Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain. 

Treatment: (procedure code 64628) thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral. 

The insurer denied coverage for (procedure code 64628) thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral. 

The denial is upheld. 

This woman has low back pain which began five years prior. She has had multiple treatments including lumbar epidural injections, medication management, microdiscectomy, physical therapy, and radiofrequency ablations (RFA). None of these interventions have provided significant sustainable relief. An MRI (magnetic resonance imaging) demonstrated degenerative endplate changes at disc space L (lumbar)5-S(sacral)1. The request is for RFA of the basivertebral nerves at L5 and S1. 

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled RCT [randomized controlled trial] evaluating the Intracept system and 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 Owestry disability index (ODI) of 30 points (on 100-point scale) and a minimum VAS [visual analog scale]of 4 cm (centimeters) (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. 

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, p=0.10. 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, p=0.019. In the 12-month PP analysis, the difference between the treatment and sham groups in mean ODI was no longer statistically significant (22.6 points versus 25.3 points, p=0.153). PP analyses of pain severity (assessed by VAS) found no significant difference between groups in VAS improvement at 3 months (p=0.083) but significantly greater improvement in the treatment compared with the control group at 6 and 12 months. Eight procedure-related events (2.7%) were reported in 6 participants following the 225 procedures; 2 of these 6 participants were in the sham arm. The events included nerve root injury (n=1), lumbar radiculopathy (n=2), retroperitoneal hemorrhage (n=1), and transient motor or sensory deficits (n=4). 

In sum, 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. 

The carrier's denial of procedure to treat low back pain (procedure code 64628) Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral should be upheld.