Regulatory

Carlsmed’s aprevo Implants Gain CMS Coverage for Cervical Fusion Procedures

The reimbursement takes effect Oct. 1.

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By: Michael Barbella

Managing Editor

The Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-On Payment (NTAP) reimbursement to cervical fusion procedures using Carlsmed Inc.’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 Oct. 1, through the NTAP program’s Hospital Inpatient Prospective Payment Systems Final Rule (IPPS) for fiscal year (FY) 2026, cervical fusion procedures using Carlsmed’s aprevo devices are eligible for additional payment from CMS and private payers. 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.

“We appreciate CMS’s support in making innovative medical technologies more accessible to Medicare beneficiaries by mitigating some of the financial burden on hospitals,” Carlsmed Chairman/CEO Mike Cordonnier said. “Our aprevo personalized surgery platform is designed to reduce the need for revision surgeries and empower surgeons to achieve optimal alignment for each patient. Building upon the CMS reimbursement granted to our lumbar fusion devices last year, we are pleased this decision enables us to continue our mission to improve outcomes and decrease the cost of healthcare for spine surgery patients.”

The aprevo devices match the unique anatomical and alignment needs of each patient through Carlsmed’s proprietary artificial intelligence (AI)-powered surgical planning platform and digital production system. Carlsmed received Breakthrough Device designation for cervical use by the U.S. Food and Drug Administration and anticipates a U.S. commercial launch in 2026.

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease healthcare costs for spine surgery and beyond.

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