- SAN JOSE, Calif., March 21, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross Blue Shield (BCBS) of Michigan, the largest commercial insurer in the state of Michigan, has issued a positive medical policy statement for minimally invasive SI joint fusion. BCBS of Michigan becomes the first of the 36 BCBS plans in the United States to establish a positive coverage policy. The new policy became effective on March 1st and states “the safety and effectiveness of minimally invasive sacroiliac joint fusion have been established and it may be considered a useful therapeutic option when supporting documentation substantiates appropriate patient selection criteria listed under inclusionary and exclusionary guidelines.” The patient selection criteria identified by BCBS of Michigan follows the International Society for the Advancement of Spine Surgery (ISASS) Proposed Recommendations/Coverage Criteria for Minimally Invasive Sacroiliac Joint Fusion that was published last year.
The decision to establish positive coverage was based on the significant number of peer-reviewed publications listed in the policy that demonstrate the safety and effectiveness of MIS SI joint fusion surgery. Almost all of those publications were specific to SI-BONE’s triangular shaped iFuse implant. iFuse is the only SI joint fusion device with an indication citing clinical studies that demonstrate improved pain, patient function and quality of life at 12 months post-implantation. To our knowledge, it is the only commercially available SI joint fusion device in the United States with published clinical evidence demonstrating safety, effectiveness and economic benefits. In fact, there are currently over 35 peer-reviewed publications supporting these findings.
“BCBS of Michigan is a leading BCBS plan and the positive medical policy statement for MIS SI joint fusion will provide access for many patients suffering from certain types of SI joint related low back pain who now will no longer have to go untreated or worse – continue to receive costly ineffective treatments such as steroid injections and/or opioid medications that only mask the problem,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.
“I have performed over 275 SI joint fusion surgeries using the iFuse Implant System with excellent results that mirror the published literature. I am very pleased to see that BCBS of Michigan has joined Priority Health and WPS Medicare to take a leadership role in Michigan by establishing coverage,” said Jurgen Luders, MD a neurological surgeon in Grand Rapids, Michigan. “This decision not only provides access to the iFuse procedure that will benefit so many patients in the state of Michigan but it also provides cost savings to BCBS of Michigan, which is so important given today’s high cost of healthcare. Hopefully, this decision will encourage BCBS health plans in other states to provide coverage and access to all those in need of this important therapy.”
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a 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 develops, manufactures and markets minimally invasive products for the SI joint. 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, and allow for biological fixation to support long term fusion. 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. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation. 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. ©2016 SI-BONE, Inc. All Rights Reserved. 9567.032116