Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Pain management services/Ablation, 1 Unit
The insurer denied coverage for pain management services/ablation, 1 unit.
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 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.

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 lumbar (L) 3 to sacral (S) 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 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 the patient having MRI evidence of Modic changes at levels other than L3-S1. MRI report states that there are Modic type I endplate changes adjacent to the thoracic (T) 12-L1 disc space. Modic changes at levels other than L3-S1 were considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil, et al. 

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. Furthermore, with MRI evidence of Modic at levels other than L3-S1, 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 the pain management services/ablation, 1 unit 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.