Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first 2 vertebral bodies, lumbar or sacral
The insurer denied: Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first 2 vertebral bodies, lumbar or sacral
The denial is: Upheld.

The patient is a female diagnosed with spondylosis without myelopathy or radiculopathy, lumbar region. Records indicate the patient was recommended to undergo the Intracept procedure, which was denied by the insurance carrier as this treatment is considered experimental and investigational.
The provider submitted a letter of appeal stating that they disagree with the denial for the Intracept procedure as this is an innovative procedure to address chronic low back pain identified by Modic changes and fulfills a treatment for patients with chronic low back pain. The provider states that the patient has a history of low back pain that began over six months ago and has had multiple treatments including home exercises, medial branch block injections, dedication management, microdiscectomy, physical therapy and radiofrequency ablations. Medications have included hydromorphone, Lyrica, Mobic, non-steroidal anti-inflammatory drugs (NSAIDs), Percocet and tizanidine and nothing has provided significant sustainable relief. Pain is rated at 10/10. The provider states the patient had a magnetic resonance imaging (MRI) performed demonstrating degenerative endplate changes at disk space lumbar (L)5 - sacral (S)1 and therefore her chronic back pain is coming from the vertebrogenic changes at L5 and S1. The provider is requesting reconsideration for approval of this procedure.
MRI of lumbar spine revealed lower lumbar posterior disc herniations resulting in impingement upon the left exiting L4 nerve root at L4 - L5 and impingement upon the right greater than left S1 nerve roots at L5 - S1 in the lower lumbar spine without fracture or malalignment. There is slight anterior spondylosis L1 - L2. The patient was noted to have disc herniations at L4 - L5 and L5 - S1. It should be noted there was no mention of Modic changes.
The proposed health service or treatment thermal destruction of intraosseous basivertebral nerve, including all imaging guidance, first 2 vertebral bodies, lumbar or sacral 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. 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 MRI report shows disc herniations at L4 - L5 and L5 - S1 with impingement on the right greater than left S1 nerve roots at L5 - S1 and impingement on the left exiting L4 nerve root at L4 - L5, suggesting multiple other causes for the patient's pain. 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'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 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. This procedure is not considered standard of care, and there is no evidence that it would be more likely to be beneficial in any standard treatment or treatments for the insured's life threatening or disabling condition or disease.