ZUSDURI (UroGen)

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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:
    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)
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

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
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
  • 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.

Claim Form
  • CMS-1450 (UB-04)
HCPCS Codes

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
CPT® Code (Administration)
  • 51720 – Bladder instillation of an anticarcinogenic agent
ICD-10-CM Diagnosis Codes
  • 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
NDC
  • 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)

Revenue Codes
  • 0636 – Drugs requiring detailed coding
  • 0510 – Non-surgical outpatient clinical service
UB-04 Claim Form Tips
  • 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
Claim Form
  • CMS-1500
HCPCS Codes
  • J9999 – Not otherwise classified, antineoplastic drugs
  • J3490 – Unclassified drugs
  • J3590 – Unclassified biologics
CPT® Code (Administration)
  • 51720 – Bladder instillation of an anticarcinogenic agent
ICD-10-CM Diagnosis Codes

(Same as HOPD – C67.x bladder cancer codes)

NDC
  • 10-digit: 72493-106-03
  • 11-digit: 72493-0106-03
CMS-1500 Claim Form Tips
  • 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)