Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve an addition to lower limb prosthesis, vacuum pump, residual limb 
volume management and moisture evacuation system (L5781) and a prosthetic sock, single ply, fitting, below 
knee (L8470). 
 
You asked the Plan to pre-approve a vacuum pump and a prosthetic sock. You say that the prosthetic is 
medically necessary. The Plan denied your request. The Plan says that experimental and investigational items 
are not covered by Medicare and are not reasonable and 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 vacuum pump and a prosthetic sock. 
Our reviewer says that the requested items/services are considered medically reasonable and necessary in this 
case. Our physician reviewer found the enrollees need for all the requested parts of this prosthesis is 
adequately described by the certified prosthetist/orthotist (CPO) note from June, his appeal letter from August, 
and the physiatrists note from May, in a way that more than satisfies general Medicare documentation 
requirements for the entirety of the requested prosthesis, but especially for L5781, particularly in absence of 
any specific requirements in regulations to justify use of vacuum assisted socket system (VASS). As for Plans 
main arguments centering on its Omnibus Codes policy, which declares this technology to be experimental and 
generally non-covered, we note that all 9 of the Omnibus Codes cited studies reported on the benefits of using vacuum suspension in properly selected amputee enrollees, most with statistically significant findings. This 
renders moot the Plans objections about sample size. The Omnibus Codes frequent refrain that more studies 
are needed seems to set an arbitrary and capricious standard for rigor of evidence that is not supported 
anywhere in Medicare policy, and it is certainly not a valid basis for declaring whole mainstream modalities as 
not medically necessary for all enrollees regardless of presentation. Indeed, any experienced clinician, 
including the treating CPO, in this space knows that VASS is very much in the mainstream of standards of 
prosthetic care. Though Medicare policy is technically non-specific about coverage rules for VASS, it does in 
fact routinely cover it, meaning it cannot be on its face experimental.  For this enrollee and many like him, 
this technology materially complies with the general reasonable and necessary criteria laid out in Chapter 13 of 
the Program Integrity Manual. There is no doubt that traditional Medicare would cover the entirety of the 
requested prosthesis for this enrollee. 
 
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 vacuum pump and a prosthetic sock have been met. Therefore, we decided 
that the Plan has to pre-approve an addition to lower limb prosthesis, vacuum pump, residual limb volume 
management and moisture evacuation system (L5781) and a prosthetic sock, single ply, fitting, below knee 
(L8470).  
 
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.