Medical Policy: 07.03.08 

Original Effective Date: November 2009 

Reviewed: November 2020 

Revised: November 2016 



This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.


This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.



A combined heart/lung transplant is intended to prolong survival and improve function in patients with end-stage cardiopulmonary or pulmonary disease. The transplant 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.


A heart/lung transplant refers to the transplantation of one or both lungs and heart from a single cadaver donor.


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 "if no suitable Status 1A isolated heart candidates are eligible to receive the heart" (Organ Procurement and Transplantation Network [2018]).


Professional Guidelines and Position Statements

International Society for Heart and Lung Transplantation

In 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 (>50%) risk of death from lung disease within 2 years if lung transplantation is not performed.
  • High (>80%) likelihood of surviving at least 90 days after lung transplantation.
  • High (>80%) likelihood of 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 patients 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 patients with pulmonary hypertension associated with right ventricular failure.


Regulatory Status

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


The FDA 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.


Prior Approval:

Prior approval is required.



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

  • Pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure
  • Emphysema with severe heart failure
  • Eisenmenger complex with irreversible pulmonary hypertension and heart failure
  • Cystic fibrosis with severe heart failure
  • Non-specific severe pulmonary fibrosis
  • Irreversible primary pulmonary hypertension with heart failure
  • Chronic obstructive pulmonary disease with heart failure
  • Alpha-1 Antitrypsin Deficiency 


Except as defined above, candidates for heart/lung transplant should meet the following general criteria:

  • Absence of active infection
  • Absence of non-curable chronic extrapulmonary infection including chronic active viral hepatitis B, hepatitis C, and human immunodeficiency virus
  • Documentation of patient compliance with medical management


The evaluation of a transplant candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.


The United Network for Organ Sharing (UNOS) believes that asymptomatic HIV-positive patients should not necessarily be excluded for candidacy for organ transplantation, stating, “A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy.” In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that the presence of AIDS could be considered a contraindication to kidney transplant unless the following criteria were present. These criteria may be extrapolated to other potential organ transplants:

  • CD4 count ≥ 200 cells/mm-3 for > 6 months
  • HIV-1 RNA undetectable
  • On stable anti-retroviral therapy > 3 months
  • No other complications from AIDS (e.g., opportunistic infection including aspergillus, tuberculosis, coccidioses mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm)
  • Meeting all other criteria for organ transplantation


It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.


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 organs as follows:


Adult patients (≥ 18 years of age)

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:

  • Mechanical circulatory support for acute hemodynamic decompensation that includes at least one of the following:
    • Left and/or right ventricular assist device implanted
    • Total artificial heart
    • Intra-aortic balloon pump
    • Extracorporeal membrane oxygenator
  • Mechanical circulatory support
  • Mechanical ventilation
  • Continuous infusion of inotropes and continuous monitoring of left ventricular filling pressures
  • If the above criteria are not met such status can be obtained by application to the applicable Regional Review Board


Status 1B

A patient has at least 1 of the following devices or therapies in place:

  • Left and/or right ventricular device implanted
  • Continuous infusion of intravenous inotropes


Pediatric patients

Status 1A

Patient meets at least one of the following criteria:

  • Requires assistance with a ventilator
  • Requires assistance with a mechanical assist device (e.g., extracorporeal membrane oxygenation [ECMO])
  • Requires assistance with a balloon pump
  • A patient less 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 ≥ 0.50 mcg/kg/min) or multiple inotropes (e.g., addition of dopamine at ≥ 5 mcg/kg/min) 


Note: A patient who does not meet the criteria above may be listed as Status 1A if the patient has a life expectancy without a heart transplant of less than 14 days, such as due to refractory arrhythmia.


Status 1B

Patient 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)
  • Less than 6 months old and does not meet the criteria for Status 1A
  • Growth failure, i.e., + 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


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.


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


Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 33935 Heart-lung transplant with recipient cardiectomy-pneumonectomy


Selected References:

  • Harringer W, Haverich A. Heart and heart-lung transplantation: standards and improvements. World J Surg 2002; 26(2):218-25.
  • Reichart B, Gulbins H, Meiser BM et al. Improved results after heart-lung transplantation: a 17-year experience. Transplantation 2003; 75(1):127-32.
  • United Network for Organ Sharing (UNOS). Policy 3.7. Organ Distribution: Allocation of Thoracic Organs UNOS Policies and Bylaws United Network for Organ Sharing, Alexandria, VA. December 2007.
  • Orens JB, Estenne M, Arcasoy S et al. Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. International guidelines for the selection of lung transplant candidates: 2006 update—a consensus report from the Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant 2006; 25(7):745-55.
  • Hayes D Jr, Galantowicz M, Hoffman TM. Combined heart-lung transplantation: A perspective on the past and the future. Pediatr Cardiol. 2012 Jun 10. [Epub ahead of print].
  • The ISHLT Guideline For the Care of Heart Transplant Recipients (J Heart Lung Transplant 2010;29(8);424-453
  • Benden C, Edwards LB, Kucheryavaya AY, et al. The registry of the international society for heart and lung transplantation: fifteenth pediatric lung and heart-lung transplantation report-2012. J Heart Lung Transplant. Oct 2012;31(10):1087-1095. PMID 22975098
  • (OPTN) OPaTN. Organ Procurement and Transplantation Network: Policies (last updated November 2, 2015). 2015
  • 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure (Endorsed by ISHLT)
  • Aguero F, Castel MA, Cocchi S, et al. An update on heart transplantation in human immunodeficiency virus-infected patients. Am J Transplant. Jan 2016;16(1):21-28. PMID 26523614
  • Goldfarb SB, Levvey BJ, Edwards LB, et al. The Registry of the International Society for Heart and Lung Transplantation: Nineteenth Pediatric Lung and Heart-Lung Transplantation Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. Oct 2016;35(10):1196-1205. PMID 27772671
  • Yusen RD, Edwards LB, Dipchand AI, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-third Adult Lung and Heart-Lung Transplant Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. Oct 2016;35(10):1170-1184. PMID 27772669 
  • Le Pavec J, Hascoët S, Fadel E. Heart-lung transplantation: current indications, prognosis and specific considerations. J Thorac Dis. 2018;10(10):5946–5952. doi:10.21037/jtd.2018.09.115
  • Dimopoulos K, Muthiah K, Alonso-Gonzalez R, et al Heart or heart-lung transplantation for patients with congenital heart disease in England Heart 2019;105:596-602.
  • Center for Medicare & Medicaid Services (CMS). Decision Memo for TRANSPLANT Centers: Re-Evaluation of Criteria for Medicare Approval (CAG-00061N). 2000.
  • Koval CE, Farr M, Krisl J, et al. Heart or lung transplant outcomes in HIV-infected recipients. J Heart Lung Transplant. Dec 2019; 38(12): 1296-1305. PMID 31636044


Policy History:

  • November 2020 - Annual Review, Policy Renewed
  • November 2019 - Annual Review, Policy Renewed
  • November 2018 - Annual Review, Policy Renewed
  • November 2017 - Annual Review, Policy Renewed
  • November 2016 - Annual Review, Policy Revised
  • November 2015 - Annual Review, Policy Revised
  • December 2014 - Annual Review, Policy Revised   
  • February 2014 - Annual Review, Policy Renewed
  • March 2013 - Annual Review, Policy Renewed
  • March 2012 - Annual Review, Policy Renewed
  • April 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.


*CPT® is a registered trademark of the American Medical Association.