Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Degenerative disc disease

Treatment: outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System

The insurer denied coverage for outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System

The denial is upheld

This is a female with a history of degenerative disc disease and osteoarthritis. She presented to the Pain Management physician's office for a follow up visit for lower back pain. Imaging revealed Modic type changes at L (lumbar) 5 - S (sacral)1. (Degenerative changes). 

The physician recommended the Intracept procedure to treat back pain. 

She had previously received treatments of medications, radiofrequency ablation (RFA), medial branch block, and sacroiliac (SI) injections. She has chronic disabling back pain. 

There has been no appreciable improvement. The "basivertebral nerve "is now proposed to be the pain generator. Nevertheless, a review of current literature reveals.: 

The Intracept 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 who 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. 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. The findings were small numbers of people evaluated for a short duration. The procedure is not mainstay nor current accepted treatment by the practicing medical community. 

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. 

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

The Food and Drug Administration (FDA) has provided an opinion where marketing is possible but no recommendations about efficacy or guidelines 

This patient is not a good candidate for the outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System. The outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System is not the best available treatment for this patient at this time.

Regarding adverse risk, there could be a possible infection. 

The requested service is not likely to be more beneficial than any of the standard treatments for this patient. The facts of this case are that no specific pain generator has ever been defined. The physician has provided injections and treatments to multiple body sites. This includes multiple medial branch blocks to the thoracic and lumbar area, RFA's (radiofrequency ablation) and sacroiliac joints. Treatments were provided to the facet joints, disc spaces and SI (sacroiliac) joints. 

The carrier's denial of outpatient procedure (64628 x 1), Intracept Intraosseous Nerve Ablation System should be upheld.