Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Orthopedic/Musculoskeletal-dysvascular left transtibial amputation. 
Treatment: Prosthetics. 

The insurer denied Addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system as experimental/investigational. The denial was overturned. 


The patient is a male, with a history of Factor 5 (V) Leiden, who underwent a left transtibial amputation from dysvascular disease. The current transtibial prosthesis is a shank foot with a vertical loading pylon combined with a built-in Vacuum Pump and a socket with suction suspension that was replaced. He is ambulating at a K3 functional level. His amputee mobility predictor (AMP) score is 43/47 supporting a K4 functional level of ability to walk at a variable cadence. References to a prosthetic evaluation  indicated that there was a 12-pound weight loss as well as pain on the distal tibia and that there is a Trendelenburg gait deviation. Multiple modifications have been made to the current socket, but the foot is too stiff and cannot dorsiflex enough to ascend and not enough plantar flex to descend. He uses 4 ply of socks and feels that the distal limb is pinched with stepping. He has uneven terrain and stairs he wants to navigate.
The note discussed recommendations that the patient have a replacement of the prosthesis as the previous one was ill fitting despite repairs. In addition, a dynamic response foot with multiaxial rotation and electric vacuum pump assist suspension was requested to allow the patient to maintain control and avoid skin breakdown as well as avoid falls with quick positional changes. 

At issue is whether the addition to lower limb prothesis, vacuum pump, residual limb volume management and moisture evacuation system is likely to be more beneficial than any standard treatment or treatments. 

The health plan's determination regarding the proposed health service or treatment is overturned in whole. 

The proposed health service or treatment of addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system is likely to be more beneficial than any standard treatment or treatments for the insured's condition. 
In review of Klute et.al., the vacuum-assisted socket suspension (VASS) as compared to the pin suspension in unilateral, transtibial amputees seemed to result in a better fitting socket as the residual limb pistoning was less with the VASS, but subjective responses and fewer steps taken were also noted. The meta-analysis from Gholizadeh et.al. noted that vacuum suspension could improve comfort and quality. As this patient has Factor V Leiden, there is an increased risk of venous leg ulceration than in the control group and the general population. (Maessen-Visch et.al.,1999) Patients with factor V Leiden mutation have an increased risk of developing deep venous thrombosis and recurrent leg ulceration. With the patient's Factor V Leiden and current anticoagulation treatments, given the old, poor fitting prosthesis and increased distal tibial pains with the changes in stump size, it is important to have a proper fitting socket as well as reduction of stump breakdown. Therefore, it is medically necessary for a vacuum-assisted socket suspension (VASS) over the standard prosthetic socket without the built-in vacuum pump for this patient. 
Therefore, the addition to lower limb prothesis, vacuum pump, residual limb volume management and moisture evacuation system is likely to be more beneficial than any standard treatment.