Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the flexible protective outer surface covering system 
and the vacuum socket (CPT code(s): L5781 and L5962). 
 
You asked the Plan to pre-approve the items. You say that the items are necessary. The Plan denied your 
request. The Plan says the records do not show the enrollee would be using their artificial leg in very harsh 
conditions, so that the approved custom shaped protective cover will not be enough. The Plan states there is a 
request for a vacuum socket for the enrollee's prosthesis. The Plan states this vacuum socket is experimental 
and cannot be approved. The Plan states that a request for a standard cover that meets the enrollee's needs and 
Medicare rules can be reviewed if submitted. 
 
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 the items. Our physician reviewer 
found there is inadequate documentation that the flexible protective outer surface covering system and the 
vacuum socket system at issue in this case meet all Medicare criteria for medically reasonable and necessary for the enrollee. Provided records from the enrollee's treating physician do not fully support the need for the 
requested flexible protective outer surface covering system and the vacuum socket system as required by the 
Local Coverage Article: Lower Limb Prostheses - Policy Article (A52496). Medical records from the physician 
do not address the vacuum socket system or document special needs for protection against unusually harsh 
environmental situations where it is necessary to protect the lower limb prosthesis beyond the level of 
protection that is afforded by a standard cover. As stated in the Local Coverage Article: Standard 
Documentation Requirements for All Claims Submitted to DME MACs - A55426: "Supplier-produced records, 
even if signed by the treating practitioner, and attestation letters (e.g. letters of medical necessity) are deemed 
not to be part of a medical record for Medicare payment purposes. Templates and forms, including CMS 
CMNs, are subject to corroboration with information in the medical record. A prescription is not considered to 
be part of the medical record. Medical information intended to demonstrate compliance with coverage criteria 
may be included on the prescription but must be corroborated by information contained in the medical record. 
The beneficiary's medical record must contain sufficient documentation of the beneficiary's medical condition 
to substantiate the necessity for the type and quantity of items ordered and for the frequency of use or 
replacement (if applicable). The information should include the beneficiary's diagnosis and other pertinent 
information including, but not limited to, duration of the beneficiary's condition, clinical course (worsening or 
improvement), prognosis, nature and extent of functional limitations, other therapeutic interventions and 
results, past experience with related items, etc." 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the items have not been met. Therefore, we decided that the Plan does not have 
to pre-approve the flexible protective outer surface covering system and the vacuum socket (CPT code(s): 
L5781 and L5962).