Heart/Lung Transplant

POLICY NUMBER

A.7.03.08

DESCRIPTION

Heart/lung transplantation involves a coordinated triple operative procedure consisting of procurement of a donor heart/lung block, excision of the heart and lungs of the recipient, and implantation of the heart and lungs into the recipient. Heart/lung transplantation refers to the transplantation of one or both lungs and heart from a single cadaver donor.

Solid organ transplantation offers a treatment option for individuals with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Patients are prioritized for transplant by mortality risk and severity of illness criteria developed by Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Most heart/lung transplant recipients have Eisenmenger syndrome (37%), followed by idiopathic pulmonary artery hypertension (28%) and cystic fibrosis (14%). Eisenmenger syndrome is a form of congenital heart disease in which systemic-to-pulmonary shunting leads to pulmonary vascular resistance. It is possible that pulmonary hypertension could lead to a reversal of the intracardiac shunting and inadequate peripheral oxygenation or cyanosis.

Heart/Lung Transplant

Combined heart/lung transplantation is intended to prolong survival and improve function in patients with end-stage cardiac and pulmonary diseases. Due to corrective surgical techniques and improved medical management of pulmonary hypertension, the total number of patients with Eisenmenger syndrome has seen a decline in recent years. Additionally, heart/lung transplants have not increased appreciably, but for other indications, it has become more common to transplant a single or double lung and maximize medical therapy for heart failure, rather than perform a combined transplant. For those indications, patient survival rates following heart/lung transplantations are similar to lung transplant rates. Bronchiolitis obliterans syndrome is a major complication. One-, 5-, and 10-year patient survival rates for heart/lung transplants performed between 1982 and 2014 were estimated at 63%, 45%, and 32%, respectively.

In 2023, 46,630 transplants were performed in the United States procured from more than 16,000 deceased donors and 6,900 living donors. Of these transplants, 54 individuals received heart/lung transplants in the U.S in 2023 (total 1,537 heart-lung transplants done to date in US). As of June 2024, 41 patients were on the waiting list for heart/lung transplants.

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

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.

Heart/lung transplantation is medically necessary for carefully selected individuals with end-stage cardiac and pulmonary disease including, but not limited to, one of the following diagnoses:

• irreversible primary pulmonary hypertension with heart failure;

• non-specific severe pulmonary fibrosis, with severe heart failure;

• Eisenmenger complex with irreversible pulmonary hypertension and heart failure;

• cystic fibrosis with severe heart failure;

• chronic obstructive pulmonary disease with heart failure;

• emphysema with severe heart failure;

• pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure.

Heart/lung retransplantation after a failed primary heart/lung transplant may be considered medically necessary in individuals who meet criteria for heart/lung transplantation.

Heart/lung transplantation is considered investigational in all other situations.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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.

Heart/Lung-Specific Criteria

When the candidate is eligible to receive a heart in accordance with United Network for Organ Sharing (UNOS) guidelines for cardiac transplantation, the lung(s) shall be allocated to the heart/lung candidate from the same donor. When the candidate is eligible to receive a lung in accordance with the UNOS Lung Allocation System, the heart shall be allocated to the heart/lung candidate from the same donor "after the heart has been offered to all heart and heart-lung potential transplant recipients in allocation classifications 1 through 4." Candidates with allocation classifications 1 through 4 fall within adult status 1 or 2 or pediatric status 1A.

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 UNOS. Donor thoracic organs are prioritized by UNOS on the basis of recipient medical urgency, distance from donor hospital, and pediatric status. Individuals who are most severely ill (status 1A) are given highest priority.

The following factors are considered in assessing the severity of cardiac illness: reliance on continuous mechanical ventilation, infusion of intravenous inotropes, and/or dependency on mechanical circulatory support (ie, total artificial heart, intra-aortic balloon pump, extracorporeal membrane oxygenator, ventricular assist device). Factors considered in assessing the severity of pulmonary illness include increased pulmonary artery systolic pressure, pulmonary arterial hypertension, and/or elevated pulmonary vascular resistance.

Additional criteria may be considered in pediatric individuals, including diagnosis of an OPTN-approved congenital heart disease diagnosis, presence of ductal dependent pulmonary or systemic circulation, and diagnosis of hypertrophic or restrictive cardiomyopathy while less than one year old. Of 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 on the pediatric criteria.

Criteria from OPTN for listing status are as follows.

Adult Patients (18 years of age or older)

Status 1AA 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:

   1. Total artificial heart

   2. Intra-aortic balloon pump: or

   3. Extracorporeal membrane oxygenator (ECMO)

2. Continuous

   mechanical ventilation

3. Requires continuous infusion of a single high-dose intravenous 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:

   1. Left ventricular assist device (LVAD)

   2. Right ventricular assist device (RVAD)

   3. 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.

Status 1BA 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 assist devices (BiVAD)

4. Continuous infusion of intravenous inotropes

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

Pediatric PatientsA 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 (eg, 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 (eg, addition of dopamine at ≥5.0 μg/kg/min); or

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

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.

In both adult and pediatric individuals, isolated cardiac or pulmonary transplantations are preferred to combined heart/lung transplantation when medical or surgical management—other than organ transplantation—is available.

Full OPTN guidelines are available online (at https://optn.transplant.hrsa.gov/governance/policies/ ).

Status 7 patients are considered temporarily unsuitable to receive a thoracic organ transplant.

Individuals who are considered temporarily unsuitable to receive a thoracic organ transplant may be assigned an inactive status.

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 Mental Health Disorders, 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 medical necessity, “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.

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: Reviewed by MPAC: "HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients."    

10/17/2005: Code Reference table updated: codes: 33930, 33960 description revised, 33933 added; diagnosis codes 277.0-277.01, 416.2 deleted, 277.02, 416.0, 491.20, 491.22, 493.20, 493.21, 493.22 added; ICD-9 procedure 00.93 added.

3/28/2006: Coding updated: CPT4 2006 revisions added to policy.

12/31/2008: Policy reviewed, prior authorization for evaluation removed.

02/24/2012: Policy statement revised to add "with severe heart failure" to the second bullet point. Deleted the following from the policy statement: HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients. Contraindications moved to the Policy Guidelines section, and the absolute and relative contraindications were combined. Deleted outdated references from the Sources section.

03/13/2013: Policy reviewed; no changes.

04/07/2014: Policy statement updated to add "Heart/lung retransplantation after a failed primary heart/lung transplant may be considered medically necessary in patients who meet criteria for heart/lung transplantation." Added statement that heart/lung transplantation in all other situations is considered investigational.

12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 33946, 33947, 33948, 33949, 33951, 33952, 33953, 33954, 33955, 33956, 33957, 33958, 33959, 33962, 33963, 33964, 33965, 33966, 33969, 33984, 33985, 33986, 33987, 33988, and 33989.

01/14/2015: Policy reviewed; description updated regarding Eisenmeger syndrome. Policy statements unchanged.

08/25/2015: Code Reference section updated for ICD-10.

03/04/2016: Policy description updated with 2014 and 2015 data. Policy statements unchanged. Policy guidelines updated regarding cardiac-specific criteria for adult and pediatric patients. Added medically necessary and investigative definitions. Removed deleted CPT code 33960 from the Code Reference section.

06/01/2016: Policy number A.7.03.08 added.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, and I50.89. Effective 10/01/2017.

12/04/2017: Policy description updated regarding patient survival rates and FDA regulation. Policy statements unchanged. Policy Guidelines updated regarding cardiac-specific criteria.

08/31/2018: Policy description updated regarding new data for heart/lung transplants in the United States. Added information regarding FDA regulation. Policy statements unchanged. Policy Guidelines updated.

09/12/2019: Policy reviewed; no changes.

09/18/2020: Policy description updated regarding solid organ transplantation and transplants performed in 2019. Policy statements unchanged. Policy Guidelines updated regarding heart/lung-specific criteria.

12/28/2021: Policy description updated regarding new data for transplants performed in the United States. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

11/15/2022: Policy description updated regarding new data for transplants. Policy statements and Policy Guidelines updated to change "patients" to "individuals." Policy Guidelines updated to add link for OPTN guidelines.

10/06/2023: Policy description updated regarding new data for transplants. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

10/21/2024: Policy description updated regarding new transplant data. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy #7.03.08

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

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.