Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: 64628 - Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 - Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The insurer denied coverage for 64628 - Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 - Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The denial is upheld 

Reviewer #2:

This patient has chronic low back pain. The patient is taking Ibuprofen for pain. The patient has had Chiropractic therapy, medial branch blocks, Lumbar Epidural Steroid injections and sacroiliac (SI) joint injections.  The patient's magnetic resonance imaging (MRI) shows Modic type changes at L (lumbar) 4, L5 and S (sacral) 1.  Also of note on the MRI are 3 levels of disc protrusion and spinal stenosis.  The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at L4, L5 and S1.   

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and RF ablation 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 radiofrequency (RF) probe was activated and the temperature at the tip was maintained at 85Celsius 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) (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.

In sum, the publications to date have been company sponsored and had methodology flaws.  There are no published data on long-term complication rates.  There are other evidence- based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches.

This procedure is NOT likely to be more beneficial than the standard of care.

In summary, the denial of 64628 - Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral. 64629 - Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral and coverage for the requested service/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.