Pneumatic Compression Devices

Pneumatic compression devices consist of an inflatable garment for the arm or leg and an electrical pneumatic pump that fills the garment with compressed air. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices.

Pneumatic devices are covered for the treatment of lymphedema or for the treatment of chronic venous insufficiency with venous stasis ulcers.

Lymphedema

Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. The accumulation of lymph fluid results from impairment to the normal clearing function of the lymphatic system and/or from an excessive production of lymph. Lymphedema is divided into two broad classes according to etiology. Primary lymphedema is a relatively uncommon, chronic condition which may be due to such causes as Milroy's Disease or congenital anomalies. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as surgical removal of lymph nodes or post radiation fibrosis, among other causes.

Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the patient has undergone a four-week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.

Chronic Venous Insufficiency With Venous Stasis Ulcers

Chronic venous insufficiency (CVI) of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins. Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers.

Pneumatic compression devices are covered in the home setting for the treatment of CVI of the lower extremities only if the patient has one or more venous stasis ulcer(s) which have failed to heal after a 6 month trial of conservative therapy directed by the treating physician. The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.

General Coverage Criteria

Pneumatic compression devices are covered only when prescribed by a physician and when they are used with appropriate physician oversight, i.e., physician evaluation of the patient's condition to determine medical necessity of the device, assuring suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment.

The determination by the physician of the medical necessity of a pneumatic compression device must include:

1. The patient's diagnosis and prognosis;
2. Symptoms and objective findings, including measurements which establish the severity of the condition;
3. The reason the device is required, including the treatments which have been tried and failed; and
4. The clinical response to an initial treatment with the device.

The clinical response includes the change in pre-treatment measurements, ability to tolerate the treatment session and parameters, and ability of the patient (or caregiver) to apply the device for continued use in the home.

The only time that a segmented, calibrated gradient pneumatic compression device (HCPCs code E0652) would be covered is when the individual has unique characteristics that prevent them from receiving satisfactory pneumatic compression treatment using a nonsegmented device in conjunction with a segmented appliance or a segmented compression device without manual control of pressure in each chamber.

09/1986 - Added section to place lymphedema pumps and accompanying information together. Non-segmental pumps are already covered. Segmental lymphedema pumps, previously noncovered, are now covered as DME if necessary criteria are met. Effective date 09/19/1986. (TN 9)

06/1995 - Clarified that nonsegmented and segmented pump without manual control of pressure in each chamber is considered the least costly alternative that meets the clinical needs of the individual for this type of DME, unless there is documentation that warrants payment of the more costly manual control pump. Effective date NA. (TN 77)

10/1995 - Changed effective date for TN 77 from NA to 06/01/1995. Effective date 06/01/1995. (TN 81)

12/2001 - Clarified policy by dividing it into 2 separate parts based on indications and establishes different coverage criteria for the 2 different indications. Effective and implementation dates 01/14/2001. (TN 148) (CR 1944)

01/2002 - Clarified language previously found in TN 148 so that it is clear when segmented, calibrated gradient pneumatic compression devices will be covered. Effective and implementaiton dates 01/14/2002. (TN 151) (CR 1944)