Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic lower back pain
Treatment: procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept).

The insurer denied coverage for procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept).

The denial is upheld.

This adult male has a history of coccyalgia, lumbago, and chronic lower back pain. He presented to the Pain Management physician's office for an initial consultation for chronic lower back pain. The patient had tried a steroid taper, lumbar epidural steroid injections (ESI), sacroiliac joint (SIJ) injections, and trigger point injections (TPI). The physician recommended the Intracept procedure to treat his back pain. 

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. A total of 225 participants with chronic (>= (greater than 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 (n (number)= (equal)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 Celsius (C) 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 visual analog scale (VAS) of 4 centimeters (cm) (10 cm scale). The primary efficacy endpoint was the comparative change in ODI from baseline to 3 months. 

At 3 months, in the ITT (Intention-to-treat) 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 (probability) =0.107. However, there was a difference between groups in the 3-month PP (Per-protocol) 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). 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. In sum, the publications to date have been company-sponsored and had methodology flaws.  There is no published data on long-term complication rates. The FDA (food and drug administration) has granted approval for marketing. 

There are other evidence-based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches. Thus, this patient is not a good candidate for this procedure.

The insurer's denial of procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral should be upheld.