Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain
Treatment: Intraosseous Basivertebral Nerve Ablation Procedure 
The insurer denied Intraosseous Basivertebral Nerve Ablation Procedure 
The determination is upheld.

This is a male patient who was diagnosed with low back pain. 
There is a letter of appeal from the provider which states that this is an innovative procedure to address chronic low back pain identified by Modic changes and fulfills a treatment gap for patients with chronic low back pain. The provider notes that the patient has a history of low back pain that began over one year ago and has had multiple treatments including chiropractic care, heat/ice, medication management, physical therapy, and transcutaneous electrical stimulation (TENS) unit. Medications have included Motrin and Tylenol. The pain has had a significant impact on the patient's activities of daily living such as exercise and walking and nothing has provided significant relief. The pain averages 8/10. It was noted the patient had a magnetic resonance imaging (MRI) scan demonstrating Modic type I changes at disc spaces lumbar (L) 5-sacral (S) 1 and therefore the patient's pain is coming from vertebrogenic changes at L5-S1. The provider is requesting reconsideration for approval of the procedure.
An MRI of the lumbar spine dated revealed marked progression of spondylosis at L5 - S1 since an earlier study with development of extensive Modic I degenerative endplate signal alteration. There is also a small Schmorl's node and very small central disc protrusion at that level without significant mass effect, unchanged.
A progress report indicated that the patient had complaints of ongoing chronic back pain. He has been doing physical therapy and chiropractic for several weeks. He points to the lumbosacral junction when describing pain. Heat and a TENS unit have not been helpful. The pain is rated at 8/10. He occasionally gets paresthesias in the bilateral lower extremities radiating from the back the setting of constant back pain. Current medications include Tylenol and Motrin as needed. The physical examination revealed normal lumbar range of motion. Lower extremity motor strength was 5/5, sensation was normal, negative Hoffman's and Sperling sign. Although it stated, there was no sensory deficit, then notes that there is decreased sensation in the L5 distribution in the bilateral lower extremities. Straight leg raise, Patrick's, Gaenslen's, and facet loading maneuvers were all negative. It was noted the differential diagnosis for the patient could be either radicular pain from L5 - S1 or vertebrogenic back point. It was recommended the patient undergo the Intracept procedure and in the meantime the patient would undergo a lumbar epidural injection at L5 - S1. At issue is whether the Intraosseous Basivertebral Nerve Ablation Procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

There is no evidence that the proposed health service or treatment Intraosseous Basivertebral Nerve Ablation Procedure 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 is noted to have a history of chronic back pain and some radicular symptoms that had not responded to conventional conservative treatment. The provider feels that the patient's pain is coming from Modic changes and he was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). However, the patient was also recommended to undergo a lumbar epidural injection in the meantime with no indication as to the patient's response to that procedure. There are a lack of high quality studies evaluating the long-term risks and benefits of the Intracept procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy. Per 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." There continue to be a lack of long term studies evaluating long term risks/benefits when compared to other standard means of treatment and further large, high-quality studies are needed. This treatment is not currently considered standard of care in the general medical community. There is no evidence that the proposed health service or treatment Intraosseous Basivertebral Nerve Ablation Procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.