Appeal type: Surgery
Decision: Favorable

 
We decided that the Plan has to pre-approve transcatheter insertion or replacement of permanent leadless 
pacemaker, right ventricular, including imaging guidance and device evaluation when performed (33274). 
 
You asked the Plan to pre-approve transcatheter insertion or replacement of permanent leadless pacemaker, 
right ventricular, including imaging guidance and device evaluation when performed. You say that this is 
medically necessary. The Plan denied your request. The Plan says that the requested service is not needed as a 
similar procedure has already been approved. The Plan also says that the requested service is denied because 
there is no documentation supporting that the enrollee is participating in an approved Coverage with Evidence 
Development (CED) study. 
 
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 transcatheter insertion or replacement 
of permanent leadless pacemaker, right ventricular, including imaging guidance and device evaluation when 
performed. Our reviewer says that the requested items/services are considered medically reasonable and 
necessary in this case. Our physician reviewer found the advantage of the leadless pacemaker is avoidance of 
an intravascular lead, while the limitation is the inability to allow pacing in the atrium, as well as the inability 
to remove and replace the generator at the time of battery depletion, roughly every 10 years, with a need to 
place a new unit at time of battery depletion. However, this patient has atrial fibrillation, and the physician does 
not feel that an atrial lead is mandatory. Advanced age also makes the patient a suitable candidate, as opposed 
to a young person, for which a leadless pacemaker might not be appropriate. Therefore, use of a leadless 
pacemaker would be at the physician's discretion and considered medically appropriate and reasonable in this 
patient's clinical management. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of transcatheter insertion or replacement of permanent leadless pacemaker, right 
ventricular, including imaging guidance and device evaluation when performed have been met. Therefore, we 
decided that the Plan has to pre-approve transcatheter insertion or replacement of permanent leadless 
pacemaker, right ventricular, including imaging guidance and device evaluation when performed (33274).  
 
Please note, the enrollee must be in a CED study in order for payment to be made for the services and this may 
be requested by the Plan after the claim is submitted. 
 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.