Heart Transplant*

Medical Policy: 07.03.07 
Original Effective Date: November 2009 
Reviewed: March 2012 
Revised:  

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

Heart transplantation is an established therapeutic option for the treatment of end-stage heart disease in adults and children.

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Prior Approval: 

Prior approval is recommended. Submit a prior approval now.

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Policy: 

Candidates for heart transplant must meet all of the following general criteria:

• Adequate pulmonary, liver, and renal status (unless a dual-organ transplant is intended, i.e., heart-lung, heart-kidney, etc.)
• Absence of significant infection that could be exacerbated by immunosuppressive therapy after transplant (i.e., chronic active viral hepatitis B, hepatitis C, and human immunodeficiency virus)
• Absence of significant systemic disease or condition that could be exacerbated by immunosuppressive therapy after transplant (i.e., systemic lupus erythematosus)
• Documentation of patient compliance with medical management

The evaluation of a transplant candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.

Adult patients

The American College of Cardiology (ACC) has established the following recipient guidelines for potential adult heart transplant recipients:

Accepted indications for transplantation:

Hemodynamic compromise due to heart failure demonstrated by any of the following:

• Maximal V02 (oxygen consumption) < 10ml/kg/min with achievement of anaerobic metabolism
• Refractory cardiogenic shock
• Documented dependence on IV inotropic support to maintain adequate organ perfusion

OR

Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty

OR

Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities

Probable indications for transplantation:

Maximal VO2 < 14 ml/kg/min and major limitation of the patient’s activities

OR

Recurrent unstable ischemia not amenable to bypass surgery or angioplasty

OR

Instability of fluid balance/renal function not due to patient noncompliance with regimen of weight monitoring, flexible use of diuretic drugs, and salt restriction

The following conditions are inadequate indications for transplantation unless other factors as listed above are present:

• Ejection fraction < 20%
• History of functional class III or IV symptoms of heart failure
• Previous ventricular arrhythmias
• Maximal VO2 > 15 ml/kg/min

Pediatric patients

The 2007 American Heart Association statement lists the following indications for pediatric heart transplantation:

Patients with heart failure with persistent symptoms at rest who require one or more of the following:

• Continuous infusion of intravenous inotropic agents
• Mechanical ventilatory support
• Mechanical circulatory support

Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:

• Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption < 50% predicted for age and sex)
• Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease
• Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator
• Restrictive cardiomyopathy with reactive pulmonary hypertension
• Reactive pulmonary hypertension and potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future
• Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle
• Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction

Relative contraindications to adult and pediatric heart transplant include any condition that may have a significant impact on the likelihood of a successful clinical outcome, such as pulmonary artery hypertension.

The United Network for Organ Sharing (UNOS) believes that asymptomatic HIV-positive patients should not necessarily be excluded for candidacy for organ transplantation, stating, “A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy.” In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that the presence of AIDS could be considered a contraindication to kidney transplant unless the following criteria were present. These criteria may be extrapolated to other potential organ transplants:

• CD4 count ≥ 200 cells/mm-3 for > 6 months
• HIV-1 RNA undetectable
• On stable anti-retroviral therapy > 3 months
• No other complications from AIDS (e.g., opportunistic infection including aspergillus, tuberculosis, coccidioses mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm)
• Meeting all other criteria for organ transplantation

It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.

UNOS prioritizes donor thoracic organs according to the severity of illness with those patients who are most severely ill (status 1A) given highest priority in allocation of the available organs as follows:

Adult patients (=/> 18 years of age)

Status 1A

A patient is admitted to the listing transplant center hospital and has at least one of the following devices or therapies in place:

• Mechanical circulatory support for acute hemodynamic decompensation that includes at least one of the following:
  • Left and/or right ventricular assist device implanted
  • Total artificial heart
  • Intra-aortic balloon pump
  • Extracorporeal membrane oxygenator
• Mechanical circulatory support
• Mechanical ventilation
• Continuous infusion of inotropes and continuous monitoring of left ventricular filling pressures
• If the above criteria are not met such status can be obtained by application to the applicable Regional Review Board

Status 1B

A patient has at least 1 of the following devices or therapies in place:

• Left and/or right ventricular device implanted
• Continuous infusion of intravenous inotropes

Pediatric patients

Status 1A

Patient meets at least one of the following criteria:

• Requires assistance with a ventilator
• Requires assistance with a mechanical assist device (e.g., extracorporeal membrane oxygenation [ECMO])
• Requires assistance with a balloon pump
• A patient less than 6 months old with congenital or acquired heart disease exhibiting reactive pulmonary hypertension at greater than 50% of systemic level. Such a candidate may be treated with prostaglandin E (PGE) to maintain patency of the ductus arteriosus
• Requires infusion of high-dose (e.g., dobutamine >/= 7.5 mcg/kg/min or milrinone >/= 0.50 mcg/kg/min) or multiple inotropes (e.g., addition of dopamine at >/= 5 mcg/kg/min)

Note: A patient who does not meet the criteria above may be listed as Status 1A if the patient has a life expectancy without a heart transplant of less than 14 days, such as due to refractory arrhythmia.

Status 1B

Patient meets at least one of the following criteria:

• Requires infusion of low-dose single inotropes (e.g., dobutamine or dopamine </= 7.5 mcg/kg/min)
• Less than 6 months old and does not meet the criteria for Status 1A
• Growth failure, i.e., + 5^th percentile for weight and/or height, or loss of 1.5 standard deviations of expected growth (height or weight) based on the National Center for Health Statistics for pediatric growth curves

Note:  Pediatric heart transplant candidates who remain on the waiting list at the time of their 18^th birthday without receiving a transplant continue to qualify for medical urgency status based upon the pediatric criteria.

The accepted indications, probable indications, and contraindications for heart transplant contained in this policy reflect the 2005 update of the American College of Cardiology and American Heart Association (ACC/AHA) joint statement on diagnosis and management of chronic heart failure in the adult. They are unchanged in the 2009 update of the ACC/AHA statement.

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
• 33940; Donor cardiectomy (including cold preservation)
• 33944; Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation.
• 33945; Heart transplant, with or without recipient cardiectomy

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Selected References: 

• Canter CE, Shaddy RE, Bernstein D et al. Indications for heart transplantation in pediatric heart disease: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young; the Councils on Clinical Cardiology, Cardiovascular Nursing, and Cardiovascular Surgery and Anesthesia; and the Quality of Care and Outcomes research Interdisciplinary Working Group. Circulation 2007; 115(5):658-76.
• Steinman TI, Becker BN, Frost AE et al. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation 2001; 71(9):1189-204.
• Banner NR, Dreyfus G, Bonser RS et al. Effect of heart transplantation on survival in ambulatory and decompensated heart failure. Transplantation 2008; 86(11): 1515-22.
• Rosenthal D, Chrisant MRK, Edens E et al. International Society for Heart and Lung Transplantation: practice guidelines for management of heart failure in children. J Heart Lung transplant 2004; 23(12):1313-33.
• United Network for Organ Sharing (UNOS). Policy 3.7. Organ distribution: allocation of thoracic organs. UNOS Policies and Bylaws. United Network for Organ Sharing, Alexandria, VA. June, 2009. Available at: http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_9.pdf Accessed April 1, 2011
• Hunt SA, Abraham WT, Chin MH et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult. J Am Coll Cardiol 2005; 46(6): e1-82.

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Policy History: 

Date                                        Reason                               Action

April 2011                              Annual review                     Policy renewed

March 2012                           Annual review                     Policy renewed

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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.