Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation (code 
64628 and 64629)
The insurer denied: Intraosseous Basivertebral Nerve Ablation (code 64628 and 64629)
The denial is upheld.

The patient is an adult female. The patient is diagnosed with low back pain. Records indicate that the patient was recommended to undergo the Intracept procedure (intraosseous basivertebral nerve ablation) for the treatment of low back pain, which was denied coverage by the health plan, as there is insufficient proof that this treatment improves health, and the request was denied as investigational. This determination is under appeal, which is the subject of this review. Letters of appeal submitted outline that the provider disagrees that this treatment is investigational.

The provider states that the patient has a history of low back pain that began many years ago and has had multiple treatments including injections, lumbar discectomy, physical therapy and radiofrequency ablations. Pain is impacting activities of daily living such as sleep and other ADLs (activities of daily living). Nothing has provided sustained relief. Pain ranges from 5-6/10. The provider states the patient had an MRI (magnetic resonance imaging) demonstrating Modic type I changes consistent with Modic at disc spaces L4 - L5 (lumbar four to lumbar five) and L5 - S1 (lumbar five to sacral one) and therefore the provider feels that this is the source of the patient's chronic back pain. 
Physical exam revealed 5/5 strength at bilateral EHL (extensor halluces longus). There were no abnormal exam findings. The patient was recommended for the Intracept procedure at L4, L5, S1 (lumbar four, lumbar five, sacral one).

The health plan should not cover the requested health service.

This treatment is considered experimental and investigational. The requested health service or treatment is not proven to be more beneficial than any standard treatments for the insured's condition or disease.

This 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 ODG (Official Disability Guidelines) by MCG (Milliman Care Guidelines), "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 BVN (basivertebral nerve) is a new procedure; it has limitations, including industry funding as 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 [basivertebral nerve] 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.

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. The requested procedure is experimental and investigational with no evidence that this treatment would be more beneficial than standard treatments for this patient's condition.