CMS Pub. 100-03, ch. 1, § 280.6

CIM 60-16

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 six 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 pretreatment 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.

Cross Reference: §280.1.