CMS Pub. 100-03, ch. 1, § 20.20

(Effective March 20, 2006)

(Rev. 50, Issued: 03-31-06; Effective: 03-20-06; Implementation: 04-03-06)

A. General

External counterpulsation (ECP), commonly referred to as enhanced external

counterpulsation, is a noninvasive outpatient treatment for coronary artery disease

refractory to medical and/or surgical therapy. Although ECP devices are cleared by the

Food and Drug Administration (FDA) for use in treating a variety of cardiac conditions,

including stable or unstable angina pectoris, acute myocardial infarction and cardiogenic

shock, the use of this device to treat cardiac conditions other than stable angina pectoris is

not covered, since only that use has developed sufficient evidence to demonstrate its

medical effectiveness. Non-coverage of hydraulic versions of these types of devices

remains in force.

B. Nationally Covered Indications

Effective for services performed on or after July 1, 1999, coverage is provided for the use

of ECP for patients who have been diagnosed with disabling angina (Class III or Class

IV, Canadian Cardiovascular Society Classification or equivalent classification) who, in

the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to

surgical intervention, such as PTCA or cardiac bypass, because:

1. Their condition is inoperable, or at high risk of operative complications or post-operative failure;

2. Their coronary anatomy is not readily amenable to such procedures; or

3. They have co-morbid states that create excessive risk.

A full course of therapy usually consists of 35 one-hour treatments which may be offered

once or twice daily, usually 5 days per week. The patient is placed on a treatment table

where their lower trunk and lower extremities are wrapped in a series of three

compressive air cuffs which inflate and deflate in synchronization with the patient’s

cardiac cycle.

During diastole, the three sets of air cuffs are inflated sequentially (distal to proximal)

compressing the vascular beds within the muscles of the calves, lower thighs and upper

thighs. This action results in an increase in diastolic pressure, generation of retrograde

arterial blood flow and an increase in venous return. The cuffs are deflated

simultaneously just prior to systole which produces a rapid drop in vascular impedance, a

decrease in ventricular workload and an increase in cardiac output.

The augmented diastolic pressure and retrograde aortic flow appear to improve

myocardial perfusion, while systolic unloading appears to reduce cardiac workload and

oxygen requirements. The increased venous return coupled with enhanced systolic flow

appears to increase cardiac output. As a result of this treatment, most patients experience

increased time until onset of ischemia, increased exercise tolerance, and a reduction in

the number and severity of anginal episodes. Evidence was presented that this effect

lasted well beyond the immediate post-treatment phase, with patients symptom-free for

several months to 2 years. This procedure must be done under direct supervision of a

physician.

C. Nationally Non-Covered Indications

All other cardiac conditions not otherwise specified as nationally covered for the use of

ECP remain nationally non-covered.

(This NCD last reviewed March 2006.)