SI-BONE, Inc. Announces Medicare Contractor Cahaba to issue positive coverage of MIS SI Joint Fusion
SAN JOSE, Calif., May 4, 2015 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced today that Cahaba Government Benefit Administrators, LLC (Cahaba), the Medicare Administrative Contractor (MAC) covering the states of Alabama, Georgia, and Tennessee, will update their Local Coverage Determination (LCD) to include "percutaneous sacroiliac minimally invasive joint stabilization for arthrodesis (CPT 27279)" effective June 1, 2015. This coverage decision "based on review of available literature using standard strength of evidence guidelines" concludes that MIS SI joint fusion is no longer considered investigational. Cahaba's decision to update their coverage policy to include CPT 27279 will provide coverage for over 3 million Medicare beneficiaries. They will become the fourth of eight MACs to issue positive coverage for MIS SI joint fusion, joining Noridian Healthcare Solutions LLC, Novitas and Palmetto GBA, to bring the total number of Medicare covered lives to over 27 million.
"Cahaba's decision reinforces the fact that MIS SI joint fusion, for appropriately selected patients, is safe and effective and not investigational," said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE. Mr. Mydra further commented: "Published clinical evidence is growing rapidly for MIS SI joint fusion, and iFuse is becoming the preferred treatment option in this area as evidenced by the fact that iFuse is the only MIS SI joint fusion technology currently on the market supported by a prospective multicenter randomized controlled trial (RCT)."1
"Almost 16,000 iFuse procedures have been performed and professional medical societies in the United States such as ISASS (International Society for the Advancement of Spine Surgery) have issued positive coverage recommendations to insurance companies. We anticipate additional society support in the future and hope to see more positive coverage decisions in the months ahead," said Jeffrey Dunn, President and CEO of SI-BONE.
Clinical publications have identified the SI joint as a pain generator in 15% to 30% of low back pain patients.2-4 In addition, the prevalence of SI joint pain in post-lumbar fusion, so called "failed back surgery" patients, has been shown to be up to 43%.6 Of these patients, some may have degenerative sacroiliitis or SI joint disruptions. Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical management of the SI joint fails, surgical options such as the iFuse procedure may be considered.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, provide immediate fixation and allow for biological fixation to support long term fusion. The iFuse System is intended for sacroiliac joint fusion for conditions including SI joint dysfunction that is a direct result of SI joint disruptions and degenerative sacroiliitis. 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 the leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company has developed, and is manufacturing and marketing, minimally invasive products for patients with certain SI joint disorders. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2015 SI-BONE, Inc. All Rights Reserved. 9190.050415
1 Whang Pa, Cher Db, et al. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. International Journal of Spine Surgery. 2015;9:Article 6.
2 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
3 Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
4 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.
5 Sembrano JNc, Polly DW.c How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
6 DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Medicine. 2011;12:732-9.
a Paid consultant of, and conducts clinical research for, SI-BONE, Inc.
b Employee of SI-BONE, Inc.
c Investigators in a clinical research study sponsored by SI-BONE, but they have no financial interest in the company.