Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 40-year-old male with a congenital limb deficiency equivalent to a right-sided above-the-knee amputation. His weight is 170 pounds. The patient needs a replacement for a right trans-femoral prosthesis and is requesting a C-leg microprocessor controlled device. The patient is noted to have mild cognitive delays but no cardiac conditions. He is described as an unlimited community ambulator (K3). He is a self-employed handyman and is currently living with his parents. The Health Plan has denied coverage for the requested prosthetic device on the basis it is considered investigational.Although it has not been shown that the C-leg controlled prosthesis is more energy efficient than a traditional knee joint, it is widely accepted for treatment of K3 level or above ambulators by the Veterans Administration and the Centers for Medicare and Medicaid. The requested C-leg prosthetic device is medically necessary and indicated for this young, active, level K3 ambulator to provide for a more normal and stable gait. This will allow for variable cadence and improved safety when climbing stairs and navigating uneven surfaces. Therefore, I have determined that the requested prosthetic device is likely to be more beneficial for treatment of the patients medical condition than any available standard device. The Health Plans denial should be overturned.Physician 2: This patient is a 40-year-old male with a congenital limb deficiency who is requesting a customized replacement trans-femoral prosthesis over a standard prosthesis. He is attempting to achieve better motion control, decrease stump irritation, and facilitate donning/doffing. The Health Plan has denied coverage for the requested prosthetic device on the basis it is considered investigational.Upon review of the submitted documentation including review of the patients functional status and his activity level, it is not likely the patient will experience superior results with the requested prosthesis and its various components including the C-leg control. Currently, there is insufficient scientific evidence demonstrating that the requested customized prosthesis is likely to be more efficacious than a standard component prosthetic device.  Accordingly, I have determined that the requested prosthetic device is not likely to be more beneficial for treatment of the patients medical condition than any available standard device. Therefore, the Health Plans denial should be upheld.Physician 3: The patient is 40-year-old male with a congenital limb deficiency.  He functions as someone with an above the knee amputation and wears a standard prosthetic device.  The condition of his current prothesis warrants replacement and it has been recommended that the new device include a C-leg microprocessor knee control and other related options.  The patients standard prosthesis appears to accommodate his unique stump configuration and allows K3 level community ambulation. The Health Plan indicates it has not authorized incorporation of the C-leg options into the new prosthetic device because the requested features are considered investigational.This patient has extensive experience with a standard prosthetic device. Additionally, he has exhibited a high level of function with a standard prosthetic device. The requested customized prosthetic device has not been shown in clinical trials to be superior to the standard prosthetic device components. Given the absence of sufficient clinical trial evidence supporting the enhanced features of the requested prosthetic device, it is not likely to be more beneficial for treatment of the patients medical condition than any available standard device. Therefore, the Health Plans denial should be upheld.