Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain. 
Treatment: Intracept Surgical Procedure.
The health plan denied the Intracept Surgical Procedure. 
The determination is overturned.

The patient is a female with chronic low back pain for years. She has some associated left lower extremity (LLE) pain, but the back pain is worse than leg pain. The physical exam is notable for 4/5 strength in the left tibialis anterior (TA) and 4/5 strength in the left extensor hallicus longus (EHL). Lumbar x-rays demonstrated transitional anatomy with lumbar 4/5 (L4/5) disc degeneration. There was no instability on dynamic films. Lumbar magnetic resonance imaging (MRI) demonstrated transitional anatomy of L5, Modic type II changes at L4/5, and no significant neural compression or disc pathology. Prior treatments include lumbar laminectomy, injections, bracing, physical therapy (PT), muscle relaxers, Lyrica, and non-steroidal anti-inflammatory drugs (NSAIDs). Symptoms affect the patient's activities of daily living (ADL). She was recommended L (lumbar) 4 and L5 Intracept procedure. 
At issue is whether the proposed health service or treatment 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 overturned in whole. 
This procedure is a low risk, potentially high reward benefit. Medical literature studies involving the Intracept procedure suggest it is a safe and effective procedure. It is in accordance with accepted standards of medical practice as per the provided references. Intracept is clinically supported for this patient due to her chronic low back pain that has been unresponsive to conservative treatment with imaging showing Modic changes, per clinical documentation. It is Food and Drug Administration (FDA) approved. It has been deemed safe and at least as effective as other treatments available. It is not more costly than continued chronic low back pain, which is extremely costly. It has supporting evidence in peer-reviewed journals. It is supported by international spine organizations such as the International Society for the Advancement of Spine Surgery (ISASS). Given this, current medical literature and standards do support the Intracept procedure. 
As per the provided references, the Intracept Procedure is neither experimental nor investigational. According to ISASS Guidelines (Reference 3): 
"Intraosseous ablation of the basivertebral nerve is a relatively new minimally invasive treatment for the relief of chronic lower back pain (CLBP) that is diagnosed using well-established clinical and MRI findings. The procedure is supported by Level I evidence including 2 randomized controlled trials (RCT) demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained to at least 24 months in a limited number of studies. These results were seen in a patient population that is one of the most expensive and difficult to provide care for, and in this era of rising healthcare costs and increasing need for therapies to reduce the use of opioids, basivertebral nerve (BVN) ablation may provide a treatment option to fill the gap in the treatment paradigm for patients that fail non-surgical treatment."