---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-020900"
form_type: "8-K"
ticker: "DCTH"
cik: "0000872912"
company_name: "DELCATH SYSTEMS, INC."
filed_at: "2024-01-31T23:59:59+00:00"
generated_at: "2026-06-06T14:26:25.689947+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "medium"
source: SEC EDGAR
---

# CMS grants permanent J-code J9248 for Delcath's HEPZATO, effective April 1, 2024

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-24-020900
- form_type: 8-K
- ticker: DCTH
- cik: 0000872912
- company_name: DELCATH SYSTEMS, INC.
- filed_at: 2024-01-31T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: medium
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/872912/000119312524020900/0001193125-24-020900-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/872912/000119312524020900/d773662d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-020900
- JSON: https://secwatch.observer/filing/0001193125-24-020900.json
- Plain text: https://secwatch.observer/filing/0001193125-24-020900.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.