Appeal type: Drugs
Decision: Partially Favorable

 
We decided that the Plan has to pre-approve Botox. We decided that the Plan does not have to pre-approve 
dermal filler.  You asked the Plan to pre-approve onabotulinumtoxinA (Botox) (J0585) and dermal filler (J3490). You say 
that you need these services due to atypical lingering facial paralysis and left sided synkinesis. You say that 
you are still experiencing oral incompetence after several years. You also say that this treatment should be 
approved. The Plan says that the enrollee's condition is not on the Medicare list of medically necessary 
diagnoses. The Plan also says that dermal filler is considered cosmetic and therefore not covered. 
 
We decided that the Plan has to pre-approve Botox.  
 
The Plan must follow Medicare rules. The rules say that Medicare may pay for unlabeled uses for FDA-
approved drugs if they are medically accepted as safe and effective or appropriate for the particular use. 
 
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 item/service at issue. Our reviewer 
says that the requested use of Botox is medically reasonable and necessary. Our physician reviewer found the 
use of Botox for treatment of synkinesis after Bell's palsy is supported by one of the major drug compendia. 
Given the off-label compendia support, Botox meets Medicare criteria for safety and efficacy and otherwise 
reasonable and 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 item/service at issue have been met. Therefore, we decided that the Plan has 
to pre-approve Botox.  
 
We also decided that the Plan does not have to pre-approve dermal filler. 
 
The Plan follows Medicare rules. Medicare rules say that medications given for a purpose other than the 
treatment of a particular condition, illness, or injury 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 item/service at issue. Our reviewer 
says that the requested use of dermal filler is not medically reasonable and necessary. Our physician reviewer 
found the use of dermal filler is considered cosmetic. Therefore, the reviewer found that the requested dermal 
filler 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 dermal filler at issue have not been met. Therefore, we decided that the Plan 
does not have to pre-approve dermal filler. 
 
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.