SI-BONE, Inc., manufacturers of the iFuse Implant System, has announced that Geisinger Health Plan has revised its medical policy for sacroiliac (SI) joint fusion that, according to the June 15, 2016 news release, “exclusively covers the iFuse Implant System for the treatment of SI joint syndrome and SI joint mediated mechanical low back pain when the five diagnostic criteria recommended by the International Society for the Advancement of Spine Surgery (ISASS) are met.”
Geisinger covers more than 500, 000 lives in the states of Delaware, Maine, New Jersey, Pennsylvania, and West Virginia. The policy also states: “the use of minimally invasive fusion products other than iFuse Implant System for sacroiliac joint fusion is considered experimental/investigational or unproven and therefore NOT COVERED.”
The news release indicates, “iFuse’s unique patented triangular shape provides 31 times the rotational resistance of a screw. It 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.”
In a separate news release on June 16, 2016, the company announced that First Coast Service Options Inc., 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 minimally invasive surgery SI joint fusion when billed using AMA CPT code 27279.
SI-BONE Vice President, Regulatory and Quality Roxanne Dubois told OTW, “SI-BONE has worked with surgeons for a number of years to generate the robust safety and effectiveness data that helped make this clearance possible. This milestone should strengthen confidence in safely and effectively treating patients with SI-BONE’s triangular implants over other unproven alternatives.”
Michael Mydra, Vice President, Health Outcomes & Reimbursement at SI-BONE, told OTW “Payors are beginning to understand the diagnosis and treatment of the SI joint. They know that there are three different surgical approaches to treat the SI joint. They understand that there are a number of different products that utilize different stabilization and fusion strategies for SI joint fusion. Geisinger performed a thorough review of the clinical evidence and determined that the evidence for SI-BONE’s triangular titanium implants, including two RCTs, a large prospective multicenter study, systematic reviews with meta-analysis, and dozens of other published studies documenting the safety and effectiveness of the procedure supports coverage. Other products and procedures are available, but there is no clinical evidence to support coverage for those products.”
