Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Degenerative disc disease

Treatment: Pain Management outpatient procedure (64628 x 1) (Intraosseous Nerve Ablation)

The insurer denied coverage for Pain Management outpatient procedure (64628 x 1) (Intraosseous Nerve Ablation).

The denial is upheld.

This is the case of an adult male with a history of degenerative disc disease, lumbar, discogenic low back pain, and vertebrogenic pain. At his office visit with his interventional pain physician, it was noted that the patient had a flare up of his back pain. He was not able to sit for 10 minutes. The preferred position was walking or lying down. The range of movement of the lumbar spine was limited, with flexion causing severe pain. His physician recommends the Intraosseous nerve ablation procedure for pain management. 

The records show no pain generator has been defined for the patient. He has received treatment for years in duration with each modality directed toward a different site. The records show he had undergone epidurolysis with hyaluronate (reported for adhesions), medial branch block (MBB) for facet disease, cluneal nerve blocks for compression, coccygeal nerve blocks for coccydynia, sacroiliac (SI) injections for SI derangement, surgery for his extruded disc, epidural steroid injection (ESI) for radicular complaints and radiofrequency ablation (RFA) for facet disease. He has several diagnoses listed without clinical correlation. His imaging studies have shown a compression fracture at a proximal level. Magnetic resonance imaging (MRI) has shown the associated Modic changes to L (lumbar) 2-L3 as well as L5-S (sacral) 1. It is extremely unlikely the L5-S1 Modic changes are responsible for the patient's pain. It would be extremely unlikely that the proposed procedure would provide benefit (i.e. ["that is"], lack of defined pain generator and current status as this procedure being effective).

Recent scientific literature does not support this procedure as effective. 

The FDA (food and drug administration) has granted approval but solely for premarket. There was no recommendation regarding efficacy nor standard of care.

Complications have been reported. They are limited but nevertheless can occur after invasive treatment.

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 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 guidelines nor indications.

A search was performed using PubMed. The key word was Intracept Lumbar. There were two references. The articles submitted by appeal were also reviewed. There were small numbers of people evaluated for a short duration. The procedure is currently being performed by an investigative group and likely IRB (Investigational Review Board). 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.

In summary, the denial of Pain Management outpatient procedure (64628 x 1) (Intraosseous Nerve Ablation) 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 not substantially increased over standard treatments.