Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Intracept Procedure (thermal destruction of intraosseous basivertebral nerve)
The insurer denied: Intracept Procedure (thermal destruction of intraosseous basivertebral nerve)
The denial is overturned.

The patient is an adult male with history of chronic low back pain of many years. The pain has affected his activities of daily living and functionality. The treating physician concluded that the pain is vertebrogenic and that the patient will benefit from the Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at lumbar vertebrae five (L5) and sacral vertebrae one (S1). The patient's magnetic resonance image (MRI) of the lumbar spine showed Modic types I and II signal changes at lumbar vertebrae five (L5) / sacral vertebrae one (S1). The patient has tried and failed conservative measures including physical therapy, spinal injections, acetaminophen, duloxetine, Norco, non-steroidal anti-inflammatory drugs (NSAIDs), other opiate analgesics, etc.

The health plan should cover the requested Intracept procedure.

The requested Intracept procedure is medically appropriate based on general standard of care for vertebrogenic pain. It also meets the following recommended requirements by RELIEVANT, the Intracept Medical device manufacturer (3) as per the Food and Drug Administration (FDA) 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 six months duration; and
2) Failed to respond to at least six months of non-surgical management; and
3) Magnetic resonance image (MRI) demonstrated Modic Type I or Type II changes* at one or more vertebrae from lumbar vertebrae three (L3) to sacral vertebrae one (S1); and
4) Activities of daily living 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 was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP 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 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 ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS 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."

The patient presents with a history of chronic low back pain of more than 12 months. He has tried and failed conservative measures including physical therapy, spinal injections, acetaminophen, duloxetine, Norco, non-steroidal anti-inflammatory drugs (NSAIDs), other opiate analgesics, etc., all treatment exceeding 12 months. The pain has affected his functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic type I changes at the lumbar vertebrae five / sacral vertebrae one (L5/S1) 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 in this case.