Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Nerve Ablation System (64628)
The insurer denied the Intraosseous Nerve Ablation System (64628)
The denial is overturned.

The patient is a male with history of chronic low back pain of more than 6 months. The pain has affected his ADLs (activities of daily living) and functionality.

The treating physician concluded that the patient's pain is vertebrogenic, and that the patient will benefit from Intracept intraosseous nerve ablation for the ablation of basivertebral nerves at L5 (fifth lumbar spine vertebra) and S1 (first sacral vertebra).

MRI (magnetic resonance imaging) lumbar spine showed Modic types 1 and 2 signal changes at L5/S1 (fifth lumbar spine vertebra/first sacral vertebra).

The patient has failed conservative measures including Physical therapy, spinal injections, Vicodin, Tylenol, Flexeril, etc.

Yes, the health plan should cover the Intraosseous Nerve Ablation System (64628).
The requested Intracept procedure is medically appropriate and should be covered by the health plan based on general standard of care for vertebrogenic pain. It also meets the following recommended requirements by RELIEVANT the Intracept Medical device manufacturer (3), 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 (third lumbar spine vertebra) 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 (basivertebral nerve) 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 presents with a history of chronic low back pain of more than 6 months. He has tried and failed conservative measures including Physical therapy, spinal injections, Vicodin, Tylenol, Flexeril, etc., all treatment exceeding 6 months. The pain has affected his functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic type 1 and 2 changes at lumbar five/sacral one (L5/S1) vertebral body.

Therefore, given the above, the health plan should cover the requested health service.
Per Khalil J, Smuck M, Koreckij T, et al, "The purpose of this RCT [randomized controlled trial] was to compare the effectiveness of intraosseous RF [radiofrequency] ablation of the BVN [basivertebral nerve] to standard care for the treatment of chronic LBP [low back pain] in a specific subgroup of patients suspected to have vertebrogenic related symptomatology." Their conclusion states, "Minimally invasive RF [radiofrequency] ablation of the BVN [basivertebral nerve] led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP (low back pain)."

Yes, the requested spinal procedure is medically appropriate and likely to be more beneficial than any standard treatments for discogenic/vertebrogenic pain due to Modic changes.