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Centers for Medicare & Medicaid Services (CMS) Issues Permanent J-Code for UroGen’s Jelmyto® Effective January 1, 2021
PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions
About this update from Urogen Pharma Ltd.
[{"type":"text","content":" PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that the Centers for Medicare & Medicaid Services (CMS) has established a permanent and product-specific J-code for Jelmyto® (mitomycin) for pyelocalyceal solution that will take effect on January 1, 2021. The J-code is expected to replace the previously issued temporary C-code and will standardize and facilitate reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care beginning on January 1, 2021.\n\n“Having a permanent J-code will simplify billing and streamline reimbursement, making it even more timely and reliable for physicians treating patients with Jelmyto,” said Jeffrey Bova, Chief Commercial Officer of UroGen Pharma. “This should translate into improved access to Jelmyto for adult patients seeking a minimally invasive, potentially kidney-sparing treatment option for low-grade upper tract urothelial cancer.”\n\nJ-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like Jelmyto that are administered by a physician. Claims submission and payment are standardized with a J-code, facilitating and streamlining billing and reimbursement.\n\nThe J-code for Jelmyto (J9281) has been published online in the CMS Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions (page 36).\n\nAbout Jelmyto®\n\nJelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel™ technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved ...