Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cervical spondylosis

Treatment: procedure code 64628 thermal destruction of intraosseous Basi vertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral 

The insurer denied coverage for procedure code 64628 thermal destruction of intraosseous Basi vertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral

The denial is upheld

This is an adult male with a history of cervical spondylosis. He presented to the Pain Management physician's office for a follow up visit for neck, shoulder, lower back, and hip pain. The patient takes ibuprofen and tizanidine with some relief. He has not undergone physical therapy. The treating practitioner recommended continuing medications and the Intracept procedure.

The Intracept procedure is "intraosseous ablation of the basivertebral nerve;" essentially a thermoablation performed within the vertebral body. 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 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 words were Intracept Lumbar. There were limited references. The articles submitted by appeal were also reviewed. There were small numbers of people evaluated for a short duration of time. The procedure is currently being performed by an investigative group and likely IRB (Investigational Review Board). 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.

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

Final approval has been provided by the FDA (Food and Drug Administration) for marketing. There are no recommendations nor guidelines provided as per efficacy. 

The requested procedure code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance: first 2 vertebral bodies, lumbar or sacral is not the best available treatment for this patient at this time. There are several other conditions which could be pain generators. The patient's MRI (magnetic resonance imaging) of the lumbar (L) spine clearly showed a new herniation to L3-4. The hip x ray showed evidence of degenerative joint disease. These conditions by themselves could be causative for pain. Treatment with this procedure based upon the above would unlikely relieve the patient's pain.

The adverse risks are increased over standard treatment/services. It is an invasive procedure and complications can occur; at the very least, infection.

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

The carrier's denial of procedure code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral should be upheld.