Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal/Back pain
Treatment: Surgical Services/Intracept System
The health plan denied the requested Intracept System as experimental/investigational. The health plan's determination is upheld.

The patient is a female who has a history of left-sided low back pain radiating into her right hip. It hurts to walk or stand, she gets some relief with sitting. Physical examination demonstrated 5 out of 5 strength in the lower extremities with sensation intact to light touch in the (lumbar-sacral) L2-S1 distribution. Her pain is 90% axial and 10% right hip. Her pain increases to a 6-8 out of 10 with activities. It hurts to ride in a car for a long period of time. She has tried and failed physical therapy, oral medications including Meloxicam and Cyclobenzaprine, anti-inflammatories and steroid medications. A magnetic resonance imaging (MRI) of the lumbar spine demonstrates desiccation of the lumbar intervertebral discs at (lumbar) L3-4 and L4-5 with multilevel disc bulges and type II Modic endplate changes at L3-4 and L4-5 along with a hemangioma in the (thoracic) T11 vertebral body. At L3-4 there is moderate left neuroforaminal stenosis and at L4-5 there is moderate bilateral neuroforaminal stenosis. The current treatment plan is Intracept procedure L3, L4, and L5 vertebral bodies. She was also recommended to undergo a right L4-5 and L5-S1 transforaminal epidural steroid injection. The current request for review is as to the medical necessity of the Intracept procedure in this scenario.
At issue is whether the proposed health service or treatment of the Intracept System is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I uphold, in whole, the health plans determination regarding the proposed health service /treatment.

No. The request for basivertebral radiofrequency ablation using Intracept is not medically necessary and is considered experimental and investigational, as per current standard of care guidelines.
Based on the provided clinical notes, medical necessity is not met for intraosseous ablation of the basivertebral nerve via an Intracept procedure. There are no high-quality non-industry sponsored studies that establish that treatment with the Intracept procedure results in improved/better health outcomes when compared to the existing treatments. There is insufficient evidence in the medical literature to obtain definitive conclusions about the clinical safety and efficacy of the Intracept procedure and therefore, the procedure remains experimental/investigational.
The requested service should not be covered. As has been previously stated, there are currently no high-quality, non-industry sponsored studies that establish that treatment with the Intracept procedure results in improved/better health outcomes when compared to the existing treatments. There is insufficient evidence in the medical literature to obtain definitive conclusions about the clinical safety and efficacy of the Intracept procedure and therefore, the procedure remains experimental/investigational.