Print Heart Transplant

Heart Transplant

 

DESCRIPTION

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. According to data from the Organ Procurement and Transplantation Network (OPTN), in 2014, a total of 2,655 heart transplants were performed in the United States. As of October 30, 2015, there were 4,207 patients on the waiting list for a heart transplant. 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 OPTN and fulfilled through a contract with the United Network for Organ Sharing.

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.

Heart transplantation is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA).

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,  

  • 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

or

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 of 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.

Cardiac-Specific Criteria

Specific criteria for prioritizing donor thoracic organs for transplant are provided by the Organ Procurement and Transplantation Network (OPTN) and implemented through a contract with the United Network for Organ Sharing (UNOS). Donor thoracic organs are prioritized by UNOS on the basis of recipient medical urgency, distance from donor hospital, and pediatric status. Patients who are most severely ill (status 1A) are given highest priority. Criteria from OPTN for listing status are as follows (Organ Procurement and Transplantation Network, 2015):

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:

1. Mechanical circulatory support that includes at least one of the following:

a. Total artificial heart
b.
Intra-aortic balloon pump: or
c. Extracorporeal membrane oxygenator (ECMO)

2. Continuous mechanical ventilation

3. Requires continuous infusion of a single high-dose intravenous inotrope or multiple intravenous inotropes, and requires continuous hemodynamic monitoring of left ventricular filling pressures.

A patient has one of the following devices or therapies in place (with or without being admitted to the listing transplant center hospital):

1. Mechanical circulatory support that includes at least one of the following:

a. Left ventricular assist device (LVAD)
b. Right ventricular assist device (RVAD)
c. Left and right ventricular assist devices (BiVAD)

2. Mechanical circulatory support and there is medical evidence of significant device-related complications including, but not limited to, thromboembolism, device infection, mechanical failure, or life-threatening ventricular arrhythmias.

1B

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

1. Left ventricular assist device (LVAD)
2. Right ventricular assist device (RVAD)
3.
Left and right ventricular devices (BiVAD)
4.
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:

1. Requires assistance with a mechanical ventilator;

2. Requires assistance with a mechanical assist device (e.g., ECMO);

3. Requires assistance with a balloon pump;

4. Is 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;

5. Requires infusion of a single high dose of an intravenous inotrope or multiple intravenous inotropes or multiple inotropes (e.g., addition of dopamine at >5.0 mcg/kg/min); or

6. Has a life expectancy without a heart transplant of less than 14 days.

1B

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

1. Requires infusion of low-dose single inotropes;
2. Is
younger than 6 months old and does not meet the criteria for Status 1A, or
3. Is in the less than 5th percentile for the candidates expected height and/or weight according to most recent Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics pediatric clinical growth chart;
4. Is 1.5 or more standard deviations below the candidate’s expected height growth or weight growth according to the most recent CDC National Center for Health Statistics pediatric clinical growth chart.

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

Policy-specific potential contraindications:

  1. 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 despite treatment*
  2. Severe pulmonary disease despite optimal medical therapy, not expected to improve with heart transplantation*

* Some patients may be candidates for combined heart-lung transplantation (see Heart/Lung Transplant medical policy)

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.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized  as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

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.

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.

08/25/2015: Code Reference section updated to add ICD-10 codes. Removed ICD-9 procedure codes 37.99 and 39.61.

03/04/2016: Policy description updated regarding 2014 and 2015 data for heart transplants. Policy section updated regarding cardiac-specific criteria for adult and pediatric patients. Policy guidelines section updated to list the policy-specific potential contraindications separately from the potential contraindications subject to the judgment of the transplant center. Added medically necessary and investigative definitions.

 

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

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

ICD-9 Procedure

ICD-10 Procedure

00.93

Transplant from cadaver

02YA0Z0, 02YA0Z1

Transplantation of Heart, Allogenic or Syngeneic, Open Approach

37.51

Heart transplantation

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.

ICD-10 Diagnosis

398.0

Rheumatic myocarditis

I09.0

Rheumatic myocarditis

422.91, 422.92, 422.93

Myocarditis (code range)

I40.0, I40.1, I40.8

Myocarditis (code range)

425.0

Endomyocardial fibrosis

I42.3

Endomyocardial (eosinophilic) disease

425.3

Endocardial fibroelastosis

I42.4

Endocardial fibroelastosis

425.4

Other primary cardiomyopathies

I42.0

Dilated cardiomyopathy

I42.5

Other restrictive cardiomyopathy

I42.8

Other cardiomyopathies

I42.9

Cardiomyopathy, unspecified

428.0

Congestive heart failure, unspecified

I50.20 - I50.9

Congestive heart failure code range

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

Heart failure (code range)

428.1

Left heart failure

I50.1

Left ventricular failure

429.1

Myocardial degeneration

I51.5

Myocardial degeneration

429.3

Cardiomegaly

I51.7

Cardiomegaly

 

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