Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Neck and Low Back Pain. 

Treatment: 64628 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; Intracept) and 64629 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral [list separately in addition to code for primary procedure]). 

The insurer denied coverage for 64628 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; Intracept) and 64629 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral [list separately in addition to code for primary procedure]). 

The denial is upheld. 

This patient has chronic neck and low back pain, status post bilateral lumbar (L) 4-L5, L5 - sacral (S) 1 facet joint radiofrequency ablation (RFA). The patient reported 50% (percent) relief but continued to have axial lower back pain with flexion and prolonged activities. A magnetic resonance imaging (MRI) of the lumbar spine was performed; the findings showed multilevel degenerative disc disease, spinal canal stenosis, and neural foraminal narrowing, with Modic changes at L3, L4 and L5. The request is for RFA of the basivertebral nerves at L3, L4 and L5. 

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

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 basiveterbral nerve (BVN). Non-industry funded high-quality, large prospective studies are needed to confirm these findings." 

In summary, the denial of 64628 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; Intracept) and 64629 (thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral [list separately in addition to code for primary 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 the adverse risk may be increased over standard treatments.