SANTA CLARA, Calif., Dec. 13, 2019 (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 CIGNA has established a positive coverage policy for minimally invasive SI joint fusion.
The new policy specifies that coverage will be exclusive for FDA cleared implants that are placed across the SI joint and intended to promote bone fusion. This decision follows an extensive amount of published clinical evidence demonstrating the safety and effectiveness of the iFuse Implant System, including a recent publication of 5-year results from a long-term prospective study called LOIS (Long Term Outcomes from INSITE and SIFI).
Cigna is the fourth largest commercial health plan in the United States with 14.6 million members. Its new policy, available at this link: (https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_0303_coveragepositioncriteria_lumbar_fusion_degenerative_conditions.pdf), became effective December 10, 2019.
“As a result of this positive coverage decision, CIGNA’s members will have access to the iFuse procedure when deemed medically necessary by their surgeons,” said Jeffrey Dunn, President, CEO and Chairman at SI-BONE. “CIGNA’s decision to cover MIS SI joint fusion is a significant milestone in the continuing adoption of this important treatment for patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.”
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 60 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. 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. ©2019 SI-BONE, Inc. All Rights Reserved. 10593.121319
Lynn Lewis or Carrie Mendivil