Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve an endoskel system below knee alignable system, lower 
limb prosthesis Mx-Axial ankle with swing phase, and the lower extremity prosthesis flex-walk system. 
 
You asked the Plan to pre-approve an endoskel system below knee alignable system, lower limb prosthesis Mx-
Axial ankle with swing phase, and the lower extremity prosthesis flex-walk system. You say that the requested 
endoskel system below knee alignable system, lower limb prosthesis Mx-Axial ankle with swing phase, and the 
lower extremity prosthesis flex-walk system are medically necessary. The Plan denied your request. The Plan 
says the requested endoskel system below knee alignable system, lower limb prosthesis Mx-Axial ankle with 
swing phase, and the lower extremity prosthesis flex-walk system are not medically necessary. 
 The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
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 an endoskel system below knee 
alignable system, lower limb prosthesis Mx-Axial ankle with swing phase, and the lower extremity prosthesis 
flex-walk system. Our reviewer says that the requested endoskel system below knee alignable system, lower 
limb prosthesis Mx-Axial ankle with swing phase, and the lower extremity prosthesis flex-walk system are not 
medically necessary. Our physician reviewer found the endoskel system below knee alignable system, lower 
limb prosthesis Mx-Axial ankle with swing phase, and the lower extremity prosthesis flex-walk system are not 
medically necessary. The current foot system is under warranty. The documentation does not reveal that the 
enrollee is a K3 ambulator. The enrollee does not meet medical necessity of a socket replacement with K3 foot 
at this time. The documentation does not reveal inability to replace L5910. The Mx-Axial Ankle with swing 
phase exceeds the enrollee's medical needs and is not medically necessary per Local Coverage Determination 
(LCD): Lower Limb Prostheses (L33787) and the Social Security Act, Section 1862 (a)1(A) and the 42 CFR 
411.15(k), as Medicare does not pay for any items or services that are not reasonable and necessary for the 
diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The 
requested items exceed the enrollee's medical need as the physician documentation does not reveal the current 
alignable system is unable to be used with the approved socket. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of an endoskel system below knee alignable system, lower limb prosthesis Mx-
Axial ankle with swing phase, and the lower extremity prosthesis flex-walk system have not been met. 
Therefore, we decided that the Plan does not have to pre-approve an endoskel system below knee alignable 
system, lower limb prosthesis Mx-Axial ankle with swing phase, and the lower extremity prosthesis flex-walk 
system.