Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the Intracept procedure. 
 
You asked the Plan to pre-approve the Intracept procedure. You say that the Intracept procedure is medically 
necessary for this patient and is not considered investigational. The Plan denied your request. The Plan says the 
Intracept procedure is considered investigational and is therefore non-covered. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
 
 
 
 
 
 
 
 
 
 We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve the Intracept procedure. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found that according to the Food and Drug Administration (FDA) Indications for Use, the 
Intracept Intraosseous Nerve Ablation System 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 also accompanied by features consistent with Type 1 or Type 2 Modic changes on imaging such as 
inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous 
tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral 
body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic 
change) This 81-year-old female was being treated for vertebrogenic low back pain; spondylosis without 
myelopathy or radiculopathy of the lumbar region. However, detailed documentation is not evident regarding 
Modic changes indicated on the June 28, 2022, imaging at all of the requested levels. Moreover, there are no 
physical examinations provided for review. In this case, there were/are multiple plausible pathologic sources of 
significant pain generation. Overall, documentation is lacking regarding reasonably detailed and/or evidenced 
findings supportive of the spinal vertebral bodies as being the overwhelming primary generators of the 
enrollees chronic persistent pain. Documentation does not support actual formal surgical ablation of pre-
designated basivertebral nerves as being medically necessary and/or reasonable at this time. There is no 
compelling rationale presented or extenuating circumstances noted to support the medical necessity of this 
request as an exception. Therefore, the requested Intracept intraosseous basivertebral nerve ablation at L3, L4, 
and L5 vertebral bodies, in this case, is not medically reasonable or necessary.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the Intracept procedure have not been met. Therefore, we decided that the Plan 
does not have to pre-approve the Intracept procedure.