MEDICAL POLICY SUBJECT: ENHANCED EXTERNAL COUNTERPULSATION

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1 MEDICAL POLICY PAGE: 1 OF: 4 If the member's subscriber contract excludes coverage for a specific service it is not covered under that contract. In such cases, medical policy criteria are not applied. Medical policies apply to commercial and Medicaid products only when a contract benefit for the specific service exists. Medical policies only apply to Medicare products when a contract benefit exists and where there are no National or Local Medicare coverage decisions for the specific service. POLICY STATEMENT: I. Based upon our criteria and assessment of the peer-reviewed literature, enhanced external counterpulsation (EECP) has been medically proven to be effective and therefore, medically appropriate in patients with disabling angina (class III or class IV Canadian Cardiovascular Society Classification, or equivalent) who, in the opinion of the cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention (e.g., PTCA, cardiac bypass) and are refractory to medical treatment because: A. their condition is inoperable, at high risk of operative complications, or post-operative failure; or B. their coronary anatomy is not readily amenable to such procedures; or C. they have co-morbid states that create excessive risk. II. Based upon our criteria and the lack of peer-reviewed literature EECP has not been medically proven to be effective and is considered investigational for all other indications, including but not limited to, congestive heart failure. POLICY GUIDELINES: The Federal Employee Health Benefit Program (FEHBP/FEP) requires that procedures, devices or laboratory tests approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational and thus these procedures, devices or laboratory tests may be assessed only on the basis of their medical necessity. DESCRIPTION: Enhanced External Counterpulsation (EECP) is a noninvasive treatment indicated as adjunctive therapy for patients with chronic coronary artery disease and left ventricular dysfunction refractory to medical or surgical management. It is a noninvasive analogue of the intra-aortic balloon pump designed to increase myocardial perfusion pressure and decrease cardiac workload. EECP has been primarily investigated as a treatment for chronic stable angina. EECP equipment is comprised of 3 major components: a control console, a treatment table and sequentially inflatable pressure cuffs. EECP involves sequential inflation and deflation of compressive cuffs wrapped around the patient s calves, lower thighs, upper thighs and buttocks to augment diastolic pressure, decrease left ventricular afterload and increase venous return. The resulting increase in coronary artery perfusion pressure may enhance coronary collateral development or increase flow through existing collaterals. Inflation and deflation of cuffs are activated by events in the cardiac cycle via microprocessor-interpreted electrocardiographic (ECG) signals. The treatment regimen established to date includes ECP one or two hours a day, five days a week, for a total of 35 hours. RATIONALE: The FDA 510(k) approval of the original EECP device was for the treatment of stable and unstable angina pectoris, acute myocardial infarction, or cardiogenic shock. In 2002, Vasomedical, Inc received FDA clearance to market the EECP Therapy System Model TS3 with Pulse Oximetry for the treatment of congestive heart failure, stable and 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.

2 PAGE: 2 OF: 4 Evidence in the peer-reviewed literature is sufficient to permit conclusions that EECP is a safe and effective treatment for patients with disabling angina who are not surgical candidates. The effectiveness of EECP for conditions other than stable disabling angina has not been established in the peerreviewed medical literature. The 2005 BCBS Association TEC Assessment included congestive heart failure in the analysis of EECP and concluded that the evidence supporting the role of EECP as an effective treatment for heart failure is lacking in both quantity and quality. Evidence is insufficient to determine whether EECP improves the net health outcome, or is as beneficial as any established alternatives in patients with chronic stable heart failure. The PEECH trial (Prospective Evaluation of EECP in Congestive Heart Failure ), a randomized, multi-center study (Feldman, 2006) compared EECP for CHF to usual care in 187 optimally medically managed patients with NYHA functional class II/III heart failure of ischemic or idiopathic etiology and an EF less than or equal to 35%. Findings were mostly inconclusive. The study found statistically improved, but modest, changes in exercise tolerance, quality of life, and NYHA functional classification without an accompanying increase in peak oxygen uptake. The 2005 ACC/AHA guideline update for the diagnosis and management of chronic heart failure states: The technique of external counterpulsation involves the use of a device with inflatable cuffs that surround the lower limbs and inflate and deflate in synchronization with the cardiac cycle. The device is designed to reduce loading conditions in systole while increasing coronary perfusion pressures in diastole. External counterpulsation has been shown to reduce the frequency and severity of anginal attacks in patients with symptomatic coronary artery disease. A possible mechanism of action for this observed clinical effect may be an improvement in endothelial function of the coronary vascular bed. Early trials of this therapy in patients with HF and low EF have been encouraging, and a randomized trial has been completed recently. Until more data are available, routine use of this therapy cannot be recommended for the management of patients with symptomatic reduced LVEF. CODES: Number Description Eligibility for reimbursement is based upon the benefits set forth in the member s subscriber contract. CODES MAY NOT BE COVERED UNDER ALL CIRCUMSTANCES. PLEASE READ THE POLICY AND GUIDELINES STATEMENTS CAREFULLY. Codes may not be all inclusive as the AMA and CMS code updates may occur more frequently than policy updates. Code Key: Experimental/Investigational = (E/I), Not medically necessary/ appropriate = (NMN). CPT: Cardioassist method of circulatory assist; external (not specific for ECP) Copyright 2014 American Medical Association, Chicago, IL HCPCS: G0166 External counterpulsation, per treatment session ICD9: Angina decubitus Other and unspecified angina pectoris Coronary atherosclerosis ICD10: I20.8-I20.9 Angina pectoris, other forms or unspecified (code range) I25.10-I I I Atherosclerotic heart disease of native coronary artery (code range) Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris (code range) I I Atherosclerosis of other coronary vessels without angina pectoris (code range) (E/I) for all other diagnoses, including but not limited to: congestive heart failure, unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.

3 PAGE: 3 OF: 4 REFERENCES: Amin F, et al. Enhanced external counterpulsation for chronic angina pectoris. Cochrane Database Syst Rev 2010;(2): CD *Arora RR, et al. The multicenter study of enhanced external counter pulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol 1999;33(7): *Arora RR, 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 counter pulsation. J Investing Med 2002;50: *BlueCross BlueShield Association. Technology Assessment Program (TEC). External counterpulsation for treatment of chronic stable angina pectoris Oct;17(15). *BlueCross BlueShield Technology Evaluation Center (TEC). External counterpulsation for treatment of chronic stable angina pectoris and chronic heart failure Nov;22(3). BlueCross BlueShield Association. Enhanced external counterpulsation (EECP). Medical Policy Reference Manual Policy # Jan 9. Bondesson S, et al. Comparison of patients undergoing enhanced external counterpulsation and spinal cord stimulation for refractory angina pectoris. Coron Art Dis 2008;19: Braith RW, et al. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation 2010; 122(16): Casey DP, et al. Effects of enhanced external counterpulsation on arterial stiffness and myocardial oxygen demand in patients with chronic angina pectoris. Am J Cardiol 2011; 107(10): Casey DP, et al. Effect of enhanced external counterpulsation on inflammatory cytokines and adhesion molecules in patients with angina pectoris and angiographic coronary artery disease. Am J Cardiol 2008 Feb 1;101(3): Erdling A, et al. Enhanced external counter pulsation in treatment of refractory angina pectoris: two year outcome and baseline factors associated with treatment failure. BMC Cardiovasc Disorders 2008, 8:39. *Feldman AM, 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 2005 Apr;11(3): Fihn SD, et al 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 2012 Dec 18;60(24):e Gloekler S, et al. Coronary collateral growth by external counterpulsation: a randomized controlled trial. Heart 2010;96: Hayes, Inc. Hayes Medical Technology Report. External Counterpulsation. Lansdale, PA: Hayes, Inc.: June 25, *Holubkov R, et al. Comparison of patients undergoing enhanced counterpulsation and percutaneous coronary intervention for stable angina pectoris. Am J Card 2002 May;89(10): *Hunt SA, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol 2005 Sep 20;46(6):e1-82.

4 PAGE: 4 OF: 4 Jolicoeur EM, et al. Clinical and research issues regarding chronic advanced coronary artery disease: part I: Contemporary and emerging therapies. Am Heart J 2008 Mar;155(3): Lawson WE, et al. Effect of enhanced external counterpulsation on medically refractory angina patients with erectile dysfunction. Int J Clin Pract 2007 May;61(5): *Lawson WE, et al. Long-term prognosis of patients with angina treated with enhanced external counterpulsation: fiveyear follow-up study. Clin Cardiol 2000 Apr;23: *Lawson WE, et al. Predictors of benefit in angina patients one year after completing enhanced external counterpulsation: initial responders to treatment versus nonresponders. Cardiol 2005;103(4): *Lawson WE, et al. Two-year outcomes in patients with mild refractory angina treated with enhanced external counterpulsation. Clin Cardiol 2006 Feb;29(2): Loh PH, 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 2008;31(4): Manchanda A and Soran O. Enhanced external counterpulsation and future directions: step beyond medical management for patients with angina and heart failure. J Am Coll Cardiol 2007 Oct 16;50(16): Martin JS, et al. Enhanced external counterpulsation (EECP) improves peripheral artery function and glucose tolerance in subjects with abnormal glucose tolerance. J Appl Physiol 2012 Mar;112(5): *McCullough PA, et al. Impact of body mass index on outcomes of enhanced external counterpulsation therapy. Am Heart J 2006 Jan;151(1):139. McKenna C, et al. Enhanced external counterpulsation for the treatment of stable angina and heart failure: a systematic review and economic analysis. Health Technol Assess 2009;13(24): iii-iv, *Michaels AD, et al. The effects of enhanced external counterpulsation on myocardial perfusion in patients with stable angina: a multicenter radionuclide study. Am Heart J 2005 Nov;150(5): *Michaels AD, et al. Two-year outcomes after enhanced external counterpulsation for stable angina pectoris (from the International EECP Patient Registry [IEPR]). Am J Cardiol 2004 Feb 15;93(4): *Soran O, et al. Enhanced external counterpulsation in patients with heart failure: a multicenter feasibility study. Congest Heart Fail 2002 Jul-Aug;8(4):204-8, 227. Soran O, et al. Impact of external counterpulsation treatment on emergency department visits and hospitalizations in refractory angina patients with left ventricular dysfunction. Congest Heart Fail 2007 Jan-Feb;13(1): Thakkur BV, et al. The efficacy and safety of enhanced external counterpulsation in patients with peripheral artery disease. Vasc Med 2010;15(1): Yang DY, et al. Vasculoprotective properties of enhanced external counterpulsation for coronary artery disease: beyond the hemodynamics. Int J Cardiol 2010 May 3 [Epub ahead of print]. *key article KEY WORDS: ECP, EECP, Enhanced external counterpulsation. CMS COVERAGE FOR MEDICARE PRODUCT MEMBERS There is currently a National Coverage Determination (NCD) for External Counterpulsation (ECP) for Severe Angina. Please refer to the following NCD website for Medicare Members:

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