BlueCross and BlueShield of Montana Medical Policy/Codes
Extracorporeal Membrane Oxygenation (ECMO)
Chapter: Medicine: Treatments
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: July 25, 2013
Description

Critical illness with severe pulmonary or cardiac failure is associated with high mortality. Advances in lung-protective strategies and cardiac assist devices have helped to improve survival for patients with lung or heart failure.  Mortality rates can be as high as 30 to 40% for patients with ARDS (adult respiratory distress syndrome) and 50% for patients with cardiac failure.  In patients who do not respond to traditional treatment algorithms, few options exist for rescue therapy.

Extracorporeal membrane oxygenation (ECMO) is a mechanical support system that provides life support through the use of a modified heart-lung machine to support gas exchange; this allows time for damaged heart or lungs to heal while "resting" the damaged organs from the effects of mechanical ventilation and inotropic drugs.  ECMO is an intensive treatment that is currently used in many specialized centers to support patients with respiratory or cardiac failure who are unresponsive to conventional therapeutic interventions

Most children and adults treated with ECMO are very ill and at risk of death.  Some causes of respiratory failure in neonates include respiratory distress syndrome (hyaline membrane disease), meconium aspiration syndrome, and congenital diaphragmatic hernia.  Some causes of respiratory and cardiac failure in post-neonatal children (at least one month old) and adults include pneumonia, septic shock, congenital heart disease, cardiomyopathy, severe burns, and pulmonary hemorrhage.  Contraindications to ECMO include overt central nervous system damage, sepsis, or other profoundly debilitating conditions that are considered incompatible with a normal life. Conventional methods of treating respiratory failure include pharmacologic treatment, supplemental oxygen and mechanical ventilation, which may further damage the lung and contribute to the increased morbidity and mortality associated with chronic pulmonary disease. 

Severe pulmonary graft failure (PGF) is the most common cause of death within the first 30 days after lung transplantation.  ECMO may provide lifesaving temporary support after lung transplantation.  When cardiopulmonary bypass is discontinued the transplanted lungs are exposed to the cardiac output, which can lead to a negative effect on early allograft function, and the need for aggressive mechanical ventilation with high tidal volumes and pressures.  All these factors can be avoided by the use of intra- and post-operative ECMO support.

Policy

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

Medically Necessary

Blue Cross and Blue Shield of Montana (BCBSMT) may consider extracorporeal membrane oxygenation (ECMO) medically necessary for:

  • Patients with cardiac or respiratory failure that is considered to be reversible, is unresponsive to optimal conventional medical management, and is not expected to improve with conventional medical management, including medication and mechanical ventilation; or
  • As an adjunct to lung transplantation, or in the postoperative period, for neonates, post-neonatal children and adults; or
  • Following heart surgery to ease transition from cardiopulmonary bypass to ventilation; or
  • As a short-term (i.e., hours to a few days) bridge to heart transplants once a donor has been identified.

Investigational

BCBSMT considers ECMO experimental, investigational and unproven for all other indications.

Rationale

In 1987, the Blue Cross Blue Shield Association (BCBSA) Technology Assessment Center (TEC) published a TEC Evaluation that stated the majority of studies indicate that ECMO decreases morbidity and mortality in neonates in respiratory failure, and concluded that ECMO is an alternative to conventional therapy in newborns with respiratory failure, whose respiratory status does not improve with the use of maximal conventional ventilatory therapy.

ECMO has also been used for neonatal, pediatric, and adult respiratory and cardiac failure. Evidence to support use of ECMO is strongest in the neonatal population, but treatment in the pediatric population is also generally accepted.  The usage of ECMO in cases of adult respiratory failure has been studied in the ongoing CESAR trial (Conventional Ventilation or ECMO for Severe Adult Respiratory Failure), which is a multicenter, prospective, randomized trial comparing ECMO to conventional ventilation in regional hospitals.  Cardiac ECMO support in patients of all age groups will likely not have randomized trials to support it as a therapy in light of the fact that it is typically used as a salvage therapy. 

In October 2009, Peek et al. published preliminary results for the CESAR trial, which is a United Kingdom-based multicenter trial that used an independent central randomization service to screen 766 patients and randomly assign 180 adults in a 1:1 ratio to receive continued conventional management or referral to consideration for treatment by ECMO.  Eligible patients were aged 18-65 years and had severe (Murray score >3.0 or pH <7.20) but potentially reversible respiratory failure.  Exclusion criteria were: high pressure (>30 cm H2O of peak inspiratory pressure) or high FiO2 (>0.8) ventilation for more than seven days; intracranial bleeding; any other contraindication to limited heparinization; or any contraindication to continuation of active treatment.  The primary outcome was death or severe disability at six months after randomization or before discharge from hospital.  Primary analysis was by intention to treat. Only researchers who did the six-month follow-up were masked to treatment assignment.  Data about resource use and economic outcomes (quality-adjusted life-years) were collected.  Sixty-eight (75%) patients actually received ECMO; 63% (57/90) of patients allocated to consideration for treatment by ECMO survived to six months without disability compared with 47% (41/87) of those allocated to conventional management (relative risk 0.69; 95% CI 0.05-0.97, p=0.03).  Referral to consideration for treatment by ECMO led to a gain of 0.03 quality-adjusted life-years (QALYs) at six-month follow-up [corrected].  The authors recommended transferring of adult patients with severe but potentially reversible respiratory failure, whose Murray score exceeds 3.0 or who have a pH of less than 7.20 on optimum conventional management, to a centre with an ECMO-based management protocol to significantly improve survival without severe disability.

In 2008, Schuerer et al. reported that, despite the highly specialized nature of ECMO, data from 145 centers in the world have been collected regarding use of ECMO.  As of that date, 24,000 neonates, 7,000 children, and 2,000 adults had been treated with ECMO.  This coincided with strong randomized data supporting ECMO usage in some areas such as neonatal respiratory failure, but more equivocal data support its usage in adults with diseases such as ARDS. 

The National Institute of Clinical Excellence (NICE) in the United Kingdom has issued these 2004 Guidances for ECMO:

Post-neonatal Children (at least one month old):

  • Current evidence on the safety and efficacy of extracorporeal membrane oxygenation in post-neonatal children appears adequate to support the use of ECMO to treat respiratory or cardiac failure that is unresponsive to all other measures, but is considered to have a reversible cause.
    • ECMO may be used following heart surgery in post-neonatal children to ease the transition from cardiopulmonary bypass.
    • ECMO is used to treat respiratory or cardiac failure that is unresponsive to all other measures, but is considered to have a reversible cause.
    • ECMO may be used following heart surgery in post-neonatal children to ease the transition from cardiopulmonary bypass.

Adults:

  • ECMO is used to treat respiratory or cardiac failure that is unresponsive to all other measures, but is considered to have a reversible cause.
  • ECMO may also be used after heart surgery to assist the transition from cardiopulmonary bypass to ventilation. 

In 2004, Takahiho et al. reviewed the use of ECMO after lung transplantation.  They concluded that ECMO results have improved with advances in oxygenator technology and surgical techniques, and the procedure can allow resolution of early pulmonary graft failure after lung transplantation.

Coding

Disclaimer for coding information on Medical Policies

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

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

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

ICD-9 Codes

39.65. Refer to the ICD-9-CM manual.

Procedural Codes: 33960, 33961, 36822
References
  1. Extracorporeal Membrane Oxygenation.  Chicago, Illinois:  Blue Cross Blue Shield Association Technical Evaluation Center Assessment (May 1987) 74-82.
  2. Pereszleny, A., Lang, G.,   et al.  Bilateral lung transplantation with intra- and postoperatively prolonged ECMO support in patients with pulmonary hypertension.  European Journal of Cardio-Thoracic Surgery (2002 May) 21(5):858-63.
  3. Hansell, D.R.  Extracorporeal Membrane Oxygenation for Perinatal and Pediatric Patients.  Respiratory care (2003 April) 48(4):352-66.
  4. NICE—Interventional procedure guideline #38 (2004 January).  Extracorporeal membrane oxygenation (ECMO) in postneonatal children.  National Institute for Clinical Excellence http://www.nice.or.uk  (accessed 2010 November 17).
  5. NICE—Interventional procedure guideline #38 (2004 January).  Extracorporeal membrane oxygenation (ECMO) in adults.  National Institute for Clinical Excellence <http://www.nice.or.uk>  (accessed 2010 November 17).
  6. Takahiho, O., Rosenfeldt, F.  Extracorporeal Membrane Oxygenation After Lung Transplantation: Evolving Technique Improves Outcomes.  Ann Thorac Surg 2004;78:1230 –5.
  7. Schuerer, D.J.E., Nikoleta, S. K., et al.  Extracorporeal membrane oxygenation: current clinical practice, coding, and reimbursement.  Chest (2008) 134:179-84.
  8. Peek, G.J., Mugford, M. et al.  Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicenter randomized controlled trial.  Lancet (2009 October 17) 374(9698): 1351-62 (Epub 2009 September).
History
July 2013 New 2013 BCBSMT medical policy.
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Extracorporeal Membrane Oxygenation (ECMO)