Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain

Treatment: Procedure code 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; and 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

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; and 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The denial is upheld

This adult female patient has chronic lower back pain status post T (thoracic) 12 kyphoplasty. The patient was seen for persistent low back pain. A repeat magnetic resonance imaging (MRI), which was performed and showed interval kyphoplasty at T12, chronic fracture deformity at the superior endplate of the T12 vertebral body with less than 20 percent vertebral body height loss, and Modic type 1 changes at L (lumbar) 3-L4 and at L5-S (sacral) 1. The request is for L3, L4, 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 (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 Owestry Disability Index (ODI) of 30 points (on 100 point scale) and a minimum VAS (Visual Analogue Scale) of 4 cm (centimeter) (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.

Procedure codes 64628 and 64629 have approval for marketing, but no statement nor recommendation of efficacy have been made, and the patient is not a good candidate.

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 adverse risks are increased over standard treatment/services, the requested procedures are not the best available treatment for this patient at this time and are unlikely to be more beneficial than the standard approaches. There are other evidence-based interventions available to this patient.

The carrier's denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; and 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (list separately in addition to code for primary procedure) should be upheld.