Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: intraosseous ablation of basivertebral nerve via Intracept Procedure

The insurer denied coverage for intraosseous ablation of basivertebral nerve via Intracept Procedure

The denial is upheld 

The 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 (RF) ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve (BVN) using radiofrequency. 

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, the evidence includes two randomized controlled trials (RCTs) (SMART and INTRACEPT trials, both sponsored by device manufacturer Relievant Medsystems, Inc.). Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. In one RCT, at 12 months, 73 percent (%) of patients crossed over to the active treatment group and therefore long-term comparative data is not available. Limitations to the other RCT include lack of a sham control and short duration of follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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 the patient having evidence of Modic changes at levels other than lumbar (L)3 - sacral (S)1. An MRI (magnetic resonance imaging) showed evidence of focal endplate irregularities and enhancement in the anterior and right side of L2 and L3 vertebrae. Marked underlying marrow edema and enhancement in L2 and L3 vertebral bodies was also noted. MRI evidence of Modic changes at levels other than L3 - S1 was considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. Full exclusion criteria in the INTRACEPT study were: 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 mm; Spondylolisthesis > 2 mm at any level; Spondylolysis at any level; Facet arthrosis/effusion correlated with facet-mediated lower back pain (LBP); Beck Depression Inventory (BDI) > 24; 3 or > Waddell's signs; Compensated injury or litigation; Addiction behavior; or BMI > 40.

Therefore, based on this evidence, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device.

There are other evidence-based medications and treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

In summary, the denial for the intraosseous ablation of basivertebral nerve via Intracept Procedure 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.