Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Low Back Pain. 
Treatment: Current Procedural Terminology (CPT) Code: 64628 - Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral; 64629 (1 unit) - Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, each additional vertebral body, lumbar or sacral. 

The insurer denied coverage for CPT Code: 64628 - Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral; 64629 (1 unit) - Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, each additional vertebral body, lumbar or sacral. 

The denial is upheld. 

This male patient has chronic low back pain. He has had Physical Therapy and takes Naproxen for pain. He has had bilateral L (lumbar) 4-L5 transforaminal epidural steroid injections. He has also had sacroiliac (SI) joint injections. His magnetic resonance imaging (MRI) shows Modic changes at lumbar level L3-L4 and L4-L5 interspaces as well as degenerative disc disease. The request is for radiofrequency ablation (RFA) of the basivertebral nerves of 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 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 85Celcius 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 analogue 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 sum, the publications to date have been company sponsored and had methodology flaws. There is no published data on long term complication rates. A Hayes technology assessment (5) has evaluated this procedure and concluded that it is still investigational.  

Urits et al (6) 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." 

There is other evidence- based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. 

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The insurer's denial of coverage for CPT Code: 64628 - Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral; 64629 (1 unit) - Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, each additional vertebral body, lumbar or sacral services is upheld. Medical Necessity is not substantiated.