Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept)
The insurer denied: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept)

The denial is overturned.

The patient is an adult female with history of chronic low back pain of more than a year. The pain has affected her ADLs (activities of daily living) and functionality. The treating physician concluded that the patient's pain is vertebrogenic and that the patient will benefit from Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L5/S1 (lumbar five/sacral one).
The patient's MRI (magnetic resonance imaging) lumbar spine showed Modic types 1 and 2 signal changes at L5/S1. The patient has failed conservative measures including Physical therapy, home exercise program, Tramadol, spinal injections, etc. She also had L5/S1 microdiscectomy to no avail. She is not taking NSAIDs (nonsteroidal anti-inflammatory drugs), as she has been on Warfarin and Enoxaparin.

The health plan should cover the requested Intracept procedure.

The requested treatment is medically appropriate based on general standard of care for vertebrogenic pain. It also meets the recommended requirements by RELIEVANT the Intracept Medical device manufacturer, as per the FDA (United States Food and Drug Administration)-approved requirements and indication for which the device is approved (3).
Per Khalil J, Smuck M, Koreckij T, et al, "The purpose of this RCT [randomized controlled trial] to compare the effectiveness of intraosseous RF [radiofrequency] ablation of the BVN [basivertebral nerve] to standard care for the treatment of chronic LBP [lower back pain] in a specific subgroup of patients suspected to have vertebrogenic related symptomatology." Their conclusion states, "Minimally invasive RF [radiofrequency] ablation of the BVN [basivertebral nerve] led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP [lower back pain]."
Per a study performed by Fischgrund JS, Rhyne A, Franke J, et al, "The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up." The conclusions of this study are cited as, "Patients treated with RF [radiofrequency] ablation of the BVN [basivertebral nerve] for CLBP [chronic lower back pain] exhibited sustained clinical benefits in ODI [Oswestry Disability Index] and VAS [Visual Analogue Scale] and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP [chronic lower pain pain]."
The patient presents with a history of chronic low back pain of more than 12 months. She has tried and failed conservative measures. She also had L5/S1 microdiscectomy to no avail. She is not taking NSAIDs (nonsteroidal anti-inflammatory drugs), as she has been on Warfarin and Enoxaparin. All treatment have exceeded 12 months. The pain has affected her functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic type 1 and 2 changes at lumbar five/sacral one (L5/S1) vertebral body.
Therefore, based on the submitted information and current peer-reviewed literature, the Intracept procedure is not experimental, investigational, or unproven in this patient's case, and the current standards of care would deem the requested Intracept Procedure to be considered medically appropriate.