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202009-130958

2020

United Healthcare Ins. Co. of NY

Indemnity

Orthopedic/ Musculoskeletal

Pain Management

Experimental/Investigational

Upheld

Case Summary

Diagnosis: Spondylosis without Myelopathy or Radiculopathy, Lumbar Region.
Treatment: Intracept Procedure-Intraosseous Ablation of the Basivertebral Nerve.
The health plan denied the requested procedure.
The health plan's determination is upheld.

This is a male who has a one year history of low back pain. Pain level 9/10. Pain is exacerbated by prolonged standing and walking. This patient has tried pain medications, physical therapy (PT) and injections. From the review the medical records, none of these treatments rendered him any significant pain relief except some improvement from radiofrequency ablation (RFA) of bilateral (lumbar-sacral) L4 to S1, and the lumbar transforaminal epidural steroid injections. He reported 80% of pain relief after the lumbar RFA. However, he continued to have pain in his lower back and into his bilateral hips when standing more than 5 minutes. Physical examination was remarkable for decreased range of motion (ROM) in the back, mild pain with extension and facet loading, and antalgic gait. His past medical history documented lumbar radiculopathy, spinal stenosis with neurogenic claudication, sacroiliac joint dysfunction, vertebrogenic pain, lumbar spondylosis, and lumbar facet arthropathy. A magnetic resonance imaging (MRI) of lumbar spine revealed Grade 2 anterolisthesis with significant compression of bilateral L5 nerve roots. Modic type 1 end plate changes adjacent to the L5-S1 disc.
This patient was recommended to have this new medical intervention named INTRACEPT. The INTRACEPT system was designed to ablate intraosseous nerve within the vertebral body for the treatment of vertebrogenic low back pain. The issue is whether this patient is a candidate for this new INTRACEPT procedure.

The health plan's determination regarding the proposed health service or treatment is upheld, in whole.

The proposed intraosseous ablation of the basivertebral nerves is not likely to be beneficial for this patient's medical condition.
The INTRACEPT system was designed to treat back pain from vertebral body by ablating intraosseous nerves. This is a relatively new and innovative approach that can potentially benefit this specific patient population with pain from vertebral body. However, the current clinical evidence indicated that this patient is not a candidate for this intervention. In one of the largest studies on the efficacy of INTRACEPT, the primary exclusion criteria included symptomatic spinal stenosis, disk protrusion>5 mm, spondylolisthesis>2 mm at any level, or radiculopathy. [1] Two other large studies adopted similar exclusion criteria [2-3]. This patient has diagnoses of lumbar radiculopathy and Grade 2 spondylolisthesis. An MRI revealed bilateral L5 nerve compression and spondylolisthesis much greater than 2mm. Therefore, this patient is not a candidate for this INTRACEPT procedure according to the current clinical evidence. The proposed intraosseous ablation of the basivertebral nerves is not likely to be beneficial for this patient's medical condition.

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