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202304-161331

2023

Empire Healthchoice Assurance Inc.

EPO

Orthopedic/ Musculoskeletal

Pain Management

Experimental/Investigational

Upheld

Case Summary

Diagnosis: back pain
Treatment: Intraosseous Basivertebral Nerve Ablation Procedure
The insurer denied Intraosseous Basivertebral Nerve Ablation Procedure. The health plan's determination is upheld.

The patient is a female with chronic low back pain. Prior treatment has included chiropractic care, injections, physical therapy, as well as medications, which include Advil to Mobic. Pain ranges from 9 out of 10 through 10 out of 10. Pain impacts her activities. Magnetic resonance imaging (MRI) lumbar spine shows Modic changes at L (lumbar)5, S (sacral) 1 vertebral bodies.

The proposed Intraosseous Basivertebral Nerve Ablation Procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient has complaints of low back pain. This procedure is not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. A Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry disability index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment, however, there is lack of data to recommend this procedure as treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.
Given the above, the proposed treatment is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

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