Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve an addition, endoskeletal system, below knee (BK), alignable 
system (L5910). 
 
You asked the Plan to pre-approve an alignable system. You say that any osseointegration system, once the 
abutment is placed, traditional prosthetic sockets can no longer be used as there is a metal rod coming out of 
the distal portion of the leg. This is the basis for the medical necessity. This is the only possible treatment 
option to progress walking with a prosthetic knee and foot. The Plan denied your request. The Plan says that 
the enrollee has an above the knee amputation. Medicare Guidance says that a prosthesis that meets, but does 
not exceed, the enrollee's need can be provided. The requested prosthetic parts exceed the enrollee's need. 
 
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 an alignable system. Our reviewer says 
that the requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found osseointegration is an area of emerging regulation for CMS. However, given that the scientific 
evidence in favor of the safety and efficacy of this technique is already so well established, we also note that 
CMS has expressed an intention to create new L-coding and permit coverage of the components in question in 
this population. The Plan itself from the beginning of this case inherently recognized the reasonableness and 
medical necessity of the components in question here, by authorizing the surgeries whose only intention is to 
permit the use of that same componentry requested on this enrollee's behalf. The Plan rightly corrected course 
in its partial approvals this month, but it is incorrect to continue to deny L5910. The CPOs note (corroborated 
by the surgeons notes) is thorough and descriptive of the medical need for L5910, as well as for all the other 
parts. Those other parts already approved do not include the traditional alignable system (e.g., titanium 4-hole 
pyramid or equivalent) needed to mate and align standard prosthetic devices with the Axor II. In this enrollee's 
case, L5910 is an essential, reasonable, and medically necessary component to permit the final attachment and 
functional alignment of distal prosthetic components to Axor II. Therefore, L5910 is hereby approved. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of an alignable system have been met. Therefore, we decided that the Plan has to 
pre-approve an addition, endoskeletal system, below knee (BK), alignable system (L5910).  
 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.