Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

This is a male patient diagnosed with low back pain. Records indicate that the patient was recommended to undergo the Intracept procedure (intraosseous basivertebral nerve ablation), which was denied by the health plan. The provider appealed this determination. Letters of appeal were submitted from the provider indicating that the provider disagrees that this treatment is experimental and investigational. The provider states that this procedure fills the treatment gap for patients with chronic back pain who do not receive adequate relief from traditional conservative methods and do not have instability to indicate that fusion is the appropriate treatment. The provider also states that procedure has Food and Drug Administration (FDA) clearance and therefore believes that this means that the procedure is safe and efficacious. The provider notes that the patient has a chronic history of low back pain that began 8 (eight) years ago. To address his pain, he has tried chiropractic care, heat, ice, home exercises, lumbar discectomy and lumbar epidural steroid injections. Medication has included non-steroidal anti-inflammatory drugs (NSAIDs). The pain is impacting activities of daily living and nothing has provided sustained relief. The pain is rated at 5/10. It was noted that the patient had magnetic resonance imaging (MRI) performed and the provider indicated that their review showed Modic changes at lumbar (L) 4, L5, sacral (S) 1 and thus the provider believes that this is the source of the patient's chronic back pain. The provider again requests reconsideration for approval of the procedure.
The patient was seen with complaints of chronic back pain rated at 5/10 and described as aching, dull and stabbing. Current medications include atorvastatin and lisinopril. The physical examination was unremarkable. It was recommended the patient undergo the Intracept procedure. At issue is whether the Intracept 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. The provider states the patient has failed conservative treatment including therapy, medications and injections, though it should be noted the patient was not on any medications for pain as the only medications being prescribed was atorvastatin and lisinopril. The physical exam was unremarkable. 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 [BVN]). However, an MRI (Magnetic resonance imaging) also shows annular fissures at L (lumbar) 4 - L5 and L5 - S (sacral) 1 in addition to a disk protrusion at L3 - L4 with nerve root compromise at the left L3 nerve root. These findings are all potential pain generators. There is a lack of high-quality studies evaluating the long-term risks and benefits of the requested procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy. There is insufficient 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. Additional studies are needed to evaluate long-term risks and benefits of this procedure.