Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic Low Back Pain

Treatment: Intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

The denial is upheld 

Reviewer #3:

The patient suffers from intractable back pain. The patient has tried and failed multiple therapeutic interventions.

The magnetic resonance imaging (MRI) report shows Grade 1 retrolisthesis of L (lumbar) 2 and L3. Modic type I endplate changes at L2-L3 level. On L2-L3 there is retrolisthesis with uncovering disc material and superimposed diffuse disc bulge. There is mild bilateral facet arthropathy. There is bilateral lateral recess and mild bilateral foraminal narrowing. Central spinal canal is patent. On L4-L5: there is disc bulge and bilateral facet arthropathy resulting mild bilateral foraminal narrowing. No spinal canal stenosis.

In the multi-center, randomized, double-blind, sham-controlled SMART trial, Fischgrund et al. (2018) evaluated the safety and efficacy of radiofrequency ablation (RFA) of the basivertebral nerve (BVN) for the treatment of chronic low back pain. A total of 225 patients diagnosed with chronic low back pain were randomized to treatment with the Intracept procedure (n=147) or sham therapy (n=78). All patients had Type I or Type II Modic changes of the treated vertebral bodies. The primary endpoint was the comparative change in the Oswestry Disability Index (ODI) from baseline to 3 months. At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm. A responder analysis based on ODI decrease  10 points showed that 75.6% (percent) of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.

The same authors reported 2-year clinical outcomes (Fischgrund et al., 2019). Participants randomized to the sham control arm were allowed to cross to RFA at 12 months. Due to a high rate of crossover, RFA treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. Clinical improvements were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and visual analog scale (VAS) compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI 10-point improvement in 76.4% of patients and ODI 20-point improvement in 57.5%; VAS 1.5 centimeters (cm) improvement in 70.2% of patients.

An industry-sponsored study by Becker et al. (2017) assessed the efficacy of intraosseous BVN ablation, with the Intracept system, in 17 patients with chronic low back pain. Sixteen patients were treated successfully. Self-reported outcome measures were collected prospectively at each follow-up interval. There was a significant decrease in the average ODI at 3 months postoperatively, which was maintained at 12 months. Significant improvement in the VAS scores and quality of life were also reported at the 3-month follow-up. This study is limited by small sample size, lack of randomization and control and short-term follow-up.      

Intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629) does not have final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is not a good candidate for intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629).     

In summary, the denial of intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629) 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.