Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Back pain.

Treatment: Intraosseous ablation of the basivertebral nerve, codes 64628 and 64629.

The insurer denied coverage for intraosseous ablation of the basivertebral nerve, codes 64628 and 64629.

The denial is upheld.

This adult patient has chronic low back pain. The patient has tried Chiropractic, Acupuncture, Physical Therapy, and a Home Exercise Program. The medication trials have included Mobic, Methocarbamol, as well as other muscle relaxants and Nonsteroidal anti-inflammatory agents (NSAIDs). The magnetic resonance imaging (MRI) shows Modic Type 2 changes at Lumbar (L) 4, L5 and Sacral (S) 1. Also, of note there are two disc protrusions and an annular tear. There is no documentation of a surgical consultation. The request is for Radiofrequency ablation (RFA) of the basivertebral nerves at L4, L5 and S1.

In 2018, 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 for the treatment of chronic low back pain. In the active treatment group, the RF probe was activated and the temperature at the tip was maintained at 85 degrees for 15 minutes. The duration of the session in the sham group was the same but the RF treatment was only simulated. 

At 24 months, 106 of 128 of individuals in the 3-month per protocol (PP) analysis of active treatment completed 24-month follow-up (Fischgrund, 2019). Mean improvement in Oswestry Disability Index (ODI), which was 20.8 points at 3 months, was 23.4 points at 24 months. A total of 100 individuals were available for analysis at the five-year follow-up (Fischgrund, 2020). There was a significant mean reduction in ODI at 5 years compared with baseline (42.8 and 25.95, respectively, p<0.001). Mean visual analogue score (VAS) was also significantly lower at 5 years (4.38) compared with baseline (6.74), p<0.001. In addition, 66% of individuals reported at least a 50% reduction in VAS at five-years compared with baseline and 34% reported complete pain resolution. 

A second RCT evaluating the Intracept system, known as the INTRACEPT trial (2), was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RF treatment to standard care in individuals with at least 6 months of chronic low back pain 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 S1. The primary study endpoint was difference in the ODI at 3 months. The interim analysis found statistically significant differences between groups on all patient-reported outcomes measures, favoring the Intracept group. For the primary outcome, the mean change in the ODI at 3 months in the interim analysis was -25.3 points in the Intracept group and -4.4 points in the standard care group, p<0.001. As specified in the study protocol, the study was halted and individuals in the standard care group were allowed to cross over to treatment with the Intracept system. Limitations of this study include the lack of a sham control and limited duration of follow-up.

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

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 intracept procedure for intraosseous ablation of the basivertebral nerve, codes 64628 and 64629 is not substantiated.