Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: intraosseous basivertebral nerve ablation (procedure code 64628)
The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure code 64628)
The denial is upheld

According to the documentation submitted, this is an adult with a history of lower back pain and obesity. The patient presented to the Pain Management physician's office for a follow up for back pain. The patient was noted to have found good relief with Nucynta without adverse effects. The patient reported that pain continued to impede daily functioning, work, and performance of activities of daily living (ADLs). The physician recommended continuing Nucynta, a home exercise program, and the Intracept procedure. 

The scientific evidence in peer-reviewed literature is insufficient to determine if the technology supports a result of in an improvement in health outcomes. 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 (BVN) using radiofrequency. 

Basivertebral nerve ablation using the Intracept procedure is Food and Drug Administration (FDA)-approved 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 - Magnetic resonance imaging (MRI) demonstrated Modic Type 1 or Type 2 changes at one or more vertebrae from lumbar 3 (L3) to sacral 1 (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, failed response to more than 6 months of non-surgical treatment, Modic type II changes at L5-S1 (reported in an addendum 6 months after the original MRI report), and ADLs that are limited by pain, this patient's MRI report and physical exam findings also suggest evidence of other pain etiology such as facet joint arthritis. Facet arthritis would correlate with this patient's complaint of pain radiating to the bilateral hips and bilateral legs. According to Cohen et al., patients with vertebrogenic pain at the L3-S1 levels describe typical anterior column symptoms with midline low lumbar pain, with or without radiation to the paraspinal region and infrequently to the gluteal regions. This is in contrast to posterior column pain that is associated with primary paraspinal tenderness with radiation to the buttocks or posterior thigh, similar to what was described in the history of present illness and physical exam notes for this patient. 

With symptoms and radiographic evidence of other pain etiology such as facet joint arthritis, this patient would have been excluded from the INTRACEPT trial. Based on this evidence, this patient is not a good candidate for intraosseous basivertebral nerve ablation procedure with the Intracept device. There are other evidence-based medications and treatments available to this patient. 

The adverse risks are increased over standard treatment/services. Any invasive procedure has risk of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments.

In summary, the denial of intraosseous basivertebral nerve ablation (procedure code 64628) and coverage for the requested service/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 increased over standard treatments.

The carrier's denial of intraosseous basivertebral nerve ablation (procedure code 64628) should be upheld.