secwatch.observer — SEC 8-K summary
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Issuer:     DELCATH SYSTEMS, INC. (DCTH)
CIK:        0000872912
Form:       8-K
Filed at:   2024-01-31T23:59:59+00:00
Accession:  0001193125-24-020900
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/872912/000119312524020900/0001193125-24-020900-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/872912/000119312524020900/d773662d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-020900

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer