Print Heart Transplant

Heart Transplant

 

DESCRIPTION

A heart transplant consists of replacing an end-stage diseased heart with a healthy donor heart.

Indications for Heart-Lung Transplantation are discussed in another policy.

 

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, or 

  • 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:
  1. Continuous infusion of intravenous inotropic agents, or
  2. Mechanical ventilatory support, or
  3. Mechanical circulatory support
  • Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have:
  1. Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <50% predicted for age and sex), or
  2. Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease, or
  3. Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator, or
  4. Restrictive cardiomyopathy with reactive pulmonary hypertension, or
  5. 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
  6. Anatomical and physiological conditions likely to worsen the natural history or congenital heart disease in infants with a functional single ventricle, or
  7. 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 heart 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

Status

Description

For Adult Patients (18 years of age or older)

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:

 

  1. Left and/or right ventricular assist device implanted, or
  2. Total artificial heart, or
  3. Intra-aortic balloon pump, or
  4. Extracorporeal membrane oxygenator (ECMO), or
  • Mechanical circulatory support
  • Mechanical ventilation
  • Continuous infusion of inotropes and continuous monitoring of left ventricular filling pressures

1B

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

  • Left and/or right ventricular device implanted, or
  • 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)

1A

A candidate listed as Status 1A meets at least one of the following criteria:

  • Requires assistance with a ventilator, or
  • Requires assistance with a mechanical assist device (e.g., ECMO), or
  • Requires assistance with a balloon pump, or
  • 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, or
  • 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
  • Has a life expectancy without a heart transplant of less than 14 days, such as due to refractory arrhythmia

1B

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), or
  • 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

 

POLICY EXCEPTIONS

None

 

POLICY GUIDELINES

Potential contraindications subject to the judgment of the transplant center:

  1. Known current malignancy, including metastatic cancer
  2. Recent malignancy with high risk of recurrence
  3. Untreated systemic infection making immunosuppression unsafe, including chronic infection
  4. Other irreversible end-stage disease not attributed to heart or lung disease
  5. History of cancer with a moderate risk of recurrence
  6. Systemic disease that could be exacerbated by immunosuppression
  7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
  8. Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance (PVR) greater than 5 Woods units, or trans-pulmonary gradient (TPG) greater than or equal to 16 mm/Hg*
  9. 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.

Cardiac Specific

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 (2):

Adult patients (18 years of age or older)

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:

  1. Mechanical circulatory support for acute hemodynamic decompensation that includes at least one of the following:
  2. Left and/or right ventricular assist device implanted
  3. Total artificial heart
  4. Intra-aortic balloon pump: or
  5. Extracorporeal membrane oxygenator (ECMO)
  6. Mechanical circulatory support
  7. Mechanical ventilation
  8. Continuous infusion of inotropes and continuous monitoring of left ventricular filling pressures
  9. If criteria a, b, c, and d are not met, such status can be obtained by application to the applicable Regional Review Board

Status 1B

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 who does not meet Status 1A or 1B is listed as Status 2.

Pediatric patients

A candidate listed as Status 1A meets at least one of the following criteria:

  • Requires assistance with a ventilator;
  • Requires assistance with a mechanical assist device (e.g., ECMO);
  • Requires assistance with a balloon pump;
  • 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;
  • 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 candidate who does not meet the criteria for Status 1A or 1B is listed as Status 2.

Note: 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.

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.

 

POLICY HISTORY

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.

 

SOURCE(S)

Blue Cross Blue Shield Association policy #7.03.09

 

CODE REFERENCE

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.

Covered Codes

Code Number

Description

CPT-4

00580

Anesthesia for heart transplant or heart/lung transplant 

01990

Physiological support for harvesting of organ(s) from brain-dead patient 

33940

Donor cardiectomy (including cold preservation)

33944

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

33945

Heart transplant, with or without recipient cardiectomy

ICD-9 Procedure

00.93

Transplant from cadaver

37.51

Heart transplantation

37.99

Other operations on heart and pericardium

39.61

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.

398.0

Rheumatic myocarditis

422.91, 422.92, 422.93

Myocarditis (code range)

425.0

Endomyocardial fibrosis

425.3

Endocardial fibroelastosis

425.4

Other primary cardiomyopathies

428.0

Congestive heart failure, unspecified

428.1

Left heart failure

428.22, 428.23, 428.32, 428.33, 428.42, 428.43, 428.9

Heart failure (code range)

429.1

Myocardial degeneration

429.3

Cardiomegaly

HCPCS

S2152

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

 

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