Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Low Back Pain (CLBP)
Treatment: Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628, Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral
The insurer denied coverage for Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628, Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral.
The denial is upheld.

This adult male patient has chronic low back pain which is exacerbated by bending, walking, standing, and sitting. He has previously undergone medial branch blocks and radio frequency ablation (RFA) treatments. A magnetic resonance imaging (MRI) of the spine revealed chronic minimal disc bulge at L (lumbar) 3-L4, mild indentation upon the ventral thecal sac and moderate bilateral neural foraminal stenosis and mild endplate spondylosis and small Schmorl's nodes at L4-L5, and severe L5-S (sacral) 1 and moderate L4-L5 degenerative disc disease with associated disc desiccation. Modic changes on MRI are also noted. The request is for the RFA of the basivertebral nerves.

Fischgrund and colleagues (1) published a double-blind, sham controlled RCT (randomized controlled trial) evaluating the Intracept system and RFA of the basivertebral nerve for the treatment of chronic low back pain (CLBP). A total of 225 participants with chronic (greater than or equal to 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 (degrees 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 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% [percent]) 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.

Urits, et al (4) also commented on the need for more research on this promising technique: "reproducible large RCTs are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RF ablation in the management of CLBP and improve the quality of life of CLBP patients in the near future."

There are other evidence-based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for the Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628, Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral is upheld. Medical necessity is not substantiated.