SI-BONE, Inc., a medical device company that pioneered the minimally invasive surgical (MIS) treatment of the sacroiliac (SI) joint with the iFuse Implant System® (“iFuse”) announced that 23 commercial health plans have published exclusive positive coverage policies for the triangular iFuse Implant System. These exclusive positive coverage policies provide access to MIS SI joint fusion using the iFuse Implant System for over 35 million health plan members in the following plans:
1. BCBS Florida
2. BCBS-Illinois (HCSC)
3. BCBS-New Mexico (HCSC)
4. BCBS-Oklahoma (HCSC)
5. BCBS-Texas (HCSC)
17. BCBS-New Jersey (Horizon)
6. BCBS-Montana (HCSC)
18. BCBS-NY (HealthNow)
8. BCBS-Kansas City
22. Select Health
11. BCBS-South Carolina
In addition to the above exclusive iFuse coverage policies, in July, eviCore healthcare, which according to their web site manages over 100 million lives, published a positive recommendation for exclusive use of the triangular iFuse ImplantTM that takes effect October 22, 2018. Also, on January 1, 2018, Blue Cross Blue Shield Association (BCBSA), a national federation of 36 independent, community-based and locally-operated Blue Cross and Blue Shield companies that collectively provide healthcare coverage for more than 106 million members across all 50 states, the District of Columbia and Puerto Rico, published their “triangular only” recommendation for MIS SI joint fusion. And on May 16th, AIM Specialty Health, which is owned by Anthem, published their exclusive iFuse policy that became effective July 1, 2018.
“Payers continually tell us that long-term outcomes data from well-designed, well-executed randomized controlled trials are critically important when determining coverage for new procedures or technologies,” said Jeffrey Dunn, President, CEO and Chairman of SI-BONE. “The threshold for positive coverage includes a reliable diagnostic algorithm combined with a broadly adoptable treatment that is safe and clinically effective with a low revision rate and is cost-effective. The iFuse Implant, that’s been available in the U.S. since 2009, has been the subject of 58 peer-reviewed publications demonstrating safety, effectiveness, biomechanical and economic benefits, including 2 randomized studies.1,2 Based on this extensive body of published evidence, many payers have concluded that the iFuse Implant is the only SI joint fusion device that meets the evidence threshold and have established exclusive coverage. We remain committed to continued investments in education and clinical evidence development in order to further expand access to all those who can benefit from surgical treatment of SI joint disorders.”
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 pain3-6, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.7 SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes. SI joint dysfunction can be identified when a patient points to the source of their pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test8, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by image-guided diagnostic injections to confirm the diagnosis. The SI joint is the largest of the eight major joints in the human body and the last to have a proven surgical treatment.
The iFuse Implant™, available since 2009, is the only SI joint fusion device known to be supported by multiple prospective clinical studies, including two randomized controlled trials, showing that the device improves pain, patient function and quality of life. The extensive body of peer-reviewed published clinical evidence, unique to the iFuse Implant, has enabled government and private payors to establish positive coverage exclusive to the iFuse triangular implant. There are over 55 peer-reviewed publications supporting the safety, effectiveness, biomechanical and economic benefits of this iFuse Implant. (www.si-bone.com/results).
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.
- Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. DOI: 10.14444/3028
- Dengler J, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P, Van Eeckhoven E, Cher D, Sturesson B. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017;20:537-550.
- 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.
- Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997;26(7):477–480.