Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain.
Treatment: Intracept Procedure.
The insurer denied the Intracept Procedure.
The determination is upheld.

This is a male patient diagnosed with low back pain. Records show that a request for the Intracept procedure (intraosseous basivertebral nerve ablation) was denied by the health plan due to a lack of evidence, no proof or not enough proof that it improves health. The provider appealed this determination.
The provider noted that the patient has a history of chronic low back pain. It was noted that the patient has tried multiple treatments including home exercises, physical therapy, and transforaminal epidural steroid injections. The patient has tried medications including diclofenac and ibuprofen. It was noted pain is impacting the patient's activities of daily living and nothing has provided significant sustained relief. The patient's pain ranges from 6-8/10. It was noted the patient had a magnetic resonance imaging (MRI) showing Modic type I changes at disc spaces lumbar (L) 5-sacral (S) 1 and therefore, the provider believes that this is the cause of the patient's back pain.
The patient was seen for a follow-up visit and noted to have a history of microdiscectomy. It was noted the patient continues with axial back pain as well as some radicular pain. The patient reported having seen several pain management doctors and he was told that he is a candidate for the Intracept procedure but this was denied. His current medications included amoxicillin, diclofenac sodium, methylprednisolone, and naproxen. The physical examination showed a positive straight leg raise on the left. The provider noted that electrodiagnostic studies confirm S1 irritation and the provider feels this is likely due to scarring in the area postoperatively. The provider noted the patient has Modic type I changes on the MRI as well and it was again noted that the patient would likely be a good candidate for the Intracept procedure.
At issue is whether the intraosseous basivertebral nerve ablation 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 proposed health service or treatment intraosseous basivertebral nerve ablation 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 that has not responded to conventional conservative treatment including therapy, home exercise, medication and injections. 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). There are a  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 the 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 (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 lower 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 insufficient 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. There is no evidence that the proposed health service or treatment is likely to be more beneficial than standard treatments for this patient's condition.