Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Surgical Services (All). 

The insurer denied Intracept Procedure. 
The denial is upheld in whole.

This is a female patient, diagnosed with low back pain and lumbar spondylosis without myelopathy or radiculopathy. It was noted the patient has complaints of back pain with radiculitis and has been treated with epidural injections, therapy, and medications previously. Records provided show the patient was recommended to undergo intraosseous basivertebral nerve ablation, which was denied by the health plan as this treatment is considered investigational and there is not enough evidence that it would be helpful for this patient's condition. This determination was appealed but upheld as investigational and not medically necessary. On appeal, the provider stated that the patient continued to have chronic low back pain that has not responded to multiple modalities of conservative care and injection/ablation therapies.
A magnetic resonance imaging (MRI) scan of the lumbar spine revealed mild lumbar spondylosis, and no high-grade central or foraminal stenosis. There was left foraminal herniation abutting the left lumbar (L)3 nerve root at L3-L4 and severe bilateral facet arthropathy at L4-L5. There was noted to be type II Modic endplate changes at L5 -sacral (S)1.
The provider stated the patient has tried home exercises, lumbar epidural injections, medication management and physical therapy and pain is impacting her activities of daily living.
At issue is whether the proposed health service or treatment Intracept Procedure is likely to be more beneficial than any standard treatment for the patient's condition.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Intracept procedure, is not 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 with radicular symptoms that have not responded to other conservative treatments and injection therapies. However, 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.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."  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." 
This treatment is not currently considered the 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. 
The requested procedure Intracept procedure remains investigational, and there is no evidence that the proposed health service or treatment is likely to be more beneficial than any standard treatment or treatments for the patient's life threatening or disabling condition or disease.