Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back/neck pain.
Treatment: Nerve treatment in spine (Intracept Procedure).
The insurer denied: Nerve treatment in spine (Intracept Procedure).
The denial is: Upheld.

The patient is a female with a diagnosis of vertebrogenic low back pain. Records indicate the patient was recommended to undergo the Intracept procedure (intraosseous basivertebral nerve ablation).
There is a letter of appeal from the provider stating that they disagree with the denial of the Intracept procedure as this is an innovative procedure to address chronic low back pain identified by Modic changes and fulfills a treatment gap for patients with chronic back pain. The provider notes that the patient has a history of low back pain beginning greater than six months ago and has tried multiple treatments including chiropractic care and facet injections. Medication has included ibuprofen without significant relief. She had a magnetic resonance imaging (MRI) several years ago showing Modic changes at disc spaces lumbar (L)4, L5, sacral (S)1 and therefore her chronic back pain is coming from vertebrogenic changes at L4, L5 and S1. The provider is requesting that the denial be overturned.

There is no evidence to suggest that the proposed health service or treatment Nerve treatment in spine is likely to be more beneficial than any standard treatment or treatments for the patient's condition.
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 MRI shows multiple findings potentially responsible for the patient's pain including right paracentral disc protrusion resulting in the effacement of the right lateral recess and contacting the descending right L4 nerve root. There is also moderate spinal canal narrowing.
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), "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."

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. There is no evidence to suggest this treatment would be more beneficial than other standard treatments for this patient's condition.