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Carlsmed's Aprevo Implants Receive CMS NTAP Approval For Cervical Fusion Procedures Under FY2026 IPPS Final Rule

Benzinga·08/01/2025 13:07:24
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Carlsmed, Inc. ("Carlsmed"), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced that in the Hospital Inpatient Prospective Payment Systems Final Rule (IPPS) for fiscal year (FY) 2026, the Centers for Medicare & Medicaid Services (CMS) granted New Technology Add-On Payment (NTAP) reimbursement to cervical fusion procedures using the company's aprevo® personalized interbody implants.

The NTAP program is designed to provide additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. These new technologies demonstrate significant clinical improvement in diagnosis or treatment for Medicare beneficiaries compared to existing alternatives. Starting October 1, 2025, through the NTAP program, cervical fusion procedures utilizing Carlsmed's aprevo® devices are eligible for additional payment from CMS and private payors. The NTAP will use unique ICD-10-PCS procedure codes and provide up to an additional $21,125 in reimbursement on top of the Medicare Severity-Diagnosis Related Groups (MS-DRGs) for qualifying inpatient procedures.

The aprevo® devices are designed to match the unique anatomical and alignment needs of each patient through Carlsmed's proprietary AI-powered surgical planning platform and digital production system. Carlsmed received Breakthrough Device designation for cervical use by the FDA and anticipates a U.S. commercial launch in 2026.