Minimally invasive fusion/stabilization of the sacroiliac joint using a titanium triangular implant




    Policies Impacted

    Musculoskeletal Services #: 00.01.66a

    Purpose

    The purpose of this communication is to provide notice regarding updated coverage position for minimally invasive fusion/stabilization of the sacroiliac joint using a titanium triangular implant.

    Background

    A number of percutaneous or minimally invasive stabilization/fusion/fixation devices have been cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process; although the iFuse® Implant System (SI Bone) is the only triangular implant with an FDA approval for Sacroiliac joint (SIJ) pain treatment.

    For individuals with SIJ pain who receive SIJ stabilization/fusion/fixation with a triangular implant, the evidence includes 2 non-blinded randomized controlled trials (RCTs) of minimally invasive fusion and 2 case series with more than 85% follow-up at 2 to 3 years. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Both RCTs reported superior short-term results for fusion, however, a preferable design for assessing pain outcomes would be independent, blinded assessment of outcomes or, when feasible, a sham-controlled trial. Longer term follow-up from these RCTs has indicated that the results obtained at 6 months persist to 2 years. An additional cohort study and case series, with sample sizes ranging from 45 to 149 individuals and low dropout rates (<15%), have also shown reductions in pain and disability at 2 years. One small case series showed outcomes that persisted to 5 years. The cohort studies and case series are consistent with the durability of treatment benefit. Analysis of an insurance database reported an overall incidence of complications to be 16.4% at 6 months and cumulative revision rate at 4 years of 3.54%. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Furthermore, comprehensive clinical input & feedback supports that stabilization/fusion/fixation of the sacroiliac joint using percutaneous and minimally invasive techniques for carefully selected patients, as outlined in statements from the North American Spine Society (NASS), provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.

    Coverage Statement

    MEDICALLY NECESSARY

    Minimally invasive stabilization/fusion/fixation of the sacroiliac joint using a titanium triangular implant, (i.e., iFuse® Implant System (SI Bone)), is considered medically necessary and, therefore, covered when ALL of the following criteria have been met:

    • Pain is consistently at 5 or above on a 0 to 10 rating scale, (e.g., visual analog scale (VAS) or a numeric rating scale etc.), that impacts quality of life or limits activities of daily living; AND
    • There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); AND
    • Patients have undergone and failed a minimum 6 months of intensive non-operative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program; AND
    • Pain is caudal to the lumbar spine (L5 vertebra), localized over the posterior sacroiliac joint, and consistent with sacroiliac joint pain; AND
    • A thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin’s point) in the absence of tenderness of similar severity elsewhere; AND
    • There is a positive response to a cluster of 3 provocative tests (e.g., thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test); AND
    • Diagnostic imaging studies include ALL of the following:
      • Imaging (plain radiographs and computed tomography or magnetic resonance imaging) of the sacroiliac joint excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy of the sacroiliac joint; AND
      • Imaging of the pelvis (anteroposterior plain radiograph) rules out concomitant hip pathology; AND
      • Imaging of the lumbar spine (computed tomography or magnetic resonance imaging) is performed to rule out neural compression or other degenerative condition that can be causing low back or buttock pain; AND
      • Imaging of the sacroiliac joint indicates evidence of injury and/or degeneration; AND
    • There is at least a 75% reduction in pain for the expected duration of an effect for the anesthetic used following an image-guided, contrast-enhanced intra-articular sacroiliac joint injection on 2 separate occasions; AND
    • A trial of a therapeutic sacroiliac joint injection (i.e., corticosteroid injection) has been performed on at least once occasion, but this treatment option did not achieve effective results.

    EXPERIMENTAL/INVESTIGATIONAL

    Stabilization/fusion/fixation of the sacroiliac joint for the treatment of back pain presumed to originate from the sacroiliac joint is considered experimental/investigational and, therefore, not covered under all other conditions and with any other devices not listed above.

    Coding

    27279

    Issued on - 05/14/2018


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