How to bill for mitomycin for intravesical solution in NMIBC

A rep just told me about a new intravesical mitomycin drug called Zusduri that is used for a specific type of bladder cancer but tells me it needs to be billed differently than regular mitomycin. Can you help us with some of the details on how it can be billed?

Thank you for this question. Yes, you are correct, there is a new intravesical therapy for bladder cancer: mitomycin for intravesical solution (Zusduri; formerly UGN-102), which the FDA approved in June 2025. Mitomycin for intravesical solution is approved only for patients with low-grade, recurrent, intermediate-risk bladder cancer. You're also correct that it is a form of mitomycin, albeit with a unique twist. Unlike traditional mitomycin, which is instilled directly into the bladder, mitomycin for intravesical solution is specially formulated to be instilled chilled, starting as a gel-like consistency but converting to a liquid when cooled, and then converting back into a gel once it warms up to body temperature by being in the bladder. This gel-like consistency in the bladder allows the medication to remain in the bladder longer (often 5 to 24 hours), providing a prolonged exposure of the bladder to the drug. And yes, you’re right again about the indications.

Here are some details about bladder cancer, this product, the context in which it is used, and how it is billed.

Bladder cancer is generally divided into 2 categories: non–muscle-invasive and muscle-invasive. Muscle-invasive cancers are more serious and usually require aggressive treatment such as cystectomy or a combination of chemotherapy and radiation. In contrast, non–muscle-invasive bladder cancers (NMIBCs) are often treated with resection and, based upon stage, often with intravesical therapies (medications placed directly into the bladder) such as BCG, mitomycin, docetaxel, and gemcitabine, among others.

Upon diagnosis, patients with non–muscle-invasive bladder cancer should be assigned a clinical stage and classified on risk, with therapy tailored to that risk category. The risk categories are low risk, intermediate risk, and high risk. A breakdown of the risk categories follows:

Low risk: Patients considered low risk have low-grade, solitary tumors less than or equal to 3 cm confined to the bladder mucosa (Ta), or have a papillary urothelial neoplasm of low malignant potential.

Intermediate risk: This category should be assigned to patients with low-grade tumors larger than 3 cm, multifocal, low-grade tumors that recur within a year, and low-grade tumors invading the lamina propria (T1). High-grade (HG) tumors confined to the mucosa (Ta) and smaller than 3 cm also fall under intermediate risk.

High risk: High risk includes high-grade tumors invading the lamina propria (T1), recurrent high-grade tumors, high-grade tumors larger than 3 cm or multifocal, any carcinoma in situ, BCG failure in high-grade patients, any variant histology, any lymphovascular invasion, and high-grade involvement of the prostatic urethra.

Of these risk categories, mitomycin for intravesical solution is indicated only for patients with recurrent, low-grade, intermediate-risk NMIBC. That means it is not indicated for low-risk bladder cancer, high-risk bladder cancer, or high-grade intermediate-risk bladder cancer.

Based on FDA labeling for the preparation and administration of mitomycin for intravesical solution, the standard dose is 75 mg of mitomycin, (56 mL of product instilled) given once per week for 6 weeks. As noted above, the medication needs to be reconstituted with its sterile hydrogel under chilled conditions due to its reverse thermal properties. At room temperature, it’s a gel, but when chilled, it becomes liquid and then turns back into a gel once it’s warmed to body temperature (around 66 °F). The reconstitution kit contains two 40-mg single-dose vials of mitomycin for intravesical use and one 60-mL vial of sterile hydrogel. Prepare the medication as instructed.

Coding: Intravesical therapies are reported using Current Procedural Terminology (CPT) code 51720 (Bladder instillation of anticarcinogenic agent [including retention time])for the administration, and the Healthcare Common Procedure Coding System (HCPCS) for the product being instilled. Traditional mitomycin for intravesical therapy is reported using HCPCS code J9280, mitomycin, 5-mg injection, for each 5 mg of product instilled. However, it would not be appropriate to use J9280 for instilling mitomycin for intravesical solution. As with many new medications or newly approved biologics a specific HCPCS code(s) is not assigned initially, this is the case with mitomycin for intravesical solution at the time of this article. Therefore, a miscellaneous J-code must be reported. J9999 (Antineoplastic drugs, not otherwise classified) fits best for this drug. (Note: Some payers may request use of unlisted code J3490 [unclassified drugs] or J3590 [unclassified biologics]). This is extremely important in this situation, as the cost of mitomycin for intravesical solution is different than traditional mitomycin.

Reimbursement for Part B drugs (drugs and biologics that are administered in the physician office and meet criteria for billing) for Medicare is calculated to 106% of the average sales price (ASP). The ASP is calculated by Medicare after collecting data from the manufacturer each quarter. Like any newly approved drug, mitomycin for intravesical solution has no sales pricing history. It typically takes at least 2 quarters of sales data to establish a sales price for the Medicare data file. Until the ASP is established by Medicare, carriers are instructed to reimburse the drug at 103% of the Wholesale Acquisition Cost (WAC). (Typically, WAC pricing is published in sources such as the RedBook and Medi-span but can be found in other sources.)

Coverage for the drug initially will typically be limited to that for which the drug has FDA approval. Documentation for the use of new drugs should include choice of drug based on patient condition. It is important to include appropriate documentation in the patient record, including bladder cancer type, stage, risk, and location for all patients. It is common for a payer to request patient records when a service, supply, or drug is reported with an unlisted code and/or category III code. Therefore, it is essential that documentation include the detailed patient history including bladder cancer type as noted above, the full description of the delivery, amount instilled, the amount discarded which will very likely be the case for this drug based on the drug viscosity (reported by amount on a separate line with same code and -JW), , and the reason mitomycin for intravesical solution is chosen for the patient. Appeal and follow-up may be required.

As with all medications and services, it is important to check with the patient’s insurer to determine their policy and whether the medication will be covered.

Send coding and reimbursement questions to Jonathan Rubenstein, MD, and Mark Painter c/o Urology Times®, at UTeditors@mjhlifesciences.com.

The information in this column is designed to be authoritative, and every effort has been made to ensure its accuracy at the time it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.