Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: nerve ablation procedure (procedure code 64628)
The insurer denied coverage for nerve ablation procedure (procedure code 64628).
The denial is upheld.

This patient has chronic low back pain. He has tried heat/ ice, physical therapy and home exercise program, Epidural Steroid injections, Medial branch blocks and then radiofrequency ablation (RFA) and sacroiliac (SI) joint injections. His medication trials have included Lidocaine patches, Medrol dose pack, Aleve, Tizanidine and Tramadol. He has had the Intracept procedure at lumbar (L) 5 and sacral (S) 1. His magnetic resonance imaging (MRI) shows changes at L3- L4 and the request is for the RFA of the basivertebral nerves (BVN) at L3 and L4.		

The publications to date have been company sponsored and had methodology flaws. There is no published data on long term complication rates. There are other evidence- based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

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 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 randomized controlled trials (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 RFA in the management of chronic lower back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis.

This patient is not a good candidate for the requested procedure. It is not the best available treatment for this patient at this time.

In summary, the denial of the nerve ablation procedure (procedure code 64628) 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.