Case Volume Justification of 3D-Navigated Spinal Procedures: A Cost-Benefit Analysis.

3D image-guidance platforms have transformed spinal surgery by enhancing visualization, increasing precision, and improving patient outcomes. However, with high procurement, operational, and maintenance costs relative to the standard of care, the benefits of acquiring these platforms must be thoroughly assessed. This study aims to develop a model that weighs the cost of a typical 3D navigation platform against its clinical benefits to determine the facility case volume required to justify its purchase. Using Medtronic's StealthStation and O-Arm as a market example, we calculated the break-even case volume by dividing the cost of the platform by the difference in gross margins between 3D navigation and the standard of care. Total gross margins earned from first-time and revision surgeries were calculated based on each payer's reimbursement rate and covered case volume, as well as each technology's revision rate. Values reported in literature and by Centers for Medicare and Medicaid Services databases were plugged into the model to calculate variables. At a 0% reimbursement rate from private payers for revision surgeries, an annual case volume of 158 spinal surgeries would be required to justify the per-year 3D navigation cost; at 100% private payer reimbursement, 352 surgeries would be required. Given these volumes, 61% of all US inpatient facilities cannot justify 3D navigation at 0% reimbursement, and 86% cannot justify it at 100% reimbursement. Accordingly, greater pricing flexibility, such as per-procedure models, is required for 3D navigation systems to standardize clinical outcomes across medical centers.