Print

Date Printed: June 28, 2017: 11:45 PM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-33000-40

Original Effective Date: 06/15/17

Reviewed: 05/25/17

Revised: 00/00/00

Subject: Extracorporeal Membrane Oxygenation (ECMO) for Adult Conditions

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates      
           

DESCRIPTION:

Extracorporeal membrane oxygenation (ECMO) provides extracorporeal circulation and physiologic gas exchange for temporary cardiorespiratory support in cases of severe respiratory and cardiorespiratory failure. ECMO has generally been used in clinical situations in which there is respiratory or cardiac failure, or both, in which death would be imminent unless medical interventions can immediately reverse the underlying disease process, or physiologic functions can be supported for long enough that normal reparative processes or treatment can occur (eg, resolution of acute respiratory distress syndrome, treatment of infection), or other life-saving intervention can be delivered (eg, provision of a lung transplant). Potential indications for ECMO in the adult population include acute, potentially reversible respiratory failure due to a variety of causes; as a bridge to lung transplant; in potentially reversible cardiogenic shock; and as an adjunct to cardiopulmonary resuscitation (ECMO-assisted cardiopulmonary resuscitation [ECPR]).

The basic components of ECMO include a pump, an oxygenator, sometimes referred to as a “membrane lung,” and some form of vascular access. Based on the vascular access type, ECMO can be described as venovenous (VV) or venoarterial (VA). VA ECMO has the potential to provide cardiac and ventilatory support.

The reversibility of the underlying respiratory failure is best determined by the treating physicians, ideally physicians with expertise in pulmonary medicine and/or critical care. Some of the underlying causes of respiratory failure, which are commonly considered reversible include acute respiratory distress syndrome (ARDS); acute pulmonary edema; acute chest trauma; infectious and noninfectious pneumonia; pulmonary hemorrhage; pulmonary embolism; asthma exacerbation; aspiration pneumonitis.

For individuals who have acute respiratory failure in adulthood who receive ECMO, the evidence includes one moderately sized randomized controlled trial, nonrandomized comparative studies, and multiple case series. The most direct evidence about the efficacy of ECMO in adult respiratory failure comes from the CESAR trial. Although the CESAR trial had limitations, including nonstandardized management in the control group and unequal intensity of treatment between the treatment and the control groups, for the study’s primary outcome of disability-free survival at 6 months, there was a large effect size, with an absolute risk reduction in mortality of 16.25%. Recent nonrandomized comparative studies generally report improvements in outcomes with ECMO. The available evidence supports the conclusion that outcomes are improved for adults with acute respiratory failure, particularly those who meet the criteria outlined in the CESAR trial. However, questions remain about the generalizability of findings from the CESAR trial and nonrandomized study results to other patient populations, and further clinical trials in more specific patient populations are needed. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

For individuals who are lung transplant candidates in adulthood who receive ECMO as a bridge to pulmonary transplant, the evidence includes small case series. Single-arm series have reported rates of successful bridge to transplant on the order of 70% to 80%. For this population, there are no other options, the alternative is likely death, and controlled trials would be extremely difficult to perform. Although the available evidence on whether use of ECMO increases the rate of successful lung, heart, or heart-lung transplantation is limited, clinical input supported its use as a short-term bridge to transplantation.

For individuals who have acute cardiac failure in adulthood who receive ECMO, the evidence includes case series and case reports. The largest body of literature for cardiorespiratory failure is in patients with postcardiotomy failure to wean off bypass. Case series in this population report rates of successful decannulation from ECMO on the order of 60%. Case series in populations affected by other causes of acute cardiac failure report rates of survival to discharge of 40% to 60%. Rates of complications are high. Evidence comparing ECMO with other medical therapy options is lacking.

For individuals who have cardiac arrest in adulthood who receive ECPR, the evidence includes nonrandomized comparative studies and case series. The most direct evidence comes from one observational study comparing ECPR to standard CPR, using propensity score matching, which reported higher rates of survival to discharge, with minimal neurologic impairment with ECPR. Other nonrandomized studies report higher survival in ECPR groups. However, the benefit associated with ECPR is uncertain given the potential for bias in nonrandomized studies. Additionally, factors related to the implementation of ECPR procedures in practice need to be better delineated.

POSITION STATEMENT:

The use of extracorporeal membrane oxygenation (ECMO) in adults meets the definition of medical necessity for the management of adults with acute respiratory failure when ALL of the following criteria are met:

• Age 18 or older

• Respiratory failure is due to a potentially reversible etiology

• Respiratory failure is severe, as determined by the Murray score* or other respiratory failure severity criteria**

AND

NONE of the following contraindications are present:

• High ventilator pressure (peak inspiratory pressure >30 cm H2O) or high fraction of inspired oxygen (>80%) ventilation for more than 168 hours

• Signs of intracranial bleeding

• Multisystem organ failure

• Prior (ie, before onset of need for ECMO) diagnosis of a terminal condition with expected survival less than 6 months

• A do-not-resuscitate directive

• Cardiac decompensation in a patient already declined for ventricular assist device or transplant

• Known neurologic devastation without potential to recover meaningful function

• Determination of care futility***

The use of ECMO in adults meets the definition of medical necessity as a bridge to heart, lung, or combined heart-lung transplantation for the management of adults with respiratory, cardiac, or combined cardiorespiratory failure refractory to optimal conventional therapy.

The use of ECMO in adult patients is considered experimental or investigational when the above criteria are not met, including but not limited to acute and refractory cardiogenic shock, and as an adjunct to cardiopulmonary resuscitation (ECPR).

BILLING/CODING INFORMATION:

CPT Coding:

33946

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; initiation, veno-venous

33947

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; initiation, veno-arterial

33948

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; daily management, each day, veno-venous

33949

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; daily management, each day, veno-arterial

33952

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed)

33954

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertion of peripheral (arterial and/or venous) cannula(e), open, 6 years and older

33956

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; insertion of central cannula(e) by sternotomy or thoracotomy, 6 years and older

33958

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed)

33962

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), open, 6 years and older (includes fluoroscopic guidance, when performed)

33964

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; reposition central cannula(e) by sternotomy or thoracotomy, 6 years and older (includes fluoroscopic guidance, when performed)

33966

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older

33984

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; removal of peripheral (arterial and/or venous) cannula(e), open, 6 years and older

33986

Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; removal of central cannula(e) by sternotomy or thoracotomy, 6 years and older

33987

Arterial exposure with creation of graft conduit (eg, chimney graft) to facilitate arterial perfusion for ECMO/ECLS (List separately in addition to code for primary procedure)

33988

Insertion of left heart vent by thoracic incision (eg, sternotomy, thoracotomy) for ECMO/ECLS

33989

Removal of left heart vent by thoracic incision (eg, sternotomy, thoracotomy) for ECMO/ECLS

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

*Murray Lung Injury Score

Subscale

Criteria

Score

Chest x-ray score

No alveolar consolidation

0

Alveolar consolidation confined to 1 quadrant

1

Alveolar consolidation confined to 2 quadrants

2

Alveolar consolidation confined to 3 quadrants

3

Alveolar consolidation in all 4 quadrants

4

Hypoxemia score

PaO2/FIO2 >300 mm Hg

0

PaO2/FIO2 225-299 mm Hg

1

PaO2/FIO2 175-224 mm Hg

2

PaO2/FIO2 100-174 mm Hg

3

PaO2/FIO2 ≤100 mm Hg

4

PEEP score (when ventilated)

PEEP ≤ 5 cm H2O

0

PEEP 6-8 cm H2O

1

PEEP 9-11 cm H2O

2

PEEP 12-14 cm H2O

3

PEEP ≥15 cm H2O

4

Respiratory system compliance score (when available)

Compliance >80 mL/cm H2O

0

Compliance 60-79 mL/cm H2O

1

Compliance 40-59 mL/cm H2O

2

Compliance 20-39 mL/cm H2O

3

Compliance ≤19 mL/cm H2O

4

**Other Respiratory Failure Severity Criteria

Respiratory failure is considered severe if the patient meets one or more of the following criteria:

• Uncompensated hypercapnia with a pH less than 7.2; or

• PaO2/FIO2 of <100 mm Hg on fraction of inspired oxygen (FIO2) >90%; or

• Inability to maintain airway plateau pressure (Pplat) <30 cm H2O despite a tidal volume of 4 to 6mL/kg ideal body weight (IBW); or

• Oxygenation Index >30: Oxygenation Index = FIO2 ´ 100 ´ MAP/PaO2 mm Hg. [FIO2 x 100 = FIO2 as percentage; MAP = mean airway pressure in cm H2O; PaO2 = partial pressure of oxygen in arterial blood]; or

• CO2 retention despite high Pplat (>30 cm H2O)

***Assessment of ECMO Futility

Patients undergoing ECMO treatment should be periodically reassessed for clinical improvement. ECMO should not be continued indefinitely if the following criteria are met:

• Neurologic devastation as defined by the following:

• Consensus from 2 attending physicians that there is no likelihood of an outcome better than “persistent vegetative state” at 6 month, AND

• At least one of the attending physicians is an expert in neurologic disease and/or intensive care medicine, AND

• Determination made following studies including computed tomography, electroencephalography, and exam.

OR

• Inability to provide aerobic metabolism, defined by the following:

• Refractory hypotension and/or hypoxemia, OR

• Evidence of profound tissue ischemia based on creatine phosphokinase (CPK) or lactate levels, lactate-to-pyruvate ratio, or near-infrared spectroscopy (NIRS)

OR

• Presumed end-stage cardiac or lung failure without “exit” plan (ie, declined for assist device and/or transplantation)

RELATED GUIDELINES:

Ventricular Assist Devices and Total Artificial Hearts, 02-33000-25

OTHER:

None applicable.

REFERENCES:

  1. Banfi C, et al. Veno-venous extracorporeal membrane oxygenation: cannulation techniques. J Thorac Dis. 2016 Dec;8(12):3762-3773.
  2. Beck L, Burg MC, Heindel W et al. Extracorporeal Membrane Oxygenation in Adults - Variants, Complications during Therapy, and the Role of Radiological Imaging. Fortschr Röntgenstr 2017; 189: 119 - 127.
  3. BlueCross BlueShield Association Medical Policy Reference Manual. 8.01.60, Extracorporeal Membrane Oxygenation for Adult Conditions (May 2016).
  4. ClinicalTrials.gov. NCT02527031: A Comparative Study Between a Pre-hospital and an In-hospital Circulatory Support Strategy (ECMO) in Refractory Cardiac Arrest (ACPAR2) (ACPAR2). Assistance Publique - Hôpitaux de Paris. July 2016.
  5. ClinicalTrials.gov. NCT02301819: ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock (ECMO-CS). General University Hospital, Prague. September 2016.
  6. Delmas C, et al. Early Prediction of 3-month Survival of Patients in Refractory Cardiogenic Shock and Cardiac Arrest on Extracorporeal Life Support. Indian J Crit Care Med. 2017 Mar;21(3):138-145.
  7. Extracorporeal Life Support Organization (ELSO). ELSO Guidelines for Adult Cardiac Failure v1.3 2013. Accessed at https://www.elso.org/resources/guidelines.aspx.
  8. Extracorporeal Life Support Organization (ELSO). ELSO Guidelines for Adult Respiratory Failure v1.3. 2013. Accessed at https://www.elso.org/resources/guidelines.aspx.
  9. Extracorporeal Life Support Organization (ELSO). ELSO Guidelines for ECPR Cases v1.3 2013. Accessed at https://www.elso.org/resources/guidelines.aspx.
  10. Hsin CH, et al. Venovenous extracorporeal membrane oxygenation in adult respiratory failure: Scores for mortality prediction. Medicine (Baltimore). 2016 Jun;95(25):e3989.
  11. Lin CY, et al. Extracorporeal membrane oxygenation support in post-traumatic cardiopulmonary failure: A 10-year single institutional experience. Medicine (Baltimore). 2017 Feb;96(6):e6067.
  12. Link MS, Berkow LC, Kudenchuk PJ, et al. Part 7: Adult advanced cardiovascular life support: 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. Nov 3 2015;132(18 Suppl 2):S444-464.
  13. National Institute for Health and Care Excellence (NICE). Interventional Procedure Guidance (IPG) 482: Extracorporeal membrane oxygenation (ECMO) for acute heart failure in adults (March 2014). Accessed at https://www.nice.org.uk/.
  14. National Institute for Health and Care Excellence (NICE). Research recommendation: efficacy of extracorporeal membrane oxygenation (ECMO) for acute heart failure (June 2015). Accessed at https://www.nice.org.uk/.
  15. Pozzi M, et al. Veno-arterial extracorporeal membrane oxygenation for cardiogenic shock due to myocarditis in adult patients. J Thorac Dis. 2016 Jul;8(7):E495-502.
  16. Romano TG, et al. Extracorporeal respiratory support in adult patients. J Bras Pneumol. 2017 Jan-Feb;43(1):60-70.
  17. Rozencwajg S, et al. Outcomes and survival prediction models for severe adult acute respiratory distress syndrome treated with extracorporeal membrane oxygenation. Crit Care. 2016 Dec 5;20(1):392.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/25/17.

GUIDELINE UPDATE INFORMATION:

06/15/17

New Medical Coverage Guideline.

Date Printed: June 28, 2017: 11:45 PM