Appeal type: Experimental/Investigational
Decision: Upheld


Diagnosis: Low back pain

Treatment: 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) and
64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (Intracept)

The insurer denied coverage for Intracept procedure

The denial is upheld.

This is the case of an adult with a history of low back pain, chronic left hip pain, lumbar spondylosis, neck pain, hypertension, glaucoma, and gastroesophageal reflux disease (GERD). According to the office visit with Anesthesiology specialist, the patient's low back pain was severe. The pain continued to impede their quality of life and activities of daily living (ADL) performance. It was noted the patient had failed conservative therapy greater than 6 months of home exercise program (HEP), physical therapy (PT), and medications including opioids, injections, as well as surgery. The provider recommended the Intracept procedure.   

The Intracept procedure is "intraosseous ablation of the basivertebral nerve." It has been proposed to address low back pain identified by Modic 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 provide guideline nor indication. 

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.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes; see the above discussion. 

Approval had been granted for premarket sales. No recommendations were made with regard to efficacy nor treatment indications. 

No specific pain generator has been defined for the patient. The patient has been treated for chronic neck and back pain for several years. The patient had undergone surgery to the lumbar spine on 2 occasions. The patient had received epidural steroid injections (ESI) with reported temporary 100% (percent) relief. The patient had facet injection as well with 100% temporary relief. The patient's pain patterns are global and nonspecific. An electromyography (EMG) test showed radiculopathy, a pelvic x-ray showed degenerative disease to the hips, and magnetic resonance imaging (MRI) showed multilevel degenerative changes. These included disc, facet, and stenosis. There are Modic changes to multiple vertebrae. The procedure itself would not likely provide benefit as multiple sites of pathology are present (disc, facet, stenosis, hip arthritis).

The requested procedure is not the best available treatment for this patient at this time. There have been reports of infection. 

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) and
64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (Intracept) should be upheld.