Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: intraosseous ablation of basivertebral nerve via Intracept procedure

The insurer denied coverage for intraosseous ablation of basivertebral nerve via Intracept procedure

The denial is upheld 

This is an adult with a history of lower back pain, diskitis, and osteomyelitis. The patient presented to the Pain Management physician's for a follow up for lower back pain. The patient finds it difficult to get up. Imaging of the back revealed Modic type 1 and 2 changes at lumbar (L)3-L4, L4-L5, and L5- sacral (S)1. The patient tried and failed 6 months of physical therapy (PT)/chiropractic treatment, an 8-week home exercise program, 6 weeks of medications, and 6 months of activity modification. The treating physician recommended the Intracept procedure to treat back pain. 

Intraosseous ablation of basivertebral nerve via Intracept procedure is not considered more beneficial for this patient's diagnosis. Recent literature reports the procedure may be of benefit for vertebrogenic pain. Reference submitted in the review documents show 65 percent (%) improvement at one year. The issue is evaluation of pain which is subjective with several different sites of pathology. This procedure has not been accepted nor used by practicing orthopedic and neurosurgeons. It is new and performed by pain management physicians. 

The Food and Drug Administration (FDA) has granted pre-market approval but there are no recommendations made of efficacy or standard of care. 

Insufficient clinical information was submitted. It is unclear what is the patient's pain generator. What has the patient received treatment for? What is her differential diagnosis? None of these facts have been provided. 

As previously stated, no pain generator has been defined. It is unclear how her "MODIC changes at multiple levels" could be causing her pain. 

The procedure is invasive. There have been complications of injection, instrument breakage and retro peritoneal hematoma. 

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

The Intercept 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 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 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 for the intraosseous ablation of basivertebral nerve via Intracept Procedure 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 risk are substantially increased over standard treatments.