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DESCRIPTIONEnhanced external counterpulsation (EECP) is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return. It has been studied primarily in patients with refractory angina and congestive heart failure.
EECP is a noninvasive treatment that uses timed, sequential inflation of pressure cuffs on the legs to augment diastolic pressure, decrease left ventricular afterload, and increase venous return. Augmenting diastolic pressure displaces a volume of blood backwards into the coronary arteries during diastole when the heart is in a state of relaxation and the resistance in the coronary arteries is at a minimum. The resulting increase in coronary artery perfusion pressure may enhance coronary collateral development or increase flow through existing collaterals. In addition, when the left ventricle contracts, it faces a reduced aortic pressure to work against since the counterpulsation has somewhat emptied the aorta.
Intra-aortic balloon counterpulsation is a more familiar, invasive form of counterpulsation that is used as a method of temporary circulatory assistance for the ischemic heart, often after an acute myocardial infarction. In contrast, EECP is thought to provide a permanent effect on the heart by enhancing the development of coronary collateral development. 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 multiple components of the procedure include the use of the device itself, finger plethysmography to follow the blood flow, continuous electrocardiograms (EKGs) to trigger inflation and deflation, and optional use of pulse oximetry to measure oxygen saturation before and after treatment.
While EECP has been primarily researched as a treatment of chronic stable angina, it has also been used in patients with congestive heart failure. The Vasomedical EECP® Therapy System Model has the following labeled indication under 510K clearance from the U.S. Food and Drug Administration (FDA):
"The EECP Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for the use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock."
Cardiomedics, Inc. has FDA 510(k) clearance to market the CardiAssist Counterpulsation System (K022107) and the CardiAssist ECP System (K010261) for the same indications as the Vasomedical EECP® systems.
Note: This policy only addresses the outpatient use of EECP, i.e., for the treatment of chronic stable angina or congestive heart failure. This policy does not address its use for unstable angina pectoris, acute myocardial infarction or cardiogenic shock.
POLICYEnhanced external counterpulsation is considered investigational for the treatment of all indications including, but not limited to, congestive heart failure,chronic stable angina pectoris, erectile dysfunction or ischemic stroke.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/1998: Approved by Medical Policy Advisory Committee (MPAC)
5/2000: Reviewed by MPAC; investigational status maintained
3/26/2001: Codes under "policy guidelines" deleted. Appropriate non-covered codes in table under "code reference"
5/2001: Reviewed by MPAC; investigational status maintained, sources updated
11/12/2001: FEP exception added; Document Reference # not available
2/8/2002: Investigational definition added
4/26/2002: Type of Service and Place of Service deleted
6/12/2002: ICD-9 diagnosis added
9/20/2002: Sources updated
3/2003: Reviewed by MPAC, changed to medically necessary, Sources and Code Reference sections updated
1/10/2007: Policy reviewed, policy statement reversed due to BCBSA review and determined that there is insufficient evidence to draw conclusions about the benefits of EECP.
4/25/2008: Policy reviewed, no changes
10/7/2008: Policy reviewed, erectile dysfunction and ischemic stroke added to the policy statement as investigational
04/23/2010: Policy description updated regarding treatment approaches. Policy statement unchanged. FEP verbiage updated in the Policy Exceptions section. Deleted outdated references from the Sources section.
04/20/2011: Policy reviewed; no changes.
03/02/2012: Policy reviewed; no changes.
05/09/2012: Added "for Chronic Stable Angina or Congestive Heart Failure" to the policy title.
04/17/2013: Policy reviewed; no changes to policy statement. Removed 413.0, 413.1, and 413.9 from the Code Reference section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.06
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.