ZUSDURI (UroGen)

Code Matrix (Download Now)

Physician Coding

Bladder Cancer: Recurrent, Low Grade-Intermediate Risk (NMIBC) Coding & Documentation Overview…

Ensure these are explicit in the note/op/report:

  • Pathology & Stage/Grade: e.g., Ta, low-grade (no CIS)…
  • Tumor Burden: size (cm), number, location(s).
  • Recurrence History: date of prior TURBT(s)…
  • Resection Quality: “Complete resection”…
  • Immediate Post-op Instillation: agent, dose, route, dwell time.
  • Planned Course: induction/maintenance schedule…
  • Medical Necessity: symptoms, findings, risk category…
  1. Diagnosis/Surveillance: cystoscopy ± cytology/biopsy.
  2. Treatment: office fulguration or TURBT…
  3. Adjuvant Therapy: intravesical induction…
  4. Follow-up: surveillance schedule…

Select one tumor-removal code based on largest lesion size treated.

Diagnostic/Surveillance
  • 52000 – Cystourethroscopy
Biopsy & Minor Lesions
  • 52204 – Biopsy
  • 52214 – Fulguration…
  • 52224 – Minor lesion(s) <0.5 cm…
TURBT / Fulguration by Size
  • 52234 – 0.5–2.0 cm
  • 52235 – 2.0–5.0 cm
  • 52240 – >5.0 cm

Bill drug supply separately from administration (51720).

  • ZUSDURI™ – J9999 (misc. antineoplastic; payer-specific)
  • Mitomycin – J9280 (traditional)
  • Gemcitabine – J9201
  • C67.0 – Trigone of bladder
  • C67.9 – Bladder, unspecified
  • Z51.11 – Encounter for antineoplastic chemotherapy
  • Z51.12 – Encounter for antineoplastic immunotherapy
  • Biopsy bundling: 52204 may be bundled…
  • Multiple tumors: code off the largest lesion.
  • Modifier –22: use only with strong documentation.

Example A: 52224 …

Example B: 52234 + 51720 …

  • Document size/number/location
  • Document agent/dose/dwell time
  • Use templates to reduce denials

Facility Coding

Facility-specific content will be added here.

EOBs

PRS Verified, Vetted, and Summarized

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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

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.  So the Box 19 entry could be written like: 72493010603 ZUSDURI Instillation ME75 ME5JW

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 recurrent, low-grade, intermediate-risk non-muscle invasive bladder cancer 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

 

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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.


Hospital Outpatient Department (HOPD)

 

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 – 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

 

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


Ambulatory Surgery Center (ASC)

 

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: Enter drug name, NDC, dose administered, wastage (if any)

  • Box 21: List appropriate ICD-10-CM diagnosis code(s)

  • Box 24D: List 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)

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