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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Treatment
Policy Number:014
Effective Date: 12/24/2011
Original Policy Date:03/20/1998
Last Review Date:06/09/2020
Date Published to Web: 11/22/2011
Subject:
Enhanced External Counterpulsation (EECP)

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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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. EECP has been studied primarily as a treatment for patients with refractory angina and heart failure.

PopulationsInterventionsComparatorsOutcomes
Individuals:
  • With chronic stable angina
Interventions of interest are:
  • Enhanced external counterpulsation
Comparators of interest are:
  • Medical management
Relevant outcomes include:
  • Overall survival
  • Symptoms
  • Morbid events
  • Functional outcomes
Individuals:
  • With heart failure
Interventions of interest are:
  • Enhanced external counterpulsation
Comparators of interest are:
  • Guideline-directed medical management
Relevant outcomes include:
  • Overall survival
  • Symptoms
  • Morbid events
  • Functional outcomes
Individuals:
  • With other conditions related to ischemia or vascular dysfunction
Interventions of interest are:
  • Enhanced external counterpulsation
Comparators of interest are:
  • Guideline-directed medical management
Relevant outcomes include:
  • Overall survival
  • Symptoms
  • Morbid events
  • Functional outcomes

BACKGROUND
Enhanced external counterpulsation (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. 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 ventricular 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 acute myocardial infarction. 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 to trigger inflation and deflation, and optional use of pulse oximetry to measure oxygen saturation before and after treatment.

Regulatory Status

A variety of EECP devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples of EECP devices with FDA clearance are outlined in Table 1. FDA product code: DRN.

Table 1. FDA-Cleared EECP Devices

DeviceManufacturerClearedIndications
External Counterpulsation SystemVamed Medical InstrumentSep 2019
  • 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
Pure Flow External Counter-Pulsation DeviceXtreem PulseMay 2018
  • 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
Renew® NCP-5 External Counterpulsation SystemRenew GroupDec 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 ModelECP HealthAug 2005
  • Stable or unstable angina pectoris
  • Acute myocardial infarction
  • Cardiogenic shock
  • Congestive heart failure
CardiAssist™ Counter Pulsation SystemCardiomedicsMar 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 DeviceApplied Cardiac SystemsAug 2004
  • Stable or unstable angina pectoris
  • Acute myocardial infarction
  • Cardiogenic shock
  • Congestive heart failure
EECP® Therapy SystemVasomedicalMar 2004
  • Stable or unstable angina pectoris
  • Acute myocardial infarction
  • Cardiogenic shock
  • Congestive heart failure

EECP: enhanced external counterpulsation; FDA: Food and Drug Administration; Vo2: oxygen consumption.

Related Policies

  • Transmyocardial Revascularization (Policy #009 in the Surgery Section)

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

1. A single course of enhanced external counterpulsation (EECP) treatment (35 one-hour treatment sessions, usually 5 sessions per week over a period of approximately 7 weeks) is considered medically necessary for:
    • members with recurrent disabling angina (Class III or Class IV, Canadian Cardiovascular Society Classification or equivalent classification) despite optimal pharmacologic therapy with anti-ischemic agents and coronary revascularization; OR
    • members with disabling angina (Class III or Class IV, Canadian Cardiovascular Society Classification or equivalent classification) who are otherwise candidates for invasive coronary revascularization procedures but are inoperable because:
      (1) they are at high risk for operative complications or post-operative failure;
      (2) their coronary anatomy is not readily amenable to invasive procedures; or
      (3) they have comorbid states which create excessive risk.
    [Canadian Cardiovascular Society Functional Classification /Grading of Angina:
    Class I: Ordinary physical activity does not cause angina; for example, walking or climbing stairs does not cause angina. Angina occurs with strenuous or rapid or prolonged exertion at work or recreation.
    Class II: Slight limitation of ordinary activity; for example, angina occurs on walking or stair climbing after meals, or in cold, or in wind, under emotional stress or only during the few hours after awakening, walking more than two blocks on the level or climbing more than one flight of ordinary stairs at a normal pace and in normal conditions.
    Class III: Marked limitation of ordinary activity; for example, angina occurs on walking one or two blocks on the level or climbing one flight of stairs in normal conditions and at a normal pace.
    Class IV: Inability to carry on any physical activity without discomfort - angina syndrome may be present at rest.]

2. Continued EECP treatment beyond the 7-week period or subsequent courses of EECP treatment requires clinical justification and approval by the Medical Director. Supporting documentation must be submitted by the requesting physician.

3. Other indications for EECP treatment are considered investigational.


Medicare Coverage:
Per National Coverage Determination (NCD) 20.20 and associated coding transmittal, coverage is provided for the use of ECP for individuals who have been diagnosed with disabling angina (Class III or Class IV, Canadian Cardiovascular Society Classification or equivalent classification) who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention, such as PTCA or cardiac bypass and who meet NCD 20.20 criteria.

For information and eligibility for enhanced external counterpulsation, refer to National Coverage Determination (NCD) for External Counterpulsation (ECP) Therapy for Severe Angina (20.20). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=97&ncdver=2&bc=AAAAgAAAAAAAAA%3d%3d&.

Medicaid Coverage:

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Enhanced External Counterpulsation (EECP)
Enhanced External Counterpulsation (EECP) for Chronic Stable Angina
ECP
EECP
Counterpulsation Treatment, Enhanced External
External Counterpulsation for Chronic Stable Angina

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): 1833-40. 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): 215-23. 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): 202-7. 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): 866-75. 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): 1612-20. 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): 1466-72. 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): 191-8. 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): 1182-6. 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): 2090-5. PMID 14680732

12. Amin F, Al Hajeri A, Civelek B, et al. Enhanced external counterpulsation for chronic angina pectoris. Cochrane Database Syst Rev. Feb 17 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): 639-45. 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): 160-6. 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): 159-64. 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): 116-8. 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. Jun 15 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): 276-84. 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): 240-5. 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): 1198-205. 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): 307-11. 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): 275-82. 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): 61-6. 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): 147-52. 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): 204-8, 227. PMID 12147943

32. Fraser SG, Adams W. Interventions for acute non-arteritic central retinal artery occlusion. Cochrane Database Syst Rev. Jan 21 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 (Philadelphia, Pa ). Aug 2004; 24(4): 541-7. 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): 757-62. 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): 1340-3. PMID 18309160

36. Lin S, Liu M, Wu B, et al. External counterpulsation for acute ischaemic stroke. Cochrane Database Syst Rev. Jan 18 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. Oct 2016; 53(5): 745-52. 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. Oct 2016; 53(5): 753-60. 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 04 2014; 64(18): 1929-49. PMID 25077860

41. Yancy CW, Jessup M, Bozkurt B, 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. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. Aug 08 2017; 136(6): e137-e161. PMID 28455343

43. Center for Medicare & Medicaid Services (CMS). National Coverage Determination for external counterpulsation (ECP) thereapy fo severe angina (20.20). 2006; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?CALId=185&CalName=PSA+(Addition+of+ICD-9- CM+600.10%2C+Nodular+prostate+without+urinary+obstruction+and+600.11%2C+with+urinary+obstruction%2C+ as+covered+indications)&ExpandComments=n&CommentPeriod=0&NCDId=97&ncdver=2&CoverageSelection=N ational&ncd_id=20.20&ncd_version=2&basket=ncd%2525253A20%2525252E20%2525253A2%2525253AExternal +Counterpulsation+%25252528ECP%25252529+for+Severe+Angin&bc=gAAAABAAQEAAAA%3D%3D&. Accessed April 2, 2020.


Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*
    92971
HCPCS
    G0166

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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