Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1 
 
A 55-year-old male insured has requested authorization and coverage for thermal destruction of 
the intraosseous basivertebral nerve, including the first two vertebral bodies, lumbar or sacral, 
Intracept procedure (CPT 64628). The Health Insurer has denied this request indicating that the 
requested services are considered investigational for the treatment of the insureds chronic back 
pain. The physician reviewer found that according to the U.S. Food and Drug Administration 
(FDA), the Intracept procedure is intended to be used in conjunction with radiofrequency 
generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief 
of chronic low back pain of at least six months duration that has not responded to at least six 
months of conservative care and is accompanied by features consistent with type 1 or type 2 
Modic changes on a magnetic resonance imaging (MRI). One study concluded that there is 
moderate quality evidence demonstrating the safety and efficacy of the Intracept procedure in 
reducing pain and disability in well-selected patients with chronic low back pain with type 1 or 2 
Modic changes (Conger, et al.). This patient is being treated for vertebrogenic low back pain and 
vertebral endplate pain. He presented with low back pain with bilateral leg thigh numbness and 
heaviness with prolonged standing. Flexing forward helps relieve the pain. Treatment with an 
epidural steroid injection was helpful for about three weeks. Evaluation with MRI of the lumbar 
spine demonstrated Modic 2 endplate changes at the lumbosacral junction. Imaging significance 
is further supported by Conger et al, evidence that suggests this procedure is effective in 
reducing pain and disability in patients with chronic low back pain who are selected based on 
type 1 or 2 Modic changes. However, also demonstrated on the MRI was disc and facet disease 
with  listhesis,  relatively  mild  central  stenosis,  and  at  least  moderate  bilateral  foraminal 
narrowing.  As  noted  by  DeVivo  and  colleagues,  selection  of  patients  is  based  on  a 
multidisciplinary  approach  including  both  conventional  Diagnostic  Radiology  and  Nuclear 
Medicine imaging. Overall, the records suggest that there are multiple plausible pathologic 
sources of significant pain generation. Per Tieppo Francio and Sayed, finding the source of 
chronic axial low back pain is clinically challenging, and often 80% of diagnoses are described as 
non-specific low back pain, and in only 20% of cases, an anatomical source can be attributed. 
The patient has reported low back and bilateral leg thigh numbness and heaviness, standing as 
a pain-aggravating factor, and flexing forward as a pain-relieving factor. The patient was noted 
to  have  an  intact  strength  examination  non-specific  to  any  pathologic  entities.  Overall, 
documentation is lacking regarding reasonably detailed and evidenced findings supportive of the 
spinal vertebral bodies as being the overwhelming primary generators of the patients chronic 
persistent pain. Therefore, the requested thermal destruction of the intraosseous basivertebral 
nerve, including the first two vertebral bodies, lumbar or sacral, Intracept procedure (CPT 64628) 
is not likely to be more beneficial for the treatment of the patients medical condition than any 
available standard therapy.