Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: 64628 Thermal destruction of intraosseous basivertebral 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 64628 and 64629.
The denial is upheld/

This is the case of an adult with past medical history of displacement of lumbar intervertebral disc, lumbosacral spondylosis, myelopathy, myofascial pain syndrome, spinal stenosis, sacroiliitis, and scoliosis. The patient was seen by Pain Medicine Specialist for low back pain. The patient reported relief with interlaminar lumbar epidural steroid injection in the past however, the patient's low back pain returned radiating into the lower extremities. The patient also noted worsening neck pain that radiates to the left upper extremity with numbness and tingling. The pain is worse with activity and prolonged standing. The patient has Spinal Cord Stimulation (SCS) that provides some relief. The patient also takes baclofen and gabapentin providing some relief.

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves (BVN), the evidence includes two randomized controlled trials (RCTs), SMART and INTRACEPT trials, both sponsored by device manufacturer. Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Therefore, based on this evidence, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device. 

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments. 

There are other evidence-based medications and treatments available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

The supporting publications to date have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. 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. Furthermore, with clinical documentation of symptomatic spinal stenosis confirmed by magnetic resonance imaging (MRI) findings, this patient would have been excluded from the INTRACEPT trial and therefore the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient.

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis.

This patient is not a good candidate for the requested procedure.  It is not the best available treatment for this patient at this time.

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.

The denial of the 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar and 64629 thermal destructions of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral should be upheld.