Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Surgical Services (All).  
The insurer denied INTRACEPT Procedure. 
The denial was upheld.

The patient is a male with a history of chronic back pain. Treatment to date has included physical therapy, massage therapy, medications of Medrol, methocarbamol, Advil, muscle relaxants and Aspirin without relief. He has had two microdiscectomies at lumbar (L)4-5, right and left. He reported worsening low back pain and new pain with radiation down the bilateral anterior thighs. His exam was normal. His pain averages 6-8/10. A lumbar magnetic resonance imaging (MRI) addendum noted a prior bilateral hemilaminectomy at L4-5 without stenosis or nerve root compression, advanced degenerative disc disease at L1-2, L4-5 and L5-sacral (S)1 with significant progression at L1-2, Modic type I endplate changes from L1-S1 and Modic type II endplate changes at L1-2, L3-4, L4-5 and L5-S1. The original MRI scan noted a disc at L3-4 impinging on the descending bilateral L4 nerve roots. The patient is recommended for the Intracept procedure at L4-5 and L5-S1.
At issue is whether the proposed health service or treatment INTRACEPT Procedure is likely to be more beneficial than any standard treatment or treatments for the patient.

The health plan's determination is upheld in whole.

The proposed health service or treatment INTRACEPT Procedure is not likely to be more beneficial than any standard treatment or treatments for the patient.
The patient has had two prior decompressions/microdiscectomies at L4-5. He has had bilateral leg pain with initial MRI prior to addendum to show nerve impingement at L3-4 bilaterally. It was then addended to show Modic changes at multiple levels from L1 to S1. It is not absolutely clear that his L4-5 and L5-S1 are both causing low back pain. The Intracept procedure has not been proven to be more beneficial than any standard treatment/treatments for the patient's condition. The Intracept procedure is still undergoing clinical trials. (1) The Intracept procedure has excluded patients with radiculopathy, leg pain and prior surgeries. (2)
For this procedure, the improvement claimed is not demonstrated to be obtainable outside the investigational or experimental setting. As the International Society for the Advancement of Spine Surgery (ISASS) states, industry funding is a potential source of study bias for the available data reviewed, there are a limited number of studies, there is short-term follow-up for the majority of studied patients and there is unknown effect on the primary degenerative process. (3) There continues to be insufficient evidence, based on the studies available, if this treatment is more beneficial over current standards of treatments, especially in those patients with prior lumbar surgery as these patients were specifically excluded in the studies completed thus far. In a peer-reviewed article by Kristin Della Volpe, she writes "Ongoing open-label reports of well-structured studies are necessary to further confirm utility of this procedure in a difficult patient population." "While this study provides additional information in support of this procedure, there should be caution used whenever the initial inclusion criteria are expanded. In addition, narcotic use is a multifactorial issue, and more attention should be directed towards the psychosocial aspects of chronic low back pain." Dr. Truumees states, "I have been in practice for 20 years now and have seen technologies come and go... am constantly reminded of Scott's parabola. Basivertebral nerve ablation is promising and does not seem to confer much risk to those trying it. However, close attention to long-term effects and benefits will be critical in determining the true position of this technology in our treatment pathways for chronic low back pain." (4)
Therefore, the proposed health service or treatment INTRACEPT Procedure is not likely to be more beneficial than any standard treatment or treatments.