Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Low back pain.
Treatment:  Nerve treatment in the spine.

The insurer denied coverage for nerve treatment in the spine.  The denial is upheld.

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 magnetic resonance imaging (MRI) evidence of non-vertebrogenic pathology. According to the MRI, there is the possibility of low-grade infection at lumbar (L)4-L5. Radiographic evidence of non-vertebrogenic pathology such as infection was considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al.

Basivertebral nerve (BVN) ablation using the Intracept procedure is Food and Drug Administration (FDA) approved in a very select group of patients who have 1) A history of chronic low back pain (cLBP) of at least 6 months duration; and 2) Failed to respond to at least 6 months of non-surgical management; and 3) MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to sacral (S)1; and 4) Activities of daily living that are limited by persistent low back pain; and 5) All other reasonable sources of pain have been ruled out.

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. Furthermore, despite FDA approval, there are many exclusion criteria.

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, 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.

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. 

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.  Furthermore, with MRI evidence of possible non-vertebrogenic pathology (possible low-grade infection at L4-L5) 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.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for nerve treatment in the spine is not substantiated.