Same as HOPD – C67.x bladder cancer codes)
- 10-digit: 72493-106-03
- 11-digit: 72493-0106-03
- Box 19: Drug name, NDC, dose administered, wastage (if any)
- Box 21: ICD-10-CM diagnosis code(s)
- Box 24D: HCPCS (J9999 or other unclassified code) + CPT® 51720
- Box 24G: Units – when using a miscellaneous J-code, enter “1”
- Box 24B: Place of service code (24 = ASC)