Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: Procedure to treat low back pain (procedure code 64628) Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral

The insurer denied coverage for procedure to treat low back pain (procedure code 64628) Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral. 

The denial is overturned. 

This case involves a male with history of low back pain who was being recommended for thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral. Records indicated the patient had magnetic resonance imaging (MRI) evidence of moderate spondylosis, disc bulging, and left foraminal disc protrusion at Lumbar (L) 2-3, mild spondylosis with a small disc bulge L3-L4, moderate spondylosis at L4-5, and severe spondylosis with a large broad-based central disc protrusion at L5-Sacral (S) 1, and who had failed various treatment measures and complained of stiffness, pain in extremes of flexion and extension, with the pain affecting his daily living and quality of life. Prior relevant treatment included injections, medication management, microdiscectomy, and physical therapy. 

There is an adequate body of literature and studies to support the Intracept procedure including two level 1 class studies (both were randomized control studies - the highest level of clinical research) which show superiority. Further, there is level 1 data extending to 5 years of efficacy.

Major specialty societies support its acceptance [Spine Intervention Society (SIS) and the International Society for the Advancement of Spine Surgery for example] and its safety and efficacy have been shown out to five years. All of these demonstrate superiority of Intracept over standard therapy. There is 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. Success of the procedure appears to be dependent on effective targeting of the basivertebral nerve with an experienced provider.

Also, the device is Food and Drug Administration (FDA) approved since 2016 and major medical societies support it application.

Literature has noted that Intracept has been FDA approved for the treatment of chronic low back pain. The treatment went through several trials whereupon it was found to be significantly resourceful in treating chronic low back pain. The information provided for the review noted that the patient had failed to respond to multiple treatment measures both surgical and nonsurgical and remains symptomatic. Given the evidence showing that the proposed treatment has been found effective for treating chronic low back pain, the recommendation was to proceed with the service. The patient was considered a good candidate given his history of treatment. The thermal destruction of the intraosseous basivertebral nerve was considered one of the best available treatments for the patient at this time given this presentation both clinically and on imaging studies. The adverse risks have not been shown to be increased over standard treatment/services and are comparable to traditional radiofrequency ablation. Based upon the patient's prior work-up and current medical literature, the procedure is likely to be more beneficial without increased risks.

The carrier's denial of procedure to treat low back pain (procedure code 64628) Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance, first two vertebral bodies, lumbar or sacral should be overturned.