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 status post left transtibial amputation secondary to underlying vascular disease. He underwent the amputation. His current prosthesis consists of a shank foot with a vertical loading pylon combined with built in L5781 Vacuum pump and socket with suction suspension that was replaced. He was re-evaluated due to an ill-fitting prosthesis. The patient lost 12 pounds which has affected the fitting of his prosthesis. He reports his pain as a 6/10 along the distal tibia with use of the prosthesis in his daily activities. Modifications have been attempted for the current socket without resolution of pain/antalgic gait. The patient's foot is also noted to be too stiff to accommodate his activities. He is also noted to have an underlying genetic disorder, Factor 5 (V) Leiden, that increases swelling, pain, and tenderness in his lower extremities. 

A re-evaluation by his provider, put him at an amputee mobility predictor 9AMP(amputee mobility predictor) score of 43/47 which supports a K4 functional level which has improved from K3 with use of his current prosthesis compared to his previous evaluation. 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 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 for the insured's condition. 
Many studies have been done evaluating what would serve as the best prosthetic component for patients with amputations based on their individual needs. For those with transtibial amputations, fluctuation in volume, pistoning and skin breakdown with use of prosthesis are concerns. Many studies have been done to compare vacuum systems to others and they have been in favor of the vacuum system. One study concluded that elevated vacuum may be more effective as a volume management strategy after accumulation of activity compared to suction prosthetic suspension for transtibial amputations. Nine unilateral transtibial amputees participated in a study that showed that the vacuum-assisted socket created significantly lower positive-pressure impulse and peak pressures during the stance phase. The pressure impulse, average, and peak negative pressures during swing phase were significantly greater in magnitude with the vacuum-assisted socket. This is significant because the lower positive pressures seen during stance using the vacuum-assisted socket reduces the fluid forced out and greater negative pressures seen during swing increases the amount of fluid drawn into the limb, thereby preventing volume loss. An older study was done to compare the use of suction and vacuum sockets and it showed that reduced pistoning and maintenance of volume allowed for a more symmetrical gait with the vacuum socket. A study was performed to compare pin locking and vacuum suspension. Surveys revealed that patients fell fewer times on average with vacuum suspension, their Activities-Specific Balance Confidence (ABC) Scale scores were significantly higher using the vacuum suspension, and they reported less pistoning and less skin problems with the vacuum suspension. 

The patient did well with the prosthesis with the exception of its fit at this time due to his weight loss and stiffness of the foot. The patient is in need of a new prosthesis as the current one has failed modifications to provide a good fit. The patient's activity level improved with the use of the prosthesis from a documented K3 to K4. He is an active, independent individual who would benefit from a new, well-fitting prosthesis to prevent further complications including but not limited to, continued pain, skin breakdown, antalgic gait, and compensation on contralateral lower limb. 

Therefore, the proposed system of 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.