Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain
Treatment: nerve ablation procedure (procedure code 64628)
The insurer denied coverage for nerve ablation procedure (procedure code 64628).
The denial is upheld.

This is a patient with a history of lower back pain. The patient has had failed conservative treatment greater than 3 months for back pain. The patient had a magnetic resonance imaging (MRI) performed that demonstrated degenerative endplate changes at disc spaces lumbar (L) 3 - L4. The physician recommended the Intracept procedure to treat the patient's lower back pain.

Basivertebral nerve (BVN) ablation using the Intracept procedure is Food and Drug Administration (FDA) approved in a very select group of 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 sacral (S) 1; and - Activities of daily living (ADL) that are limited by persistent low back pain; and - All other reasonable sources of pain have been ruled out.

The recommended requirements have not been met for BVN ablation procedure with Intracept. According to the documents provided, the appealing physician states that the MRI demonstrated degenerative endplate changes at disc spaces L3-L4 and states that the patient's pain is due to these vertebrogenic changes. However, the MRI report only mentions Modic type I changes at L4-L5 and Modic type II changes at L5-S1 where the patient had a previous Intracept procedure. There is no mention of Modic changes at L3-L4 in the MRI report. The MRI report does demonstrate chronic subacute Schmorl's nodes at the inferior endplate of L3, inferior endplate of L4 and superior endplate of L5. While Schmorl's nodes are a common finding with MRI of the thoracic or lumbar spine, there is evidence supporting the damaging effects of active and/or large nodes regarding inflammation in the bone. Radiographic evidence of other pain etiology was considered an exclusion criterion for use of the Intracept procedure in the INTRACEPT study by Khalil et al. 

There are other evidence-based medications and treatments available to this patient. 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. Despite previous success with the Intracept procedure at L5-S1, there are MRI findings of other possible sources for this patient's pain. With these 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.

In summary, the denial of the nerve ablation procedure (procedure code 64628) and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.