Appeal type: Experimental/Investigational
Decision: Overturned

Orthopedic/ Musculoskeletal/Back Pain/ Low Back Pain
Surgical Services (All)/Intraosseous Basivertebral Nerve Ablation
The health plan denied the requested treatment as experimental/investigational. The health plan's determination is upheld.

This is a patient with adiagnosis low back pain. The provider recommended the patient undergo the intraosseous basivertebral nerve ablation (Intracept procedure). This procedure was denied by the insurance carrier as investigational. The provider is appealing that determination, which is the subject of this review.
There were letters of appeal submitted from the provider stating that the provider disagrees that this treatment is experimental and notes that the patient's primary problem is chronic low back pain from degenerative endplate changes. It was noted the patient's back pain began over 2 years ago. He has had multiple treatments including chiropractic care and medication management with use of Flexeril. Pain is impacting bending, lifting, changing positions, sitting to stand and sitting. Nothing has provided significant sustainable relief. The provider noted the patient had an magnetic resonance imaging (MRI) which demonstrated Modic changes that disk space is (lumbar) L4 - L5 and (lumbar-sacral) L5 - S1. The provider feels that this is the cause of the patient's chronic back pain. The provider requests that the procedure be approved.
Progress note indicated the patient with complaints of back pain that began two years ago and the patient would wake up with tight muscles. He attributes the pain to playing ice hockey. Pain has increased over the past six months. He has been using Flexeril which is not effective. He had over six months of chiropractic care with no relief and is opposed to taking narcotics. He wants to discuss further treatments. On physical examination, there was normal range of motion, normal strength, normal sensation, normal reflexes. The patient was given a prescription for Zanaflex and recommended for the Intracept procedure at levels L4, L5, S1.
A lumbar spine MRI showed multilevel degenerative disc disease with spinal canal stenosis and neuroforaminal narrowing. There was noted to be a central annular fissure at L4 - L5. There was mention of Modic type I changes at L5 - S1.

At issue is whether the proposed health service or treatment of an Intraosseous Basivertebral Nerve Ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I uphold, in whole, the health plan's determination regarding the proposed health service or treatment.

There is no evidence that the proposed health service or treatment Intraosseous Basivertebral Nerve Ablation 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 was noted to have complaints of chronic back pain, although the only conservative treatment noted was Flexeril and chiropractic treatment. The provider feels that the Modic changes are the source of the patient's back pain, though the patient was also noted to have an annular fissure at L4 - L5 as well as spinal canal stenosis and neural foraminal narrowing which are potential pain generators. The requested 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. 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. This treatment is not currently considered standard of care in the general medical community. There is a lack of high-grade 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 not considered medically necessary and would be considered experimental and investigational.