{"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","discovered_at":"2026-05-14T18:03:27.097595+00:00","generated_at":"2026-06-06T14:26:25.689947+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"medium","headline":"CMS grants permanent J-code J9248 for Delcath's HEPZATO, effective April 1, 2024","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-020900","json":"https://secwatch.observer/filing/0001193125-24-020900.json","markdown":"https://secwatch.observer/filing/0001193125-24-020900.md","text":"https://secwatch.observer/filing/0001193125-24-020900.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T14:26:25.689947+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}