Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Low Back Pain.
Treatment:  Nerve Treatment in the Spine.

The insurer denied the nerve treatment in the spine.  The health plan's determination is upheld.

The patient is a female, who was diagnosed with low back pain. The patient was recommended to undergo the Intracept procedure (thermal destruction of intraosseous basivertebral nerve), which was denied by the insurance carrier as experimental and investigational. The provider is appealing this determination, which is the subject of this review.

The provider has submitted multiple letters of appeal stating that they disagree with the denial of the Intracept procedure. The provider notes that the patient has a history of low back pain that began over six months ago. She has had multiple treatments including home exercise, medial branch block injections, medication management, microdiscectomy, physical therapy, radiofrequency ablations, sacroiliac joint injections, transforaminal epidural steroid injections and trigger point injections. Her medications have included Ambien, Aspirin, Celecoxib, Gabapentin and nonsteroidal anti-inflammatory drugs (NSAID's). Nothing has provided significant sustained relief. Her pain level averages 7 out of 10. The provider reports she had a magnetic resonance imaging (MRI) demonstrating degenerative endplate changes consistent with Modic changes at lumbar vertebrae (L)4 - L5 and L5 - sacral vertebrae (S)1 and therefore this is the source of her chronic back pain. The provider is requesting reconsideration for approval of this procedure.

The proposed health service of nerve treatment in the spine is not likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease. The patient is noted to have complaints of chronic back pain that she reports has been present for over 40 years. The patient has had conservative treatment, medication management and multiple injections with varying degrees of benefit but no lasting relief. The provider notes that the patient had an MRI showing degenerative endplate changes/Modic changes at L4 - L5 and feels that this is the source of the patient's pain, although there are multiple findings on the MRI including disc protrusions and degenerative disc disease with listhesis. 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.

According to 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 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 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." According to 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.