Appeal type: DME/ Orthotics
Decision: Partially Favorable

 
We decided that the Plan has to pre-approve an all-lower extremity prosthesis, flex-walk system (L5981) and a 
vertical shock reducing pylon feature (L5988). We decided that the Plan does not have to pre-approve a below 
the knee, flexible protective outer surface covering system (L5962).  
 
You asked the Plan to pre-approve a below the knee, flexible protective outer surface covering system (L5962), 
an all-lower extremity prosthesis, flex-walk system (L5981) and an addition to lower limb prosthesis, vertical 
shock reducing pylon feature (L5988). You say that the requested prosthetics are necessary for the enrollee. 
The Plan says that the request for an advanced foot feature, a shock reducing pylon and extra covering cannot 
be approved at this time by Medicare or the health plan. The enrollee may meet criteria for a simpler foot. 
 
We decided that the Plan has to pre-approve an all-lower extremity prosthesis, flex-walk system (L5981) 
and a vertical shock reducing pylon feature (L5988).  
 
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 a below the knee, flexible protective 
outer surface covering system, an all-lower extremity prosthesis, flex-walk system and an addition to lower 
limb prosthesis, vertical shock reducing pylon feature. Our reviewer says an all-lower extremity prosthesis, 
flex-walk system (L5981) and a vertical shock reducing pylon feature (L5988) are considered medically 
reasonable and necessary in this case. Our physician reviewer found that the medical record (e.g., the certified 
prosthetist/orthotist (CPO) note from August, corroborated by the primary care physician (PCP) note from 
July) satisfies Medicare policy in demonstrating this enrollee has a K3 functional level and qualifies for the 
requested foot. LCD L33787 states simply "flex foot system (L5981) is covered for enrollees whose functional 
level is 3 or above." No further specific documentation is actually required in the LCD, the Policy Article, or 
any of the relevant Medicare manuals because Medicare's policy recognizes that flex-walk feet (and their 
standard addition codes) are part of the basic standard of care for all community K3 amputee ambulators given 
that the evidence of their benefits and superiority to less sophisticated alternatives are so well proven and long 
standing. It is highly likely that original Medicare would have covered the requested prosthetic foot for this 
enrollee. Therefore, we decided that the Plan has to pre-approve an all-lower extremity prosthesis, flex-walk 
system (L5981) and a vertical shock reducing pylon feature (L5988).  
 
We also decided that the Plan does not have to pre-approve a below the knee, flexible protective outer 
surface covering system (L5962). 
 
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 a below the knee, flexible protective 
outer surface covering system, an all-lower extremity prosthesis, flex-walk system and an addition to lower 
limb prosthesis, vertical shock reducing pylon feature. Our reviewer says that a below the knee, flexible 
protective outer surface covering system (L5962) is not considered medically reasonable and necessary in this 
case. Our physician reviewer found that regarding L5962, Policy Article A52496, states, "Protective outer 
surface covering systems (L5962, L5964, and L5966) are specialized covers intended to be worn over an 
existing prosthesis. They are used by a beneficiary who has special needs for protection against unusually harsh 
environmental situations where it is necessary to protect the lower limb prosthesis beyond the level of 
protection that is afforded by L5704, L5705, L5706, and L5707. They are not for cosmetic or convenience 
reasons, or for everyday usage in a typical environment." Given the specific documentation requirements for 
this component, it is incumbent on the CPO to provide a medical record that meets these requirements. 
However, in this case, no such justification or context is found in the record to suggest that this enrollee's 
prosthesis will be exposed to unusually harsh environments necessitating additional protection beyond what is 
provided with a typical cover (e.g., L5704, which has already been approved by the Plan). Therefore, we 
decided that the Plan does not have to pre-approve a below the knee, flexible protective outer surface covering 
system (L5962). 
 
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.