Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic lower back pain. 
Treatment: Nerve treatment of the spine (Intracept procedure). 

The insurer denied coverage for nerve treatment of the spine (Intracept procedure). 

The denial is upheld. 

This elderly gentleman has chronic low back pain. He has tried Gabapentin, Cymbalta, and Tylenol for pain. He has tried epidural steroid injection, ice/heat application, physical therapy, and a home exercise program. His magnetic resonance imaging (MRI) shows Modic changes at lumbar (L)3-L4, L4-L5 and L5- Sacral (S)1. The request is for radiofrequency ablation (RFA) of the basivertebral nerves at L3, L4, L5 and S1. 

Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and RFA of the basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham or treatment intervention. In the active treatment group, the radiofrequency (RF) probe was activated and the temperature at the tip was maintained at 85 degrees Celsius  for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. Study participants had a minimum Oswestry disability index (ODI) of 30 points (on 100-point scale) and a minimum visual analog scale (VAS) of 4 centimeters (10 centimeter scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. Both intention-to-treat (ITT) and per protocol (PP) analysis were pre-planned. 

At 3 months, there was no statistically significant difference between groups in the primary outcome. However, there was a difference between groups in the 3-month PP analysis: the mean ODI in the treatment arm improved 20.5 points and 15.2 points in the sham arm. In the 12-month PP analysis, the difference between the treatment and sham groups in mean ODI was no longer statistically significant. PP analyses of pain severity found no significant difference between groups in VAS improvement at 3 months but significantly greater improvement in the treatment compared with the control group at 6 and 12 months. Data beyond 12 months on outcomes in the sham-treated group were not available as unblinding occurred at that time and most individuals crossed over to treatment with the Intracept system. Thus, long-term comparative outcomes are not known.

The publications to date have been company sponsored and had methodology flaws. There is no published data on long term complication rates. UpToDate has evaluated this procedure and concluded that it is still investigational. There are other evidence- based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

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

The health plan acted reasonably with sound medical judgment in the best interest of the patient. 

The insurer's denial of coverage for Intracept procedure is upheld. Medical Necessity is not substantiated.