Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation Procedure 
The insurer denied: Intraosseous Basivertebral Nerve Ablation Procedure as experimental/investigational. 
The health plan's determination is upheld.

The patient is a male with back pain. Records indicate the patient was recommended to undergo the Intracept procedure.
It is noted that the patient has a history of low back pain that began six years ago and has had multiple treatments including activity modification, acupuncture, chiropractic care, heat, ice, home exercise, injections, lumbar epidural injections, medication management and physical therapy. Medication has included non-steroidal anti-inflammatory drugs (NSAIDs). Pain is impacting activities of daily living and ranges from 3-7/10. Nothing has provided significant relief. The patient had a magnetic resonance imaging (MRI) demonstrating mixed Modic type I and II changes at disc spaces (lumbar) L4 - L5 and (lumbar-sacral) L5 - S1 and therefore this is the cause of the patient's pain. The provider states that the patient clearly meets Food and Drug Administration (FDA) indications for use.

The proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient is noted to have a history of chronic back pain (CLBP) that has not responded to conventional conservative treatment. The provider feels that the patient's pain is coming from Modic changes and was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). However, the patient is also noted to have multilevel disc herniations at L4 - L5 and L5 - S1, likely contributing to the patient's pain. This procedure remains experimental and investigational, as there is a lack of high quality studies evaluating the long-term risks and benefits of this procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy. Per Official Disability Guidelines (ODG) by Milliman Care Guidelines (MCG), "Not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required." The International Society for the Advancement of Spine Surgery's guideline on "Intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain" (Lorio et al, 2020) stated that intraosseous ablation of the basivertebral nerve (BVN) is a new procedure; its limitations included industry funding is a potential source of study bias for the available data reviewed, limited number of studies, short-term follow-up for the majority of studied patients, and unknown effect on the primary degenerative process." Per Becker et al, " Ablation of the 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." However, this is noted to be an industry sponsored study and does not demonstrate long term effects of the procedure beyond one year. Per Fischgrund et al, "Patients treated with radiofrequency ablation of the BVN for CLBP exhibited significantly greater improvement in Owestry Disability Index (ODI) at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain." Again, there appears to positive initial results, however, the study was fairly small (225 patients with chronic back pain) and there continues to be a lack of long-term studies evaluating long term risks/benefits when compared to other standard means of treatment and further large, high-quality studies are needed. This treatment is not currently considered standard of care in the general medical community. 
The proposed health service or treatment Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.