SAN JOSE, Calif., June 16, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that FCSO the Medicare Administrative Contractor (MAC) covering the state of Florida as well as Puerto Rico and the U.S. Virgin Islands, has established coverage criteria for MIS SI joint fusion when billed using AMA CPT® code 27279. FCSO “has removed CPT code 27279 from the Noncovered Services LCD (L33777) for services rendered on or after June 16, 2016 and will be considered for coverage on a case by case basis for the treatment of chronic back pain for certain patients, assuming all other applicable program requirements are met.” Coverage criteria was based on the North American Spine Society’s (NASS) Coverage Policy Recommendations. FCSO becomes the eighth and final MAC to provide access to coverage for MIS SI joint fusion and now Medicare beneficiaries in all 50 states and the District of Columbia have access to the iFuse Implant System.
This positive coverage decision by First Coast is based on the extensive amount of positive clinical evidence published on iFuse along with the common nature of SI joint dysfunction due to degenerative sacroiliitis and SI joint disruption. 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 40 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse. 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.
“With this positive coverage decision by First Coast Service Options, iFuse is now covered by all Medicare Administrative Contractors. Hence, Medicare beneficiaries across the entire country have access to this life changing procedure. This is a major milestone and should help the many people who are affected by debilitating SI joint disease,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.
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. 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. 9470.061616
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