Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: 64628; thermal destruction of intraosseous basivertebral nerve (BVN), including all imaging guidance; first 2 vertebral bodies, lumbar (L) or sacral (S) and 64629; thermal destruction of intraosseous BVN, including all imaging guidance; each additional vertebral body, L or S

The insurer denied coverage for 64628; thermal destruction of intraosseous BVN, including all imaging guidance; first 2 vertebral bodies, L or S and 64629; thermal destruction of intraosseous BVN, including all imaging guidance; each additional vertebral body, L or S.

The denial is upheld.


This patient has chronic low back pain. The patient has had Physical Therapy (PT), epidural steroid injections (ESI), and trigger point injections. The patient's medication trials have included Advil, Diclofenac, Oxycodone, Dexamethasone and Tylenol. The patient's magnetic resonance imaging (MRI) shows Modic changes at L (lumbar) 3-L4 and L4-L5.  The request is for radiofrequency ablation (RFA) of the basivertebral nerves (BVN) at L3, L4 and L5.

In 2018, Fischgrund and colleagues (1) published a double-blind, sham controlled randomized controlled trial (RCT) evaluating the Intracept system and RFA of the BVN 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=78) or treatment (n=147) intervention. In the active treatment group, the radiofrequency (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% (percent)] 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.  

Conger, et al (3) pointed out that all of the major studies while supportive, have been funded by the company:

"There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

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

In summary, the denial of 64628; thermal destruction of intraosseous BVN, including all imaging guidance; first 2 vertebral bodies, L or sacral (S) and 64629; thermal destruction of intraosseous BVN, including all imaging guidance; each additional vertebral body, L or S and coverage for the requested 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 risks are substantially increased over standard treatments.