Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve a vacuum-assisted socket system (VASS). 
 
You asked the Plan to pre-approve a VASS. You say that the requested VASS is medically necessary.  The 
Plan denied your request. The Plan says that the requested VASS is 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 VASS. Our reviewer says that the 
requested VASS is medically necessary.  Our physician reviewer found the enrollee's 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 physician note from June 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 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 patients, 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 patients 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 Ch 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 VASS have been met. Therefore, we decided that the Plan has to pre-approve 
a vacuum-assisted socket system (VASS).  
 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.