Medical Policies - Medicine


Enhanced External Counterpulsation (EECP)

Number:MED202.050

Effective Date:10-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Enhanced External Counterpulsation (EECP) may be considered medically necessary for patients who meet ALL the following criteria:

Have been diagnosed with disabling angina (New York Heart Association Class III or IV, or equivalent classification), AND

In the opinion of a cardiologist or cardiothoracic surgeon, are refractory to maximum medical therapy, AND

Are not readily amenable to surgical intervention, such as percutaneous transluminal coronary angioplasty (PTCA) or cardiac bypass because of any of the following:

o Their condition is inoperable, or at high risk of operative complications or postoperative failure; or

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

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

NOTE: 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 use of EECP is considered experimental, investigational and/or unproven for all other indications not noted above including but not limited to the following:

Class II angina (New York Heart Association),

Arrhythmia,

Aortic Insufficiency,

Peripheral vascular disease or phlebitis,

Severe hypertension,

Acute retinal artery occlusion,

Acute myocardial infarction,

Erectile dysfunction,

Ischemic stroke,

Cardiogenic shock, or

Heart failure.

Description:

Enhanced external counterpulsation (EECP) is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return. EECP has been studied primarily as a treatment for patients with refractory angina and heart failure.

Background

Enhanced external counterpulsation 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. The proposed mechanism of action is the augmentation of diastolic pressure by displacement of a volume of blood backward into the coronary arteries during diastole when the heart is in a state of relaxation and 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. Also, when the left ventricle contracts, it faces reduced aortic counterpressure, because 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 (MI). In contrast, EECP is thought to provide a permanent effect on the heart by enhancing the 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 a 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.

Table 1. New York Heart Association and Canadian Cardiovascular Society Functional Classifications

Class

New York Heart Association Functional Classification

Canadian Cardiovascular Society Functional Classification

I

Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina occurs with strenuous or rapid or prolonged exertion at work or recreation.

II

Patients 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.

Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold, in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions.

III

Patients 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.

Marked limitation of ordinary physical activity. Walking one to two blocks on the level and climbing one flight in normal conditions and at a normal pace.

IV

Patient 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.

Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.

Regulatory Status

A variety of EECP devices have been cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process. Examples of EECP devices with FDA clearance are outlined in Table 2. FDA product code: DRN.

Table 2. FDA-Cleared EECP Devices

Device

Manufacturer

Cleared

Indications

Renew® NCP-5 External Counterpulsation System

Renew Group

Dec 2015

Chronic stable angina refractory to optimal anti-anginal medical therapy and without options for revascularization

In healthy patients to improve vasodilation, increase VO2, and increase blood flow

ECP Health System Model

ECP Health

Aug 2005

Stable or unstable angina pectoris

Acute myocardial infarction

Cardiogenic shock

Congestive heart failure

CardiAssist™ Counter Pulsation System

Cardiomedics

Mar 2005

Ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction, and cardiogenic shock

ACS Model NCP-2 External Counterpulsation Device

Applied Cardiac Systems

Aug 2004

Stable or unstable angina pectoris

Acute myocardial infarction

Cardiogenic shock

Congestive heart failure

EECP® Therapy System

Vasomedical

Mar 2004

Stable or unstable angina pectoris

Acute myocardial infarction

Cardiogenic shock

Congestive heart failure

Rationale:

This medical policy was created in January 1998 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through August 31, 2018.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

The literature base consists of a small number of RCTs, some of which have reported relevant clinical outcomes, and others that have reported intermediate, or physiologic outcome measures. Also, there are a large number of observational studies, including publications from enhanced external counterpulsation (EECP) registries and case series, that have generally reported pre- and posttreatment measures of EECP effectiveness.

Chronic Stable Angina

Randomized Controlled Trials

Arora et al. (1999) presented results of the MUST-EECP trial. (1) The MUST-EECP trial applied a randomized controlled, double-blinded protocol that compared active treatment with placebo (inactive counterpulsation sham treatment) among 139 patients with Canadian Cardiovascular Society (CCS) Classification Scales (a functional assessment tool based on the level of exertion that elicits symptoms) class I, II, or III chronic, stable angina. Four outcomes were examined: 1) self-reported frequency of angina, analyzed 2 ways; 2) self-reported use of on-demand nitroglycerin; 3) exercise duration tolerance testing; and 4) time to exercise-induced ischemia (defined as time to depression of ≥1mm in the ST segment on an electrocardiogram).

All patients underwent the same 35-hour protocol, followed by an exercise tolerance test within 1 week of completing therapy. Follow-up beyond the treatment period was not conducted. Intention-to-treat analyses were reported for the angina count and nitroglycerin usage outcomes only. There was a statistically significant difference (p=0.01) between groups in the change in time to 1 mm or greater ST-segment depression. Patients in the EECP group had an average difference of 37 seconds longer time to ST-segment depression than the sham-treated group.

Of the 4 end points of interest, only time to ST-segment depression differed statistically in the EECP group compared with the sham group. The clinical significance of a 37-second improvement in time to ST-segment depression is unknown. That both groups showed increased exercise duration suggests a degree of placebo effect; exercise duration possesses a motivational component that time to ST-segment depression does not.

Arora et al. (2002) published a 12-month follow-up to the MUST-EECP trial. (2) Only 71 (54%) of the original 139 subjects were included in the study. Subjects treated with EECP reported greater improvement in several quality of life (QOL) scales.

A small unblinded RCT published by Bondesson et al. (2011) addressed a single health outcome (change after 7 weeks in CCS angina class), along with multiple intermediate outcomes. (3) Twenty patients with refractory angina (CCS class III) were randomized to EECP or no EECP. Mean CCS class was significantly improved in the EECP group but not in the no-EECP group. At the 7-week follow-up, soluble interleukin-2 receptor (a potential indicator of lymphocyte activation in atherosclerosis) measurements significantly increased in the EECP group and significantly decreased in the no-EECP group.

Additional RCTs have reported on intermediate, or physiologic, outcomes. One such RCT (N=20), published by Gloekler et al. (2010), compared intracoronary blood flows in patients treated using EECP with those treated using a sham procedure. (4) This trial was designed to detect statistically significant differences in collateral flow rates by angiography, not anginal symptoms. After 7 weeks of treatment, collateral flow index increased significantly in the EECP group compared with sham treatment. Similar findings were noted in a comparative study by Buschmann et al. (2009) of 23 patients. (5)

Two publications reported on a single trial evaluating blood flow and other measures of arterial function. (6, 7) This trial randomized 42 patients with coronary artery disease and chronic angina to EECP or sham EECP. EECP improved flow-mediated dilation in the brachial and femoral arteries and improved numerous serum markers of blood flow and inflammation. The same trial also reported that measures of arterial stiffness were improved in the EECP group.

In a randomized pilot study, Shakouri et al. (2015) reported on intermediate outcome measures, including plasma nitric oxide, endothelin 1, and high-sensitivity C-reactive protein levels, as well as QOL, in patients with coronary artery disease allocated to 20 sessions of EECP (n=21) or cardiac rehabilitation (n=21). (8) There were no statistically significant improvements in the physiologic markers and QOL over time in either group and no statistically significant between-group differences in change in any of the parameters evaluated.

Systematic Reviews

This medical policy was originally informed by a Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment (1999) on EECP for chronic stable angina, which was updated in 2002 and again in 2005. (9) These Assessments concluded that the evidence was insufficient to determine whether EECP improved the net health outcome or was as beneficial as any established alternatives in patients with chronic stable angina.

Specifically, the 2005 Assessment offered the following observations and conclusions regarding EECP for chronic stable angina (9):

The results of the single RCT, the Multicenter Study of Enhanced External Counterpulsation (MUST-EECP), must be interpreted with caution given the following factors: 1) the high subject dropout rate; and 2) the uncertain clinical significance of the reported improvement in physiologic measures, especially when intention-to-treat analysis was applied. (1, 2)

Comparative studies of EECP did not address the hard outcomes of cardiac death or recurrent cardiac events, such as myocardial infarction and revascularization procedures. (10, 11)

Several case series and registry-based studies have reported the outcomes of large numbers of patients treated in a number of different institutions. There were several problems with this kind of evidence: 1) these studies, while contributing to the body of knowledge of EECP, did little to address the efficacy or durability of EECP treatment; and 2) the lack of comparison groups made it impossible to rule out either placebo effect or spontaneous recovery among patients with milder disease.

Other systematic reviews have evaluated EECP for chronic stable angina. Amin et al. (2010) published a Cochrane review of major databases through 2008 evaluating evidence of the effectiveness of EECP for chronic angina pectoris. (12) The solitary RCT identified was the MUST-EECP trial. Reviewers highlighted patient selection for this trial. They noted that limiting the study population to patients with CCS class below IV diminished the trial’s generalizability to patients of interest, i.e., patients with the most severe symptoms of chronic angina pectoris.

Shah et al. (2010) published a meta-analysis of prospective studies, not limited to RCTs, of EECP in stable angina in which CCS class was adequately reported before and after treatment. (13) The MUST-EECP RCT was not included because the change in CCS class was not a reported outcome. Thirteen studies met these inclusion criteria (total N=949 patients). Overall, improvement of at least 1 level of angina class occurred in 86% of patients (95% confidence interval, 82% to 90%; p=0.008).

McKenna et al. (2009) reported on a systematic review and economic analysis of EECP for the treatment of stable angina and heart failure. (14) Four studies (1 RCT, 3 nonrandomized comparative studies) comparing EECP treatment with no treatment in adults with chronic stable angina were selected. (1, 2, 10, 11) The systematic review also included a study by Barsheshet et al. (2008) in which 25 patients (15 EECP, 10 controls) were evaluated at the end of treatment. (15) Similar to the Schechter et al. (2003) study, (11) “CCS classification improved with EECP but not with usual care, however statistical analysis of between-group differences was not reported and, for CCS classification, the data were treated as continuous data which is inappropriate for this four-category classification.”

A systematic review and meta-analysis by Qin et al. (2016) focused on the effect of EECP on the intermediate measure of myocardial perfusion in patients with coronary artery disease. (16) Reviewers included 6 studies reporting on myocardial perfusion or coronary flow outcomes published from 1992 to 2007, including 5 RCTs and 1 prospective, observational, blinded study. In the pooled analysis, EECP was associated with increased myocardial perfusion in patients with coronary artery disease (pooled weighted mean difference, -0.19; 95% confidence interval, -0.38 to 0.00; p=0.049).

Registry Studies

Registry-based studies have reported on relatively large numbers of patients. In a registry-based study by Soran et al. (2007), 450 patients with left ventricular dysfunction (ejection fraction, ≤40%) and refractory angina had 0.7 fewer emergency department visits and 0.8 fewer hospitalizations 6 months after treatment with EECP compared with the 6 months before EECP; 6-month data were available on only 81 patients. (17)

Another study from the International Enhanced External Counterpulsation Patient Registry, reported by Loh et al. (2008), provided 3-year results for patients with chronic refractory angina. (18) The registry enrolled 5000 patients from 99 U.S. and 9 international centers between 1999 and 2001. However, this analysis was completed only for those centers that had at least 80% compliance with follow-up data submission; the study reported results on 1427 patients. In this select group, 220 (15.4%) patients died, while 1061 (74.4%) patients completed their follow-up. Immediately post-EECP, the proportion of patients with severe angina (CCS class III or IV) was reduced from 89% to 25% (p<0.001). This improvement was sustained in 74% of the patients during follow-up. More severe baseline angina and a history of heart failure or diabetes were independent predictors of unfavorable outcome.

The International Enhanced External Counterpulsation Patient Registry data have also been examined to determine the safety and efficacy of EECP in patients with peripheral arterial disease (PAD). PAD, while a common comorbidity of coronary artery disease, has been regarded as a contraindication to EECP due to concerns about compression on peripheral blood flow and a potentially greater risk of aortic rupture. Thakkar et al. (2010) compared registry data in patients who had PAD with those who did not. (19) Based on a reduction of 1 or more CCS angina classes, patients with PAD had a similar rate of improvement as did the group without PAD (76.6% vs 79.0%, respectively; p=0.27). Rates of hospitalization for all cardiac causes (6.1% vs 4.4%, respectively; p=0.17) and for unstable angina (5.4% vs 3.5%, respectively; p=0.25) were also similar between groups.

Observational Studies

Numerous individual observational studies have been detailed above and are included in systematic reviews previously described (2, 5, 10, 11, 15, 20) For example, 2 prospective cohort studies (N=55 and N=61) with 1-year outcomes have been reported. (21, 22) Improved CCS classification was the main reported outcome, which was maintained for 1 year in 79% and 78% of patients in the respective studies. Both studies had higher rates of treatment completion, and follow-up than the previously reported (registry) studies assessing long-term outcomes.

Section Summary: Chronic Stable Angina

The single randomized trial (MUST-EECP) that included relevant clinical outcomes reported a benefit on 1 of 4 main angina-related outcomes, and the magnitude of this benefit was of uncertain clinical significance. RCTs that have reported on intermediate outcomes offer evidence on possible physiologic mechanisms underlying EECP treatment. Observational studies (e.g., registry data, case series) offer some evidence as to efficacy.

Heart Failure

The U.S. Food and Drug Administration (FDA) 510(k) approval of the Vasomedical devices stated that objective measures, such as peak oxygen consumption, exercise duration, and preload-adjusted maximal left ventricular power, are improved following EECP therapy, as are subjective measures of patient response to therapy, such as QOL and functional ability. (23) However, no clinical details of these studies were provided in the FDA summary, and these data were not from controlled trials.

The 2005 BCBSA TEC Assessment included heart failure in its analysis and concluded the evidence supporting the role of EECP as an effective treatment for heart failure was lacking in both quantity and quality. (9) A single randomized, multicenter study has compared EECP with usual care in 187 optimally medically managed patients with New York Heart Association functional class II or III heart failure who had an ejection fraction of 35% or less of ischemic or idiopathic etiology. (24) This study, the Prospective Evaluation of EECP in Congestive Heart Failure (PEECH trial), was mostly inconclusive. The trial design and methodology were published by Feldman et al. (2005). (23) PEECH trial results, as reported by Feldman et al. (2006), indicated statistically improved, but modest, changes in exercise duration and improved functional class but not in QOL or peak oxygen consumption. (24)

A 2006 subgroup analysis of the PEECH trial showed that subjects ages 65 years and older treated with EECP (n=41) were more likely to meet the exercise duration (35% vs 25% increased by ≥60 seconds) and peak oxygen consumption (30% vs 11% increased by ≥1.25 mL/kg/min) improvement thresholds compared with those undergoing sham treatment (n=45); there was no difference at 6 months in New York Heart Association class. (25)

Rampengan et al. (2015) reported on a double-blinded RCT evaluating EECP in patients with congestive heart failure treated in Indonesia. (26) Patients with New York Heart Association functional class I or II symptomatic heart failure of various causes were included. Patients were randomized to active EECP (n=56) or sham EECP (n=56), which involved the use of the EECP device at only 77 mm Hg of pressure vs the standard 300 mm Hg. The analysis was per protocol, excluding 6 and 7 patients who dropped out of the active and sham groups, respectively. Postintervention, active EECP group patients were more likely to have a 6-minute walk distance of 300 meters or greater (98.0% vs 32.7%, p<0.01). The change in 6-minute walk distance was greater (improved) for the active EECP patients (192.6 meters) than for the sham control patients (-9 meters; p<0.05).

Similar to the registry evidence for EECP for angina, registry studies for heart failure have provided relatively little insight into the comparative efficacy of EECP. (27-30) A single-arm study by Soran et al. (2002) indicated that patients showed some improvements, but the lack of a comparison arm precluded inferences about the true effects of therapy. (31)

The previously described review by McKenna (2009) (14) included the only trial of EECP for heart failure available at that time, the 2006 PEECH study. (24) Reviewers concluded that the studies did not provide firm evidence of the clinical effectiveness of EECP in heart failure and that high-quality studies would be required to investigate the benefits of EECP and whether they outweigh the common adverse events.

Section Summary: Heart Failure

The evidence for the use of EECP in heart failure includes 2 RCTs that reported on clinical outcomes. One study reported modest improvements for some outcomes and none on others. A second study reported improvements in the 6-minute walk test but had methodologic limitations that, in turn, limited the conclusions that could be drawn from the study. The observational studies added little to the evaluation of efficacy due to the variable natural history of heart failure, the multiple confounding variables for cardiac outcomes, and the potential for a placebo effect. Further high-quality RCTs would be needed to determine whether EECP is a useful treatment for heart failure.

Other Indications

The use of EECP for other conditions associated with ischemia or vascular dysfunction has been investigated. In a Cochrane review, Fraser and Adams (2009) evaluated interventions for central retinal artery occlusion. (32) One of the 2 RCTs identified compared hemodilution with EECP against hemodilution without further intervention. In this trial by Werner et al. (2004), the EECP intervention was a single, 2-hour treatment. (33) According to reviewers, in this study, 20 patients were randomized but not blinded; no sham treatment was given. Primary outcomes were Doppler flowmetry of retinal perfusion and visual acuity.

Published registry studies have also demonstrated improvements in erectile function. Erectile function was improved in a study by Lawson et al. (2007) of 120 men prospectively enrolled from 16 centers. (34) Three of 5 domains of the International Index of Erectile Function were statistically improved with EECP treatment (erectile function, intercourse satisfaction, overall satisfaction), and the total score improved from 28 to 32, a statistically significant improvement. The noncomparative design of this study makes drawing conclusions on treatment efficacy difficult.

Preliminary studies from Asia have also reported on early results using EECP to treat the lower extremities after acute ischemic stroke. (35) A Cochrane review by Lin et al. (2012) assessed 2 RCTs of EECP in acute ischemic stroke concluded that the methodologic quality of the studies was poor and reliable conclusions could not be reached from this evidence. (36)

Sardina et al. (2016) reported on an RCT that allocated 30 patients with type 2 diabetes in a 2:1 ratio to EECP (n=20) or standard care for diabetes (n=10), and reported results out to 3 (37) and 6 months. (38) At 6-month follow-up, patients in the EECP group had significant decreases in variety of biomarkers of advanced glycation end products, inflammation, and oxidative stress; the percent change in advanced glycation end products and receptor of advanced glycation end products differed significantly between groups (p<0.05).

Summary of Evidence

For individuals who have chronic stable angina who receive enhanced external counterpulsation (EECP), the evidence includes randomized controlled trials (RCTs), observational studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. There is a single-blind RCT that includes clinical outcomes, and it reported benefit on only 1 of 4 main angina outcomes. Additional small RCTs have reported changes in physiologic measures associated with EECP. Observational studies, including registry studies with large numbers of patients, add evidence, although limited.

For individuals who have heart failure who receive EECP, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. One RCT that reported on clinical outcomes found a modest benefit with EECP on some outcomes but not others. A second RCT reported improvements on the 6-minute walk test with EECP but had methodologic limitations; RCT findings ultimately proved inconclusive. The observational studies on EECP in heart failure have limited ability to inform the evidence on EECP due to the multiple confounding variables for cardiac outcomes and the potential for a placebo effect. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have other conditions related to ischemia or vascular dysfunction who receive EECP, the evidence includes RCTs, registry studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and functional outcomes. Two RCTs have assessed use of EECP for treatment of central retinal artery occlusion; both trials had methodologic limitations. Registry studies of erectile function have reported improvements for some outcomes with ECCP but design shortcomings limit conclusions drawn. EECP has also been used to treat acute ischemic stroke, but the evidence base in is not robust. EECP has been used in a small RCT to treat type 2 diabetes. Reported follow-up was short term. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

The American College of Cardiology Foundation, American Heart Association, and 5 other medical societies published joint guidelines (2012) that recommended: “[patients with stable ischemic heart disease who indicate for enhanced external counterpulsation (EECP)] may be considered for relief of refractory angina.” This recommendation was class IIb, based on level B evidence (i.e., the efficacy of the intervention is not well established, and further studies would be helpful). (39)

In 2014, the American College of Cardiology Foundation and American Heart Association updated to these joint guidelines. (40) Based on this review, the groups did not change their recommendation on EECP from the 2012 guidelines.

The American College of Cardiology Foundation and American Heart Association issued guidelines (2013) on the management of heart failure but did not address EECP. (41)

Medicare National Coverage

Medicare has published a national coverage decision on EECP that mandates coverage for the following indications (42):

“Coverage is provided for the use of EECP for patients who have been diagnosed with disabling angina who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention, such as percutaneous transluminal coronary angioplasty 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 amendable to such procedures; or 3) They have co-morbid states which create excessive risk.”

Medicare’s coverage decision also noted that while the U.S. Food and Drug Administration has cleared EECP “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….”

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov did not identify any ongoing or unpublished trials that would likely influence this medical policy.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

92971

HCPCS Codes

G0166

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Arora RR, Chou TM, Jain D, et al. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. Jun 1999; 33(7):1833-1840. PMID 10362181

2. Arora RR, Chou TM, Jain D, et al. Effects of enhanced external counterpulsation on Health-Related Quality of Life continue 12 months after treatment: a substudy of the Multicenter Study of Enhanced External Counterpulsation. J Investig Med. Jan 2002; 50(1):25-32. PMID 11813825

3. Bondesson SM, Edvinsson ML, Pettersson T, et al. Reduced peripheral vascular reactivity in refractory angina pectoris: Effect of enhanced external counterpulsation. J Geriatr Cardiol. Dec 2011; 8(4):215-223. PMID 22783308

4. Gloekler S, Meier P, de Marchi SF, et al. Coronary collateral growth by external counterpulsation: a randomised controlled trial. Heart. Feb 2010; 96(3):202-207. PMID 19897461

5. Buschmann EE, Utz W, Pagonas N, et al. Improvement of fractional flow reserve and collateral flow by treatment with external counterpulsation (Art.Net.-2 Trial). Eur J Clin Invest. Oct 2009; 39(10):866-875. PMID 19572918

6. Braith RW, Conti CR, Nichols WW, et al. Enhanced external counterpulsation improves peripheral artery flow- mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. Oct 19 2010; 122(16):1612-1620. PMID 20921442

7. Casey DP, Beck DT, Nichols WW, et al. Effects of enhanced external counterpulsation on arterial stiffness and myocardial oxygen demand in patients with chronic angina pectoris. Am J Cardiol. May 15 2011; 107(10):1466-1472. PMID 21420062

8. Shakouri SK, Razavi Z, Eslamian F, et al. Effect of enhanced external counterpulsation and cardiac rehabilitation on quality of life, plasma nitric oxide, endothelin 1 and high sensitive CRP in patients with coronary artery disease: a pilot study. Ann Rehabil Med. Apr 2015; 39(2):191-198. PMID 25932415

9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). External Counterpulsation for Treatment of Chronic Stable Angina Pectoris and Chronic Heart Failure. TEC Assessments. 2005; 20; Tab 12.

10. Holubkov R, Kennard ED, Foris JM, et al. Comparison of patients undergoing enhanced external counterpulsation and percutaneous coronary intervention for stable angina pectoris. Am J Cardiol. May 15 2002; 89(10):1182-1186. PMID 12008172

11. Shechter M, Matetzky S, Feinberg MS, et al. External counterpulsation therapy improves endothelial function in patients with refractory angina pectoris. J Am Coll Cardiol. Dec 17 2003; 42(12):2090-2095. PMID 14680732

12. Amin F, Al Hajeri A, Civelek B, et al. Enhanced external counterpulsation for chronic angina pectoris. Cochrane Database Syst Rev. 2010(2):CD007219. PMID 20166092

13. Shah SA, Shapiro RJ, Mehta R, et al. Impact of enhanced external counterpulsation on Canadian Cardiovascular Society angina class in patients with chronic stable angina: a meta-analysis. Pharmacotherapy. Jul 2010; 30(7):639-645. PMID 20575628

14. McKenna C, McDaid C, Suekarran S, et al. Enhanced external counterpulsation for the treatment of stable angina and heart failure: a systematic review and economic analysis. Health Technol Assess. Apr 2009; 13(24): iii-iv, ix-xi, 1-90. PMID 19409154

15. Barsheshet A, Hod H, Shechter M, et al. The effects of external counter pulsation therapy on circulating endothelial progenitor cells in patients with angina pectoris. Cardiology. 2008; 110(3):160-166. PMID 18057883

16. Qin X, Deng Y, Wu D, et al. Does enhanced external counterpulsation (EECP) Significantly affect myocardial perfusion? A systematic review & meta-analysis. PLoS One. 2016; 11(4):e0151822. PMID 27045935

17. Soran O, Kennard ED, Bart BA, et al. Impact of external counterpulsation treatment on emergency department visits and hospitalizations in refractory angina patients with left ventricular dysfunction. Congest Heart Fail. Jan- Feb 2007; 13(1):36-40. PMID 17268208

18. Loh PH, Cleland JG, Louis AA, et al. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. Apr 2008; 31(4):159-164. PMID 18404725

19. Thakkar BV, Hirsch AT, Satran D, et al. The efficacy and safety of enhanced external counterpulsation in patients with peripheral arterial disease. Vasc Med. Feb 2010; 15(1):15-20. PMID 19841026

20. Kumar A, Aronow WS, Vadnerkar A, et al. Effect of enhanced external counterpulsation on clinical symptoms, quality of life, 6-minute walking distance, and echocardiographic measurements of left ventricular systolic and diastolic function after 35 days of treatment and at 1-year follow up in 47 patients with chronic refractory angina pectoris. Am J Ther. Mar-Apr 2009; 16(2):116-118. PMID 19300038

21. Pettersson T, Bondesson S, Cojocaru D, et al. One year follow-up of patients with refractory angina pectoris treated with enhanced external counterpulsation. BMC Cardiovasc Disord. 2006; 6:28. PMID 16776842

22. Loh PH, Louis AA, Windram J, et al. The immediate and long-term outcome of enhanced external counterpulsation in treatment of chronic stable refractory angina. J Intern Med. Mar 2006; 259(3):276-284. PMID 16476105

23. Feldman AM, Silver MA, Francis GS, et al. Treating heart failure with enhanced external counterpulsation (EECP): design of the Prospective Evaluation of EECP in Heart Failure (PEECH) trial. J Card Fail. Apr 2005; 11(3):240-245. PMID 15812754

24. Feldman AM, Silver MA, Francis GS, et al. Enhanced external counterpulsation improves exercise tolerance in patients with chronic heart failure. J Am Coll Cardiol. Sep 19 2006; 48(6):1198-1205. PMID 16979005

25. Abbottsmith CW, Chung ES, Varricchione T, et al. Enhanced external counterpulsation improves exercise duration and peak oxygen consumption in older patients with heart failure: a subgroup analysis of the PEECH trial. Congest Heart Fail. Nov-Dec 2006; 12(6):307-311. PMID 17170583

26. Rampengan SH, Prihartono J, Siagian M, et al. The effect of enhanced external counterpulsation therapy and improvement of functional capacity in chronic heart failure patients: a randomized clinical trial. Acta Med Indones. Oct 2015; 47(4):275-282. PMID 26932695

27. Soran O, Kennard ED, Kelsey SF, et al. Enhanced external counterpulsation as treatment for chronic angina in patients with left ventricular dysfunction: a report from the International EECP Patient Registry (IEPR). Congest Heart Fail. Nov-Dec 2002; 8(6):297-302. PMID 12461318

28. Lawson WE, Kennard ED, Holubkov R, et al. Benefit and safety of enhanced external counterpulsation in treating coronary artery disease patients with a history of congestive heart failure. Cardiology. 2001; 96(2):78-84. PMID 11740136

29. Lawson WE, Silver MA, Hui JC, et al. Angina patients with diastolic versus systolic heart failure demonstrate comparable immediate and one-year benefit from enhanced external counterpulsation. J Card Fail. Feb 2005; 11(1):61-66. PMID 15704066

30. Vijayaraghavan K, Santora L, Kahn J, et al. New graduated pressure regimen for external counterpulsation reduces mortality and improves outcomes in congestive heart failure: a report from the Cardiomedics External Counterpulsation Patient Registry. Congest Heart Fail. May-Jun 2005; 11(3):147-152. PMID 15947536

31. Soran O, Fleishman B, Demarco T, et al. Enhanced external counterpulsation in patients with heart failure: a multicenter feasibility study. Congest Heart Fail. Jul-Aug 2002; 8(4):204-208, 227. PMID 12147943

32. Fraser SG, Adams W. Interventions for acute non-arteritic central retinal artery occlusion. Cochrane Database Syst Rev. 2009(1):CD001989. PMID 19160204

33. Werner D, Michalk F, Harazny J, et al. Accelerated reperfusion of poorly perfused retinal areas in central retinal artery occlusion and branch retinal artery occlusion after a short treatment with enhanced external counterpulsation. Retina. Aug 2004; 24(4):541-547. PMID 15300074

34. Lawson WE, Hui JC, Kennard ED, et al. Effect of enhanced external counterpulsation on medically refractory angina patients with erectile dysfunction. Int J Clin Pract. May 2007; 61(5):757-762. PMID 17493089

35. Han JH, Leung TW, Lam WW, et al. Preliminary findings of external counterpulsation for ischemic stroke patient with large artery occlusive disease. Stroke. Apr 2008; 39(4):1340-1343. PMID 18309160

36. Lin S, Liu M, Wu B, et al. External counterpulsation for acute ischaemic stroke. Cochrane Database Syst Rev. 2012; 1:CD009264. PMID 22259001

37. Sardina PD, Martin JS, Avery JC, et al. Enhanced external counterpulsation (EECP) improves biomarkers of glycemic control in patients with non-insulin-dependent type II diabetes mellitus for up to 3 months following treatment. Acta Diabetol. May 14 2016. PMID 27179825

38. Sardina PD, Martin JS, Dzieza WK, et al. Enhanced external counterpulsation (EECP) decreases advanced glycation end products and proinflammatory cytokines in patients with non-insulin-dependent type II diabetes mellitus for up to 6 months following treatment. Acta Diabetol. Jun 9 2016. PMID 27278477

39. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. Dec 18 2012; 60(24):e44-e164. PMID 23182125

40. Fihn SD, Blankenship JC, Alexander KP, et al. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. Nov 4 2014; 64(18):1929-1949. PMID 25077860

41. Writing Committee M, Yancy CW, Jessup M, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. Oct 15 2013; 128(16):e240-327. PMID 23741058

42. Center for Medicare & Medicaid Services (CMS). National Coverage Determination for external counterpulsation (ECP) therapy for severe angina (20.20). 2006. Available at: <https://www.cms.gov> (accessed August 31, 2018).

43. Enhanced External Counterpulsation (EECP) for Chronic Stable Angina or Congestive Heart Failure. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 May) Medicine 2.02.06.

Policy History:

Date Reason
10/15/2018 Document updated with literature review. Coverage unchanged. Added reference 42.
8/15/2017 Reviewed. No changes.
10/1/2016 Document updated with literature review. Coverage unchanged.
6/1/2015 Reviewed. No changes.
8/1/2014 Document updated with literature review. Coverage unchanged.
8/15/2013 Document updated with literature review. The following was added: Enhanced External Counterpulsation (EECP) may be considered medically necessary for patients who meet all the following criteria: 1) Have been diagnosed with disabling angina (New York Heart Association Class III or IV, or equivalent classification) 2) In the opinion of a cardiologist or cardiothoracic surgeon, are refractory to maximum medical therapy, and 3) Are not readily amenable to surgical intervention, such as PTCA or cardiac bypass because of any of the following: Their condition is inoperable, at high risk of operative complications or postoperative failure, their coronary anatomy is not readily amenable to such procedures, or they have co-morbid states that create excessive risk. In addition, the following was added: The use of EECP is considered experimental, investigational and unproven for all other indications including but not limited to class II angina, arrhythmia, aortic insufficiency, peripheral vascular disease or phlebitis, severe hypertension, acute retinal artery occlusion, acute myocardial infarction, erectile dysfunction, ischemic stroke, cardiogenic shock, or heart failure.
8/15/2010 Revised/Updated Entire Document. Document updated with literature review. Coverage unchanged and remains experimental, investigational and unproven for all indications. An additional two indications (erectile dysfunction and ischemic stroke) added under examples of experimental, investigational, and unproven indications.
6/15/2008 Revised/Updated Entire Document
4/15/2006 Revised/Updated Entire Document
12/1/2003 Revised/Updated Entire Document
11/1/2000 Revised/Updated Entire Document
5/1/2000 Revised/Updated Entire Document
3/1/2000 Revised/Updated Entire Document
8/1/1999 Revised/Updated Entire Document
6/1/1999 Revised/Updated Entire Document
8/1/1998 New Medical Document

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