Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain

Treatment: Low back pain (procedure codes 64628 & 64629), DOS (date of service) TBD (to be determined)

The insurer denied coverage for low back pain (procedure codes 64628 & 64629), DOS (date of service) TBD (to be determined).

The denial is upheld.

This patient has a history of low back pain beginning more than 6 months ago. The patient has had multiple treatments including activity modification, chiropractic care, medial branch blocks, lumbar epidural steroid injections, medication management and physical therapy. Medications have included: Gabapentin; Lidocaine patches, non-steroid anti-inflammatory drugs (NSAIDs), Tizanidine, and Tylenol. 

The patient had a magnetic resonance imaging (MRI) performed. The MRI demonstrated Modic type II changes at disc spaces L (lumbar) 3-L4, L4-L5, L5-S (sacral) 1.   The request is for radiofrequency ablation (RFA) of the basivertebral nerves (BVN) at L3, L4, L5 and S1.

(1) A published a double-blind sham controlled RCT evaluated 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 85 (degree) 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 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% [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.

Urits et al (5) also commented on the need for more research on this promising technique:  "reproducible large RCTs are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RF ablation in the management of chronic low back pain (CLBP) and improve the quality of life of CLBP patients in the near future."

In another recent review,"Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: A Scoping Review of the Literature" concluded after a review of 12 articles that study demographics need to be diversified, there is a lack of true control groups lacking due to crossover, very few high level long terms studies have been published, funding is mostly industry-led, and the studies are limited to a very specific chronic pain population."  (6) Additionally, the Official Disability Guidelines (ODG) by Milliman Care Guidelines (MCG) do not recommend treatment with the Intracept procedure because further trials with longer-term outcomes and less risk of bias are required.

In summary, the denial of low back pain (procedure codes 64628 & 64629) DOS (date of service) TBD (to be determined) 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.