On November 5, 2024, SI-BONE, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through (TPT) payment status for its iFuse Bedrock Granite™ system. This status, effective January 1, 2025, will last for up to three years under the Medicare Hospital Outpatient Prospective Payment System.
A key aspect of this determination is that CMS confirmed no device offset will be applied to lumbar spinal fusion procedures involving pelvic fixation with Granite. This means hospitals will be reimbursed for 100% of the technology cost in outpatient settings, allowing them to maintain their usual facility payment rates while receiving additional TPT payment for Granite implants.
This reimbursement decision is expected to significantly enhance patient and surgeon access to the Granite system, which was FDA cleared in May 2022 and received Breakthrough Device Designation in November 2021. The TPT status provides a crucial incentive for the adoption of this innovative technology in the growing outpatient surgical environment, where approximately 130,000 lumbar spinal fusion procedures ending at the pelvis are performed annually in the U.S.
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