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 lower back pain. The patient has Modic changes in lumbar (L) 3, L4 , L5 and Sacral (S) 1 vertebral bodies. The request is for the Intracept procedure, which is under medical review.

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. The patient is not a good candidate for this procedure at this time. The risks of complications are increased over the standard treatment and services. Therefore, the request is denied. 

In the multi-center, randomized, double-blind, sham-controlled SMART trial, Fischgrund, J.S., 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% 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, J.S., 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. 

"The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation's clinical effectiveness with broader application outside of strict trial inclusion criteria" (Macadaeg, K., et al. 2020).

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.