Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: intraosseous basivertebral nerve ablation (procedure code 64628)
The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure code 64628)
The denial is upheld

This is an adult with a history of lower back pain and obesity. The patient presented to the Pain Management physician's office for a follow up for back pain. The patient found good relief with Nucynta without adverse effects. The patient reported that pain continued to impede daily functioning, work, and activities of daily living (ADL's) performance. The physician recommended continuing Nucynta, a home exercise program, and the Intracept procedure. 

The Intercept procedure is "intraosseous ablation of the basivertebral nerve." The procedure is performed within the vertebral body. It has been proposed to address low back pain identified by Modic changes and has been proposed that pain relief is manifested by patients no longer requiring narcotics. For one level of disc disease each vertebral body requires precise targeting. 

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

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 operation is not recognized by practicing neurosurgeon nor spine surgeon. There are no National Organizations which provide guideline nor indication. The procedure is not mainstay nor current accepted treatment by the practicing medical community.

The requested procedure does have Food and Drug Administration (FDA)-approval for pre marketing. However, there are no recommendations nor guidelines provided by FDA. 

The patient would not be considered a good candidate for intraosseous basivertebral nerve ablation as there is no defined pain generator. The clinical history is inconsistent for isolated vertebrogenic disease as causing the pain and the physical findings are non specific. The patient has limited motion, spasm, and global tenderness. The patient has been treated for several conditions including disc disease, facet disease and radiculopathy, with reported relief. He has received multiple medial branch blocks (MBB), trigger point injections and epidural steroid injections (ESI). It is important to note the clinical record stated that the patient was at baseline, but the pain recently returned secondary to lifting a couch. This is not consistent for a person who has reported limitations to their activities. 

Intraosseous basivertebral nerve ablation is therefore not the best available treatment for this patient at this time, per above.

Adverse risks are increased over standard treatment/services. Infection can occur with any invasive procedure. There also can be mechanical breakage of instrumentation. There are case reports of this occurring.

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are increased over standard treatments. 

The carrier's denial of intraosseous basivertebral nerve ablation (procedure code 64628) should be upheld.