Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Intracept procedure
The insurer denied coverage for the Intracept procedure.
The denial is upheld.

In assessing whether intraosseous basivertebral nerve ablation using the Intracept device is considered more beneficial for this patient than standard treatments or procedures, it is important to know that the publications in peer-reviewed literature to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve (BVN) using radiofrequency (RF). Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

Basivertebral nerve (BVN) ablation using the Intracept procedure is FDA approved in a very select group of patients who have - A history of chronic low back pain (CLBP) of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - magnetic resonance imaging (MRI) that demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from lumbar (L)3 to sacral (S)1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out.

Based on these criteria this patient is not a good candidate for intraosseous basivertebral nerve ablation. There are other evidence-based treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. The basivertebral nerve ablation procedure with the Intracept device is not the best available treatment for this patient based on her history of previous lumbar spine surgery. There is insufficient information in the medical record regarding the patient's prior lumbar surgery to determine if the INTRACEPT procedure will be of benefit to this patient. Previous lumbar spine surgery was considered an exclusion criterion in the INTRACEPT study by Khalil et al. Full exclusion criteria in the INTRACEPT study were: magnetic resonance imaging (MRI) evidence of Modic at levels other than L3-S1; Radicular pain (defined as nerve pain following a dermatomal distribution and that correlates with nerve compression in imaging); Previous lumbar spine surgery (discectomy/laminectomy allowed if > 6 months prior to baseline and radicular pain resolved); Symptomatic spinal stenosis (defined as the presence of neurogenic claudication confirmed by imaging); Metabolic bone disease, spine fragility fracture history, or trauma/compression fracture, or spinal cancer; Spine infection, active systemic infection, bleeding diathesis; Radiographic evidence of other pain etiology; Disc extrusion or protrusion > 5 millimeters (mm); Spondylolisthesis > 2 mm at any level; Spondylolysis at any level; Facet arthrosis/effusion correlated with facet-mediated LBP; Beck Depression Inventory (BDI) > 24; 3 or > Waddell's signs; Compensated injury or litigation; Addiction behavior; or BMI (body mass index) > 40.The supporting publications to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. UpToDate does not support the use of radiofrequency ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency.

In summary, the denial of an Intracept procedure: Thermal destruction of intraosseous basivertebral nerve, inclusive of imaging guidance, first two vertebral bodies, lumbar/sacral and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.