Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Intracept procedure
The insurer denied the Intracept procedure
The denial is overturned

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

The treating physician concluded that the pain is vertebrogenic and that the patient 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) lumbar spine showed Modic type 1 signal changes at L3/L4 (third lumbar spine vertebra/fourth lumbar spine vertebra).

The patient has failed conservative measures including tried and failed physical therapy, home exercise program, caudal epidural steroid injections, lumbar facet injections, NSAIDs (nonsteroidal anti-inflammatory drugs), Tizanidine, etc.

Yes, the health plan should cover the Intracept procedure.
The Intracept procedure is medically appropriate based on general standard of care for vertebrogenic pain and 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:
- A history of low back pain of at least 6 months duration; and
- Failed to respond to at least 6 months of non-surgical management; and
- 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
- Activities of daily living that are limited by persistent low back pain; and all other reasonable sources of pain have been ruled out.

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]."

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 presents with a history of chronic low back pain of more than 12 months.  He has tried and failed physical therapy, home exercise program, caudal epidural steroid injections, lumbar facet injections, NSAIDs (nonsteroidal anti-inflammatory drugs), Tizanidine, etc., all treatment exceeding 12 months. The pain has affected his functionality. The magnetic resonance imaging (MRI) of the lumbar spine showed Modic type 1 changes at lumbar three/four (L3/L4) vertebral body.

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