SI-BONE, Inc. Announces Minimally Invasive SI Joint Fusion using the iFuse Implant System® Maintains Exclusive Positive Coverage with Blue Cross and Blue Shield of Illinois, Montana, New Mexico, Oklahoma and Texas
Exclusive positive coverage policy update includes additional iFuse Implant publications that further support exclusive coverage with triangular titanium implants
SAN JOSE, Calif., August 2, 2017 -- SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Health Care Service Corporation (HCSC) and its divisions of Blue Cross and Blue Shield® (BCBS) in Illinois, Montana, New Mexico, Oklahoma, and Texas have updated their coverage policy for MIS SI joint fusion and maintained their exclusive positive coverage for the iFuse Implant System. The updated policy, which took effect July 15th, 2017, includes additional iFuse Implant System clinical publications and can be found at the link below.
The policy specifically states that “use of minimally invasive or percutaneous SIJ fusion products other than titanium triangular implants/devices (e.g., iFuse Implant System) is considered experimental, investigational and/or unproven.” In other words, only the iFuse Implant System is considered a proven MIS SI joint fusion procedure and is covered by the policy.
Blue Cross and Blue Shield® (BCBS) plans of Illinois, Montana, New Mexico, Oklahoma and Texas, under the umbrella of HCSC, is the largest customer-owned health insurer in the United States and the fourth largest commercial health insurer overall, covering approximately 15 million lives. The iFuse exclusive positive coverage policy, which originally became effective January 1, 2017, is based on the large body of published clinical evidence supporting the use of the patented triangular titanium iFuse ImplantsTM for SI joint fusion. The policy has been further strengthened with additional iFuse Implant publications demonstrating the safety and effectiveness of the iFuse ProcedureTM. The BCBS plans in Illinois, Montana, New Mexico, Oklahoma and Texas join SelectHealth in Utah and Geisinger in Pennsylvania as a growing number of commercial health plans to offer exclusive positive coverage for the iFuse Implant System.
Ralph Rashbaum, MD of the Texas Back Institute in Plano, TX commented: “this exclusive coverage policy update by the five Blue Cross and Blue Shield plans in Illinois, Oklahoma, New Mexico, Montana and my home state of Texas further validates the strength of the clinical evidence supporting the iFuse Implant System as the only minimally invasive SI joint fusion device with appropriate and sufficient data to support coverage.”
About SI Joint Dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side.
SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it. While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test. The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint.
About the iFuse Implant System
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape and press fit insertion technique are both patented and designed to provide immediate fixation by minimizing the SI joint’s unique motion of nutation. The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth6, facilitating long-term fusion of the joint. The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.
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. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9954.080217
- Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
- Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
- Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
- Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
- DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
- MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.