Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: 64628 - Intraosseous Basivertebral Ablation (Intracept)
The insurer denied 64628 - Intraosseous Basivertebral Ablation (Intracept).
The denial is overturned.

The member is an adult female with history of chronic low back pain of many years. 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 she will benefit from Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L (lumbar) 4 and L5. The patient's MRI (magnetic resonance imaging) lumbar spine showed Modic types 1 and 2 signal changes at L4/L5. The patient has failed back surgery and conservative measures including physical therapy, spinal injections, Methocarbamol, Nortriptyline, NSAIDs (nonsteroidal anti-inflammatory drugs), etc. ("and the rest").

The health plan should cover the requested Intracept procedure.

The Intracept procedure is medically appropriate, based on general standard of care for vertebrogenic pain. The request also meets the following recommended requirements by 
RELIEVANT, the Intracept Medical device manufacturer (3), as per the FDA (United States Food and Drug Administration)-approved requirements and indication for which the device is approved. Intracept is medically indicated in patients who have:

1) A history of low back pain of at least 6 months duration 2) Failed to respond to at least 6 months of non-surgical management 3) MRI demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S (sacral) 1 4) ADLs that are limited by persistent low back pain and all other reasonable sources of pain have been ruled out.

Per Khalil J, Smuck M, Koreckij T, et al, "The purpose of this RCT [randomized controlled trial] was to compare the effectiveness of intraosseous RF [radiofrequency] ablation of the BVN [basivertebral nerve] to standard care for the treatment of chronic LBP [low back pain] in a specific subgroup of patients suspected to have vertebrogenic related symptomatology." Their conclusion states: "Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP."

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 RF ablation of the 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 ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI [Oswestry Disability Index] and VAS [Visual Analogue Scale] and maintained high responder rates at 2 years following treatment. BVN ablation appears to be a durable, minimally invasive treatment for the relief of CLBP."

The patient in this case presents with a history of chronic low back pain of more than 12 months. She has tried and failed back surgery and conservative measures including Physical therapy, spinal injections, Methocarbamol, Nortriptyline, NSAIDs, etc., all treatments exceeding 12 months. The pain has affected her functionality. The MRI of the lumbar spine showed Modic type 1 changes at L4/L5 vertebral body. Therefore, based on the submitted information, current peer-reviewed literature and the current standards of care, the requested Intracept Procedure would be considered medically appropriate for this patient.