SAN JOSE, Calif., Sept. 28, 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 Nebraska has updated its medical policy to provide coverage for minimally invasive SI joint fusion using CPT 27279. BCBS of Nebraska becomes the second BCBS plan following Michigan to establish a positive coverage policy for MIS SI joint fusion. The new policy is based on a review of published clinical literature available as of March, 2016 and states: "fusion/stabilization of the sacroiliac joint for the treatment of back pain is scientifically validated when the patient has had a positive result with dual diagnostic blocks using 2 anesthetic agents with different duration of action and has tried and failed therapeutic injections and has tried and failed 12 weeks of conservative management which must consist of documented physical therapy and nonsteroidal anti-inflammatory medications."
References cited within the new coverage policy consisted of published studies specific to iFuse1,2. iFuse is the only SI joint fusion device with a patented triangular profile that resists joint motion and is supported by more than 45 peer-reviewed positive publications. No other SI joint fusion device has peer-reviewed published evidence supporting safety and effectiveness, and iFuse is the only such device commercially available in the United States with an indication citing clinical studies that demonstrate improved pain, patient function and quality of life.
"BCBS of Nebraska joins BCBS of Michigan along with a growing list of leading edge private insurers as well as Medicare nationwide to provide coverage for iFuse. This positive coverage decision provides access to appropriate care for Blue Cross Blue Shield members throughout Nebraska who have been suffering with chronic SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption," said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.
"I see patients in my practice on a regular basis who have suffered from chronic sacroiliac joint dysfunction for years and no longer respond to non-surgical treatment. Many of these patients are surgical candidates," said John Hain, MD at Nebraska Spine Hospital in Omaha, Nebraska. "I am pleased that I can now offer my BCBS Nebraska patients the only minimally invasive procedure supported by two year outcomes data and give them a chance to have a better quality of life."
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 with a porous surface creating an interference fit designed to help decrease joint motion, and allow for biological fixation to support long-term fusion. iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results). It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.
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. 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. 9729.092816
- Whang P. et al. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 2015;9:Article 6.
- Graham Smith A, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, et al. Open Versus Minimally Invasive Sacroiliac Joint Fusion: A Multi-center Comparison of Perioperative Measures and Clinical Outcomes. Ann Surg Innov Res. 2013;7:14. doi: 10.1186/1750-1164-7-14.
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SOURCE SI-BONE, Inc.