First Commercial Positive Coverage Decision Adds to Prior Policies by Medicare (Novitas and Palmetto)
PR Newswire
SAN JOSE, Calif., Aug. 21, 2014
SAN JOSE, Calif., Aug. 21, 2014 /PRNewswire/ — SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced that Priority Health (Michigan) published an update to its Lumbar Fusion Medical Policy No. 91590-R4 providing positive coverage for SI-BONE’s MIS SI joint fusion procedure. The policy states that the fusion procedure, which employs the iFuse Implant System, may now be considered medically necessary for members with SI joint disruptions and degenerative sacroiliitis. The full policy can be found at: https://www.priorityhealth.com/provider/manual/auths/~/media/documents/medical-policies/91590.pdf
Priority Health is the third largest commercial insurer in Michigan, covering over half a million lives.
“This positive coverage decision from a leading commercial insurer is another welcome validation of the clinical benefits of the iFuse Implant System for treating patients with SI joint dysfunction directly resulting from SI joint disruptions and degenerative sacroiliitis,” said Michael Mydra, Vice President of Health Outcomes and Reimbursement for SI-BONE. “The growing body of clinical evidence and positive coverage policies, like that coming from Priority Health, once again confirm that the procedure represents an accepted standard of care in the medical community. We are pleased that a growing number of U.S. patients seeking a minimally invasive surgical approach to pain relief from certain SI Joint disorders will now have access to this unique treatment option.” SI-BONE had previously announced positive coverage news from Medicare Administrative Contractors Novitas Solutions, Inc. and Palmetto GBA, LLC earlier this year.
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.
Clinical publications have identified the SI joint as a pain generator in up to 22% of low back pain patients.1 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator in 43% to 61% of symptomatic post-lumbar fusion, so-called “failed back surgery,” patients.2 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
The iFuse Implant System is a commercially available device in the U.S. and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and 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. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
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 diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. 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. ©2014 SI-BONE, Inc. All Rights Reserved. 8909.082114
1 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain.Clinical Orthopedics and Related Research. 1987;217:266–80.
2 DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.
SOURCE SI-BONE, Inc.
