Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: 64628 - thermal destruction of instraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar (L) or sacral (S)

The insurer denied coverage for 64628 - thermal destruction of instraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral

The denial is upheld 

This patient has chronic low back pain. The patient has had Chiropractic therapy, Physical therapy and a Home Exercise program.  The patient has tried heat and Ice.  The patient has had non-steroidal anti-inflammatory drugs (NSAIDs) as a medication trial. The patient's magnetic resonance imaging (MRI) shows Modic changes at lumbar (L)5 and sacral (S)1. It also shows a disc Herniation at L4-L5 and a disc bulge at L5-S1 and facet arthropathy at that level. The request is for radiofrequency ablation (RFA) of the Basivertebral nerves at 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 (CLBP). A total of 225 participants with chronic (>= 6 [greater than or equal] 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 85C (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 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. 

In sum, the publications to date have been company sponsored and had methodology flaws.  There is no published data on long-term complication rates.  There is other evidence- based interventions available to this patient.  This procedure is unlikely to be more beneficial than the standard approaches.

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 basivertebral nerve (BVN). Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

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 CLBP and improve the quality of life of CLBP patients in the near future."

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for 64628 - thermal destruction of instraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral is not substantiated.