Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Intracept procedure
The insurer denied coverage for the Intracept procedure.
The denial is upheld.

This is a patient with a history of chronic back pain, lumbar (L) 4-5 discectomy, and bilateral carpal tunnel release. The patient was seen at an office visit for follow up of low back pain. The patient complained of pain which was affecting activities of daily living (ADLs) and their quality of life. The patient had tried physical therapy (PT), activity modification, oral medications, and pain injections without sustainable relief. The findings of a magnetic resonance imaging (MRI) included multilevel degenerative changes throughout the lumbar spine and foraminal stenoses at the L4-5 and L5-sacral (S1) levels. The physician recommended an L5, S1 Intracept basivertebral nerve ablation for treatment of Modic end plate changes at L5 and S1.

It is unclear if the scientific evidence in peer-reviewed literature supports a result of improvement in health outcomes. There are several studies; however, no conclusions can be made. No definite statements or guidelines showing  definitive efficacy have been reported.

FDA (Food and Drug Administration) approval had been granted for Pre Market approval. The FDA does not provide statements regarding benefit.

This patient is not a good candidate for an Intracept procedure: Thermal destruction of intraosseous basivertebral nerve, inclusive of imaging guidance, and the first two vertebral bodies, lumbar/sacral. No defined pain generator is present. The records show chronic back pain with several sites of pathology. Surgery and conservative treatments have been completed for facet disease, disc disease, stenosis and herniations. There is pathology to several levels. The report of axial pain vs radicular pain is inconsistent. The likelihood of the basivertebral nerve causing the back pain is not credible based upon clinical presentation and underlying disease.

An Intracept procedure: Thermal destruction of intraosseous basivertebral nerve (BVN), inclusive of imaging guidance, first two vertebral bodies, and lumbar/sacral is not the best available treatment for this patient at this time.

The procedure is invasive. There have been reported complications of infection, broken hardware and retroperitoneal hematoma.

The requested service is not likely to be more beneficial than any of the standard treatment/procedures.

The Intracept procedure is "intraosseous ablation of the basivertebral nerve". It has been proposed to address low back pain identified by Mobic changes. The procedure is performed within the vertebral body. It has been proposed that pain relief is manifested by patients who no longer require their narcotics. For one level of disc disease each vertebral body requires precise targeting. The operation is not recognized by practicing neurosurgeons nor spine surgeons. There are no National Organizations which provides guidelines or indications.

A search was performed using PubMed. The key word was Intracept Lumbar. There were references. The articles submitted by appeal were also reviewed. There was a reported 65% success rate and further high quality studies were recommended. The procedure is not mainstay or current accepted treatment by the practicing medical community.

*The procedure is essentially a thermoablation performed within the vertebral body. 
There are several level 1 studies showing the benefit of this procedure up to 2 years after treatment compared to controls. However, all of these studies were either funded by the manufacturer and/or authored by consultants from the manufacturer. No high-quality study exists that does not have a significant conflict of interest with the manufacturer.

In summary, the denial of an Intracept procedure: Thermal destruction of intraosseous basivertebral nerve, inclusive of imaging guidance, first two vertebral bodies, and lumbar/sacral and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.