Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain (CLBP)
Treatment: procedure code 64628 (Intracept procedure; intraosseous basivertebral nerve ablation)
The insurer denied coverage for procedure code 64628 (Intracept procedure; intraosseous basivertebral nerve ablation)
The denial is upheld

This adult patent has chronic low back pain (CLBP). The patient has tried acupuncture, chiropractic, heat/ice, massage therapy, physical therapy, lumbar epidural steroid injections, radiofrequency ablation (RFA) of the medial branches and trigger point injections. The patient takes Flexeril, ibuprofen and hydrocodone. Magnetic resonance imaging (MRI) shows multi-level degenerative disc disease with foraminal stenosis and facet disease. The patient has Modic changes at lumbar (L)5 and sacral (S)1. The request is for RFA of the basivertebral nerves of L5 and S1.

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 (>[less then]=[equal] 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 85 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) (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. (6) 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 is no published data on long term complication rates. There are other evidence-based interventions available to this patient. 

In summary, the denial of procedure code 64628 (Intracept procedure; intraosseous basivertebral nerve ablation) 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 may be increased over standard treatments.