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) 
 
You asked the Plan to pre-approve a vacuum pump. You say that you have lost weight and the old prosthetic 
leg does not work for you anymore. The current leg causes you to have pain that directly effects your ability to 
remain active. The leg has also caused you to experience phantom pain due to the continual movement of the 
stump inside the sleeve as it no longer fits. The Plan denied your request. The Plan says that experimental items 
and items that are not shown to be safe and effective cannot be covered. Therefore, that requested vacuum 
socket cannot be covered. Plan guidelines say there are not enough studies to show vacuum socket is safe and 
effective for your condition. 
 
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. Our reviewer says that 
the requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found your need for the requested component is amply described in a way that more than satisfies 
general Medicare documentation requirements, particularly in absence of any specific requirements in 
regulations to justify use of VASS. As for the Plan's main arguments centering on its Omnibus Codes policy, 
which declare 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 patients, 
most with statistically significant findings. This renders moot the Plan's 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 patients regardless of presentation. 
Moreover, any experienced clinician in this space knows that VASS is very much in the mainstream of 
standards of prosthetic care. Though the 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."  Indeed, for you and 
many like you, this technology materially complies with the general reasonable and necessary criteria laid out 
in Ch 13 of the Program Integrity Manual. Therefore, L5781 is 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 a vacuum pump 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)  
 
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.