Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intraosseous Nerve Ablation (64628x1, 64629x1)
The insurer denied: Intraosseous Nerve Ablation (64628x1, 64629x1)
The denial is overturned

The patient is an adult female with a history of chronic low back pain of several years. The pain has affected her activities of daily living (ADLs) and functionality. The treating physician concluded that the pain is vertebrogenic and that the patient will benefit from Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L3 (lumbar three), L4 (lumbar four) and L5 (lumbar five). Magnetic resonance image (MRI) of the lumbar spine showed Modic types I signal changes at L3/L4 (lumbar three/lumbar four) and L4/L5 (lumbar four/lumbar five).

The patient has failed conservative measures including physical therapy, spinal injections, Valium, diclofenac, Flexeril, diazepam, Medrol Dose Pak, etc.

The health plan should cover the proposed Intracept procedure.

The Intracept procedure is medically appropriate based on general standard of care for vertebrogenic pain.  It 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 demonstrated Modic Type I or Type II 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(randomised control trial) 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(Oswestry Disability Index) and VAS(Visual Analog 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."

The patient presents with a history of chronic low back pain (LBP) of several years.  She has tried and failed conservative measures including physical therapy, spinal injections, Valium, diclofenac, Flexeril, diazepam, Medrol Dose Pak, etc.; all treatment exceeding 12 months. The pain has affected her functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic types I signal changes at L3/L4 (lumbar three/lumbar four) and L4/L5 (lumbar four/lumbar five) bodies.  Therefore based on the submitted information, current peer-reviewed literature and the current standards of care, the requested Intracept procedure is considered medically appropriate.