Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Vertebrogenic Low Back Pain
Treatment: Pain Management Services /Ablation, 3 Units 
(Intracept procedure)
The insurer denied: Pain Management Services /Ablation, 3 Units (Intracept procedure)
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. The treating physician concluded that the pain is vertebrogenic, and that she will benefit from Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L3, L4, L5 and S1 (lumbosacral). The patient's MRI (magnetic resonance imaging) lumbar spine showed Modic type 2 signal changes at L3/L4, L4/L5 and L5/S1. The patient has failed conservative measures, including home exercise program, physical therapy, spinal injections, Tylenol, muscle relaxants, NSAIDs (nonsteroidal anti-inflammatory drugs), etc. The health plan denied coverage of the requested Intracept procedure, citing lack of enough proof or not enough proof that it improves health, and they deemed it as investigational. The reason for the 
appeal is its relevance in treating vertebrogenic pain.

The health plan should cover the requested 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:
* A history of low back pain of at least 6 months duration; and
* Failed to respond to at least 6 months of non-surgical management; and
* MRI (magnetic resonance imaging) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1; and
* 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 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 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 home exercise program, physical therapy, spinal injections, Tylenol, muscle relaxants, NSAIDs (nonsteroidal anti-inflammatory drugs), etc, all treatment exceeding 12 months. The pain has affected her functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic type 2 changes at L3/L4, L4/L5 and L5/S1 vertebral bodies. 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. Withholding the treatment is reasonably expected to affect the patient's health adversely.