Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain. 
Treatment: Outpatient procedure (64628 x 1) and coverage for the requested service/treatment. 
The insurer denied coverage for outpatient procedure (64628 x 1) and coverage for the requested service/treatment. 
The denial is upheld. 

This adult has chronic low back pain. The patient has tried Advil, Aleve, Flexeril, Gabapentin, Mobic, and Tylenol for pain. The patient has tried Physical Therapy and radiofrequency ablation (RFA) of his facet joints. Magnetic resonance imaging (MRI) shows Modic changes at lumbar 5 (L5) and sacral 1 (S1). The request is for RFA of the basivertebral nerve at L5 and S1. 

In 2018, Fischgrund and colleagues (1) published a double-blind, sham-controlled randomized control trial (RCT) evaluating the Intracept system and RF (radiofrequency) 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 (number)=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 visual analog scale (VAS) of 4 centimeters (cm) on a 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) analysis 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. 

In sum, the publications to date have been company-sponsored and had methodology flaws. There is no published data on long term complication rates. As per a discussion on use of radiofrequency for low back pain, Up To Date states, "We suggest not using radiofrequency denervation for the management of chronic low back pain. The available data are inconsistent and suggest that, compared with placebo, radiofrequency denervation may modestly reduce pain in the short-term; however, there does not appear to be clear long-term benefit. When added to a treatment regimen that includes a regular exercise program and psychologic support, radiofrequency denervation provides little additional benefit." 

There are other evidence-based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. 

In summary, the denial of outpatient procedure (64628 x 1) and coverage for the requested service/treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.