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Progenitor Cell Therapy for the Treatment of Damaged Myocardium Due to Ischemia

Policy Number: MP-173

Latest Review Date: May 2024

Category: Surgery                                                                  

POLICY:

Progenitor cell therapy, including but not limited to skeletal myoblasts or hematopoietic stem cells, is considered investigational as a treatment of damaged myocardium.

Infusion of growth factors (i.e., granulocyte colony stimulating factor [GCSF]) is considered investigational as a technique to increase the numbers of circulating hematopoietic stem cells as treatment of damaged myocardium.

DESCRIPTION OF PROCEDURE OR SERVICE:

Progenitor cell therapy describes the use of multipotent cells of various cell lineages (autologous or allogenic) for tissue repair and/or regeneration.  Progenitor cell therapy is being investigated for the treatment of damaged myocardium results from acute or chronic cardiac ischemia for refractory angina.

Ischemia

Ischemia is the most common cause of cardiovascular disease and myocardial damage in the developed world.  Despite impressive advances in treatment, ischemic heart disease is still associated with high morbidity and mortality.  

Treatment

Current treatments for ischemic heart disease seek to revascularize occluded arteries, optimize pump function, and prevent future myocardial damage. However, current treatments do not reverse existing heart muscle damage. Treatment with progenitor cells (i.e., stem cells) offers potential benefits beyond those of standard medical care, including the potential for repair and/or regeneration of damaged myocardium. Potential sources of embryonic and adult donor cells include skeletal myoblasts, bone marrow cells, circulating blood-derived progenitor cells, endometrial mesenchymal stem cells, adult testis pluripotent stem cells, mesothelial cells, adipose derived stromal cells, embryonic cells, induced pluripotent stem cells, and bone marrow mesenchymal stem cells, all of which can differentiate into cardiomyocytes and vascular endothelial cells for regenerative medicine advanced therapy (RMAT). The RMAT designation may be given if: (1) the drug is a regenerative medicine therapy (i.e., a cell therapy), therapeutic tissue engineering product, human cell and tissue product, or any combination product; (2) the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and (3) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs.

KEY POINTS:

The most recent literature review was performed through April 8, 2024.

Summary of Evidence

For individuals who have acute cardiac ischemia who receive progenitor cell therapy, the evidence includes 2 phase 3 randomized controlled trials (RCT), numerous small, early-phase RCTs, and meta-analyses of these RCTs. Relevant outcomes are disease-specific survival, morbid events, functional outcomes, quality of life, and hospitalizations. Limited evidence on clinical outcomes has suggested that there may be benefits from improving left ventricular ejection fraction (LVEF), reducing recurrent myocardial infarction (MI), decreasing the need for further revascularization, and perhaps even decreasing mortality; however, a recent, large meta-analysis reported no improvement in mortality. No adequately powered trial has reported benefits in clinical outcomes (e.g., mortality, adverse cardiac outcomes, exercise capacity, quality of life). Overall, this evidence has suggested that progenitor cell treatment may be a promising intervention, but robust data on clinical outcomes are lacking. High-quality RCTs, powered to detect differences in clinical outcomes, are needed to answer this question. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic cardiac ischemia who receive progenitor cell therapy, the evidence includes 1 phase 3 RCT with more than 100 participants, 3 phase 2 RCTs with more than 100 participants, systematic reviews of smaller, early-phase RCTs, and a nonrandomized comparative trial. Relevant outcomes are disease-specific survival, morbid events, functional outcomes, quality of life, and hospitalizations. The studies included in the meta-analyses have reported only on a small number of clinical outcome events. Two phase 2 RCTs (CONCERT-HF and ixCELL-DCM) found significant benefit on heart failure-related death and other cardiac events with cell therapy compared to placebo. Another phase 2 RCT found that cell therapy was safe, but did not impact left ventricular end-systolic volume or secondary quality of life and cardiac outcomes compared to placebo. A well-conducted phase 3 RCT trial failed to demonstrate superiority of cell therapy for its primary composite outcome that included death, worsening heart failure events, and other multiple events. The nonrandomized STAR-Heart trial showed a mortality benefit as well as favorable hemodynamic effect, but a lack of randomization limits interpretation due to the concern about selection bias and differences in known and unknown prognostic variables at baseline between both arms. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have refractory angina who receive progenitor cell therapy, the evidence includes a systematic review of RCTs, phase 2 trials and a phase 3 pivotal trial. Relevant outcomes are disease-specific survival, morbid events, functional outcomes, quality of life, and hospitalizations. The only phase 3 trial identified was terminated early and insufficiently powered to evaluate clinical outcomes. Additional larger trials are needed to determine whether progenitor cell therapy improves health outcomes in patients with refractory angina. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Cardiology Foundation/American Heart Association

In 2015, the American College of Cardiology Foundation, American Heart Association, and the Society for Cardiovascular Angiography and Interventions issued a Focused Update on Primary Percutaneous Coronary Interventions for Patients With ST-Elevation Myocardial Infarction. This guideline was an update of the 2011 guideline for percutaneous coronary intervention and the 2013 guideline on managing ST-elevation myocardial infarction. In 2021, these same organizations published a guideline on coronary artery revascularization. Progenitor cell therapy was not mentioned in any of these guidelines.

The most recent guidelines on treatment of heart failure with reduced ejection fraction from the American College of Cardiology (2023) and American Heart Association/American College of Cardiology/Heart Failure Society of America (2022) do not mention progenitor cell therapy.

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Autologous cell transplantation, BioHeart, autologous skeletal myoblasts, cardiovascular disease, congestive heart failure, coronary disease, heart disease, myoblast transplantation, myocardial infarction, allogeneic human mesenchymal stem cell, hMSC, Prochymal, progenitor cells, post-infarct necrosis, regeneration, stem cells, transfusion, Athersys, Multistem®, Osiris, Provacel®, infusion of growth factors, intramyocardial stem cell injection, MyoCell®, Ixmyelocel-T

APPROVED BY GOVERNING BODIES:

Multiple progenitor cell therapies such as MyoCell® (U.S. Stem Cell, formerly Bioheart), Ixmyelocel-T (Vericel, formerly Aastrom Biosciences ), MultiStem® (Athersys) and CardiAMPTM (BioCardia) are being commercially developed, but none have been approved by the FDA so far.

MyoCell® comprises patient autologous skeletal myoblasts that are expanded ex vivo and supplied as a cell suspension in a buffered salt solution for injection into the area of damaged myocardium.  In 2017, U.S. Stem Cell reprioritized its efforts away from seeking RMAT designation for MyoCell®.The expanded cell product enriched for mesenchymal and macrophage lineages might enhance potency. Vericel has received RMAT designation for Ixmyelocel-T.

MultiStem (Athersys) is an allogeneic bone marrow‒derived adherent adult stem cell product that received RMAT designation.

CardiAMPTM Cell Therapy system consists of a proprietary assay to identify patients with a high probability to respond to autologous cell therapy, a proprietary cell processing system to isolate process and concentrate the stem cells from a bone marrow harvest at the point of care, and a proprietary delivery system to percutaneously inject the autologous cells into the myocardium. BioCardia has received an investigational device exemption from the FDA to perform a trial of CardiAMP and is designated as an FDA Breakthrough Device.

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

CURRENT CODING:

There are no specific CPT codes for this procedure.

REFERENCES:

  1. Achilli F, Malafronte C, Lenatti L et al. Granulocyte colony-stimulating factor attenuates left ventricular remodelling after acute anterior STEMI: results of the single-blind, randomized, placebo-controlled multicentre STem cEll Mobilization in Acute Myocardial Infarction (STEM-AMI) Trial. Eur J Heart Fail 2010; 12(10):1111-21.
  2. Achilli F, Malafronte C, Maggiolini S et al. G-CSF treatment for STEMI: final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial. Heart 2014; 100(7):574-81.
  3. Afzal MR, Samanta A, Shah ZI, et al. Adult bone marrow cell therapy for ischemic heart disease: evidence and insights from randomized controlled trials. Circ Res. Aug 28, 2015; 117(6):558-575.
  4. Assmus B, Rolf A, Erbs S, et al. Clinical outcome 2 years after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction.  Circ Heart Fail, January 2010; 3(1): 89-96.
  5. Assmus B, Walter DH, Seeger FH et al. Effect of shock wave-facilitated intracoronary cell therapy on LVEF in patients with chronic heart failure: the CELLWAVE randomized clinical trial. JAMA 2013; 309(15):1622-31.
  6. Autologous cultured myoblast (BioWhittaker) transplanted via myocardial injection, www.clinicaltrials.gov/ct/show/NCT00050765?order=1.
  7. Bartunek J, Terzic A, Davison BA, et al. Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial. Eur Heart J. Mar 01 2017; 38(9):648-660.
  8. Bartunek J, Terzic A, Davison BA, et al. Cardiopoietic stem cell therapy in ischaemic heart failure: long-term clinical outcomes. ESC Heart Fail. Dec 2020; 7(6): 3345-3354.
  9. Bolli R, Mitrani RD, Hare JM, et al. A Phase II study of autologous mesenchymal stromal cells and c-kit positive cardiac cells, alone or in combination, in patients with ischaemic heart failure: the CCTRN CONCERT-HF trial. Eur J Heart Fail. Apr 2021; 23(4): 661-674.
  10. Clifford DM, Fisher SA, Brunskill SJ et al. Stem cell treatment for acute myocardial infarction. Cochrane Database Syst Rev 2012; 2:CD006536.
  11. de Jong R, Houtgraaf JH, Samiei S et al. Intracoronary stem cell infusion after acute myocardial infarction: a meta-analysis and update on clinical trials. Circ Cardiovasc Interv Apr 2014; 7(2):156-67.
  12. Delewi R, Hirsch A, Tijssen JG et al. Impact of intracoronary bone marrow cell therapy on left ventricular function in the setting of ST-segment elevation myocardial infarction: a collaborative meta-analysis. Eur Heart J Apr 2014; 35(15):989-98.
  13. Donndorf P, Kaminski A, Tiedemann G et al. Validating intramyocardial bone marrow stem cell therapy in combination with coronary artery bypass grafting, the PERFECT Phase III randomized multicenter trial: study protocol for a randomized controlled trial. Trials 2012; 13:99.
  14. Fisher SA, Brunskill SJ, Doree C et al. Stem cell therapy for chronic ischaemic heart disease and congestive heart failure. Cochrane Database Syst Rev Apr 29 2014; (4):CD007888.
  15. Fisher SA, Doree C, Taggart DP, et al. Cell therapy for heart disease: trial sequential analyses of two Cochrane reviews. Clin Pharmacol Ther. Jul 2016; 100(1):88-101.
  16. Fisher SA, Doree C, Mathur A, et al. Stem cell therapy for chronic ischaemic heart disease and congestive heart failure. Cochrane Database Syst Rev. Dec 24 2016;12(12):Cd007888.
  17. Fisher SA, Zhang H, Doree C, et al. Stem cell treatment for acute myocardial infarction. Cochrane Database Syst Rev. Sep 30 2015; 2015(9):CD006536.
  18. Gyongyosi M, Wojakowski W, Lemarchand P, et al. Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in Patients With Acute Myocardial Infarction Based on Individual Patient Data. Circ Res. Apr 10 2015; 116(8):1346-1360.
  19. Hamshere S, Choudhury T, Jones DA et al. A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI). BMJ Open 2014; 4(2):e004258.
  20. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. J Card Fail. May 2022; 28(5): e1-e167.
  21. Hirsch A, Nijveldt R, van der Vleuten PA et al. Intracoronary infusion of mononuclear cells from bone marrow or peripheral blood compared with standard therapy in patients after acute myocardial infarction treated by primary percutaneous coronary intervention; results of the randomized controlled HEBE trial. Eur Heart J Jul 2011; 32(14):1736-47.
  22. Huikuri HV, Kervinen K, et al. Effects of intracoronary injection of mononuclear bone marrow cells on left ventricular function, arrhythmia risk profile, and restenosis after thrombolytic therapy of acute myocardial infarction. Eur Heart J 2008; 29(22): 2723-2732.
  23. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  24. Jimenez-Quevedo P, Gonzalez-Ferrer JJ, Sabate M, et al. Selected CD133(+) progenitor cells to promote angiogenesis in patients with refractory angina: final results of the PROGENITOR randomized trial. Circ Res. Nov 7 2014;115(11):950-960.
  25. Khan AR, Farid TA, Pathan A, et al. Impact of cell therapy on myocardial perfusion and cardiovascular outcomes in patients with angina refractory to medical therapy: a systematic review and meta-analysis. Circ Res. Mar 18 2016;118(6):984-993.
  26. Kittleson MM, Panjrath GS, Amancherla K, et al. 2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. May 09 2023; 81(18): 1835-1878.
  27. Lalu, MM, Mazzarello, S, Zlepnig, J, et al. Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis. Stem Cells Transl Med, Dec 2018;7(12): 857-866.
  28. Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. Jan 18 2022; 79(2): e21-e129.
  29. Lee MS, Makkar RR. Stem-cell transplantation in myocardial infarction: a status report. Ann Intern Med. May 04 2004; 140(9): 729-37.
  30. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. Dec 06 2011; 124(23): e574-651.
  31. Levine GN, Bates ER, Blankenship JC, et al. 2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial Infarction: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. May 2016; 87(6): 1001-19.
  32. Losordo DW, Henry TD, Davidson C et al. Intramyocardial, autologous CD 34+ cell therapy for refractory angina. Circ Res 2011; 109(4):428-36.
  33. Losordo DW, Schatz RA, White CJ, et al. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: A phase I/IIa double-blind randomized controlled trial. Circulation Jun 26 2007; 115(25):3165-72.
  34. Maddox TM, Januzzi JL, Allen LA, et al. 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. Feb 16 2021; 77(6): 772-810.
  35. Marban E, Malliaras K. Mixed results for bone marrow-derived cell therapy for ischemic heart disease. JAMA 2012; 308(22):2405-6.
  36. Moazzami K, Roohi A, Moazzami B. Granulocyte colony stimulating factor therapy for acute myocardial infarction. Cochrane Database Syst Rev May 31, 2013; 2013(5):CD008844.
  37. O'Gara PT, Kushner FG, Ascheim DD et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol Jan 29 2013; 61(4):e78-140.
  38. Patel AN, Henry TD, Quyyumi AA, et al. Ixmyelocel-T for patients with ischemic heart failure: a prospective randomized double-blind trial. Lancet. Jun 11 2016; 387(10036):2412-2421.
  39. Patila T, Lehtinen M, Vento A, et al. Autologous bone marrow mononuclear cell transplantation in ischemic heart failure: a prospective, controlled, randomized, double-blind study of cell transplantation combined with coronary bypass. J Heart Lung Transplant. Jun 2014; 33(6):567-574.
  40. Perin EC, Sanz-Ruiz R, Sanchez PL, et al. Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial. Am Heart J. Jul 2014; 168(1):88-95 e82.
  41. Pokushalov E, Romanov A, Chernyavsky A, et al. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study. J Cardiovasc Transl Res. Apr 2010;3(2):160-168.
  42. Pompilio G, Nigro P, Bassetti B, et al. Bone marrow cell therapy for ischemic heart disease: the never ending story. Circ Res. Aug 28, 2015; 117(6): 490-493.
  43. Povsic TJ, Henry TD, Traverse JH, et al. The RENEW trial: efficacy and safety of intramyocardial autologous CD34 (+) cell administration in patients with refractory angina. JACC Cardiovasc Interv. Aug 8 2016; 9(15):1576-1585.
  44. Qayyum AA, van Klarenbosch B, Frljak S, et al. Effect of allogeneic adipose tissue-derived mesenchymal stromal cell treatment in chronic ischaemic heart failure with reduced ejection fraction - the SCIENCE trial. Eur J Heart Fail. Apr 2023; 25(4): 576-587.
  45. Schächinger V, Erbs S, Elsässer A, et al. Improved clinical outcome after intracoronary administration of bone-marrow-derived progenitor cells in acute myocardial infarction: final 1-year results of the REPAIR-AMI trial. Eur Heart J. Dec 2006; 27(23): 2775-83.
  46. Schächinger V, Erbs S, Elsässer A, et al. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med. Sep 21 2006; 355(12): 1210-21.
  47. Strauer BE, Yousef M, Schannwell CM. The acute and long-term effects of intracoronary Stem cell Transplantation in 191 patients with chronic heARt failure: the STAR-heart study. Eur J Heart Fail Jul 2010; 12(7):721-9.
  48. Surder D, Manka R, Lo Cicero V et al. Intracoronary injection of bone marrow-derived mononuclear cells early or late after acute myocardial infarction: effects on global left ventricular function. Circulation 2013; 127(19):1968-79.
  49. Surder D, Schwitter J, Moccetti T et al. Cell-based therapy for myocardial repair in patients with acute myocardial infarction: rationale and study design of the SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI). Am Heart J 2010; 160(1):58-64.
  50. Taljaard M, Ward MR, Kutryk MJ, et al. Rationale and design of Enhanced Angiogenic Cell Therapy in Acute Myocardial Infarction (ENACT-AMI): The first randomized placebo-controlled trial of enhanced progenitor cell therapy for acute myocardial infarction.  Am Heart J, March 2010; 159(3): 354-360.
  51. Traverse JH, Henry TD, Pepine CJ et al. Effect of the use and timing of bone marrow mononuclear cell delivery on left ventricular function after acute myocardial infarction: the TIME randomized trial. JAMA 2012; 308(22):2380-9.
  52. Traverse JH, Henry TD, Pepine CJ et al. One-year follow-up of intracoronary stem cell delivery on left ventricular function following ST-elevation myocardial infarction. JAMA 2014; 311(3):301-2.
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POLICY HISTORY:

Medical Policy Group, June 2004

Medical Policy Administration Committee, July 2004

Available for comment July 12-August 25, 2004

Medical Policy Group, June 2005 (1)

Medical Policy Group, June 2006 (1)

Medical Policy Group, January 2007 (2)

Medical Policy Group, January 2008 (1)

Medical Policy Group, February 2009 (4)

Medical Policy Group, February 2010 (1)

Medical Policy Group, July 2010 (1): Medical policy updated, coverage remains unchanged, name change

Medical Policy Administration Committee, July 2010

Medical Policy Group, July 2011 (1): Update to Key Points and References

Medical Policy Group July 2012 (1): Update to 2012 Key Points and References

Medical Policy Panel, June 2013

Medical Policy Group, June 2013 (3):  2013 Update to Key Points and References; no change in policy statement; Removed information concerning MyoCell study (2006) which was never completed.

Medical Policy Panel

Medical Policy Group, June 2014 (3):  2014 Updates to Key Points, Key Words, Governing Bodies & References; no change in policy statement

Medical Policy Panel, June 2015

Medical Policy Group, June 2015 (4): Updates to Key Points and References.  No change in policy statement.

Medical Policy Panel, December 2016.

Medical Policy Group, January 2017 (4): Updates to Description, Key Points, Key Words, Approved Governing Bodies, and References.  No change in policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, August 2017 (4): Updates to Key Points, Governing Bodies, Key Words and references. No change to policy statement.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (4): Updates to Key Points, Approved by Governing Bodies and References.  No change to Policy statement.

Medical Policy Panel, May 2019

Medical Policy Group, May 2019 (4): Updates to Description, Key Points, and References.  No change to policy statements.

Medial Policy Panel, May 2020

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

Medical Policy Panel, May 2021

Medical Policy Group, May 2021 (4): Updates to Description, Key Points, Governing Bodies and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, May 2022

Medical Policy Group, May 2022 (4): Updates to Key Points, Practice Guidelines and References.

Medical Policy Panel, May 2023

Medical Policy Group, May 2023(4): Updates to Key Points, Benefit Application and References.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (4): Updates to Key Points, Approved by Governing Bodies, 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.