Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lower back pain. 
Treatment: Procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept). 

The insurer denied coverage for procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept). 

The denial is upheld. 

The publications to date have been 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. 

The INTRACEPT trial (sponsored by Relievant Medsystems, Inc.) was an open-label RCT (randomized control trial) conducted at 20 U.S. (united states) sites. (Khalil 2019). A total of 140 patients with lower back pain of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 (lumbar 3) and S1 (sacral 1) were randomized to undergo radiofrequency ablation of the basivertebral nerve (BVN) or continue standard care. Patients with lumbar radicular pain were excluded from the trial. Treatment of up to 4 vertebrae in nonconsecutive levels from L3 to S1 was allowed. The primary study endpoint was change in Oswestry Disability Index (ODI) at 3 months. A pre-planned interim analysis was undertaken when 60% of participants reached the 3 month follow-up (n (number)=51 in the treatment group and n=53 in the standard care group), and reported statistically significant differences between groups on all patient-reported outcome measures, favoring the treatment group. The study was halted, and the individuals were allowed to cross over to the treatment arm. Study limitations include short term follow-up, lack of a sham group and allowance of crossover at 3 months. 

Intracept 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 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. 

There are other evidence-based procedures available to this patient. This procedure is unlikely to be more beneficial than the standard approaches. 

Visit notes state that the patient has intermittent right side L5-S1 lumbar radiculopathy consistent with MRI findings of moderate to severe neuroforaminal stenosis and disk herniation. Both of which would be considered exclusion criteria for use of the Intracept device. 

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 risks of bleeding, infection, nerve injury or retained foreign body compared to non-invasive treatments. 

Based on the clinical findings of lumbar radicular pain, along with MRI findings of potential other causes for the patient's pain, lack of documentation of evidence based nonpharmacologic or pharmacologic treatment, and confirmation biased/industry supported studies, the Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. 

In summary, the denial of  procedure code 64628, thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intracept) 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 may be increased over standard treatments.