Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain
Treatment: Intraosseous basivertebral nerve ablation procedure
The insurer denied coverage for intraosseous basivertebral nerve ablation procedure.
The denial is upheld.

This is a review for an intraosseous basilar vertebral nerve ablation. According to documentation, this adult patient has a history of chronic lower back pain that has failed conservative care as well as injection therapy. The patient has also trialed radiofrequency ablations (RFA). The patient does have Modic changes on magnetic resonance imaging (MRI). The physical exam showed decreased range of motion in the lumbar spine with facet loading. At this point the patient is experiencing significant decrease in quality of life and activities of daily living secondary to the pain. The physician has recommended an intraosseous basivertebral nerve (BVN) ablation as the physician is treating the patient's lower back paindue to vertebrogenic changes. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes. Per Tieppo and Sayed, "Clinical studies published to date on BVN ablation utilized a similar patient population, including patients with chronic axial LBP (lower back pain) greater than six months of duration that has been refractory to non-operative treatment for at least six months, in addition to the confirmed presence of Modic changes (MCs) type 1 or type 2 on magnetic resonance imaging (MRI) in at least one vertebral endplate, at one or more levels from the L (lumber) 3 to S (sacral)1 region. Some studies excluded subjects with a history of spinal surgery, spinal stenosis, and use of opioids, while other studies included these, allowing for a more generalizable patient population more similar to daily clinical practice." 

Per Fischgrund et al. (2018), "Results: At 3 months, the average Oswestry disability index (ODI) in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease  10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.

Conclusion: Patients treated with  radiofrequeny (RF) ablation of the BVN for chronic low back pain (CLBP) exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain."

Further higher powered, randomized controlled studies must be established to fully understand the short-term and long-term efficacy of this procedure as it is in regard to this patient's pain and several other patient prototypes.  In addition, risk exposure to patients must be investigated as well. 

The intraosseous basilar vertebral nerve ablation does not have final approval by regulatory bodies. 

This patient is not a good candidate for a basivertebral nerve ablation and the ablation is not the best available treatment for this patient at this time. 

There are adverse risks to this treatment, including nerve damage, bleeding, infection, and death. 

In summary, the denial of intraosseous basivertebral nerve ablation procedure 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.