Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.

Treatment: a procedure to treat low back pain (intraosseous basivertebral nerve ablation).

The insurer denied coverage for a procedure to treat low back pain (intraosseous basivertebral nerve ablation).

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) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L (lumbar) 3 to S (sacral) 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.

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 lack of sufficient MRI evidence of Modic changes at any levels. The MRI report states that the marrow signal showed no marrow replacing lesions. There is no mention of Modic changes at any level in the MRI report. Degenerative decreased thoracic (T) 2-disc signal from L2-L3 through L5-S1 is noted, which may represent decreased disc hydration of the disc space. This does not, however, meet the definition of Modic changes where there is bone marrow edema (Modic type I) or fatty endplate changes (Modic type II). The MRI report does have evidence of other pain etiology though, with diffuse disc bulging at L2-L3, L3-L4, L4-L5, L5-S1 and disc herniation at L2-L3 and L3-L4. Chart notes also describe back pain radiating to the right leg and down the back of the leg to the knees at times. The MRI demonstrates L3-L4 disc herniation compressing the right L4 nerve roots with moderate foraminal narrowing. Radicular pain, was considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

There are other evidence-based medications and treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

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. With insufficient MRI evidence of Modic changes as well as radicular pain, this patient would have been excluded from the INTRACEPT trial and therefore the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient.

In summary, the denial for a procedure to treat low back pain (intraosseous basivertebral nerve ablation) 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 risks are substantially increased over standard treatments.