Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal
Treatment: Surgical Services. 
The insurer denied spinal surgery (facet joint injection). 
The denial is overturned.

The patient is a male with chronic lower back pain (LBP) for greater than (>) 10 years causing significant impact on his activities of daily living (ADLs), including walking, and sleeping. The patient rates his pain on Visual Analog Scale (VAS) on average 7/10, noting that the pain is sharp and throbbing with radiation to bilateral legs. He notes 80% (percent) of the pain is in his low back while 20% is in his legs. Despite multiple therapies he has not achieved any significant sustained relief from his pain. Past medical history included diabetes mellitus (DM), enlarged heart and thyroid disease. He was taking gabapentin. The patient (pt) used nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, opioids, as well as physical therapy, home exercises and status/post (s/p) laminectomy, multiple lumbar epidural steroid injections (ESIs) and facet injections. The patient is 6'3" 240 pounds with a body mass index (BMI) of 30. Physical examination documented pain with lumbar flexion, limitations of extension, tenderness to palpation lumbar paraspinals consistent with (c/w) muscle spasm. Autonomic testing demonstrated autonomic neuropathy. Pertinent magnetic resonance imaging (MRI) findings include multiple areas in the lumbar spine of disc bulge, advanced degenerative disc disease, central canal spinal stenosis at lumbar (L)3-4 and spondylolisthesis. There was significant progression from a previous MRI. Additionally, there were Modic II changes at L2-3 and Modic I at L3-4. He was subsequently diagnosed with spondylosis and radiculitis with vertebrogenic etiology of his chronic back pain. The subject under review is whether the Intracept procedure is likely to be more beneficial for this patient than standard treatments.

The health plan's determination is overturned.

The Intracept procedure is in its infancy but has received at least Food and Drug Administration (FDA) 510k clearance, meaning that is safe and effective compared to currently available therapies. This does not represent a full approval or speak to the overall effectiveness since other therapies have significant limitations. With that said, there is at least moderate-quality evidence that some patients have significant reductions in pain and disability due to chronic LBP with Modic 1 or 2 changes. This is also predicated on the ability to adequately target and ablating the intraosseous basilar nerve. Based on the available literature documenting the procedures safety and efficacy it is safe to say the procedure is no longer experimental. Our understanding of pain and LBP continues to evolve but there remains significant limitation in both evaluating and treating these patients. There are also limitations in the available literature including mostly device company funded studies. As a result, many clinicians are including short tau inversion recovery (STIR) imaging to evaluate for endplate edema which may be more indicative of patients who respond to the procedure. Many clinicians are finding mixed results, but identifying patients who will benefit most, as well as continued research in the future will hopefully determine the utility of this procedure.
Given this patient has failed multiple other conservative therapies including surgical intervention, other surgical options would not guarantee relief or are appropriate at this time. Given the MRI demonstrating Modic I changes, there is a significant probability that the patient will obtain relief from the requested procedure, therefore it would be of greater benefit to the patient than any standard treatment.