A heart transplant consists of replacing a diseased heart with a healthy donor heart. Transplantation is used for patients with refractory end-stage cardiac disease.
In the United States, approximately 5.8 million people have heart failure and 300,000 die each year from this condition. The reduction of cardiac output is considered to be severe when systemic circulation cannot meet the body’s needs under minimal exertion. Heart transplantation can potentially improve both survival and quality of life in patients with end-stage heart failure.
Heart failure may be due to a number of differing etiologies, including ischemic heart disease, cardiomyopathy, or congenital heart defects. The leading indication for heart transplant has shifted over time from ischemic to nonischemic cardiomyopathy. During the period 2005 to 2010, the primary causes of heart failure in patients undergoing transplant operations were nonischemic cardiomyopathy (53%) and ischemic cardiomyopathy (38%). Approximately 3% of the heart transplants during this time period were in adults with congenital heart disease.
The demand for heart transplants far exceeds the availability of donor organs, and the length of time patients are on the waiting list for transplants has increased. In 2013, a total of 1,244 heart transplants were performed in the United States. There were 4,068 patients on the heart transplant waiting list as of September 19, 2014. Also in recent years, advances in medical and device therapy for patients with advanced heart failure has improved the survival of patients awaiting heart transplantation. The chronic shortage of donor hearts has led to the prioritization of patients awaiting transplantation to ensure greater access for patients most likely to derive benefit. (Prioritization criteria are issued by UNOS and are described in the Policy Guidelines section.)
From 2005 to 2010, approximately 3% of heart transplants were repeat transplantations. Heart retransplantation raises ethical issues due to the lack of sufficient donor hearts for initial transplants. UNOS does not have separate organ allocation criteria for repeat heart transplant recipients.
Indications for Heart-Lung Transplantation are discussed in another policy.
No benefits will be provided for a covered transplant procedure unless the Member receives prior authorization through case management from Blue Cross & Blue Shield of Mississippi.
A human heart transplant is considered medically necessary for selected adult and pediatric patients with end-stage heart failure who meet the following criteria below (I) and fall within acceptable guidelines for patient selection below (II), and fall within the highest priority of allocation (III) as indicated below:
I. Patients must meet all of the following criteria:
- Adequate pulmonary, liver, and renal status
- Absence of significant infection that could be exacerbated by immunsuppressive therapy (e.g., 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 (e.g., systemic lupus erythematosus)
- No history of malignancy within 5 years of transplantation, excluding nonmelanomatous skin cancers
- Documentation of patient compliance with medical management
II. The following indications are to be used as a guideline for patient selection
A. For Adult Patients:
(The American College of Cardiology (ACC) has established the following recipient guidelines for potential adult heart transplant recipients):
- Accepted Indications for Transplantation:
1. For hemodynamic compromise due to heart failure demonstrated by any of the following 3 bulleted items,
- Maximal V02 (oxygen consumption) <10 ml/kg/min with achievement of anaerobic metabolism
- Refractory cardiogenic shock
- Documented dependence on intravenous inotropic support to maintain adequate organ perfusion
2. Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty, or
3. Recurrent symptomatic ventricular arrhythmias refractory to ALL accepted therapeutic modalities
- Probable Indications for Cardiac Transplantation:
1. Maximal VO2 <14 ml/kg/min and major limitation of the patient’s activities, or
2. Recurrent unstable ischemia not amenable to bypass surgery or angioplasty, or
3. Instability of fluid balance/renal function not due to patient noncompliance with regimen of weight monitoring, flexible use of diuretic drugs, and salt restriction
- Inadequate indications for transplantation unless other factors as listed above are present:
1. Ejection fraction <20%
2. History of functional class III or IV symptoms of heart failure
3. Previous ventricular arrhythmias
4. Maximal VO2 >15 ml/kg/min
B. For Pediatric Patients:
(A 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, or
- Mechanical ventilatory support, or
- Mechanical circulatory support
- Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have:
- Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <50% predicted for age and sex), or
- Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease, or
- Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator, or
- Restrictive cardiomyopathy with reactive pulmonary hypertension, or
- Reactive pulmonary hypertension and potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future, or
- Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle, or
- Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction
Heart retransplantation after a failed primary heart transplant may be considered medically necessary in patients who meet criteria for heart transplantation.
Heart transplantation is considered investigational in all other situations.
III. The following indications are to be used as a guideline for priority allocation. (The United Network for Organ Sharing (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 organ as follows):
UNOS STATUS CATEGORIES
For Adult Patients (18 years of age or older)
A patient is admitted to the listing transplant center hospital and has at least one of the following devices or therapies in place:
(a) Mechanical circulatory support for acute hemodynamic decompensation that includes at least one of the following:
1. Left and/or right ventricular assist device implanted
2. Total artificial heart
3. Intra-aortic balloon pump: or
4. Extracorporeal membrane oxygenator (ECMO)
(b) Mechanical circulatory support
(c) Continuous mechanical ventilation
(d) Continuous infusion of inotropes and continuous monitoring of left ventricular filling pressures
(e) If criteria a, b, c, and d are not met, such status can be obtained by application to the applicable Regional Review Board
A patient has at least one of the following devices or therapies in place:
1. Left and/or right ventricular device implanted, or
2. Continuous infusion of intravenous inotropes
(A patient that does not meet Status 1A or 1B is listed as Status 2)
For Pediatric Patients
(Pediatric heart transplant candidates who remain on the waiting list at the time of their 18th birthday without receiving a transplant continue to qualify for medical urgency status based upon the pediatric criteria)
A candidate listed as Status 1A meets at least one of the following criteria:
(a) Requires assistance with a ventilator;
(b) Requires assistance with a mechanical assist device (e.g., ECMO);
(c) Requires assistance with a balloon pump;
(d) A candidate younger 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;
(e) Requires infusion of high dose (e.g., dobutamine >7.5 mcg/kg/min or milrinone >0.5 mcg/kg/min) or multiple inotropes (e.g., addition of dopamine at >5.0 mcg/kg/min); or
A candidate who does not meet the criteria specified in a, b, c, d, or e may be listed as Status 1A if the candidate has a life expectancy without a heart transplant of less than 14 days, such as due to refractory arrhythmia.
A candidate listed as Status 1B 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);
Younger than 6 months old and does not meet the criteria for Status 1A, or
Growth failure, i.e., greater than 5th 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.
A heart transplant should be considered under the members contract transplant benefit.
Coverage is not provided for:
- Services for which the cost is covered/funded by governmental, foundation, or charitable grants
- Organs sold rather than donated to the recipient
Potential contraindications subject to the judgment of the transplant center:
- Known current malignancy, including metastatic cancer
- Recent malignancy with high risk of recurrence
- Untreated systemic infection making immunosuppression unsafe, including chronic infection
- Other irreversible end-stage disease not attributed to heart or lung disease
- History of cancer with a moderate risk of recurrence
- Systemic disease that could be exacerbated by immunosuppression
- Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
- Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance (PVR) greater than 5 Wood units, or trans-pulmonary gradient (TPG) greater than or equal to 16 mm/Hg*
- Severe pulmonary disease despite optimal medical therapy, not expected to improve with heart transplantation
Patients must meet the United Network for Organ Sharing (UNOS) guidelines for 1A, 1B, or 2 Status and not currently be Status 7.
A candidate who does not meet the criteria for Status 1A or 1B is listed as Status 2.
Status 7 patients are considered temporarily unsuitable to receive a thoracic organ transplant.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
8/1998: Approved by Medical Policy Advisory Committee (MPAC)
5/1/2002: Type of Service and Place of Service deleted
7/21/2005: Review by MPAC: Policy updated; "HIV positivity is not an absoulte contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients."
10/26/2005: Code Reference section updated: HPCS S2152 added; ICD-9 procedure code 00.93 added, 5th digit added to 37.51; ICD-9 Diagnosis code: 398.0, 422.91, 422.92, 422.93, 425.0, 425.3, 425.4, 428.0, 428.1, 428.22, 428.23, 428.32, 428.33, 428.42, 428.43, 428.9, 429.1, 429.3 added
3/27/2006: Coding updated. CPT4 2006 revisions added to policy
12/31/2008: Policy reviewed, prior authorization for evaluation removed
11/23/2009: Policy Description revised to add link to Heart-Lung Transplantation policy, Policy Statement Section revised to add new medically necessary criteria being patients must now meet specific criteria, fall within patient selection ACC guidelines and priority allocation UNOS guidelines, specific medically necessary criteria added, revised ACC guideline information added, revised UNOS priority allocation information added, non-coverage information added, Coding Section revised to add ICD9 procedure codes 37.99 and 39.61 to Covered Codes Table, ICD9 Diagnosis codes 422.91, 422.92, 422.93 replaced incorrect codes 442.91, 442.93, 442.94 on the Covered Codes Table.
02/24/2012: Contraindications moved to the Policy Guidelines section, and the absolute and relative contraindications were combined. Deleted outdated references from the Sources section.
03/31/2013: Policy reviewed; no changes.
04/24/2014: Added the following policy statements: 1) Heart retransplantation after a failed primary heart transplant may be considered medically necessary in patients who meet criteria for heart transplantation. 2) Heart transplantation is considered investigational in all other situations.
02/19/2015: Policy description updated. Policy statement criteria for pediatric patients regarding anatomical and physiological conditions updated to change "natural history or congenital heart disease" to "natural history of congeital heart disease." In the UNOS priority allocation statement, "donor heart organs" changed to "donor thoracic organs." Added the following statement for Status 1A Adult Patients: If criteria a, b, c, and d are not met, such status can be obtained by application to the applicable Regional Review Board. Revised the statement for Status 1A Pediatric Patients to state that a candidate who does not meet the criteria specified in a, b, c, d, or e may be listed as Status 1A if the candidate has a life expectancy without a heart transplant of less than 14 days, such as due to refractory arrhytmia.
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Anesthesia for heart transplant or heart/lung transplant
Physiological support for harvesting of organ(s) from brain-dead patient
Donor cardiectomy (including cold preservation)
Backbench standard preparation of cadaver donor heart/lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, and trachea for implantation
Heart transplant, with or without recipient cardiectomy
Transplant from cadaver
Other operations on heart and pericardium
Extracorporeal circulation auxiliary to open heart surgery
ICD-9 Diagnosis - Codes related to end-stage heart failure that may be due to a wide variety of cardiac disorders. This is not intended to be a comprehensive list of covered diagnosis codes.
422.91, 422.92, 422.93
Myocarditis (code range)
Other primary cardiomyopathies
Congestive heart failure, unspecified
Left heart failure
428.22, 428.23, 428.32, 428.33, 428.42, 428.43, 428.9
Heart failure (code range)
Solid organ(s), complete or segmental, single organ or combination of organs; deceased or living donor(s), procurement, transplantation, and related complications including: drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition