Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic lower back pain

Treatment: procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept).

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

The denial is upheld.

This is an adult male with a history of coccyalgia, lumbago, and chronic lower back pain. He presented to the Pain Management physician's office for an initial consultation for chronic lower back pain. The patient was noted to have tried a steroid taper, lumbar epidural steroid injections (ESI), sacroiliac (SI) joint injections, and trigger point injections (TPI). The physician recommended the Intracept procedure to treat back pain.

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 neurosurgeon nor spine surgeon. 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 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. As such, at this time the Intracept procedure is experimental/investigational and therefore not medically necessary.

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

The FDA (food and drug administration) has granted approval for marketing but no recommendations regarding efficacy.

The records show the patient has chronic pain to several sites. His consultation noted a diagnosis of coccygeal pain. He had reported treatments to multiple body sites with no improvement. i.e., SI joint, facet injections, radiofrequency ablation (RFA), ESI and multiple physical modalities. However, no specific pain generator has ever been defined. The most recent physical examination was normal. The practitioner has recommended this treatment modality solely on his interpretation of the magnetic resonance imaging (MRI). The diagnosis of basivertebral nerve pain does not have credence based upon the patient's clinical course. These findings do not substantiate the patient as a good candidate (i.e., lack of clinical correlation for any treatment to the basivertebral nerve).

The 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.

The adverse risks do increase over standard treatment/services.

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