Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Basivertebral Low Back Pain
Treatment: Thermal destruction of intraosseous Basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept)
The insurer denied coverage for Thermal destruction of intraosseous Basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept).
The denial is upheld.

The patient has a history of low back pain beginning several years ago and has had multiple treatments including heat/ice, lumbar epidural steroid injections, medial branch block injections, physical therapy, and sacroiliac joint injections. Nothing has provided significant sustainable relief. The severity of pain on the Visual Analog Scale (VAS) ranges between 3/10 and 10/10. The patient had magnetic resonance imaging (MRI) that demonstrated Modic changes at disc space lumbar (L5)-sacral (S)1. The request is for radiofrequency ablation (RFA) of the basivertebral nerves (BVN) at L5 and S1.  Thermal destruction of interosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) has final approval from the appropriate regulatory bodies for this diagnosis.

The scientific evidence in peer-reviewed literature, however, does not support a result of improvement in health outcomes. 

Fischgrund and colleagues (1) published a double- blind, sham-controlled randomized controlled trial (RCT) evaluating the Intracept system and RFA of the basivertebral nerve 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 radio frequency (RF) probe was activated and the temperature at the tip was maintained at 85C (Celsius) 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 VAS of 4 centimeters (cm) (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.

Conger et al (3) pointed out that all of the major studies while supportive, have been funded by the company: "There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

In sum, the publications to date have been company-sponsored and had methodology flaws. There is no published data on long-term complication rates. The patient is not a good candidate for the requested procedure; there are other evidence-based interventions available to this patient.

In summary, the denial of Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and coverage for the requested treatment should be upheld. This procedure is not likely to be more beneficial than any standard treatments for this patient's condition and adverse risks may be increased over standard treatments.