Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: intraosseous basivertebral nerve ablation, current procedural terminology (CPT) codes 64628 and 64629
The insurer denied coverage for intraosseous basivertebral nerve ablation, current procedural terminology (CPT) codes 64628 and 64629
The denial is upheld. 

This adult patient has chronic low back pain. The patient has tried acupuncture, home exercise program, facet injections and radiofrequency ablation (RFA). The medication trials have included Advil, Celebrex and Robaxin. The patient has had lumbar (L)3-L4 and L4-L5 laminectomies. The MRI (magnetic resonance imaging) shows Modic changes at L3-L4 and L4-L5. Also noted on the MRI is severe Left neural foraminal narrowing with encroachment on the Left L3 nerve root." No surgical consultation is included in the file. The request is for 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 Radio Frequency (RF) ablation of the Basivertebral nerve for the treatment of chronic low back pain. 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.

A second RCT evaluating the Intracept system, known as the INTRACEPT trial (2), was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RF treatment to standard care in individuals with at least 6 months of chronic low back pain who had not responded to at least 6 months of conservative care. The interim analysis found statistically significant differences between groups on all patient-reported outcomes measures, favoring the Intracept group. Limitations of this study include the lack of a sham control and limited duration of follow-up.

Conger et al (3) pointed out that all of the major studies while supportive, have been funded by the company:

"Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (4) while favorable pointed out the limitations of the current literature: Industry funding is a potential source of study bias for the available data reviewed, limited number of studies, short-term follow up for the majority of studied patients, unknown effect on the primary degenerative process

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 summary, the denial of intraosseous basivertebral nerve ablation, current procedural terminology (CPT) 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 risk are substantially increased over standard treatments.