Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain.
Treatment: Intraosseous Basivertebral Nerve Ablation.
The insurer denied: Intraosseous Basivertebral Nerve Ablation.
The denial is overturned.

The patient 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. She has failed conservative measures including chiropractic manipulation, physical therapy, home exercise program, spinal injections, Tramadol, Ibuprofen, Cymbalta, et cetera. The patient's MRI (magnetic resonance imaging) lumbar spine showed Modic signal changes at L4/L5.
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 L4 and L5. The health plan denied coverage of the Intracept procedure as investigational, citing that there is lack of enough proof or not enough proof that it improves health.

The health plan should cover the Intracept procedure.

The 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 as per the FDA (United States Food and Drug Administration) approved requirements and indication for which the device is approved (3):
Intracept is medically indicated in patients who have:
1)A history of low back pain of at least 6 months duration; and
2) Failed to respond to at least 6 months of non-surgical management; and
3) MRI (magnetic resonance imaging) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to 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 [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 [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 [low backpain]."
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 low backpain] 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 low back pain]."
The patient presents with a history of chronic low back pain of more than 12 months. She has tried and failed conservative measures including chiropractic manipulation, physical therapy, home exercise program, spinal injections, Tramadol, Ibuprofen, Cymbalta, et cetera., all treatment exceeding 12 months. The pain has affected her functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic 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 and not investigational.