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 (Intracept). 

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 (Intracept). 

The denial is upheld. 

This is an adult with a history of radiculopathy of the cervical region. The patient presented to the Pain Management physician's office for a follow up for lower back pain. The patient has a history of L3-L4 (lumbar 3 - lumbar 4) and L4-L5 diskectomy with minimally invasive surgery. There were Modic type changes at L4-L5 and L5-S1 (sacral 1). The physician recommended the Intracept procedure to treat lower back pain. 

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 no longer requiring 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. 

A search was performed using PubMed. The key word was Intracept Lumbar. There were two references. The articles submitted by appeal were also reviewed. There were small numbers of people evaluated for a short duration. The procedure is currently being performed by an investigative group and likely IRB (Investigational Review Board) The procedure is not mainstay nor current accepted treatment by the practicing medical community. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

Final approval has been granted for marketing. No recommendations were made with regard to efficacy or standard of care. 

This patient is not a good candidate for procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept). The records show the patient has no defined pain generator. The patient's pains is chronic to the cervical and lumbar area. The physician has documented several conditions with long history of treatments. The patient has been treated for (solely in lumbar area), facet disease, disc disease, radiculopathy and sacro iliac pathology. Recent imaging continues to show pathology localized to these sites. The recent hypothesis of the basivertebral nerve causing pain and likely to respond to an ablation has no credence. There simply are many other conditions which more than likely are causative. As noted above, this procedure is not mainstay in the practicing medical community. 

Procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral is not the best available treatment for this patient at this time; see the above discussion. 

It is invasive and complications can occur (at the very least infection). 

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

In summary, the denial of procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) 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.