Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Intracept Procedure
The insurer denied: Intracept Procedure
The denial is: Upheld

This is a male diagnosed with low back pain. The patient was recommended to undergo the Intracept procedure (intraosseous basivertebral nerve ablation), which was denied by the insurance carrier as experimental and investigational. The provider is appealing this determination, which is the subject of this review.

There is no evidence that the proposed health service or treatment Intracept procedure is 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 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's magnetic resonance imaging (MRI) shows multilevel disc herniations, nerve root impingement, and varying degrees of spinal canal and neural foraminal stenosis as well as facet arthropathy. These are all likely pain generators. The Intracept procedure is experimental and investigational.
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 patient's 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."

There are insufficient long term studies evaluating long term risks/benefits when compared to other standard means of treatment. 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.