Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

The denial is upheld 

Reviewer #1:

This is a patient with chronic low back pain. The patient has had physical therapy and is doing a Home Exercise program. The patient has had sacroiliac (SI) joint injection and Trigger Point Injections. The patient is taking Tizanidine and Voltaren for pain. The physician states that there are Modic changes on the magnetic resonance imaging (MRI) at L (lumbar) 3-L4, L4-L5. The radiologist report however documents Modic changes only at L2-L3.  Also noted was diffuse disc bulge at L2-L3 and disc bulge and facet arthropathy at L4-L5. The request is radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at L3, L4 and L5.	

In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled randomized controlled trial (RCT) evaluating the Intracept system and radiofrequency (RF) ablation of the Basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (>=(greater or 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 (degree) 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.

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

Urits et al (5) 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 chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

In sum, this procedure is not likely to be more beneficial than the standard of care.

In summary, the denial of intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629) 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 risks are substantially increased over standard treatments.