Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Spondylosis without Myelopathy or Radiculopathy, Lumbar Region. 
Treatment: Intracept Procedure-Intraosseous Ablation of the Basivertebral Nerve. 

The health plan denied the requested procedure. 
The health plan's determination is upheld. 

The patient is a male with low back pain and degenerative disc disease seen on lumbar magnetic resonance imaging (MRI). Intracept Procedure (Intraosseous Ablation of the Basivertebral Nerve) is proposed.

The health plan's determination regarding the proposed health service or treatment is upheld, in whole. 

No, the proposed health service or treatment Intracept Procedure-Intraosseous Ablation of the Basivertebral Nerve (BVN) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

A prospective case series and review of literature of basivertebral and sinuvertebral nerve ablation states (in part) "A review in literature is done on the pathoanatomy, pathophysiology and pain generation pathway in degenerative disc disease and chronic back pain. 30 patients with 38 levels of intervertebral disc presented with discogenic back pain" [1]. The case series and review of literature is limited to a small number of subjects. 

A guideline issued by the International Society for the Advancement of Spine Surgery Guideline on intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain concludes (in part) "Intraosseous ablation of the BVN is a relatively new minimally invasive treatment for the relief of CLBP (chronic lower back pain) that is diagnosed using well-established clinical and magnetic resonance imaging (MRI) findings. The procedure is supported by level 1 evidence including 2 randomized controlled trials (RCTs) demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained to at least 24 months in a limited number of studies" [2]. Multiple limitations of the guideline are present, including:
(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. 
(4) Unknown effect on the primary degenerative process. 
A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain [3] describes improvements in pain and function following treatment, but the study is limited to 28 patients. 
The current standard of care is summarized in a Clinical Practice Guideline from the American College of Physicians on the Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain [4]: 
Reliable evidence shows that the consensus among qualified objective experts regarding the inherent nature of the Intercept Procedure is that further clinical studies, clinical outcomes research, or clinical trials are necessary to determine its safety, efficacy and anticipated outcomes as compared with the standard means of treatment of the condition in question and is therefore considered experimental/investigational.