Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cervical spondylosis

Treatment: procedure code 64628 thermal destruction of intraosseous Basi vertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral

The insurer denied coverage for procedure code 64628 thermal destruction of intraosseous Basi vertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral

The denial is upheld

This adult male has chronic low back pain. He is taking ibuprofen and tizanidine for pain. The provider reports he has had physical therapy, a home exercise program, massage therapy, chiropractic as well as medial branch blocks and trigger point injections. His MRI (magnetic resonance imaging) shows multiple herniated discs which abut spinal roots as well as abutting the thecal sac. He has not had a surgical consultation for these herniated discs. Rather, the physician is recommending RFA (radiofrequency ablation) of the basivertebral nerves.

A RCT (randomized control trial) evaluating the Intracept system, known as the INTRACEPT trial (2), was published by Khalil and colleagues in 2019. The trial was open label and compared intraosseous RF (radiofrequency) treatment to standard care in individuals with at least 6 months of chronic low back pain who had not responded to at least 6 months of conservative care. Intervention with the Intracept system consisted of treatment of up to 4 vertebrae in non-consecutive levels from L (lumbar) 3 to S (sacral) 1. Individuals in the standard care arm continued treatment with conservative therapy. The primary study endpoint was difference in the ODI (Oswestry Disability Index) at 3 months. A pre-planned interim analysis was undertaken when 60% of participants reached the 3-month follow-up (n (number of trials)=51 in the Intracept group and n=53 in the standard care group). The interim analysis found statistically significant differences between groups on all patient-reported outcomes measures, favoring the Intracept group. For the primary outcome, the mean change in the ODI at 3 months in the interim analysis was -25.3 points in the Intracept group and -4.4 points in the standard care group, p<0.001. Mean change in VAS (visual analogue scale) was -3.46 points in the Intracept group and -0.01 in the standard care group, p (probability) <0.001. As specified in the study protocol, the study was halted and individuals in the standard care group were allowed to cross over to treatment with the Intracept system. Limitations of this study include the lack of a sham control and limited duration of follow-up.

In sum, the publications to date have been company-sponsored and had methodology flaws. There is no published data on long term complication rates. There are other evidence-based interventions available to this patient and the adverse risks of the requested procedure are increased over standard treatments.

This requested procedure is unlikely to be more beneficial than the standard approaches and the patient is not a good candidate. He has not had a surgical consultation for his herniated discs.

The carrier's denial of procedure code 64628 thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral should be upheld.