Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Below the knee transtibial amputation.
Treatment: addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot.
The insurer denied addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot. 
The determination is upheld.

The patient has a right below the knee transtibial amputation performed due to trauma. The medical records stated that she had a normal gait except for a slight limp. There was slight tenderness in the bottom of the left foot. She was independent with her activities of daily living (ADLs). She was very active, mowed her lawn with a push mower on uneven terrain, cleaned, cooked, did housework, all terrain vehicle (ATV) riding, hiking, and riding a motorcycle. The socket had cracked and her residual limb had changed shape since her current socket had been fit. The componentry did not work due to delamination of the carbon fiber. There was excessive wear and looseness of the ankle joints. There was redness and moderate swelling of the residual limb. Gait and balance were good. At issue is whether the proposed health service or treatment: addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment: addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot is not the standard treatment for patients with right below the knee amputation. There are no well-designed well conducted studies published in peer-reviewed journals to support the addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot, demonstrate that the addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot affects health outcomes, or show that the addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot is equally or more effective than conventional therapies. There are many standard treatments for the diagnosis of right below the knee amputation including a conventional right below the knee prosthesis. The use of the addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system; lower extremity prosthesis- right pro-flex pivot foot MyoPro Motion Device is not considered medically necessary, not supported by the peer-reviewed medical literature, and is not considered the standard of care in United States at this time.