Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar Degenerative Disc Disease
Treatment: Intercept Procedure
The health plan has denied the requested procedure. 
The health plan determination is upheld.

The patient has low back pain and reports of lumbar degenerative disc disease. The Intercept procedure is proposed.

The proposed health service or treatment (Intracept procedure), destruction of intraosseous basivertebral nerve (BVN), first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum is not likely to be more beneficial than any standard treatment or treatments. 

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 that is diagnosed using well-established clinical and magnetic resonance imaging (MRI) findings. The procedure is supported by level 1 evidence including 2 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.


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]:

Recommendation 1: Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation).

Recommendation 2: For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation).

Recommendation 3: In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence)".

In short, 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, and not likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease.