Diagnosis: Orthopedic/Musculoskeletal
Treatment: Surgical Services
The insurer denied Intracept Procedure.
The denial is upheld in whole.

The patient is a female with low back pain. Magnetic resonance imaging (MRI) by report is significant for degenerative disc disease. The Intracept procedure is proposed to treat low back pain symptoms.

The subject under review is the medical necessity for the procedure.

The health plan's determination is upheld in whole.

The requested Intracept procedure is not medically necessary for this patient.

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 (BVN) 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 chronic low back pain (CLBP) 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 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.

In short, reliable evidence shows that the consensus among qualified objective experts regarding the inherent nature of the Intracept 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 not considered the standard of care. It would therefore not be considered medically necessary.