Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain. 
Treatment: Basivertebral nerve radiofrequency ablation (The Intracept System) . 
The insurer denied Basivertebral nerve radiofrequency ablation (The Intracept System). 
The determination is upheld. 

This is a female patient whose diagnoses include Vertebrogenic Low Back Pain and Other Intervertebral Disc Degeneration (Lumbar). According to the information provided for review, the patient was previously recommended to undergo intraosseous basivertebral nerve ablation procedure, which was denied as experimental and investigational.
The provider submitted letters of appeal indicating disagreement regarding denial of the procedure and does not feel that it is experimental and investigational. It was noted the patient has a history of low back pain that began more than three years ago and has had multiple treatments including chiropractic, facet injections, home exercises, massage therapy, physical therapy, radiofrequency ablation, sacroiliac (SI) joint injections and epidural steroid injections. Medications have included meloxicam and muscle relaxants. The patient has pain ranging from 6-10/10 and nothing has provided significant relief. Activities of daily living are affected by pain. The provider states the patient's magnetic resonance imaging (MRI) demonstrated Modic type I changes at disc space lumbar (L) 5 -sacral (S) 1 and the provider believes the patient is having pain coming from vertebrogenic changes at this level. The provider feels that the Intracept procedure is medically reasonable and necessary to solve the patient's chronic low back pain.
The patient was noted to have bilateral L5 - S-1 pain and radicular pain. She also complained of migraines and has vertebrogenic pain. The physical examination showed tenderness at the spinous process of L5 and a transverse process on the left. There was pain with range of motion. There was no neurological exam performed. Range of motion was normal. The provider performed a lumbar epidural steroid injection, and it was recommended that the patient undergo the Intracept procedure at L5 and S1. At issue is whether this is likely to be more beneficial than standard treatment(s). 

The proposed health service or treatment Intraosseous Basivertebral Nerve Ablation (BVN) (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 has chronic back pain and radicular pain with MRI findings of disc extrusion at L4 - L5 as well as severe L5 - S1 disc degeneration with mild Modic type I marrow changes. 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. 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 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. This treatment is not currently considered standard of care in the general medical community. There is a lack of high-grade evidence in large, long-term studies found in the peer-reviewed medical literature demonstrating this treatment to be either safe or effective or resulting in superior benefits over that of other standard means of treatment.