Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain.

Treatment: Surgical procedure to treat low back pain (Procedure Code 64628).

The insurer denied coverage for surgical procedures to treat low back pain (Procedure Code 64628.)

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 and 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 SS, 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 sham control and short duration of follow-up.

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 lumbar (L)3 and sacral (S)1 were randomized to undergo radiofrequency ablation of the basivertebral nerve (BVN) or continue standard care. Patients with other pain etiology such as disc extrusion or protrusion > 5 millimeters (mm) 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 a 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. 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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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

In summary, 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. Despite FDA approval, Centers for Medicare and Medicaid Services (CMS) guidelines limit the use of basivertebral nerve ablation to a very select group of patients who meet very strict criteria, which excludes patients with disc extrusion or protrusion > 5 millimeters (mm). The Intracept procedure is unlikely to be more beneficial than standard treatments/procedures for this patient. The denial is upheld.

In summary, the denial of surgical procedures to treat low back pain (Procedure Code 64628) 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 risk are substantially increased over standard treatments.