Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain
Treatment: Intraosseous basivertebral nerve ablation procedure
The insurer denied coverage for intraosseous basivertebral nerve ablation procedure.
The denial is upheld.

This patient with chronic low back pain has been treated with physical therapy, a home exercise program, Mobic, Advil and opiates. Magnetic resonance imaging (MRI) shows Modic type changes at lumbar (L)4-L5 and L5-sacral (S)1. The request is for radiofrequency ablation (RFA) of the basivertebral nerves at L4, L5 and S1.

Fischgrund and colleagues (1) published a double-blind, sham-controlled randomized controlled trial (RCT) evaluating the Intracept system and RFA of the basivertebral nerve (BVN) for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (n=78) or treatment (n=147) intervention. In the active treatment group, the radiofrequency (RF) probe was activated and the temperature at the tip was maintained at 85 Celsius (C) for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Oswestry disability index (ODI) of 30 points (on 100 point scale) and a minimum visual analog scale (VAS) of 4 centimeters (cm) on a 10 cm scale. The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. A total of 19 of 147 (13%) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure and 2 for protocol non-compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance.

Although intraosseous basivertebral nerve ablation procedure does have final approval from the appropriate regulatory bodies for this diagnosis, it is unclear if the scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. The publications to date have been company-sponsored and had methodology flaws. There is no published data on long-term complication rates. It is unclear if the adverse risks are increased over standard treatment/services.

It is also unclear if the patient is a good candidate for the intraosseous basivertebral nerve ablation procedure. The patient has baseline osteopenia and the long-term effect of this procedure on the development of vertebral osteoporosis is unknown. Therefore, Intraosseous basivertebral nerve ablation procedure is not the best available treatment for this patient at this time. There are other evidence-based interventions available to this patient.

In summary, the denial of intraosseous basivertebral nerve ablation 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 it is unclear if the adverse risks are substantially increased over standard treatments.