Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 
Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) and 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The insurer denied coverage for the 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) and 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 
The denial is upheld. 

This adult patient has chronic low back pain. Her medication trials have included Lyrica, Motrin, Percocet and Prednisone. She has had Epidural Steroid injections as well as Medial branch blocks and radiofrequency ablation (RFA) of those branches. She is doing Home Exercises. A magnetic resonance imaging (MRI) shows Modic changes at lumbar (L)3-L4, L4/L5 and L5/ sacral (S)1. The request is for RFA of the Basivertebral nerve (BVN) at L3 to S1.  The MRI is also notable for L4-L5 disc protrusion and L3-L4 spinal stenosis. There is no surgical consultation on the chart. 

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:  1) Industry funding is a potential source of study bias for the available data reviewed; 2) Limited number of studies; 3) Short-term follow up for the majority of studied patients; and 4) 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 trials 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 low back pain (CLBP) and improve the quality of life of CLBP patients in the near future." 

This procedure is NOT likely to be more beneficial than the standard. 

In summary, the denial of 64628 Thermal destruction of Intraosseous Basivertebral Nerve, including all imaging guidance, first 2 Vertebral bodies, Lumbar or Sacral (Intracept) and 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral 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.