Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve an addition to lower limb prosthesis, multiaxial ankle 
with swing phase active dorsiflexion feature (L5968), an all lower extremity prostheses, flex-walk system or 
equal (L5981), an addition to lower limb prosthesis, vacuum pump, residual limb volume management and 
moisture evacuation system (L5781), an all endoskeletal lower extremity prosthesis, axial rotation unit, with or 
without adjustability (L5984) and an addition to lower limb prosthesis, vertical shock reducing pylon feature 
(L5988). You asked the Plan to pre-approve prosthesis replacement. You say that the enclosed information provides 
medical necessity for a new prosthetic leg to include a foot. The foot is out of warranty and is starting to 
deteriorate. The enrollee has also had residual limb changes. The Plan denied your request. The Plan says the 
requested prosthetic parts can be covered except for the computerized knee. Medicare guidance says that the 
requested foot and prosthetic components (shock reducing pylon, vacuum socket) exceeds the enrollee's needs. 
 
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 prosthesis replacement. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found based on the medical records provided, there is inadequate documentation that the K3 
level foot and prosthetic components (shock reducing pylon and vacuum socket) at issue in this case meets all 
Medicare criteria for medically reasonable and necessary. Provided records do not document a face-to-face 
physical examination of the enrollee's right lower extremity stump by her physician to meet criteria for the 
vacuum socket system. Physician records do not document that the enrollee engages in high impact activity to 
require the shock reducing pylon system. Physician records do not demonstrate why a K2 level foot would not 
be adequate for the enrollee's needs and the physician records do not adequately corroborate statements from 
the device vendor that the enrollee is or has the potential to be a K3 level ambulator to meet criteria for the K3 
level foot. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of prosthesis replacement have not been met. Therefore, we decided that the Plan 
does not have to pre-approve an addition to lower limb prosthesis, multiaxial ankle with swing phase active 
dorsiflexion feature (L5968), an all lower extremity prostheses, flex-walk system or equal (L5981), an addition 
to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system 
(L5781), an all endoskeletal lower extremity prosthesis, axial rotation unit, with or without adjustability 
(L5984) and an addition to lower limb prosthesis, vertical shock reducing pylon feature (L5988).