RegulatoryJun 23, 2026, 08:26 AM
SeaStar Medical's QUELIMMUNE Receives CMS Billing Codes
AI Summary
SeaStar Medical Holding Corporation announced that its Selective Cytopheretic Device (SCD) therapy, QUELIMMUNE, has received dedicated ICD-10-PCS codes from the Centers for Medicare & Medicaid Services (CMS). These codes will enable standardized administrative, billing, and statistical reporting for the therapy's use in inpatient hospital settings for acute kidney injury (AKI) patients requiring renal replacement therapy. This development is expected to significantly ease logistics for existing customers and pave the way for broader adoption, particularly in the adult AKI market, which is estimated to be approximately $4.5 billion. The new codes are set to take effect on October 1, 2026.
Key Highlights
- SeaStar Medical's SCD therapy received dedicated ICD-10-PCS codes from CMS.
- New codes enable standardized inpatient hospital billing for QUELIMMUNE® (SCD-PED).
- Codes are crucial for potential launch in the adult AKI market, estimated at $4.5 billion.
- The new ICD-10-PCS codes are expected to take effect on October 1, 2026.
- QUELIMMUNE (SCD-PED) was approved in February 2024 for pediatric AKI.
- Clinical trials showed a 77% survival rate for QUELIMMUNE vs. standard of care.
- NEUTRALIZE-AKI pivotal trial is evaluating SCD therapy in adult AKI patients.
Price Impact
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