External Counterpulsation (ECP) Therapy

External Counterpulsation (ECP) is a noninvasive therapy developed for the treatment of coronary artery disease refractory to medical and/or surgical therapy. This therapy is performed using non-invasive external counterpulsation devices cleared by the Food and Drug Administration (FDA) for use in treating a variety of cardiac conditions. Medicare coverage for its use in heart disease is limited to patients with stable angina pectoris who fulfill certain criteria (see Coverage Issues Manual (CIM) Section 35-74).

Recently, questions have arisen concerning Medicare coverage for similar devices cleared by the FDA for the treatment of non-cardiac conditions, particularly lower extremity circulatory disease. The Circulator Boot Corporation requests that HCFA revise CIM section 35-74, contending that HCFA has misinterpreted the original ECP evidence to include non-coverage of other end diastolic pneumatic compression devices intended for the treatment of non-cardiac conditions. In their request, the Circulator Boot Corporation states that "the evidence originally considered for this policy does not support HCFA's statement that other uses of this device and similar devices remain non-covered."

Accordingly, we are currently evaluating whether CIM 35-74 needs to be revised to limit the policy only to ECP devices intended for the treatment of stable angina pectoris. We are requesting that the public submit any information regarding whether CIM 35-74 is relevant to other end diastolic pneumatic compression devices for the treatment of non-cardiac conditions.

July 10, 2001