Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: chronic low back pain, cervical spondylosis and pain

Treatment: Intracept Procedure

The insurer denied coverage for the Intracept Procedure

The denial is upheld

The patient is an adult female. Lumbar spine magnetic resonance imaging (MRI) revealed multilevel degenerative changes including progression of a right L (lumbar) 2-3-disc herniation associated with mild stenosis. The patient reported pain of the cervical and lumbar spine. Low back pain radiated to the left lower extremity. Prior treatment included activity modification, physical therapy, ibuprofen, and acetaminophen. Physical examination of the low back was notable for positive facet loading tests. The paraspinal muscles were tender. The patient was diagnosed with cervical spondylosis and low back pain. The treating physician reported that Modic changes were present MRI at an unspecified level and appeal letter claimed that the lumbar spine MRI read by the radiologist demonstrated unspecified Modic changes at L5-S (sacral)1. However, such findings were not corroborated by the radiologist's report.

Intracept is a Food and Drug Administration (FDA) approved procedure for treatment of low back pain that is accompanied by Type 1 or Type 2 Modic changes on an MRI.

Fischgrund, J. S., Rhyne, A., Franke, et al., write that, "Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9% [percent], respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI 10-point improvement in 76.4% of patients and ODI  20-point improvement in 57.5%; VAS 1.5 cm improvement in 70.2% of patients."

Although the Intracept procedure has supporting evidence in peer-reviewed literature as a treatment for chronic low back pain associated with Modic changes on lumbar spine MRI, in this case, the lumbar spine MRI report includes no mention of such Modic changes, and the treating physician's claim of such Modic changes is not corroborated by the radiologist. Intracept has not been studied as a treatment for chronic low back pain in the absence of such imaging findings. Thus, for chronic low back pain in the absence of Modic changes on lumbar spine MRI, scientific evidence does not support improvements in health outcomes.

This patient is not a good candidate for the Intracept Procedure because the radiologist's report of lumbar spine MRI findings did not identify Modic changes. The MRI revealed multilevel degenerative changes including progression of a right L2-3 disc herniation associated with mild stenosis.

The Intracept Procedure is not the best available treatment for this patient at this time. The Intracept procedure has not been studied as a treatment for chronic low back pain in the absence of Modic changes on lumbar spine MRI.

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. Intracept has not been studied in comparison with other treatments or procedures in the context of chronic low back pain in the absence of Modic changes.

Intracept is an invasive treatment that has greater risk than non-invasive treatment for chronic low back pain.

The requested service is not likely to be more beneficial than any standard treatment/procedure and the adverse risks are increased over other treatments/procedures.

The insurer's denial of the intracept procedure is upheld.