Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Lower back pain

Treatment: Intracept procedure

The insurer denied coverage for Intracept procedure

The denial is upheld

This patient has chronic low back pain. Magnetic resonance imaging (MRI) of the lumbar spine revealed multilevel degenerative disc disease along with moderate central canal stenosis at L (lumbar)4-5. He has Modic Type I changes at L4-L5 and L5-S (sacral)1. The patient has tried and failed physical therapy (PT), is currently taking Tramadol and Buprenorphine, and has implemented activity modifications.  The request is for radiofrequency ablation (RFA) of the Basivertebral nerves at L4, L5, and S1.

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. Study limitations included short term follow-up, lack of a sham group and allowance of crossover at 3 months. UpToDate does not support the use of radiofrequency ablation for low back pain: "The available data are inconsistent and suggest that, compared with placebo, radiofrequency denervation may modestly reduce pain in the short-term; however, there does not appear to be clear long-term benefit." The Spine Society makes no mention of the Intracept procedure or ablation of the basivertebral nerve using radiofrequency.

Intracept is indicated in 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 demonstrated Modic Type 1 or Type 2 changes* at one or more vertebrae from L3 to S1; 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 degenerative endplate changes at L5-sacral (S)1 the patient also has L3-S1 diffusely bulging discs, L4-L5 moderate central spinal canal and bilateral lateral recess stenosis and bilateral foraminal stenosis at L4-L5. There is also L4-L5 Grade I spondylolisthesis. All of these may be contributing to his pain. Disc extrusion or protrusion > 5 mm (millimeters), spondylolysis, as well as spondylolisthesis > 2 mm at any level were considered exclusion criteria in the Intracept studies cited by the appealing party.

This procedure is unlikely to be more beneficial than the standard approaches to disc or stenosis related back pain. All invasive procedures have risks: bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

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 22899, unlisted procedure, spine (Intracept Procedure) and C9752 (destruction of intraosseous basivertebral nerve, verts two vertebral bodies, including imaging guidance, lumbar/sacrum) should be upheld.