This document addresses the use of devices that create compression for the treatment of lymphedema. This therapy involves the use of garments designed for various body parts and include mechanisms intended to compress specific body parts targeted for treatment. Compression devices may be used in clinics or can be purchased or rented for home use. This document addresses the home use of compression devices used to treat lymphedema.

Note: This document addresses devices for the treatment of lymphedema only. Compression devices used in the treatment or prevention of venous thrombosis, venous insufficiency with refractory edema or ulceration, and therapy for musculoskeletal injury are NOT addressed in this document. For information regarding the use of compression devices for other indications please see:

• CG-DME-46 Pneumatic Compression Devices for Prevention of Deep Vein Thrombosis of the Extremities in the Home Setting

Note: This document does not address compression devices with combined cooling or heating functions intended to treat conditions other than lymphedema. For more information regarding such devices, please see:

• DME.00037 Cooling Devices and Combined Cooling/Heating Devices

Note: This document does not address gradient compression sleeves used to treat upper extremity lymphedema following breast surgery. Such sleeves are considered DME and may be subject to the WHCRA coverage mandate.

Note: The Women’s Health and Cancer Rights Act of 1998 (WHCRA) is federal legislation that provides that any individual with insurance coverage who is receiving benefits in connection with a mastectomy covered by their benefit plan (whether or not for cancer) who elects breast reconstruction, must receive coverage for the reconstructive services as provided by WHCRA. This includes reconstruction of the breast on which the mastectomy has been performed, surgery and reconstruction of the other breast to produce a symmetrical appearance and prostheses and treatment of physical complications of all stages of the mastectomy including lymphedemas. If additional surgery is required for either breast for treatment of physical complications of the implant or reconstruction, surgery on the other breast to produce a symmetrical appearance is reconstructive at that point as well. The name of this law is misleading because: 1) cancer does not have to be the reason for the mastectomy; and 2) the mandate applies to men, as well as women. WHCRA does not address lumpectomies. Some states have enacted similar legislation, and some states include mandated benefits for reconstructive services after lumpectomy.

Clinical Indications

Medically Necessary:

Single or multi-chamber or segment non-programmable compression devices are considered medically necessary when the criteria below have been met:

1. Treatment of upper or lower limb lymphedema; and
2. The individual’s lymphedema is not improving; and
3. The individual has been compliant with conservative therapy*

*Conservative therapy may include any combination of the following: elevation of the affected limb, exercise, massage, use of an appropriate compression bandage system or compression garment.

Single or multi-chamber or segment programmable (for example, calibrated gradient pressure) compression devices are considered medically necessary when the criteria below have been met:

1. The criteria above for a non-programmable compression device have been met: and
2. Criteria 1 or 2 below have been met:
   1. All of the below:
      1. A single or multi-chamber or segment non-programmable compression device has been tried for a minimum of 3 months; and
      2. There is documentation of compliance with treatment with the non-programmable pneumatic compression device; and
      3. The records provide objective documentation that lymphedema has progressed;
         or
   2. There is clear documentation of a condition that prevents the satisfactory treatment of lymphedema with a non-programmable device. Such conditions may include, but are not limited to the following:
      1. Contracture; or
      2. Sensitive skin; or
      3. Significant scarring.

Not Medically Necessary:

Single or multi-chamber or segment programmable or non-programmable compression devices for the treatment of upper or lower limb lymphedema are considered not medically necessary when the criteria above have not been met.

Two-stage* multi-chamber or segment programmable compression devices are considered not medically necessary for the treatment of upper or lower limb lymphedema.

*Note: Two-stage devices involve an initial programmed compression of the chest and/or trunk, the “preparatory stage,” followed by a second programmed compression of the affected limb(s), the “drainage” stage.

The use of compression devices to treat lymphedema in any body part other than the upper or lower extremities is considered not medically necessary.