Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain

Treatment: 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first two vertebral bodies, lumbar or sacral (Intracept), 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 (Intracept)

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

The denial is upheld

Reviewer #2:

This patient was in a motor vehicle accident (MVA) and has had chronic low back pain ever since. The patient has tried Chiropractic and Physical therapy.  The patient is doing a home exercise program. The patient's medications include Tylenol, Motrin and Tramadol. The patient's magnetic resonance imaging (MRI) shows post-operative changes at L (lumbar) 4-L5 and L3-L4.  The patient has disc herniations at L2-L3 and L5-S (sacral) 1. Modic Type II changes are noted by the physician at L4, L5 and S1.  The request is for radiofrequency ablation (RFA) of basivertebral nerves at those levels. 

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 centimeter (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 summary, the denial of 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first two vertebral bodies, lumbar or sacral (Intracept), 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 (Intracept) and coverage for the requested service should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.