HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-125-017
Topic:
Heart/Lung Transplant
Section:
Surgery
Effective Date:
October 1, 2023
Issued Date:
October 1, 2023
Last Revision Date:
September 2023
Annual Review:
October 2020
 
 

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.

Policy Position

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:

  • Irreversible primary pulmonary hypertension with severe heart failure; or
  • Nonspecific severe pulmonary fibrosis, with severe heart failure; or
  • Eisenmenger complex with irreversible pulmonary hypertension and severe heart failure associated with congenital heart disease that is unable to be surgically repaired; or
  • Cystic fibrosis with severe heart failure; or
  • Chronic obstructive pulmonary disease with heart failure; or
  • Emphysema with severe heart failure; or
  • Pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure.
  • 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.

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:

  • Known current malignancy, including metastatic cancer; or
  • Recent malignancy with high risk of recurrence; or
  • Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
  • Other irreversible end-stage diseases not attributed to heart or lung disease; or
  • History of cancer with a moderate risk of recurrence; or
  • Systemic disease that could be exacerbated by immunosuppression; or
  • 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 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.


Related Policies

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.


Professional Statements and Societal Positions Guidelines

The International Society for Heart and Lung Transplantation-2014

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:

  • High (greater than 50%) risk of death from lung disease within two (2) years if lung transplantation is not performed. 
  • High (greater than 80%) likelihood of surviving at least 90 days after lung transplantation. 
  • High (greater than 80%) likelihood of five (5) year post-transplant survival from a general medical perspective provided that there is adequate graft function." 

For combined heart/lung transplant, the guidelines have stated that [individuals] with irreversible myocardial dysfunction or irreparable congenital defects in conjunction with intrinsic lung disease or severe pulmonary arterial hypertension are appropriate candidates for heart/lung transplantation. The guidelines also mentioned that isolated bilateral lung transplantation is associated with comparable or better outcomes in most [individuals] with pulmonary hypertension associated with right ventricular failure.


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Place of Service: Inpatient



The policy position applies to all commercial lines of business



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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.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • 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.