Latest Review Date: May 2024

Category:  Medical                                                                

POLICY:

Enhanced external counterpulsation (EECP) may be considered medically necessary when all the following criteria are clearly documented in the patient’s medical record:

• The patient has a diagnosis of stable or unstable angina; AND

• The patient has New York Heart Association (NYHA) or Canadian Cardiovascular Society Classification (CCSC) Class III or Class IV angina (see below); AND
• The patient is refractive to maximum medical therapy; AND
• ONE of the following:
  1. The patient is not a candidate for a re-vascularization procedure such as percutaneous transluminal coronary angioplasty (PTCA), coronary artery stenting, or coronary artery bypass graft (CABG), because in the opinion of a cardiologist or cardiovascular surgeon* one or more of the following conditions exists:
     • The condition is inoperable;
     • There is a high risk of operative complications or postoperative failure;
     • The coronary anatomy is not readily amenable to such procedure; or
     • There are comorbid conditions which create unacceptable surgical risk;

OR

2. The only other treatment options available to the patient are transmyocardial laser revascularization (TMLR), cardiac transplant, or participation in a clinical trial.

 

*A cardiologist or cardiovascular surgeon must evaluate the patient and recommend EECP.

 

Only one course of treatment of EECP will be covered if the above criteria are met.  A repeat course of treatment of EECP will not be covered. 

 

Enhanced external counterpulsation (EECP) is considered investigational for all other conditions including, but not limited to:

• congestive heart failure in the absence of angina,
• decompensated congestive heart failure with or without angina,
• uncontrolled arrhythmias,
• aortic insufficiency,
• acute myocardial infarction,
• cardiogenic shock,
• severe peripheral arterial disease or phlebitis,
• severe hypertension (BP >180/100mmHg),
• sustained tachycardia (heart rate > 120 beats per minute),
• bleeding diathesis (INR>2.0),
• pregnancy or the potential for pregnancy,
• in lieu of a physician recommended revascularization procedure such as PTCA, coronary artery stenting, or CAGB,
• erectile dysfunction,
• Ischemic stroke 

 

Angina Classification

Classification	NYHA	CCSC
O	Not applicable	Asymptomatic
I	Patients with no limitation of activities; they suffer no symptoms from ordinary activities	Angina with strenuous exercise
II	Patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion	Angina with moderate exertion
III	Patients with marked limitation of activity; they are comfortable only at rest	Angina with mild exertion Walking 1-2 level blocks at normal pace Climbing 1 flight of stairs at normal pace
IV	Patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest	Angina at any level of physical exertion

 

 

DESCRIPTION OF PROCEDURE OR SERVICE:

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 heart failure.

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. 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 (ECGs) to trigger inflation and deflation, and optional use of pulse oximetry to measure oxygen saturation before and after treatment.

KEY POINTS:

The most recent literature review was performed through March 12, 2024.

Summary of Evidence

For individuals who have 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-blinded randomized controlled trial (RCT) that includes clinical outcomes, and this trial reported benefit on 1 of 4 main angina outcomes. Additional small RCTs have reported changes in physiologic measures associated with EECP. One systematic review reports a decrease in severe angina from 89% to 25% post EECP. The improvement was sustained during follow up. EECP has been shown to improve the quality of life for those with refractory angina who are inoperable.  The evidence is sufficient to determine that the technology results in an improvement in health outcomes.

For individuals who have heart failure without angina 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 reported a modest benefit with EECP on some outcomes and no benefit on 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 that the technology results in an improvement in 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. A RCT assessed the use of EECP for treatment of central retinal artery occlusion and failed to find clinical benefit. 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 several small RCTs to treat type 2 diabetes. Reported follow-up was short term, and trials had methodologic limitations. The evidence is insufficient to determine the technology results in an improvement in health outcomes.

Practice Guidelines and Position Statements

The 2012 American College of Cardiology Foundation, American Heart Association, and 5 other medical societies published joint guidelines that recommended: “[patients with stable ischemic heart disease who indicate EECP] may be considered for relief of refractory angina.” (Class IIb, Level of Evidence B)

In 2014, the ACCF/AHA issued a Focused Update on the 2012 guideline on the diagnosis and management of patients with stable ischemic heart disease in which they specifically reviewed their recommendation on EECP.  Based on their review, the recommendation on EECP remains unchanged from the 2012 guideline.

The 2022 American College of Cardiology Foundation, American Heart Association, and Heart Failure Society of America guidelines on the management of heart failure do not address EECP. 

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Enhanced external counterpulsation, EECP, external counterpulsation, ECP, angina, congestive heart failure, CHF

APPROVED BY GOVERNING BODIES:

A variety of enhanced external counterpulsation (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 below.

FDA-Cleared EECP Devices

Device	Manufacturer	Clearance Date	Indications
External Counterpulsation System	Vamed Medical Instrument	Sep 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 Device	Xtreem Pulse	May 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 System	Renew Group (Rockville, MD)	December 2015	Treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. For use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow.
ECP Health System Model	ECP Health	August 2005	Stable or unstable angina pectoris Acute myocardial infarction Cardiogenic shock Congestive Heart Failure
CardiAssist™ Counter Pulsation System	Cardiomedics (Irvine, CA)	March 2005	Treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, MI, and cardiogenic shock
ACS Model NCP- 2 External Counterpulsation Device	Applied Cardiac Systems (Laguna Hills, CA)	August 2004	Stable or unstable angina pectoris Acute myocardial infarction Cardiogenic shock Congestive Heart Failure
EECP® Therapy System	Vasomedical (Westbury, NY)	March 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

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT code:

92971	Cardioassist-method of circulatory assist; external
93041	Rhythm EKG, one to three leads; tracing only without interpretation and reports

HCPCS code:

G0166

External counterpulsation, per treatment session

REFERENCES:

1. 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 2006; 12 (6): 307-11.
2. Amin F, Al Hajeri A, Civelek B, et al. Enhanced external counterpulsation for chronic angina pectoris. Cochrane Database Syst Rev. 2010(2):CD007219.
3. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. JACC 2007; 50: 652-726.
4. Arora RR, et al. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Amer C of Cardio; 33(7) 1999.
5. 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, 50:25-32; 2002.
6. 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.
7. Bondesson SM, Edvinsson ML, Pettersson T et al. Reduced peripheral vascular reactivity in refractory angina pectoris: Effect of enhanced external counterpulsation. J Geriatric Cardiol 2011; 8(4):215- 23.
8. Braith RW, Conti CR, et al. Enhanced External Counterpulsation Improves Peripheral Artery Flow Mediated dilation in Patients with Chronic Angina: A Randomized Sham-Controlled Study. Circulation. 2010 Oct 19; 122(16): 1612-20.
9. 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 2009; 39(10):866-75.
10. Caceres J, Atal P, Arora R, Yee D. Enhanced external counterpulsation: a unique treatment for the “no-option” refractory angina patient. J Clin Pharm Ther. 2021 Apr;46(2):295-303.
11. Campbell AR, Satran D, Zenovich AG, et al. Enhanced external counterpulsation improves systolic blood pressure in patients with refractory angina. Am Heart Journal, December 2008; 156(6): 1217-1222.
12. 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 2011; 107(10):1466-72.
13. Erdling A, Bondesson S, et al. Enhanced external counter pulsation in treatment of refractory angina pectoris: Two year outcome and baseline factors associated with treatment failure. BMC Cardiovascular Disorders 2008; 8:39.
14. 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 2005; 11 (3): 240-5.
15. 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 2012; 60(24):e44-e164.
16. 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.
17. Fraser SG, Adams W. Interventions for acute non-arteritic central retinal artery occlusion. Cochrane Database Syst Rev 2009; (1):CD001989.
18. Gloekler S, Meier P, de Marchi SF et al. Coronary collateral growth by external counterpulsation: a randomised controlled trial. Heart 2010; 96 (3): 202-7.
19. Han JH, Leung TW, Lam WW et al. Preliminary findings for external counterpulsation for ischemic stroke patient with large artery occlusive disease. Stroke 2008; 39(4):1340-3.
20. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. May 03 2022; 79(17): e263-e421.
21. 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 2002; 89(10):1182-6.
22. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
23. Lawson WE, Hui JCK and Cohn PF. Long-term prognosis of patients with angina treated with enhanced external counterpulsation: Five-year follow-up study. Clin. Cardiol. 23: 254-8; 2000.
24. Lawson WE, Hui JC and Lang G. Treatment benefit in the enhanced external counterpulsation consortium. Cardiology, 94:31-35; 2000.
25. 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, 96(2): 78-84; 2001.
26. Lawson WE, Hui JC, Kennard ED et al. Effects of enhanced external counterpulsation on medically refractory angina patients with erectile dysfunction. INt J Clin Pract 2007; 61(5):757-62.
27. 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 2005; 11 (1): 61-6.
28. Lin S, Liu M, Wu B et al. External counterpulsation for acute ischaemic stroke. Cochrane Database Syst Rev 2012; 1:CD009264.
29. Lin JC, Song S, Ng SM, et al. Interventions for acute non-arteritic central retinal artery occlusion. Cochrane Database SystRev. Jan 30 2023; 1(1): CD001989.
30. 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.
31. 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.
32. 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 2009; 13 (24): 1-90.
33. Nagendra L, Dutta D, Sharma M, et al. Impact of Enhanced External Counter-pulsation Therapy on Glycaemic Control in People With Prediabetes and Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Touch REV Endocrinol.Nov 2023; 19(2): 9-15.
34. Qin X, Deng Y, Wu D, et al. Does enhanced external counterpulsation (EECP) significantly affect myocardial perfusion? A systematic review and meta-analysis. PLoS One. 2016; 11(4):E0151822.
35. 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.
36. Sardina PD, Martin JS, Avery JC, et al. Enhanced external counterpulsation 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.
37. Sardina PD, Martin JS, Dzieza WK, et al. Enhanced external counterpulsation 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.
38. 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.
39. 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.
40. Shechtner M, Matezky S, Feinberg MS et al. External counterpulsation therapy improves endothelial functions in patients with refractory angina pectoris. J Am Coll Cardiol 2003:42(12):2090-5.
41. Soran O, Fleishman B, Demarco T, et al. Enhanced external counterpulsation in patients with heart failure: A multicenter feasibility study. CHF July/August 2002.
42. 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 2002; 8(6):297-302.
43. Stys T, Lawson WE, Hui JC, et al. Acute hemodynamic effects and angina improvement with enhanced external counterpulsation. Angiology, 52(10):653-8, 2001.
44. Stys TP, Laswon WE, Hui JC, et al. Effects of enhanced external counterpulsation on stress radionuclide coronary perfusion and exercise capacity in chronic stable angina pectoris. Am J Cardiol 2002, 89(7):82204.
45. 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 2005; 11 (3): 147-52.
46. 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 2004; 24(4):541-7.
47. Wu E, Martensson J, Kesta L, Brostrom A. Adverse events and their management during enhanced external counterpulsation treatment in patients with refractory angina pectoris: observations from a routine clinical practice.  Eur J Cardiovasc Nurs.  2022 Mar 3;21(2):152-160.
48. 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.
49. 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

POLICY HISTORY:

TEC, 1999(2)

Medical Review Committee May 2000

Medical Review Group, May 2002

Medical Review Committee, June 2002

Medical Policy Administration Team, August 2002

Available for comment August 13-September 27, 2002

Medical Policy Group, July 2003

Medical Review Committee, August 2003

Medical Policy Administration Committee, September 2003

Available for comment October 7-November 20, 2003

Medical Policy Group, August 2005 (1)

Medical Policy Group, August 2007 (1)

Medical Policy Group, August 2009 (1)

Medical Policy Panel, February 2010

Medical Policy Group, March 2010 (2)

Medical Policy Administration Committee, April 2010

Available for comment April 7-May 21, 2010

Medical Policy Group, February 2012 (1): Update to Key Points and References; no change in policy statement

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (1): 2013 Update to Key Points and References; no change in policy statement

Medical Policy Panel January 2014

Medical Policy Group January 2014 (4):  Updated Key Points, Approved Governing Bodies, and References.  Removed policy section that was February 2010 and earlier, but there was no actual change to the policy statement.

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (4): Updates to Description, Key Points, Approved Governing Bodies, Coding section and References.  No policy statement change.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4): Updates to Key Points, Approved Governing Bodies, and References. No change to policy statement.

Medical Policy Panel, October 2017

Medical Policy Group, October 2017 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (4): Updates to Description and Key Points.  No change to policy statement.

Medical Policy Panel, May 2019

Medical Policy Group, May 2019 (4): Updates to Key Points. No change to policy statement.

Medical Policy Panel, May 2020

Medical Policy Group, May 2020 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, May 2021

Medical Policy Group, May 2021 (4): Updates to Key Points and References.  Policy statement updated to remove “not medically necessary,” no change to policy intent. Removed the following references: Campeau L. Grading of angina pectoris; Soran O, Crawford LE, et al. Enhanced external counterpulsation in the management of patients with cardiovascular disease; Kannel WB and Belanger AJ. Epidemiology of heart failure; Eriksson H.  Heart failure: A growing public health problem.

Medical Policy Panel, May 2022

Medical Policy Group, June 2022 (4): Updates to Key Points and References. Policy statements unchanged.

Medical Policy Panel, May 2023

Medical Policy Group, May 2023 (4): Updates to Key Points, Benefit Application, and References.  No change to policy statements.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (4): Updates to Description, Key Points, and References.  No change to policy statements.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.