Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept Procedure (22899 & C9752)
The insurer denied the Intracept Procedure (22899 & C9752).
The denial is overturned. 

The patient is a male with history of chronic low back pain for many years after an MVA (motor vehicle accident). The pain has affected his ADLs (activities of daily living) and functionality. The patient has failed conservative measures, including spinal injections like facet nerve blocks and lumbar epidural steroid injections, Motrin, etc.

The treating physician concluded that the patient's pain is vertebrogenic and that he will benefit from intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L3 (third lumbar spine vertebra) and L4 (fourth lumbar spine vertebra).

MRI (magnetic resonance imaging) of the patient's lumbar spine showed Modic type 2 signal changes at L3/L4.

Yes, the health plan should cover the Intracept Procedure.

The requested intracept procedure is medically appropriate, based on general standard of care for vertebrogenic pain. The requested intracept procedure also meets the following recommended requirements by RELIEVANT the Intracept Medical device manufacturer, as per the FDA (United States Food and Drug Administration)-approved requirements and indication for which the device is approved:

Intracept is medically indicated in patients who have:
1) A history of low back pain of at least 6 months duration; and 2) Failed to respond to at least 6 months of non-surgical management; and 3) MRI (magnetic resonance imaging) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from L3 to S1 [first sacral vertebra]; and 4) Activities of daily living that are limited by persistent low back pain; and all other reasonable sources of pain have been ruled out.

Per a study performed by Fischgrund JS, Rhyne A, Franke J, et al: "The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up." The conclusions of this study are cited as, "Patients treated with RF [radiofrequency] ablation of the BVN [basivertebral nerve] for CLBP [chronic low back pain] exhibited sustained clinical benefits in ODI [Oswestry Disability Index] and VAS [Visual Analogue Scale] and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP [chronic low back pain]."

The patient in this case presented with a history of chronic low back pain for many years after an MVA. He has tried and failed conservative measures, including spinal injections such as facet nerve blocks and lumbar epidural steroid injections, Motrin, etc. The pain has affected his functionality and ADLs (activities of daily living). The magnetic resonance imaging (MRI) of the lumbar spine showed Modic type 2 signal changes at L3/L4 (third lumbar spine vertebra/fourth lumbar spine vertebra).

Yes, the requested Intracept procedure is more beneficial than any standard treatments for discogenic/vertebrogenic pain due to Modic changes.

Therefore, based on the submitted information, current peer-reviewed literature and the current standards of care, the requested Intracept Procedure would be considered medically appropriate. It is a procedure that is recognized as safe and effective for the diagnosis or treatment of the stated clinical condition, based on clinical evidence published in peer-reviewed medical literature.