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 (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 radiofrequency. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

For individuals who have vertebrogenic low back pain who receive ablation of BVNs, the evidence includes two randomized controlled studies (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.

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, failed to respond to at least 6 months of non-surgical management, 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, 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 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 evidence in the medical record morbid obesity and MRI evidence of lumbar spondylosis.

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 denial of intraosseous ablation (heat destruction) of the BVN (nerve branches that supply the lower vertebrae) (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 risks are substantially increased over standard treatments.