Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve a Freedom Proteor Quattro K3 microprocessor knee (L5856, 
L5828, L5848, K5845, L5850, and L5925), Shockwave K3 foot (L5984 and L5987), and alignable system 
(L5920). 
 
You asked the Plan to pre-approve a Freedom Proteor Quattro K3 microprocessor knee (L5856, L5828, L5848, 
K5845, L5850, and L5925), Shockwave K3 foot (L5984 and L5987), and alignable system (L5920). You say 
that the requested Freedom Proteor Quattro K3 microprocessor knee (L5856, L5828, L5848, K5845, L5850, 
and L5925), Shockwave K3 foot (L5984 and L5987), and alignable system (L5920) are medically necessary.  
The Plan denied your request. The Plan says that the requested Freedom Proteor Quattro K3 microprocessor 
knee (L5856, L5828, L5848, K5845, L5850, and L5925), Shockwave K3 foot (L5984 and L5987), and 
alignable system (L5920) are not medically necessary.  
 
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 a Freedom Proteor Quattro K3 
microprocessor knee (L5856, L5828, L5848, K5845, L5850, and L5925), Shockwave K3 foot (L5984 and 
L5987), and alignable system (L5920). Our reviewer says that the requested Freedom Proteor Quattro K3 
microprocessor knee (L5856, L5828, L5848, K5845, L5850, and L5925), Shockwave K3 foot (L5984 and 
L5987), and alignable system (L5920) are medically necessary.  Our physician reviewer found the Plan erred in 
its denial of the requested microprocessor knee, shank style, multi-axial foot, and the alignable system. 
 
We note first, as to the issue as to whether or not the enrollee qualifies for a new prosthesis at this juncture, that 
in the governing Policy Article A52496 one of the criteria sufficient for justifying the replacement of a 
prosthetic component is A change in the physiological condition of the beneficiary. 
 
The Certified Prosthetist/Orthotist (CPO) note from June and August, as well as the physician clinic note from 
May, establish that this a medically well managed patient who is progressing normally through his prosthetic 
rehab at a K3 level. The medical record is explicit that his residual limb no longer properly fits the socket 
previously made for him, and his functional needs, as they have advanced, are not being met by the knee and 
foot. This is wholly credible and predictable given the background and time course. The enrollees function 
would effectively be normalized with more appropriate componentry that would permit variable cadence, give reasonable assurance against falling, and permit a wider range of motion in the foot/ankle. Both the change in 
residual limb shape and increase in functional status constitute physiological change necessary to justify 
replacing his prosthesis at this juncture, which the Plan has approved. 
 
As to whether or not he qualifies for the requested microprocessor knee and shank style foot with its addition 
code, LCD L33787 merely states ...electronic/microprocessor knee...is covered for beneficiaries whose 
functional level is 3 or above, and also that ...shank foot system with vertical loading pylon (L5987) 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 shank style 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/less 
dynamic alternatives are so well proven and long standing.  
 
Finally, regarding the Plans very specific denial of L5920, despite having approved the rest of the socket, it is 
highly unusual for a Plan to approve a replacement socket but specifically deny a small, inexpensive 
constituent part that is essential to the use of device.  Given that the medical record overall has been deemed by 
the Plan 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 a 
small subpart of the overall approved service which neither a prosthetist nor a prescribing physician would 
think to speak to in the creation of authentic medical records.  In situations where Congress or Medicare have 
seen fit to specifically regulate certain subparts of an overall Durable Medical Equipment, Prosthetics, 
Orthotics and Supplies (DMEPOS) device, they write statutes/regulations governing those codes expressly.  No 
such regulations exist governing the use of L5920 in either the LCD L33787 or in the Policy Article A52496.  
Moreover, this part is not usually recycled between sockets precisely because it is laminated directly into the 
structure of the previous socket; a new alignable system is necessary every time a new lower extremity 
prosthetic socket is fabricated. 
 
There is little reason to doubt that original Medicare would cover the entire requested prosthesis for this K3-
level enrollee whose function continues to improve. 
 
Therefore, the alignable system (L5920) and replacement components including microprocessor knee (L5828, 
L5845, L5848, L5850, L5856, L5925) as well as shank style foot with multi-axial rotation unit (L5987, L5984) 
for this enrollee, meet Medicare criteria. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of a Freedom Proteor Quattro K3 microprocessor knee (L5856, L5828, L5848, 
K5845, L5850, and L5925), Shockwave K3 foot (L5984 and L5987), and alignable system (L5920) have been 
met. Therefore, we decided that the Plan has to pre-approve a Freedom Proteor Quattro K3 microprocessor 
knee (L5856, L5828, L5848, K5845, L5850, and L5925), Shockwave K3 foot (L5984 and L5987), and 
alignable system (L5920).  
 
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.