ECP may be considered medically necessary using an FDA approved device when BOTH of the following are met:
- The individual has been diagnosed with disabling chronic stable angina (Class III or Class IV, New York Heart Association Functional Classification of Cardiac Disability); and
- A cardiologist or cardiothoracic surgeon, documented that the individual is not a candidate for surgical intervention, such as percutaneous coronary intervention (PCI) or cardiac bypass because:
- Their condition is inoperable, or at high risk of operative complications or post-operative failure; or
- Their coronary anatomy is not readily amenable to such procedures; or
- They have co-morbid states which create excessive risk.
A full course of therapy usually consists of up to 35 one (1) hour treatments, which may be offered once (1) or twice (2) daily, usually five (5) days per week.
This procedure must be done under direct supervision of a physician.
ECP for any other indication including, but not limited to, the following is considered not medically necessary:
- Unstable angina
- Acute myocardial infarction
- Cardiogenic shock
- Erectile dysfunction
- Ischemic stroke
Documentation in the medical record must contain a history and physical pertinent to the indications of this policy and be available upon request.
Repeat courses of ECP will be considered medically necessary for individuals with chronic stable angina if ALL of the following criteria are met:
- Individual meets medical necessity criteria for ECP; and
- Prior ECP has resulted in a sustained improvement in symptoms, with;
- A significant (greater than 25%) reduction in frequency of angina symptoms; or
- Improvement by one or more angina classes; and
- Three (3) or more months has elapsed from the prior ECP treatment.
Repeat courses of ECP for any other indication is considered not medically necessary.
Hydraulic versions of ECP devices are non-covered due to the limited use of the device.
New York Heart Association Functional Classification of Cardiac Disability:
|Class I||Individuals with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.|
|Class II||Individuals with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.|
|Class III||Individuals with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.|
|Class IV||Individuals with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased|
Source: American Heart Association, Classes of Heart Failure. 2017.