Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic back pain
Treatment: Procedure codes 64628 and 64629 (intraosseous basivertebral nerve ablation) (procedure to treat your back)
The insurer denied coverage for procedure codes 64628 and 64629 (intraosseous basivertebral nerve ablation) (procedure to treat your back)
The denial is upheld

This is an adult with a history of lower back pain. The patient presented to the Pain Management physician's office for an evaluation of lower back pain. The patient had Modic type 2 changes at the lumbar (L)4-L5 endplate and minimal Modic change at the L3 endplate. The patient had an epidural steroid injection (ESI) with limited improvement. The patient tried heat, ice, transcutaneous electrical nerve stimulation (TENS), physical therapy (PT), and Tylenol without improvement. The physician recommended the Intracept procedure to treat lower back pain. 

No defined pain generator is present. The records show the patient has chronic back pain with several sites of pathology. Injections and multiple conservative treatments have been completed. There is presence of stenosis, disc protrusions and facet disease. There is evidence of nerve compression.The physician makes no mention of the nerve root compression which is pathologic.

The likelihood of the basivertebral nerve causing the back pain is not credible. Utilization of a "new diagnostic parameter" (Modic changes) as causative would not be applicable for this clinical scenario.

It is unclear if the scientific evidence in peer reviewed literature supports a result of improvement in health outcomes.

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

This patient is not a good candidate for intraosseous basivertebral nerve ablation (procedure code 64628, 29).

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

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 or spine surgeons. 

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 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 procedure codes 64628 and 64629 (intraosseous basivertebral nerve ablation) (procedure to treat your back) and coverage for the requested service/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.