Appeal type: Surgery
Decision: Partially Favorable

 
We decided that the Plan has to pre-approve Aziyo Osteogrov allograft. We decided that the Plan does not have 
to pre-approve bone marrow aspirate, Zavation cervical cage, and Zavatuib Varisync instrumentation.  
 
You asked the Plan to pre-approve Aziyo Osteogrov allograft. You say that the services are necessary. The 
Plan says that based on the documentation provided, coverage criteria has not been met. 
 
We decided that the Plan has to pre-approve Aziyo Osteogrov allograft.  
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
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 Aziyo Osteogrov allograft. Our 
reviewer says that the requested items/services are considered medically reasonable and necessary in this case. 
Our physician reviewer found the enrollee meets criteria for cervical surgery and it has been approved. 
However, only a cervical plate for instrumentation and a structural allograft or iliac crest bone graft is needed. The Anterior cervical discectomy and fusion surgery with a conventional cervical plate and conventional 
structural bone grafting should be approved. This is the gold standard. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Aziyo Osteogrov allograft have been met. Therefore, we decided that the Plan 
has to pre-approve Aziyo Osteogrov allograft.  
 
We also decided that the Plan does not have to pre-approve bone marrow aspirate, Zavation cervical cage, 
and Zavatuib Varisync instrumentation. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
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 bone marrow aspirate, Zavation 
cervical cage, and Zavatuib Varisync instrumentation. Our reviewer says that the requested items/services are 
not considered medically reasonable and necessary in this case. Our physician reviewer found there is no need 
for experimental bone marrow aspirate, a cervical cage, or Zavatuib instrumentation. All of those are 
experimental for use in spine surgery. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of bone marrow aspirate, Zavation cervical cage, and Zavatuib Varisync 
instrumentation have not been met. Therefore, we decided that the Plan does not have to pre-approve bone 
marrow aspirate, Zavation cervical cage, and Zavatuib Varisync instrumentation. 
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.