The iFuse Bedrock Granite™ system is a Breakthrough System Designation expertise that gives pelvic fixation and sacroiliac joint fusion, at the side of lumbar spinal fusion procedures
SANTA CLARA, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical system firm devoted to offering surgical options for sacropelvic problems, right now introduced that the Facilities for Medicare & Medicaid Companies (CMS) has granted Transitional Move-By (TPT) fee standing for the iFuse Bedrock Granite™ (Granite) system, used for pelvic fixation and sacroiliac joint fusion at the side of lumbar spinal fusion procedures, underneath the Medicare Hospital Outpatient Potential Fee System. TPT fee standing, which shall be efficient as much as three years starting January 1, 2025, permits affected person entry to new and progressive expertise like Granite by offering an add-on fee to hospitals and ambulatory surgical procedure facilities supporting it.
As a part of the TPT willpower, CMS confirmed {that a} customary deduction from the add-on fee, referred to as a tool offset, is not going to be utilized to lumbar spinal fusion procedures involving pelvic fixation with Granite. This resolution acknowledges that Granite prices should not at present included within the current facility fee quantity for the procedures utilizing this expertise.
“We’re happy that CMS has acknowledged the significance of offering outpatient-based Granite procedures with TPT fee standing and no system offset, permitting hospitals to take care of their ordinary facility fee charges for lumbar fusion procedures, whereas receiving TPT fee for Granite implants they report as a part of the Medicare circumstances they assist,” mentioned Laura Francis, CEO of SI-BONE. “With a rising variety of specialty degenerative spine procedures shifting to the outpatient setting, the extra reimbursement for Granite ensures that sufferers and surgeons can entry new expertise and procedures with out regard to the positioning of service through which they’re carried out.”
In response to CMS, a “Transitional Move-By” fee is a brief, further fee offered to healthcare suppliers for brand new, progressive applied sciences like Granite, permitting sufferers higher entry whereas CMS helps hospitals and gathers knowledge to precisely incorporate their value into customary facility fee charges. Its intent is to offer an incentive for the usage of new medical advances by supplying the next reimbursement to the ability through which they’re used for as much as three years.
Granted BDD in November 2021 and cleared by the U.S. Food and Drug Administration (FDA) in Could 2022, Granite is meant to offer fusion and fixation to the pelvis when used at the side of sure pedicle screw fixation programs as a foundational ingredient for segmental spinal fusion. In finalizing its resolution, CMS famous the individuality of the system’s porous floor and interstices, and that fixation happens by the system’s helical threaded design and conventional posterior fixation rod connection. Yearly, roughly 130,000 lumbar spinal fusion procedures that finish on the pelvis are carried out in america to deal with grownup deformity and degenerative spine circumstances.
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a worldwide chief in expertise for surgical remedy of sacropelvic problems. Since pioneering minimally invasive surgical procedure of the SI joint in 2009, SI-BONE has supported over 3,900 surgeons in performing a complete of greater than 100,000 sacropelvic procedures. A novel physique of medical proof helps the usage of SI-BONE’s applied sciences, together with two randomized managed trials and over 140 peer reviewed publications. SI-BONE has leveraged its management in minimally invasive SI joint fusion to commercialize novel options for adjoining markets, together with grownup deformity, spinopelvic fixation, and pelvic trauma.
For added data on the corporate or the merchandise together with dangers and advantages, please go to www.si-bone.com.
iFuse Bedrock Granite and SI-BONE are registered emblems of SI-BONE, Inc. ©2024 SI-BONE, Inc. All Rights Reserved.
Investor Contact: Saqib Iqbal traders@si-bone.com
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