Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Basivertebral Low Back Pain
Treatment: Thermal destruction of intraosseous Basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept)
The insurer denied coverage for Thermal destruction of intraosseous Basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept)
The denial is upheld.

According to the documentation submitted, this is an adult with a history of low back pain. A magnetic resonance imaging (MRI) showed changes at disc space lumbar (L) 5 - sacral (S) 1. The patient had failed more than 6 months of pain treatment. The physician recommended the Intracept procedure to treat the patient's lower back pain.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 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 ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. Basivertebral nerve ablation using the Intracept procedure is Food and Drug Administration (FDA)-approved in patients who have - A history of low back pain of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1; 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 Thermal destruction of intraosseous Basi vertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept). There are other evidence-based treatments available to this patient. Despite a history of chronic low back pain of more than six months, and failed response to more than 6 months of non- surgical treatment, there is no evidence provided of pharmacologic treatment with second-line medication such as duloxetine, tramadol, or tricyclic antidepressants. Intracept is medically indicated in patients who have - A history of low back pain of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out.

The requirements have not been met for basivertebral nerve ablation procedure with Intracept. In addition, the patient has radiographic evidence of "nonspecific bone marrow signal changes" that are not specifically described in the MRI report as Modic changes. Despite current pain, these bone marrow changes are not present in the MRI. Progressive degenerative changes of the vertebral endplates are not uncommon findings on spinal MRI.

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. Furthermore, with radiographic evidence of other pain etiology, 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 of Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or 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 risks are increased over standard treatments.