Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Back pain.
Treatment: Intracept Procedure (C9752, C9753, 22899).
The insurer denied the Intracept Procedure (C9752, C9753, 22899).
The denial is overturned.

The patient is a female with diagnosis of Spinal stenosis of lumbar region without neurogenic claudication; Degenerative disc disease, lumbar.

The patient has a history of low back pain that began more than two decades ago. She has had multiple treatments that included radiofrequency ablations, medial branch blocks, intralaminar Epidural steroid injection, activity modifications, and medications. Her pain has had a significant impact upon ADLs (activities of daily living). Her MRI (magnetic resonance imaging) shows Modic type I and II degenerative endplate changes at L4-5 (fourth lumbar spine vertebra-fifth lumbar spine vertebra) and L5-S1 (fifth lumbar spine vertebra-first sacral vertebra) discs.

The request is for Intracept Procedure (C9752, C9753, 22899). The request was denied by the health plan, because it is considered experimental. This is being appealed.

Yes, the health plan should cover the Intracept procedure.
According to Khalil, current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN).

According to Fischgrund, patients treated with RF (radiofrequency) ablation of the BVN (basivertebral nerve) for CLBP (chronic low back pain) exhibited significantly greater improvement in ODI (Oswestry Disability Index) at 3 months and a higher responder rate than sham treated controls. BVN (basivertebral nerve) ablation represents a potential minimally invasive treatment for the relief of chronic low back pain.

Per Becker, ablation of the basivertebral nerve (BVN) for the treatment of chronic lumbar back pain significantly improves patients' self-reported outcome early in the follow-up period; the improvement persisted throughout the 1-year study period.

Per Smuck, BVN (basivertebral nerve) ablation demonstrates significant improvements in pain and function over SC (standard care), with treatment results sustained through 12 months in patients with chronic low back pain of vertebrogenic origin.

The Intracept System is FDA (United States Food and Drug Administration)-approved for treatment of chronic low back pain. When axial chronic low back pain does not respond to conservative care, ablation of the intraosseous basivertebral nerve (BVN) that courses within the vertebral body may be an effective treatment for select patients, according to findings from a prospective, single-arm, multicenter study published in the February issue of The Spine Journal.

The scientific evidence permits conclusions concerning the effect of the technology on health outcomes. The technology improves the net health outcome of patients suffering from chronic low back pain. The technology has demonstrated a majority of patients can decrease or cease the use of opioid medication. The improvement is sustainable and available outside of investigational setting.

The patient has diagnosis of Spinal stenosis of lumbar region without neurogenic claudication; Degenerative disc disease, lumbar. The patient has a history of low back pain that began more than two decades ago. She has had multiple treatments that included radiofrequency ablations, medial branch blocks, intralaminar Epidural steroid injection, activity modifications, medications. Her pain has had a significant impact upon ADLs (activities of daily living). Her MRI (magnetic resonance imaging) shows Modic type I and II degenerative endplate changes at L4-5 (fourth lumbar spine vertebra-fifth lumbar spine vertebra) and L5-S1 (fifth lumbar spine vertebra-first sacral vertebra) discs.

Therefore, based on the information provided and peer-reviewed literature, the health plan should cover the requested Intracept procedure.

Yes, the Intracept procedure is more beneficial.