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.
Brennan MJ, Miller LT. Overview of treatment options and review of the current role and use of compression garments, intermittent pumps, and exercise in the management of lymphedema. Cancer 1998; 83:2821.
Poage E, Singer M, Armer J, Poundall M, Shellabarger MJ. Demystifying lymphedema: development of the lymphedema putting evidence into practice card. Clin J Oncol Nurs 2008 Dec;12(6):951-64. [61 references]
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