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 vertebrogenic low back pain. The provider notes that the patient has a history of low back pain and has had multiple treatments including home exercise, physical therapy, and epidural injections. Medications tried include diclofenac and ibuprofen. The pain is impacting the patient's activities of daily living and ranges from 6-8/10. The provider referenced a magnetic resonance imaging (MRI) scan reportedly showing Modic type I changes at disk space is lumbar (L) 5-sacral (S) 1 and states that this is the source of the patient's back pain. The provider has requested approval again of this procedure.

There was a progress note noting the patient is status post microdiscectomy. He has some axial back pain and radicular pain is still problematic for him. He has been to several pain management doctors and told he was a candidate for Intracept. Current medications included amoxicillin, diclofenac sodium, methylprednisolone, and naproxen. On physical exam, there was positive straight leg raise on the left, otherwise normal exam. It was noted that electromyography (EMG) studies confirm some S1 irritation, likely due to some scarring in that area postsurgically. The patient was also noted to have Modic changes and potentially a pain generator for the axial back pain. It was felt he would be a very good candidate for a procedure such as Intracept or vertebrobasilar nerve ablation but the provider notes this is not a procedure that they can offer him and he is referred back to pain management specialist for reconsideration. At issue is whether 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.

There is no evidence that the proposed health service or treatment 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 patient has a history of chronic back pain with radiculopathy/radicular pain and has failed conservative management including medications, therapy and injections. The provider feels the patient is a candidate for the Intracept procedure due to Modic type I changes on MRI.
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 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 is insufficient evidence in the peer-reviewed medical literature showing this treatment to improve overall net health outcomes as compared to standard treatment options for this patient's condition.