{"id":900395,"date":"2025-10-27T10:14:00","date_gmt":"2025-10-27T14:14:00","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/centers-for-medicare-and-medicaid-services-assigns-permanent-j-code-for-zusduri-effective-january-1-2026\/"},"modified":"2025-10-27T10:14:00","modified_gmt":"2025-10-27T14:14:00","slug":"centers-for-medicare-and-medicaid-services-assigns-permanent-j-code-for-zusduri-effective-january-1-2026","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/centers-for-medicare-and-medicaid-services-assigns-permanent-j-code-for-zusduri-effective-january-1-2026\/","title":{"rendered":"Centers for Medicare and Medicaid Services Assigns Permanent J Code for ZUSDURI\u2122 Effective January 1, 2026"},"content":{"rendered":"
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PRINCETON, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) — UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, for ZUSDURI (mitomycin) for intravesical solution, the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The J Code will be effective January 1, 2026, and is intended to facilitate standardized billing and claims submission across hospital outpatient departments and physician office settings.<\/p>\n

\u201cSecuring a permanent J Code from CMS is an important operational milestone for the ZUSDURI launch,\u201d said Liz Barrett, President and Chief Executive Officer of UroGen. \u201cThe new J Code is expected to simplify reimbursement processes for providers across sites of care, subject to individual payor coverage policies. More importantly, it represents another step in ensuring that patients with recurrent LG-IR-NMIBC have streamlined access to this innovative treatment option. By reducing administrative barriers, we are helping physicians focus on delivering care and helping patients access the therapy they need without unnecessary delays or uncertainty.\u201d<\/p>\n

A J Code is\u00a0a specific type of HCPCS Level II code used for billing non-oral medications, such as chemotherapy, immunosuppressant drugs, and inhalation products.\u00a0The HCPCS is a standardized system used for billing claims for medical supplies, durable medical equipment, and other services not included in the Current Procedural Terminology codes, which handle procedures.\u00a0<\/p>\n

\n About ZUSDURI<\/strong>\n <\/p>\n

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen\u2019s proprietary\u00a0RTGel\u00ae<\/em>\u00a0technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.<\/p>\n

\n About Non-Muscle Invasive Bladder Cancer (NMIBC)\u00a0<\/strong>
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LG-IR-NMIBC affects around 82,000 people in the\u00a0U.S.\u00a0every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at\u00a0www.BladderCancerAnswers.com<\/a>.\u00a0<\/p>\n

\n About\u00a0UroGen Pharma Ltd.\u00a0<\/strong>
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UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed\u00a0RTGel<\/em>\u00a0reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen\u2019s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product is approved to treat low-grade upper tract urothelial cancer, and our second product, ZUSDURI (mitomycin) for intravesical solution, is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in\u00a0Princeton, NJ\u00a0with operations in\u00a0Israel. Visit\u00a0www.UroGen.com<\/a>\u00a0to learn more or follow us on X, @UroGenPharma.\u00a0<\/p>\n

\n IMPORTANT SAFETY INFORMATION<\/strong>
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\n APPROVED USE FOR ZUSDURI<\/strong>\n <\/p>\n

ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.<\/p>\n

\n IMPORTANT SAFETY INFORMATION<\/strong>\n <\/p>\n

\n You should not receive ZUSDURI if you<\/strong>\u00a0have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.<\/p>\n

\n Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:<\/strong>\n <\/p>\n