Delcath Systems, Inc. announced that the Centers for Medicare & Medicaid Services ("CMS") has established a permanent and product-specific J-code (J9248) for HEPZATO. The J-code will become effective on April 1, 2024. J-codes are a form of Healthcare Common Procedure Coding System Level II identifiers used by payors to streamline the billing of Medicare Part B drugs.

In its summary of Delcath's application for the J-code, CMS stated that "xistng melphalan hydrochloride is FDA approved at 0.25 mg/kg via intravenous infusion for patients with multiple myeloma and is not substitutable for the melphalan hydrochloride in the HEPZATO KIT which is approved at 3.0 mg/kg via intraarterial delivery for patients with metastatic ocular melanoma. The HEPZATO KIT is a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.