Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Diabetes; Left trans-tibial amputation
Treatment: Replacement artificial leg
The insurer denied the replacement artificial leg.
The denial is upheld. 

That patient is a male who has a history of diabetes complicated by a non-healing left foot wound.  He ultimately underwent a left trans-tibial amputation.  He resumed ambulation using an initial temporary prosthesis.  He was rated to be a K3 level ambulator.  Adjustments were made to the initial prosthesis, including with respect to the socket to improve fit, to extend its life.

As of a visit with the physician, he was noted to be ready for a definitive limb.  He had trialed a Propio foot for a few days and experienced dramatic improvements in mobility and function compared with his initial prosthetic foot, including walking on varied and uneven terrain during his work commute and climbing stairs at home.  He also felt less fatigue at the end of the day using the Propio foot.  It was reported that he was able to participate in outside recreational activity "since the first time since his amputation," and specifically an hour long hike, which he was only able to accomplish with the Propio foot.

At a prosthetist visit, he was noted to be living at home, requiring no assistance at home.  He was commuting to work.  He was enjoying taking his dog for hikes in the woods.  He was finding hikes to be "a chore" with his Tru-step prosthetic foot.  On examination, he was walking without gait deviations.  He was deemed ready for a definitive prosthesis.

Replacement prosthesis with a second generation Proprio foot has been prescribed to replace his initial prosthesis.

A replacement socket was approved for coverage by the health plan.  Coverage for the remainder of the prosthesis was denied by the health plan.

No, the Replacement artificial leg is not medically necessary.

The patient developed significant volume loss in his residual limb. A replacement socket in such a scenario would then be medically appropriate. His prosthesis is otherwise allowing him to walk with a normal gait. He has a Tru-step foot, which is a multiaxial foot rated as K3 to K4. He is able to hike in the woods with his dog using this prosthetic foot. His gait efficiency should improve with improved socket fitment.

There are insufficient outcomes data available from controlled clinical trials published in the peer-reviewed literature to establish any marginal improvements in safety and effectiveness of microprocessor-controlled prosthetic foot componentry over conventional (i.e., non-microprocessor-controlled and non-powered) designs.  The available data are from small pilot studies, which, on balance, have not consistently demonstrated clinically significant advantages of these components over conventional ankle foot components.

Overall, based on the extant literature, there are no proven clinical or functional advantages of this type of the proposed foot componentry that would offset its heavier weight and significantly increased bulk. The patient would remain at risk for adverse events such as falls given his underlying condition, with no proven improvement in risk with the proposed foot componentry. In addition, there are risks if the electronics on this type of prosthetic foot componentry fails during ambulation, either due to mechanical failure or battery power loss, which include significantly increasing the work of ambulation and increasing the risk of falls. The proposed replacement prosthesis with microprocessor foot is not medically necessary, as a socket replacement would meet the patient's activities of daily living and instrumental activities of daily living needs.