Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: traumatic amputation at level between knee and ankle, right lower leg

Treatment: Healthcare Common Procedure Coding System (HCPCS) code L5781 (additional to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system)- modifier RT (right side)

The insurer denied coverage for Healthcare Common Procedure Coding System (HCPCS) code L5781 (additional to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system)- modifier RT (right side)

The denial is upheld

According to the documentation submitted, this patient with a past medical history of complete traumatic amputation at level between knee and ankle, right lower leg had a Telehealth visit with Physiatrist, for prosthetic evaluation. Per the visit notes, the patient reported that he has been active with below the knee prosthesis since childhood without issues. The notes state that the patient required new custom molded right below the knee prosthesis due to old/worn and cracked right below knee prosthesis greater than 10 years old. Healthcare Common Procedure Coding System (HCPCS) code L5781 (additional to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system)- modifier RT (right side) was provided to the patient. 

The scientific evidence in peer reviewed literature does not support improvement in health outcome. In a randomized cross-over study, Klute et al (2011) examined the effect of a vacuum assisted socket system (VASS) system as compared with pin suspension on lower extremity amputees. The authors concluded that VASS [vacuum assisted socket system] resulted in a better fitting socket as measured by limb movement relative to the prosthetic socket (pistoning), although the clinical significance is difficult to discern. Treadmill walking had no effect, suggesting that a skilled prosthetist can control for daily limb volume fluctuations by using conventional, non-vacuum systems. Participants took approximately 50% [percent] as many steps while wearing the VASS which, when coupled with their subjective responses, suggests a patient preference for the pin suspension system. The need for fewer check sockets and shorter time to obtain an adequate fit suggests a clinical preference for the pin suspension.

The VASS does not have final approval from the appropriate regulatory bodies for this diagnosis. 

The patient does not meet criteria for medical necessity for the VASS. The specialized vacuum pump residual limb volume management is required when any of the following criteria are met:

.	excessive pistoning of the socket of the residual limb interface that cannot be resolved by adjustments in the current suspension system

.	excessive residual limb hyperemia from prior socket use; or

.	excessive skin hyperhidrosis from prior socket use; or

.	multiple falls in below knee amputees (transtibial amputation)

This is not the best available treatment for this patient at this time because he does not meet criteria for medical necessity and this treatment is considered experimental and investigational. In the a visit with his physician, the patient was documented to be a K3 (ability/ability to ambulate) functional amputee level. He is able to ambulate with variable cadence and perform activities based simple locomotion. Per the visit notes, the patient reported that he has been active with below the knee prosthesis since childhood without issues. The notes state that the patient required new custom molded right below the knee prosthesis due to old/worn and cracked right below knee prosthesis. 

This item is not more beneficial than any of the standard treatments for this patient. The VASS is not demonstrated through prevailing peer-reviewed medical literature to be safe and effective for treating or diagnosing the condition or illness for which its use is proposed. 

Some of the adverse risks reported are increased time to obtain an adequate fit and a need for more check sockets. Elevated vacuum systems may have advantages over the traditional suspension systems, but may not be appropriate for all people with limb loss. This could improve quality of life for some people with limb loss, However, future investigations with larger sample sizes are needed to provide statistical conclusions and to evaluate long term effects of these systems.

The insurer's denial of coverage for Healthcare Common Procedure Coding System (HCPCS) code L5781 (additional to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system)- modifier RT (right side) is upheld. this item is not likely to be more beneficial.