Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Back pain

Treatment: Nerve treatment in the spine

The insurer denied coverage for nerve treatment in the spine

The denial is upheld.

This adult patient has chronic low back pain (CLBP). The Magnetic Resonance Imaging (MRI) shows Modic Type 2 changes at Lumbar (L)2, L3, and L4 as well as multi-level degenerative disc and facet changes.

Fischgrund and colleagues (1) published a double-blind, sham controlled Randomized Controlled Trial (RCT) evaluating the Intracept system and Radiofrequency (RF) Ablation of the Basivertebral Nerve (BVN) for the treatment of CLBP. 225 participants with chronic (greater or equal to 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (sample size (n)=78) or treatment (n=147) intervention. In the active treatment group, the 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 simulated. Study participants had a minimum Owestry disability index (ODI) of 30 points (100-point scale) and a minimum Visual Analogue Scale (VAS) of 4 centimeters (cm) (10cm 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 preplanned.

At 3 months, in the ITT analysis, there was no statistically significant difference between groups in the primary outcome, mean ODI. ODI improved a mean of 19.0 points in the treatment group and 15.4 points in the sham group. 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 analysis 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.

A second RCT known as the INTRACEPT trial (2), was published by Khalil et al. The trial was open label and compared intraosseous RF treatment to standard care in individuals with at least 6 months of CLBP who had not responded to at least 6 months of conservative care. Intervention with the Intracept system consisted of treatment of up to 4 vertebrae in non-consecutive levels from L3 to sacral (S)1. The study found statistically significant differences between groups on all patient-reported outcome measures, favoring the Intracept group. The study was halted and individuals in the standard care group were allowed to cross to the treatment group. Limitations of this RCT include the lack of a sham control and limited duration of follow-up.
 
Per Conger et al, (3) there is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with CLBP who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed.

A clinical practice guideline (4) while favorable pointed out that industry funding is a potential source of study bias for the available data reviewed, limited number of studies, short-term follow up for the majority of participants, and unknown effect on the primary degenerative process.

Per Urits et al, (5) reproducible large RCTs are still needed. Further research is needed on the anatomy of the vertebrae to optimize the method of treatment.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for nerve treatment in the spine is not substantiated.