Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.
Treatment: Intraosseous basivertebral nerve (BVN) ablation.
The insurer denied coverage for intraosseous BVN ablation.
The denial is upheld.

In assessing whether intraosseous basivertebral nerve (BVN) 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 (RF) ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the BVN using RF. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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 of at least 6 months duration, failed to respond to at least 6 months of non-surgical management, magnetic resonance imaging (MRI) demonstrated by Modic Type 1 or Type 2 changes at one or more vertebrae from L (lumbar) 3 to S (sacral) 1, 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 BVN ablation. There are other evidence-based treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. The BVN ablation procedure with the Intracept device is not the best available treatment for this patient based on MRI evidence of other pain etiology with lumbar compression deformities seen in lumbar levels, most prominent at the L4 level, in addition to Modic changes. These compression deformities may represent severe osteoporosis (more common in elderly women) or previous lumbar compression fractures given the patient's back injury history where "he has sustained injuries from multiple accidents" as documented in the provided chart notes. Regardless of the mechanism for the compression deformities, the Intracept procedure was not designed or approved to treat this type of pathology. Radiographic evidence of other pain etiology such as a trauma/compression fracture was also 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.

In summary, 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 RF ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the BVN using RF. Despite limited FDA approval, there are many exclusion criteria. Furthermore, with MRI 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 procedure (intraosseous BVN ablation) to treat low back pain 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.