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Enhanced 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 as a treatment for patients with refractory angina and congestive heart failure, as well as for other indications such as erectile dysfunction and ischemic stroke.
EECP uses timed, sequential inflation of pressure cuffs on the calves, thighs, and buttocks 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. EECP has been primarily investigated as a treatment for chronic stable angina.
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 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 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 uses of EECP, i.e., for the treatment of chronic stable angina or 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, 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 is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
03/12/2014: Policy reviewed; no changes.
07/08/2015: Policy title changed from "Enhanced External Counterpulsation (EECP) for Chronic Stable Angina or Congestive Heart Failure" to "Enhanced External Counterpulsation." Policy description updated. Policy statement updated to change "congestive heart failure" to "heart failure."
07/20/2015: Code Reference section updated for ICD-10.
06/06/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.06
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.