SAN JOSE, Calif., Aug. 23, 2017 /PRNewswire/ -- 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 Highmark, Inc., the nation's 4th largest Blue Cross and Blue Shield-affiliated insurer, has established an exclusive positive coverage policy for MIS SI joint fusion using the iFuse Implant System. Highmark, Inc., an independent licensee of the Blue Cross and Blue Shield Association, is among the top 10 largest health insurers in the United States and includes Blue Cross Blue Shield (BCBS) of Pennsylvania, BCBS of Delaware and BCBS of West Virginia.
Based on the more than 50 peer-reviewed clinical studies and publications, the policy, available at the link below, provides iFuse coverage for more than 4.5 million Blue Cross Blue Shield plan members in Pennsylvania, Delaware and West Virginia effective August 21, 2017.
The Following Blue Cross Blue Shield Plans now cover iFuse:
- BCBS of Texas: HCSC: Exclusive to iFuse
- BCBS of Oklahoma: HCSC: Exclusive to iFuse
- BCBS of New Mexico: HCSC: Exclusive to iFuse
- BCBS of Montana: HCSC: Exclusive to iFuse
- BCBS of Illinois: HCSC: Exclusive to iFuse
- BCBS of Pennsylvania: Highmark: Exclusive to iFuse
- BCBS of Delaware: Highmark: Exclusive to iFuse
- BCBS of West Virginia: Highmark: Exclusive to iFuse
- BCBS of Michigan
- BCBS of Vermont
- BCBS of Nebraska
Over 22.5 million BCBS health plan members are now covered for MIS SI joint fusion.
"The SI joint is a common source of low back pain in many patients. I have performed over 90 procedures with the iFuse Implant System and it has been a rewarding procedure for my patients and for me as a spine surgeon. I am very pleased to now be able to offer appropriately diagnosed Blue Cross Blue Shield patients this clinically proven SI joint fusion procedure," said Michael Oh, MD, neurosurgeon at Allegheny General Hospital in Pittsburgh, PA.
"For almost 10 years, we have been keenly focused on building products and an effective procedure that benefits patients who have SI joint disruption and/or degenerative sacroiliitis. We are of course pleased that Highmark has decided to provide coverage based on the extensive published data demonstrating safety, clinical effectiveness, durability, low revision rates and opioid user reduction of the iFuse Implant System that has been available since 2008," said Jeffrey Dunn, President, Chairman and CEO at SI-BONE.
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 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.
SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.
The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.
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
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9752.08232017
- 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.
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SOURCE SI-BONE, Inc.