Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain

Treatment: Intracept procedure

The insurer denied coverage for Intracept procedure

The denial is upheld.

This is an adult with a history of arthritis, bipolar disease, deviated nasal septum, gastroesophageal reflux disease (GERD), hypertension, obesity, obstructive sleep apnea (OSA), and prostate enlargement. The patient presented to the Pain Management physician's office for a follow up for chronic lower back pain. The patient had temporary relief from medial branch blocks and epidural steroid injections. He also has multiple courses of physical therapy (PT) without relief. The treating physician recommended the Intracept procedure to treat back pain. 

Percutaneous Vertebral Disc and Vertebral Endplate Procedures (SURG.00052). 

There are studies completed but the study groups are heterogenous with multiple pain generators present. Many of the studies have been funded by the manufacturer and are performed with Institutional Review Board (IRB). 

It does not need approval for use. The Food and Drug Administration (FDA) has granted premarket approval. The FDA has not made any recommendations as to indications and standard of care.

There is no defined pain generator. He has received multiple treatments for several "pain generators." Simply stated his pain generator is not known. Treatments have been provided for facet disease, discogenic disease and radiculopathy. The likelihood of vertebrogenic pathology improving with this additional injection is unlikely. It is an invasive procedure and instrument breakage and infection can occur. These complications have been reported in the scientific literature.

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 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. It is "pain management procedure" with limited conclusive followup. 

A search was performed using PubMed. The key word was Intracept Lumbar. There were several references.  The articles submitted by appeal were also reviewed. 

The findings were this procedure is currently investigational/experimental. There were small numbers of people evaluated for a short duration. The procedure is currently being performed by an investigative group and likely IRB. The procedure is not mainstay nor currently accepted treatment by the practicing medical community. 

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. As such, at this time the Intracept procedure is experimental/investigational. 

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.

The carrier's denial of Intracept procedure should be upheld.