Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging, first 2 vertebral bodies, lumbar or sacral

The insurer denied coverage for Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging, first 2 vertebral bodies, lumbar or sacral

The denial is upheld 

This patient has chronic low back pain. The patient has had Physical therapy and is doing a home exercise program. The patient's medications have included Aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), and Tylenol. The patient has had Epidural steroid injection and Sacroiliac joint injection. The patient's magnetic resonance imaging (MRI) shows Modic changes at L (lumbar) 5-S (sacral) 1.  It also shows Left disc extrusion which contacts the Left S1 nerve root and a disc bulge at L4-L5 which contacts the L4 nerve root.  There is no surgical consultation documented. The request is for radiofrequency ablation (RFA) of Basivertebral nerve (BVN) at 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. 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 85Celsius 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 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. 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.  There are other evidence- based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches.

In sum, this procedure is NOT likely to be more beneficial than the standard of care.

In summary, the denial of Intracept procedure for intraosseous ablation of the basivertebral nerve, code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging, first 2 vertebral bodies, lumbar or sacral 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 not substantially increased over standard treatments.