The iFuse Bedrock Granite™ system is a Breakthrough Device Designation technology that provides pelvic fixation and sacroiliac joint fusion, in conjunction with lumbar spinal fusion procedures

SANTA CLARA, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for the iFuse Bedrock Granite™ (Granite) system, used for pelvic fixation and sacroiliac joint fusion in conjunction with lumbar spinal fusion procedures, under the Medicare Hospital Outpatient Prospective Payment System. TPT payment status, which will be effective up to three years beginning January 1, 2025, allows patient access to new and innovative technology like Granite by providing an add-on payment to hospitals and ambulatory surgery centers supporting it.

As part of the TPT determination, CMS confirmed that a customary deduction from the add-on payment, known as a device offset, will not be applied to lumbar spinal fusion procedures involving pelvic fixation with Granite. This decision recognizes that Granite costs are not currently included in the existing facility payment amount for the procedures using this technology.

“We are pleased that CMS has acknowledged the importance of providing outpatient-based Granite procedures with TPT payment status and no device offset, allowing hospitals to maintain their usual facility payment rates for lumbar fusion procedures, while receiving TPT payment for Granite implants they report as part of the Medicare cases they support,” said Laura Francis, CEO of SI-BONE. “With a growing number of specialty degenerative spine procedures moving to the outpatient setting, the additional reimbursement for Granite ensures that patients and surgeons can access new technology and procedures without regard to the site of service in which they are performed.”

According to CMS, a “Transitional Pass-Through” payment is a temporary, additional payment provided to healthcare providers for new, innovative technologies like Granite, allowing patients better access while CMS supports hospitals and gathers data to accurately incorporate their cost into standard facility payment rates. Its intent is to provide an incentive for the use of new medical advances by supplying a higher reimbursement to the facility in which they are used for up to three years.