Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve an addition, endoskeletal knee-shin system (L5828), an addition, 
endoskeletal, stance flexion feature (L5845), an addition to endoskeletal knee-shin system, fluid stance 
extension (L5848), a microprocessor control feature (L5856), an above knee or hip disarticulation, alignable 
system (L5920), an above knee, knee disarticulation or hip disarticulation, manual lock (L5925) and an all 
lower extremity prostheses, flex-walk system (L5981). 
 
You asked the Plan to pre-approve prosthetics. You say that the enrollee needs a replacement prosthetic. The 
enrollee currently has a temporary/starter prosthetic leg and is now ready for the permanent one. The Plan 
denied your request. The Plan says that Medicare Guidance says that the requested computerized knee 
advanced feet exceed the enrollee's needs. 
 
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 prosthetics. Our reviewer says that the 
requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found the medical record provided (i.e., the certified prosthetist/orthotist (CPO) note from August and 
the physiatrist notes from April and July) more than satisfies the documentation requirements, not least of all 
by describing his K4 functional potential and the problems with his existing prosthesis. At the heart of these 
denials is whether the enrollee qualifies now for replacement of the various components of his original, K2-
level prosthesis provided early in his rehab. One of the criteria that is sufficient for replacement of a 
prosthesis/component per Policy Article A52496 is change in the physiological condition of the 
beneficiary.  The Plan seems to have accepted that such a change has occurred by virtue of approving the 
replacement socket, and there is no doubt that such an enrollee would eventually be higher than a K2 functional 
level with a properly designed prosthesis, which also amounts to a physiological change compared to his early 
post-op state. However, it is highly unusual for a Plan to approve a replacement socket but then specifically 
deny a small, inexpensive constituent part that is essential to the use of device, such as the alignable system. Given that the medical record overall has been deemed to be sufficient to cover the replacement socket 
generally, it creates an undue burden, which is not supported nor called for in Medicare policy, on the enrollee 
to demand that the record specifically address the re-usability of a small subpart of the overall approved service 
which neither a prosthetist nor a prescriber would think to speak to in the creation of authentic medical records. 
Indeed, a new alignable system is needed with each prosthesis, and it is not usually recycled between sockets 
precisely because key parts of it are laminated directly into the structure of the previous socket. Regarding the 
criteria for coverage of the requested knee and foot, LCD L33787 states simply A fluid, pneumatic, or 
electronic/microprocessor knee is covered for beneficiaries whose functional level is 3 or above, and it also 
states, flex foot system (L5981) is covered for beneficiaries whose functional level is 3 or above.  No further 
specific documentation is required in the LCD, the Policy Article, or any of the relevant Medicare manuals 
because Medicares policy recognizes that microprocessor knees and flex-walk feet are part of the basic 
standard of care for all community above knee amputee ambulators given that the evidence of their benefits and 
superiority to less sophisticated alternatives are so well proven and long standing. In the case of this enrollee, 
and all comparable K3-K4 ambulators, lesser devices simply do not meet his functional needs and amount to 
substandard care. There is no doubt that traditional Medicare would cover the entirety of the requested 
prosthesis for this K4 enrollee. Therefore, the requested alignable system (L5920), microprocessor knee 
(L5828, L5845, L5848, L5850, L5856, L5925), and flex-walk style foot (L5981) are all 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 prosthetics have been met. Therefore, we decided that the Plan has to pre-
approve an addition, endoskeletal knee-shin system (L5828), an addition, endoskeletal, stance flexion feature 
(L5845), an addition to endoskeletal knee-shin system, fluid stance extension (L5848), a microprocessor 
control feature (L5856), an above knee or hip disarticulation, alignable system (L5920), an above knee, knee 
disarticulation or hip disarticulation, manual lock (L5925) and an all lower extremity prostheses, flex-walk 
system (L5981).  
 
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.