Lymphedema pumps (pneumatic compression devices) are generally considered medically necessary for home use for the treatment of lymphedema if the member has undergone a four-week trial of conservative therapy and the treating doctor determines that there has been no significant improvement or if significant symptoms remain after the trial.
The ReidSleeve® (Peninsula Medical, Inc., Scotts Valley, CA) is a custom-fitted, non-elastic sleeve that provides compression to assist in flow of lymphatic fluid. According to the manufacturer’s website, the sleeve contains a foam insert and works by applying high and low pressure to different parts of the affected area. The high-pressure zones force excess fluid into the areas under lower pressure, forming channels by which the lymphatic fluid can be removed through the lymphatic and venous system. The Contour® and Optiflow® sleeves are made by the same manufacturer as the ReidSleeve and use the same technology but are lighter sleeves that are intended for patients with mild to moderate lymphedema. ArmAssist® and LegAssist® (MedAssist Group, Tampa, FL) are other custom-fabricated, non-elastic compression sleeves. CircAid® (CircAid Medical Products Inc., San Diego, CA) is a non-elastic compression sleeve that is available prefabricated and custom-fitted. THe FDA approval was based on the original study that demonstrated that edema in the hands of affected patients was reduced by an average of 80%. U.S. Food and Drug Administration (FDA): The FDA has classified compression sleeves as Class I devices, therapeutic medical binders. They are exempt from the premarket notification procedure. Such devices meet a much lower burden of proof to be considered medically necessary.
Read the Professional version here.