Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower Back Pain. 
Treatment: Procedure codes 22899, unlisted procedure, spine 64628- thermal destruction of intraosseous basiverterbral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral, and 64629- thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 

The insurer denied coverage for procedure codes 22899, unlisted procedure, spine 64628- thermal destruction of intraosseous basiverterbral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral, and 64629- thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral. 

The denial is upheld. 

The patient has a history chronic low back pain. Recent intervention included performing LMBB (Lumbar Medial Branch Block). The pain was diminished after the intervention, pain was diminished by 80% and painrelief duration was 5 days. Symptoms include lower extremity pain and lower back pain, while symptoms do not include lower extremity numbness, back numbness, paresthesias or leg weakness. Pain scores include a current pain level of 2 /10 and a maximum pain level of 8 /10. The pain is located in the lumbar area. The pain radiates to the left posterior thigh and the right posterior thigh. The patient describes the pain as sharp, dull, aching, throbbing and stabbing. The pain is intermittent (especially during her periods). The patient describes symptoms as unchanged. Symptoms are exacerbated by bending, lifting, standing, sneezing and straining, while symptoms are not exacerbated by sitting or coughing. Symptoms are relieved by lying down, opioid analgesics and exercise regimen, while symptoms are not relieved by standing, ice, heat, nonsteroidal anti-inflammatory drugs, non-opioid analgesics or physical therapy. Associated symptoms do not include urinary incontinence or fecal incontinence. Functional Limitations: general activity, mood, walking ability, work, housework, activities of daily living, hobbies, social relationships, sleep and enjoyment of life. Current treatment includes nonsteroidal anti-inflammatory drugs and non-opioid analgesics. 

While there are RCT (randomized controlled trials) that show its effectiveness at two years and a follow-up study where it was recommended that patients cross over to the treatment arm due to effectiveness early on, these publications to date have been company sponsored and had methodologic flaws. UpToDate does not support the use of radiofrequency ablation for low back pain. The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency. 

Intracept is FDA (Food and Drug Administration) and CMS (Center for Medicaid and Medicare Services) approved in select patients who have - a history of low back pain of at least 6 months duration; and - Failed to respond to at least 6 months of non-surgical management; and - MRI (Magnetic Resonance Imaging) demonstrated Modic Type 1 or Type 2 changes* at one or more vertebrae from L (Lumbar)3 to S (Sacral)1; and - Activities of daily living that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out. 

Despite a history of chronic low back pain of more than six months, and MRI findings described as "discogenic endplate changes" at L5-S1 the patient also has L4-L5 and L5-S1 disc herniations which may be contributing to her pain. Her medical record also indicates diagnoses of: Lumbar spondylosis- Bilateral (M47.816); LUMBOSACRAL NEURITIS UNSPEC; SPONDYLOSIS WITH MYELOPATHY, LUMBAR REGION; INJURY TO LUMBAR NERVE ROOT; and Lumbar radiculopathy (M54.16). Spondylolysis at any level was considered an exclusion criterion in the Intracept studies cited by the appealing party. 

There are other evidence-based procedures available to this patient. This procedure is unlikely to be more beneficial than the standard approaches to disc related back pain. 

There is insufficient clinical evidence in the literature to support the use of Intracept for this patient's treatment. There is insufficient data to support that this procedure is more beneficial than other standard treatments such as physical therapy, therapeutic home exercise program, anti-inflammatory medications, and spinal injection. 

The carrier's denial of procedure codes 22899, unlisted procedure, spine 64628- thermal destruction of intraosseous basiverterbral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral, and 64629- thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral should be upheld.