Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: Nerve treatment in the spine 
The insurer denied Nerve treatment in the spine.
The determination is upheld.

This is a patient who was diagnosed with low back pain. The provider stated that the patient has failed conservative treatment and recommended that the patient undergo the Intracept procedure (intraosseous bassivertebral nerve ablation), which was denied by the health plan..
Lumbar spine magnetic resonance imaging (MRI) revealed multilevel degenerative changes with mild spinal canal stenosis at multiple levels. There is an addendum to this note stating that there is mild bone marrow edema involving the inferior aspect of the lumbar (L)4 vertebral body, suggesting the presence of Modic type I changes.
There is a progress note indicating the patient with complaints of chronic back pain and occasional radiation into the left buttock as well as the groin. The patient was noted to have difficulty with activities of daily living, increasing pain and was not able to don shoes or socks. It was noted that the patient has tried conservative treatment including chiropractic, injections, and medication. The patient previously tried Baclofen and currently was using occasional Advil. On physical examination, there was no tenderness at the lumbar spine, negative facet loading. A straight leg raise was negative. The neurological exam was intact. It was noted there was tenderness with palpation of the left greater trochanteric bursa. The plan was for the patient to undergo the Intracept procedure at lumbar (L) 3, L4, L5, sacral (S)1 as well as continue medications, acupuncture and trigger point injections.
There is an undated letter of appeal from the patient outlining the history of chronic back pain, prior treatment, difficulty performing daily activities as well as self-care and is noted to have developed some issues with going to the bathroom. The patient wants to pursue this procedure.
There is a letter of appeal from the treating provider. The provider states that the patient has chronic back pain and has tried conservative measures including acupuncture, caudal epidural injections, chiropractic treatment, medication management and trigger point injections. Medications tried include Advil and baclofen. The pain is impacting activities of daily living, home exercise, sleep and self-care. Nothing has provided sustained relief. The patient reports pain rated at 8/10. The provider indicates the patient had an MRI showing Modic type I changes at lumbar (L) 3, L4, L5 and sacral (S) 1 disc spaces. the provider again is requesting approval for this procedure. At issue is whether the nerve treatment in the spine 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 nerve treatment in the spine 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. It was noted the patient has tried acupuncture, chiropractic treatment, trigger point injections, epidural injections, and medication. The provider feels that the patient's pain is coming from Modic changes and he was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). 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 low back pain (CLBP) exhibited significantly greater improvement in 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 evidence with 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. The proposed health service or treatment nerve treatment in the spine is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.