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Updated Blue Cross Blue Shield Association Evidence Rating Supports only Triangular Implants
SANTA CLARA, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced today that effective November 25, 2020, Priority Health Michigan became the 36th U.S. payor with an exclusive, positive iFuse coverage policy. Prior to its November 2020 update, the Priority Health policy covered sacroiliac (SI) joint fusion without a requirement that any particular implant be used. This change provides coverage for minimally invasive (MIS) SI joint fusion for the treatment of lower back pain with a diagnosis of sacroiliac joint disruption or degenerative sacroiliitis, and is notable in that the revised, updated policy requires the use of the iFuse Implant System. MIS SI joint fusion will remain experimental and/or investigational for all other systems and approaches, including cylindrical threaded implants. Priority Health is the second largest health plan in the state of Michigan, with more than 780,000 covered lives. Priority Health has enrollees in commercial, Medicare Advantage, and Medicaid health plans it operates.
SI-BONE also announced that the Blue Cross Blue Shield Association (BCBSA) Evidence Street® Opinion on Diagnosis and Treatment of Sacroiliac Joint Pain (6.01.23) was updated on December 7, 2020 to reflect recent evidence for triangular implants (e.g., iFuse) as well as for all other types of implants used in SI joint fusion procedures. The updated BCBSA Opinion states that for individuals with common disorders affecting the sacroiliac joint who are treated with sacroiliac fusion/fixation with triangular implants, the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. By contrast, the BCBSA Opinion states that the evidence is insufficient to determine the net health outcome for patients treated with cylindrical threaded implants, therapeutic corticosteroid injections, or with radiofrequency ablation.
Jeffrey Zigler, Vice President of Market Access and Reimbursement at SI-BONE, said “Priority Health’s decision to limit its coverage policy for its members to minimally invasive SI joint fusion procedures exclusively using iFuse was supported by more than 85 peer-reviewed articles reviewing iFuse patient outcomes, including randomized controlled trials and other independent studies, which is in line with the Blue Cross Blue Shield Assocation Opinion published this month.”
Priority Health Michigan is not affiliated with the Blue Cross Blue Shield Association. Priority Health is a subsidiary of Spectrum Health.
SI-BONE is a medical device company that pioneered the iFuse Implant System, a minimally invasive surgical system for fusion of the sacroiliac joint to treat sacroiliac joint dysfunction. The SI joint is believed to be the last major joint with a clinically proven surgical treatment. The iFuse Implant™, commercially available since 2009, is believed to be the only SI joint fusion device supported by multiple prospective clinical studies showing improved pain, patient function and quality of life resulting from treatment. There are over 85 peer-reviewed publications supporting the safety, effectiveness, and biomechanical and economic benefits unique to the iFuse Implant (www.si-bone.com/results). This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to augment stabilization and immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. In addition, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2020 SI-BONE, Inc. All Rights Reserved. 12212020
Matt Bacso, CFA