Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic low back pain

Treatment: Intracept Procedure, codes 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and 64629 x 2 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The insurer denied coverage for Intracept Procedure, codes 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and 64629 x 2 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The denial is upheld 

This patient has chronic low back pain.  The note indicates a history of playing rugby for about 30 years and multiple injuries from playing. Back pain dates back about 10 years. "There is mild bilateral lower extremity radiculopathy." The patient has tried Chiropractic, Physical Therapy (PT), massage, and is doing a home exercise program. The patient's medication trials have included Advil, Aleve and Tylenol.  The patient's magnetic resonance imaging (MRI) shows Modic Type II changes at L (lumbar) 3-L4, L4-L5 and L5-S (sacral) 1. Also noted were concentric disc bulging at L2-L3 and disc bulging with moderate bilateral foraminal narrowing at L5-S1. The note recognizes that the pain may be multifactorial. The request is for radiofrequency ablation (RFA) of the Basivertebral nerves (BVN) at L3, L4, 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. A total of 225 participants with chronic (>= more or equal 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 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.

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 radiofrequency (RF) ablation in the management of chronic low back pain (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 Intracept Procedure, codes 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral and 64629 x 2 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral is not substantiated.