Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Procedure to treat low back pain (procedure codes 64628 and 64629)

The insurer denied coverage for procedure to treat low back pain (procedure codes 64628 and 64629)

The denial is upheld 

Reviewer #3:

In assessing whether intraosseous basivertebral nerve (BVN) 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% 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.

The INTRACEPT trial (sponsored by Relievant Medsystems, Inc.) was an open-label RCT conducted at 20 U.S. 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 and S1 were randomized to undergo radiofrequency ablation of the BVN or continue standard care. Patients with other pain etiology such as radicular pain were excluded from the trial. Treatment of up to 4 vertebrae in nonconsecutive levels from L (lumbar) 3 to S (sacral) 1 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=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. Study limitations include short term follow-up, lack of a sham group and allowance of crossover at 3 months. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Basivertebral nerve (BVN) ablation using the Intracept procedure is 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 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 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.

In summary, the denial of procedure to treat low back pain (procedure codes 64628 and 64629), to be provided, on a date to be determined 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.