Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain

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

The insurer denied coverage for procedure code 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; and 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral

The denial is upheld

This is the case of an adult female with a history of lower back pain status post T (thoracic) 12 kyphoplasty. The patient was seen by a Interventional Radiologist for persistent low back pain. She was recommended to repeat her magnetic resonance imaging (MRI), and it showed interval kyphoplasty at T12, chronic fracture deformity at the superior endplate of the T12 vertebral body with less than 20 percent vertebral body height loss, and Modic type 1 changes at L (lumbar) 3-L4 and at L5-S (sacral) 1.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. Procedure codes 64628 and 64629 have approval for marketing, but no statement nor recommendation of efficacy has ever been made.

The patient is not a good candidate for procedure codes 64628 or 64629.

Procedure codes 64628 and 64629 are not the best available treatment for this patient at this time.

The adverse risks are increased over standard treatment/services.

The requested service is NOT more likely to be more beneficial than any of the standard treatment procedures for this patient. 

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 provide guidelines nor indications.

There has been no specific confirmation of what is causing the patient's chronic back pain. She had undergone a kyphoplasty for back pain. There was 20% collapse. This by itself could be responsible for her pain. The imaging studies showed multilevel degenerative changes. There was disc pathology and facet arthrosis. Likewise, these conditions could be causative. The physician has opined Mobic changes were present.
These changes were reported at multiple levels. It is unclear which level or levels is the proposed pain generator.

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 manufacturer's web site reported a Professional Statement was provided for support of the procedure.

The carrier's denial of 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral; and 64629 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (list separately in addition to code for primary procedure) should be upheld. It is not more beneficial than any other standard treatments.