Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Back Pain
Treatment: intraosseous basivertebral nerve ablation (Intracept)
The insurer denied: intraosseous basivertebral nerve ablation (Intracept)
The denial is: Upheld


The patient is a female diagnosed with low back pain. Records indicate the patient was recommended to undergo the Intracept procedure (intraosseous basivertebral nerve ablation).
There is a letter of appeal from the provider stating that the patient has chronic low back pain and degenerative disc disease that has resulted in the development of Modic changes. Pain is affecting the patient's daily life and she has failed conservative treatment including aquatic therapy, back brace, heat, ice, massage, and transforaminal epidural steroid injections. Medications have included Celebrex and Mobic. Pain is impacting activities of daily living such as household chores and nothing has provided significant relief. Pain ranges from 5-10/10. The provider states she had a magnetic resonance imaging (MRI) performed showing Modic type II changes consistent with disease at lumbar (L)3 - L4, L4 - L5 and L5 - sacral (S)1 and therefore this is the cause of her back pain. The provider is requesting approval for the Intracept procedure.

The proposed intraosseous basivertebral nerve ablation is not likely to be more beneficial than any standard treatment or treatments for patient's condition. The patient is noted to have a history of chronic back pain 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, it should be noted that the patient has other obvious causes for the pain as well including disc herniation at L3 - L4 impinging on the left exiting L3 nerve root in addition to scattered and plate degenerative changes.
The Intracept 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 guideline on "Intraosseous ablation of the basivertebral nerve (BVN) 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. Per Fischgrund et al., "Patients treated with radiofrequency (RF) ablation of the BVN for chronic low back pain (CLBP) exhibited significantly greater improvement in Oswestry 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. There is a lack of high-grade evidence and 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. Additional studies are needed to evaluate long-term risks and benefits of this procedure. There is no evidence to suggest this treatment is more likely to be beneficial than other standard treatment options.