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.
Heart/lung transplantation may be considered medically necessary for carefully selected individuals with end-stage cardiac and pulmonary disease including, but not limited to ONE of the following diagnoses:
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.
Note: In all of the above, heart failure must be severe enough that it is unlikely to recover after lung-only transplantation.
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 or retransplantation not meeting the criteria as indicated in this policy is considered not medically necessary.
In addition to the above criteria and subject to the discretion of the transplant center, a Hepatitis C Virus (HCV) positive donor organ maybe considered an acceptable organ option for an HCV negative adult recipient 18 years of age or older.
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General Criteria
The factors below are potential contraindications subject to the judgment of the transplant center:
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 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 1-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.
Individuals who are considered temporarily unsuitable to receive a thoracic organ transplant may be assigned an inactive status.
Refer to Medical Policy S-12, Team Surgery, for additional information
Refer to Medical Policy S-16, Assistant Surgery Eligibility Criteria, for additional information.
Refer to Medical Policy S-122, Heart Transplant, for additional information.
Refer to Medical Policy S-123, Lung and Lobar Lung Transplant, for additional information.
The International Society for Heart and Lung Transplantation-2021
The International Society for Heart and Lung Transplantation updated its consensus-based guidelines on the selection of lung transplant recipients.
These guidelines made the following statements about lung transplantation:
Lung transplantation should be considered for adults with chronic, end-stage lung disease who meet all the following general criteria:
1. High (>50%) risk of death from lung disease within 2 years if lung transplantation is not performed.
2. High (>80%) likelihood of 5-year post-transplant survival from a general medical perspective provided that there is adequate graft function.
Prior to determining that a patient is not a candidate for lung transplantation, referring providers should communicate directly with at least one lung transplant program with experience with
the candidate’s potential contraindication(s).
Early referral is recommended to facilitate transplant education for the patient and caregivers, an initial assessment of barriers to transplant, and determination of timing for full evaluation with specific recommendations for optimization of candidacy.
Determination of candidacy requires a detailed evaluation not only to select appropriate candidates, but also to optimize each individual’s status to provide them with the best chance for a successful
outcome.
Individual transplant candidacy at a particular institution depends on that center’s expertise for management of patients who have risk factors posing high or substantially increased risk.
Decision making regarding timing of listing for transplant should take into consideration results of the full evaluation, including disease severity and trajectory, estimated wait time for donor organ(s) and survival time without transplant, and candidate’s readiness for transplant.
Just as the decision to list is carefully considered, interval reassessment for continued listing should take place to evaluate the risks and benefits of transplant when considering any changes to the candidate’s status that may impact predicted perioperative or post-transplant outcomes.
When referring for lung transplant evaluation, consider simultaneous referral to palliative care to provide decision support and treatment selection that is consistent with goals of care throughout the transplant evaluation, listing, surgery, and posttransplant.
For combined heart/lung transplant, the guidelines have stated that:
Heart-lung and other multi-organ transplantation should be limited to centers with experience in such procedures and where specialists are available to manage each of the transplanted organs.
Candidates should meet the criteria for lung transplant listing and have significant dysfunction of one or more additional organs, or meet the listing criteria for a non-pulmonary organ transplant and have significant pulmonary dysfunction.
Waiting times are likely to be longer and the likelihood of receiving a transplant is reduced when an individual requires more than one organ. Thus, referral should occur earlier in the disease course if multi-organ transplantation may be considered.
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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
