regulatory
confidence medium
sentiment positive
materiality 0.60
CMS grants permanent J-code J9248 for Delcath's HEPZATO, effective April 1, 2024
DELCATH SYSTEMS, INC.
- CMS established permanent product-specific J-code (J9248) for HEPZATO (melphalan/Hepatic Delivery System).
- J-code becomes effective April 1, 2024, enabling streamlined Medicare Part B billing for HEPZATO.
- CMS noted existing IV melphalan (0.25 mg/kg) is not substitutable for HEPZATO (3.0 mg/kg intraarterial).
- HEPZATO is liver-directed treatment for adult patients with metastatic uveal melanoma with hepatic metastases.
- CEO Gerard Michel says J-code will facilitate patient access and efficient reimbursement for HEPZATO KIT.