Hub Home
List a Product About PRS

ZUSDURI (UroGen)

ZUSDURI™ Coding & Reimbursement Hub

How to use this page

  • Start here (Overview): quick orientation to ZUSDURI™ access, coding, coverage, and reimbursement issues.
  • Physician Coding tab: professional claim guidance for office-based administration, product units, NDC reporting, wastage, diagnosis coding, and documentation.
  • Facility Coding tab: hospital outpatient department billing guidance, revenue code logic, UB-04/CMS-1450 claim form considerations, and charge capture alignment.
  • Right-side “Additional Resources”: UroGen Support™, access resources, PA tools, sample claim forms, and PRS quick-reference tools.

What ZUSDURI™ is

ZUSDURI™ (mitomycin) for intravesical solution is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

ZUSDURI™ is administered by urinary catheter once weekly for a total of 6 intravesical instillations. Each dose contains mitomycin 75 mg in 56 mL of hydrogel and may be administered in a physician office or hospital outpatient department by a trained healthcare professional.

Reimbursement orientation

  • Product coding: HCPCS Level II J9282 — Mitomycin, intravesical instillation, 1 mg.
  • Effective date: J9282 is approved for dates of service beginning January 1, 2026.
  • Dose and billing units: report 75 units for the amount instilled and 5 units for discarded drug when appropriate. J9282 has a unit description of 1 mg.
  • NDC reporting: 10-digit NDC 72493-106-03; 11-digit NDC 72493-0106-03.
  • Procedure coding: 51720 may describe bladder instillation of an anticarcinogenic agent, including retention time.
  • Site of care matters: physician office claims generally use CMS-1500/837P logic; HOPD claims generally use CMS-1450/UB-04 or 837I logic.

Coverage and access workflow at a glance

  • Verify medical benefit coverage and confirm whether the payer requires prior authorization.
  • Validate contract reimbursement adequacy before administering buy-and-bill medications, especially for Medicare Advantage, Medicaid Managed Care, and commercial plans.
  • Submit payer-required documentation, including diagnosis support, indication statement, Prescribing Information, prior therapy history, and PA approval number when required.
  • Confirm the claim includes the correct HCPCS, NDC, diagnosis code, procedure code, units, modifiers, place of service or revenue codes, and any payer-required remarks.
  • Track claim submission, reimbursement, denials, and appeals with UroGen Support™ resources when appropriate.

Transparency

  • Thank you to UroGen for supporting this hub and the development of reimbursement education resources.
  • PRS retains editorial control over independent coding, billing, and reimbursement interpretation.
  • ZUSDURI™-specific product information, labeling, and proprietary reimbursement materials are subject to UroGen review and approval.
  • This content is educational and does not guarantee coverage, payment, or payer acceptance.

Physician Coding (ZUSDURI™)

Professional reporting should reflect the diagnosis, the ZUSDURI™ product administered, the bladder instillation service performed, and payer-specific requirements for NDC, units, modifiers, prior authorization, and claim remarks.

Product code

  • J9282 — Mitomycin, intravesical instillation, 1 mg.
  • Permanent J-code effective for dates of service beginning January 1, 2026.
  • ZUSDURI™ is supplied as a single-dose kit containing two 40-mg mitomycin vials and one 60-mL hydrogel vial.

Units and wastage

  • Report the amount instilled to the patient on the first product line: J9282 x 75 units.
  • Report the remaining discarded drug on a second product line with the payer-required discarded-drug modifier: J9282-JW x 5 units.
  • Document the amount administered and the amount discarded in the medical record.

NDC reporting

  • 10-digit NDC: 72493-106-03
  • 11-digit NDC: 72493-0106-03
  • Professional claim example: N472493010603ME75 and N472493010603ME5 when NDC detail is required by payer.

Administration procedure

  • 51720 — Bladder instillation of anticarcinogenic agent, including retention time.

Diagnosis coding should reflect the patient’s documented bladder cancer diagnosis and code to the highest specificity supported by the medical record. Codes that may be relevant include:

  • 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

Practical point: align diagnosis reporting with the approved indication, payer medical-necessity criteria, and documentation of recurrent LG-IR-NMIBC.

Documentation should support the diagnosis, medical necessity, product, dose, route, procedure, and claim line logic.

  • Diagnosis: recurrent low-grade intermediate-risk non-muscle invasive bladder cancer; anatomic site of bladder malignancy when known; relevant history and prior therapy.
  • Product: ZUSDURI™ name, dose prepared, dose instilled, route of administration, NDC when required, and lot information per practice policy.
  • Administration: intravesical instillation by urinary catheter, date of service, retention time when documented, patient tolerance, and any complications.
  • Wastage: amount instilled and amount discarded; the expected split is 75 mg instilled and 5 mg discarded.
  • Prior authorization: PA approval number when required and confirmation that authorization matches the drug, procedure, diagnosis, site of service, and date range.
  • Medical necessity support: indication statement, Prescribing Information, diagnosis documentation, previous therapy history, and rationale for treatment.

Claim and modifier considerations

  • JW modifier: use on the discarded-drug line when reporting the 5 mg discarded amount, consistent with payer requirements.
  • POS 11: physician office claims generally use place of service 11 when the service is furnished in the office.
  • Box 19: may be used to list drug name, dose, route, and 11-digit NDC when required by payer.
  • Box 24A shaded area: may require NDC information with the N4 qualifier, unit of measure, and quantity administered.
  • Prior authorization: Medicare Advantage, Medicaid Managed Care, and commercial plans may require PA aligned to label or payer medical necessity criteria.

Common physician-side pitfalls

  • Unit mismatch: reporting the kit as 1 unit instead of J9282 units by mg.
  • Wastage omitted: not splitting the administered 75 mg and discarded 5 mg across two J9282 lines when required.
  • NDC formatting errors: payer requires the 11-digit NDC format, but the claim uses 10-digit format or omits the N4 qualifier.
  • Authorization mismatch: drug authorization obtained but procedure, site of service, or date range not verified.
  • Contract risk: benefit investigation confirms coverage, but contracted reimbursement is inadequate for buy-and-bill economics.

Facility Coding (ZUSDURI™)

Facility reporting should align pharmacy, chargemaster, clinical documentation, authorization records, and institutional claim lines. ZUSDURI™ may be administered in the hospital outpatient department, where billing generally follows UB-04/CMS-1450 or electronic 837I logic.

Product and revenue coding

  • J9282 — Mitomycin, intravesical instillation, 1 mg.
  • 11-digit NDC: 72493-0106-03.
  • Revenue code 0636 — Drugs requiring detailed coding.
  • Revenue code 0510 — Non-surgical outpatient clinical service, when applicable to the administration service line and hospital billing policy.

Units and wastage

  • Report J9282 x 75 units for the amount administered.
  • Report J9282JW x 5 units for the discarded amount when payer rules require separate wastage reporting.
  • In FL 43, payer-required NDC detail may appear as N472493010603ME75 and N472493010603ME5.

Administration procedure

  • 51720 — Bladder instillation of anticarcinogenic agent, including retention time.

Facility diagnosis reporting should match the reason for the encounter and the treating record. ICD-10-CM diagnosis codes for bladder cancer may include:

  • 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

Practical point: In outpatient facility reporting, use the first-listed diagnosis that best explains the encounter and report additional relevant diagnoses supported by the record.

Facility reimbursement depends on clean alignment among the physician order, procedure note, pharmacy record, nursing documentation, charge capture, and claim.

  • Product capture: ZUSDURI™ name, NDC, amount prepared, amount administered, amount discarded, acquisition pathway, pharmacy preparation/mixing record, and charge capture.
  • Procedure capture: urinary catheter administration, bladder instillation of anticarcinogenic agent, date of service, department/location, and patient tolerance.
  • UB-04 support: revenue code, HCPCS, service units, date of service, NDC detail in FL 43 when required, diagnosis codes in FL 66, and remarks in FL 80 when required.
  • Authorization support: payer authorization number, benefit category, coverage determination, and any payer-required forms or attachments.
  • Record alignment: pharmacy/supply record, medication administration record, physician documentation, nursing note, and claim lines should tell the same story.

Acquisition and site-of-care issues

  • Medical benefit coverage: most payers cover physician-administered products such as ZUSDURI™ under the medical benefit; Medicare generally covers under Part B when medically necessary.
  • Contract validation: benefit investigation does not guarantee adequate reimbursement under the facility’s contract. Validate expected reimbursement before administering buy-and-bill medications.
  • PA coordination: ensure the payer authorization covers the correct drug, procedure, site, provider/facility, and planned dates of service.
  • UroGen Support™: may assist with insurance coverage determination, financial assistance resources, order management, and support resources.

Common facility-side pitfalls

  • Revenue code mismatch: drug line does not use the payer-expected revenue code for detailed drug coding.
  • Drug wastage unsupported: claim reports J9282JW but the medical record does not document discarded amount.
  • NDC detail omitted: payer requires NDC formatting in FL 43 or remarks, but claim lacks N4 qualifier, ME unit of measure, or quantity.
  • Charge capture disconnect: pharmacy record, procedure note, and UB-04 service lines do not match.
  • Appeals file incomplete: denial response lacks Prescribing Information, medical necessity letter, PA record, claim copy, denial letter, purchase invoice, or supporting clinical notes.