Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.
Treatment: Outpatient procedures (64628 x 1, 64629 x 1), Radiofrequency ablation (RFA) of basivertebral nerves at L (lumbar) 4, L5 and S (sacral)1.
The insurer denied coverage for radiofrequency ablation (RFA) of basivertebral nerves at L4, L5 and S1.
The denial is upheld.

This gentleman has chronic low back pain. He takes Percocet and cyclobenzaprine for pain. His magnetic resonance imaging (MRI) shows disc herniations at L(lumbar)3-L4, L4-L5, and L5-S(sacral)1, and Modic changes at the end plates of L4, L5, and S1. The request is for radiofrequency ablation (RFA) of basivertebral nerves at L4, L5, and S1.	
In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled randomized control trial (RCT) evaluating the Intracept system and radiofrequency ablation (RF) ablation of the basivertebral nerve for the treatment of chronic low back pain. A total of 225 participants with chronic (>= 6 months) isolated lumbar pain who had not responded to at least 6 months of non-operative management were randomized to either a sham (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 85C (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 a 100-point scale) and a minimum VAS (Visual Analogue Scale) of 4 cm (10 cm 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) analyses were pre-planned. A total of 19 of 147 (13%) participants in the treatment group were excluded from the PP analysis; 16 for a targeting failure, 1 for procedural failure, and 2 for protocol non-compliance. One participant in the sham group was excluded from the PP analysis and this was for protocol non-compliance.

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. Individuals in the standard care continued treatment with conservative therapy. The primary study endpoint was a difference in the ODI at 3 months. A pre-planned interim analysis was undertaken when 60% of participants reached the 3-month follow-up (n=51 in the Intracept group and n=53 in the standard care group). 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 (probability) <0.001. The mean change in VAS was -3.46 points in the Intracept group and -0.01 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 sham control and the limited duration of follow-up.
 
The outpatient procedures (64628 x 1, 64629 x 1), and intraosseous nerve ablation, are not the best available treatment for this patient at this time. It is uncertain if the adverse risks increased over standard treatment/services.

The carrier's denial of outpatient procedures (64628 x 1, 64629 x 1), and intraosseous nerve ablation should be upheld.