Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Low back pain

Treatment: Procedure code 64628, thermal destruction of intraosseous basivertebral nerve and code 64629, thermal destruction of intraosseous basivertebral nerve

The insurer denied coverage for procedure code 64628, thermal destruction of intraosseous basivertebral nerve and code 64629, thermal destruction of intraosseous basivertebral nerve.

The denial is upheld.

In assessing whether intraosseous basivertebral nerve ablation using the Intracept device is considered more beneficial for this patient than standard treatments or procedures, it is important to know that the publications in peer-reviewed literature 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. Furthermore, despite Food and Drug Administration (FDA) approval, there are many exclusion criteria.

For individuals who have vertebrogenic low back pain who receive ablation of basivertebral nerves, the evidence includes two randomized controlled trials (RCTs) (SMART and INTRACEPT trials, both sponsored by device manufacturer Relievant Medsystems, Inc.). Relevant outcomes were symptoms, functional outcomes, quality of life and treatment-related morbidity. In one RCT, at 12 months, 73% (percent) of patients crossed over to the active treatment group and therefore long-term comparative data is not available. Limitations to the other RCT include lack of a sham control and short duration of follow-up. Furthermore, a 2021 systematic review (Conger et al.) concluded that further high-quality, large prospective studies, that are not industry funded, are needed to confirm these findings.

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 chronic low back pain (cLBP) 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 (L) 3 to sacral (S)1; and - Activities of daily living that are limited by persistent low back pain; AND - All other reasonable sources of pain have been ruled out.

This patient is not a good candidate for intraosseous basivertebral nerve ablation. 

The basivertebral nerve ablation procedure with the Intracept device is not the best available treatment for this patient based on clinical evidence of other pain etiology, such as radicular pain. There is also insufficient evidence in the medical record of failed non-invasive treatments such as medication, physical therapy, or home exercises. In fact, clinic notes state the patient has not tried a course of nonsteroidal anti-inflammatory drugs (NSAID)s for greater than 4 weeks and that he was "unable to participate in home exercise program due to never been into exercising". 

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 denial of procedure code 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 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.