Medical Policy

 

Subject: Heart Transplantation
Document #: TRANS.00033 Publish Date:    04/25/2018
Status: Reviewed Last Review Date:    03/22/2018

Description/Scope

This document addresses cardiac transplantation, a therapeutic modality for individuals with end-stage heart disease, characterized by cardiac failure that does not respond to standard, optimal medical or surgical treatments.

Note: Please see TRANS.00026 Heart/Lung Transplantation for additional information.

Position Statement

Medically Necessary:

Heart transplantation is considered medically necessary in carefully selected individuals when the following clinical indications and the General Individual Selection criteria below are met.

Adult Clinical Indications* - Adults with end-stage, irreversible, refractory, symptomatic heart failure requiring maximal continuous medical or mechanical support must have:

  1. A low functional status; and
  2. A poor probability of survival; and
  3. ONE of the following underlying conditions:
    1. Presence of an implanted ventricular assist device; or
    2. Presence of an intra-aortic balloon pump (IABP); or
    3. Refractory cardiogenic shock; or
    4. dependency on intravenous (IV) inotropic support to maintain adequate organ perfusion; or
    5. Maximal VO2 less than or equal to 10 ml/kg/min with achievement of anaerobic metabolism; or
    6. Maximal VO2 greater than 10 and less than 15 ml/kg/min (or 55% of predicted) and major limitation of the individual’s activities; or
    7. Severe ischemia consistently limiting routine activity not amenable to bypass surgery or percutaneous coronary intervention (PCI); or
    8. Recurrent unstable ischemia not amenable to bypass surgery or percutaneous coronary intervention (PCI); or
    9. Recurrent symptomatic ventricular arrhythmias refractory to ALL therapeutic modalities; or
    10. Ischemic cardiomyopathy not amenable to medical therapy or revascularization procedures.

Pediatric Clinical Indications* - Heart transplant is an accepted treatment option for selected children with end-stage heart disease characterized by intractable symptoms and heart failure that cannot be treated with conventional medical or surgical methods. Children must have:

  1. Low cardiac output; and
  2. ONE of the following conditions:
    1. Intractable heart failure not amenable to medical or surgical interventions; or
    2. Complex congenital heart disease not amenable to surgical repair or palliation or for which the surgical procedure carries a higher risk of mortality than transplantation; or
    3. Heart disease with reactive pulmonary hypertension and a potential of developing fixed, irreversible increased pulmonary vascular resistance (PVR) that would preclude a future orthotopic heart transplantation; or
    4. Heart disease associated with near sudden death; or
    5. Life-threatening arrhythmias untreatable with medications or an implantable defibrillator.

*Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member’s candidacy for transplantation.

Heart Retransplantation

Retransplantation in individuals with graft failure of an initial heart transplant, due to either technical reasons or hyperacute rejection is considered medically necessary.

Retransplantation in individuals with chronic rejection, moderate graft vasculopathy or recurrent disease is considered medically necessary when the individual meets general individual selection criteria as defined below.

Investigational and Not Medically Necessary:

A heart transplantation is considered investigational and not medically necessary when the above criteria are not met.

General Individual Selection Criteria

In addition to having end-stage heart disease, the member must not have a contraindication to transplantation, as defined by the American Society of Transplantation (Steinman, 2001) and the International Society for Heart and Lung Transplantation (Mehra, 2016) as listed below.

Relative Contraindications for Transplant Recipients include, but are not limited to, the following:

  1. Pulmonary hypertension that is fixed as evidenced by either:
    1. Pulmonary vascular resistance (PVR) greater than 5 Wood units; or
    2. Trans-pulmonary gradient (TPG) greater than or equal to 16 mm/Hg.

Absolute Contraindications for Transplant Recipients include, but are not limited to, the following:

  1. Metastatic cancer;
  2. Ongoing or recurring infections that are not effectively treated;
  3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery;
  4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured;
  5. Active, systemic lupus erythematosus or sarcoid with multisystem involvement;
  6. Any systemic condition with a high probability of recurrence in the transplanted heart;
  7. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations;
  8. Potential complications from immunosuppressive medications are unacceptable to the patient;
  9. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200 cells/mm3) unless the following are noted:
    1. CD4 count greater than 200 cells/mm3 for greater than 6 months;
    2. HIV-1 RNA undetectable;
    3. On stable anti-retroviral therapy greater than 3 months;
    4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm);
    5. Meeting all other criteria for heart transplantation.
Rationale

The number of heart transplant candidates and heart transplants performed in the U.S. continues to rise annually, with 2819 heart transplants performed in 2015 (Colvin, 2017). Heart transplantation is a standard treatment for individuals with end-stage heart disease that is not amenable to medical or surgical therapies. In the 2013 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) guideline for the management of heart failure authors reported:

Cardiac transplantation is considered the gold standard for the treatment of refractory end-stage HF. Since the first successful cardiac transplantation in 1967, advances in immunosuppressive therapy have vastly improved the long-term survival of transplant recipients with a 1, 3, and 5 year post-transplant survival rate of 87.8%, 78.5%, and 71.7% in adults, respectively. Similarly, cardiac transplantation has been shown to improve functional status and heart failure with reduced ejection fraction (HRQOL) (Yancy, 2013).

The previous guidelines for heart transplantation from the International Society for Heart and Lung Transplantation (ISHLT) were developed before the incorporation of β-blocker and device therapies for the treatment of late or end-stage heart disease (Mehra, 2006). Mehra and colleagues (2006) reported early studies showing a significant survival benefit with heart transplantation in adults with a peak VO2  less than 14 ml/kg/min when compared to individuals who were not considered eligible for transplantation and were maintained on a medical regimen. A subset of individuals with a peak VO2 less than 10 ml/kg/min who achieved anaerobic threshold had a lower survival rate when compared to individuals with a VO2 between 10-14 ml/kg/min. Medical therapies utilized in adults for treatment of heart disease have also been incorporated into the pediatric population. In addition, there have been significant improvements in overall survival for staged palliative surgeries for left hypoplastic heart disease (Canter, 2007). Therefore, the heart transplant listing criteria for adults and pediatrics were re-evaluated.

Over time complex congenital heart disease may be worsened with specific anatomic and physiological conditions. These individuals are eligible for heart transplantation and the conditions described by Canter and colleagues (2007) include, but are not limited to:

Cardiopulmonary exercise test results are routinely utilized to determine transplant candidacy. Testing is limited to individuals older than 7-8 years of age (Canter, 2007). Maximal VO2 describes the maximum amount of oxygen utilized while exerting maximal physical activity per kilogram of body weight per minute. The testing is usually performed on a treadmill or on a cycloergometer. There are different calculators to estimate VO2 max. Individuals that are physically fit have higher VO2 max values and can perform more intense exercises. VO2 max is properly determined by the Fick Equation: VO2max = Q (CaO2−CvO2) where Q is cardiac output, CaO2 is arterial oxygen content, and CvO2 is venous oxygen content. The average young untrained male will have a VO2 max of approximately 45 ml/min/kg. The average young untrained female will score a VO2 max of 38 ml/min/kg. These scores can improve with training and generally decrease with age.

Post-transplant morbidity and mortality are frequently caused by right heart failure. Recommendations by the International Society for Heart and Lung Transplantation (ISHLT) include a pre-transplant vasodilator challenge to be administered if either pulmonary vascular resistance (PVR) is greater than 3 Wood units or the transpulmonary gradient (TPG) is greater than or equal to 15. Despite the lack of absolute cutoff values that would contraindicate transplantation, analyses of the ISHLT registry demonstrated incremental risks as PVR increased. Survival comparison of those with 1-3 Wood units had better outcomes when compared to individuals with a PVR of greater than 5 Wood units. Relative contraindications to heart transplant include PVR greater than 5 Wood units or TPG greater than 16-20 mm Hg or PVR index is greater than 6 (Canter, 2007; Mehra, 2016).

Coronary artery vasculopathy (CAV) is a diffuse disease process that results in progressive coronary artery atherosclerosis and is a threat to long-term survival. CAV is the most common cause of complications and death after the first year post-heart transplant. Angiographically confirmed graft vasculopathy results in a poor prognosis. Graft loss or death within 2 years of diagnosis was noted in 24% of individuals with any degree of vasculopathy and 50% of individuals with moderate to severe graft vasculopathy. Canter and colleagues (2007) reported a 2-3% annual risk of death or graft loss, with 70% of the events due to cardiac failure resulting from graft vasculopathy, rejection or a combination of both. A pediatric study resulted in similar 3-year survivals of 82% compared with 77% in re-transplantations versus primary transplantations (Canter, 2007). There have been various hypotheses and studies to determine the etiology, diagnosis, prevention and treatment of CAV. Despite therapeutic interventions, CAV may result in end-stage heart failure requiring a retransplantation. Because of limited donors and the mortality rates with CAV, ongoing clinical studies are focused on preventive therapies to reduce the incidence and severity of CAV (Boucek, 2007; Kobashigawa, 2000; Ross, 2007).

Groetzner and colleagues (2005) reported on 50 pediatric heart transplantations performed between 1988 and 2002. Actuarial survival rates at 1, 5 and 10 years were 86%, 80% and 80% for individuals transplanted thru 1995. With the addition of newer drugs such as the calcineurin inhibitor tacrolimus, immunosuppressant mycophenolate mofetil (MMF), and improved prophylactic therapies, the actuarial survival rates improved to 92% for both 1 and 5 years for individuals transplanted after 1995. A 6% perioperative mortality rate was a result of primary graft failure. Acute rejections resulted in death for 12% of individuals. Rejection and infections continue to be serious complications for pediatric heart transplantation. Additional studies need to be continued to determine the long-term effects of immunosuppressants, graft vessel disease, neoplastic disorders, renal complications and quality of life. The shortage of donor organs limits pediatric heart transplantation to individuals that have medically and surgically untreatable heart failure without therapeutic options (Groetzner, 2005).

Background/Overview

Heart transplants involve the removal of either all or part of a cadaver heart and its implantation into a recipient. There are two types of cardiac transplant: orthotopic and heterotopic. Orthotopic transplant is the usual method and involves implanting the ventricles of the donor heart onto the right atria and main arteries of the recipient’s heart. Heterotopic transplants involve placing the entire donor heart into the chest cavity and surgically attaching it to the recipient’s entire heart.

In contrast to the 1980s when the majority of heart transplant recipients were sick but stable individuals waiting at home, the majority of heart transplant recipients are now hospitalized Status 1A or 1B individuals at the time of transplant. This shift has occurred due to the increasing demand on the scarce resource of donor organs resulting in an increased waiting time for donor organs. Individuals initially listed as a Status 2 candidate may deteriorate to a Status 1A or 1B candidate before a donor organ becomes available. At the same time, medical therapy of heart failure has improved (particularly with the advent of ACE inhibitors), making it imperative that heart transplantation be limited to those individuals who have truly exhausted medical therapy and thus are likely to derive the maximum benefit from heart transplantation. Consequently, there has been a search to identify prognostic criteria that could identify such individuals. As noted in the American College of Cardiology (ACC) criteria (Hunt, 2009), the VO2 max serves as a critical objective criterion. The VO2 max, measured during maximal exercise, reflects the functional reserve of the heart. Studies have suggested that transplantation can be safely deferred in those individuals with a VO2 max of greater than 14 ml/kg/min. The importance of the VO2 max has also been emphasized by an American Heart Association Scientific Statement addressing heart transplant candidacy (Costanzo, 1995; Mudge, 1995). In past years, a left ventricular ejection fraction of less than 20% or an NYHA Class III or IV status may have been used to determine transplant candidacy. However, as indicated by the ACC criteria, these measurements are no longer considered adequate to identify transplant candidates. These measurements may be used to identify individuals for further cardiovascular workup, but should not be the sole criteria for transplant.

The 2018 United Network for Organ Sharing (UNOS) policy for allocation of heart and heart-lungs organs prioritizes donor heart organs according to the severity of illness as follows (UNOS, 2018):

Adult Candidate Status:

Adult (at least 18 years old at the time of registration) Status 1A Requirements for Candidates Currently Admitted to the Transplant Hospital

A candidate listed as Status 1A is admitted to the listing transplant hospital that registered the candidate on the waiting list, or an affiliated Veteran’s Administration (VA) hospital, and the candidate also meets at least one of the following:

  1. Has one of the following mechanical circulatory support devices in place:
    • Total artificial heart
    • Intra-aortic balloon pump
    • Extracorporeal membrane oxygenator (ECMO)

Candidate's initial listing as Status 1A to extend the Status 1A listing.

  1. Requires continuous mechanical ventilation. Qualification for Status 1A under this criterion is valid for 14 days and must be recertified by an attending physician every 14 days from the date of the candidate’s initial registration at adult status 1A to extend the Status 1A registration.
     
  2. Requires continuous infusion of a single high-dose intravenous inotrope or multiple intravenous inotropes, in addition to continuous hemodynamic monitoring of left ventricular filling pressures. The OPTN Contractor will maintain a list of the OPTN-approved qualifying inotropes and doses. Qualification for Status 1A under this criterion is valid for 7 days and may be renewed for an additional 7 day period for each occurrence of a Status 1A listing under this criterion for the same candidate.

A candidate who is at least 18 years old at the time of registration, and may or may not be currently admitted to the transplant hospital, may be assigned adult status 1A if the candidate meets at least one of the requirements above.

Adult Status 1A for Candidates- Current Hospitalization Not Required

Status 1A

  1. An individual has at least 1 of the following devices or therapies in place:
    • Left ventricular assist device (LVAD)
    • Right ventricular assist device implanted
    • Left and right ventricular assist devices (BiVAD)

      Qualification for Status 1A under this criterion is valid for 30 days and may be registered as adult status 1A for 30 days at any point after being implanted once an attending physician determines the candidate is medically stable. The 30 days do not have to be consecutive. However, if the candidate undergoes a procedure to receive another device, then the candidate qualifies for a new term of 30 days. Any 30 days granted by the new device would substitute and not supplement any time remaining from the previous about status 1a classification.
       
  2. Candidate has 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. A candidate’s sensitization is not an acceptable device-related complication to qualify as adult status 1A. If a transplant program reports a complication that is not listed here, the registration will be retrospectively reviewed by the heart regional review board (RRB). Qualification for Status 1A under this criterion is valid for 14 days, and must be recertified by an attending physician every 14 days from the date of the candidate’s initial registration as adult status 1A to extend the adult status 1A registration.

Adult Heart Status 1B Requirements

To assign a candidate adult status 1B, the candidate’s transplant program must submit a Heart Status 1B Justification Form to the OPTN Contractor. A candidate is not assigned adult status 1B until this form is submitted.

The candidate’s transplant program may assign the candidate as adult status 1B if the candidate is at least 18 years old at the time of registration and 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 or intravenous inotropes

Adult Heart Status 2 Requirements

If the candidate is at least 18 years old at the time of registration and does not meet criteria for adult Status 1A or 1B but is suitable for transplant, then the candidate may be assigned adult status 2.

Pediatric Candidate Status:

Status 1A

Each candidate awaiting heart transplantation is assigned a status code which corresponds to how medically urgent it is that the candidate receive a transplant. Medical urgency is assigned to a heart transplant candidate who is less than 18 years of age at the time of listing as follows: Pediatric heart transplant candidates who remain on the Waiting List at the time of their 18th birthday without receiving a transplant, shall continue to qualify for medical urgency status based upon the criteria set forth in policy.

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

Qualification for a candidate meeting the requirements for pediatric status 1A due to life expectancy without transplant of less than 14 days will be reviewed retrospectively by the Regional Review Board if any additional 14 day periods are received.

Pediatric Status 1A is valid for 14 days from the date of the candidate's initial registration as Status 1A and must be recertified by an attending physician every 14 days from the date of the candidate’s initial registration as pediatric status 1A to extend the status 1 A registration.

When a candidate’s pediatric status 1A expires, the candidate will be assigned pediatric status 1B. The attending physician must classify the candidate as pediatric status 2 or inactive status if the candidate’s medical condition does not qualify for pediatric status 1B.

Status 1B

Pediatric status 1B is applicable if the candidate is less than 18 years old at the time of registration and meets at least one of the following criteria:

For all pediatric candidates listed as Status 1B, a completed Heart Status 1B Justification Form must be received on OPTN Contractor in order to list a candidate as Status 1B. A candidate who does not meet the criteria for Status 1B may nevertheless be assigned to such status upon application by his/her transplant physician(s) and justification to the applicable Regional Review Board that the candidate is considered, using accepted medical criteria, to have an urgency and potential for benefit comparable to that of other candidates in this status as defined above. The justification must include a rationale for incorporating the exceptional case as part of the status criteria. A report of the decision of the Regional Review Board and the basis for it may be forwarded for review by the Thoracic Organ Transplantation and Membership and Professional Standards Committees to determine consistency in application among and within Regions and continued appropriateness of the candidate status criteria.

Definitions

End-stage heart failure: In people with heart failure, the body does not receive an adequate supply of oxygen. As a result, they can feel weak, fatigued or short of breath resulting in limited functional capacity. Everyday activities such as walking, climbing stairs, carrying groceries and yard work can become quite difficult. In end-stage heart failure, the heart is so weakened the individual will die without a heart transplant.

Heart transplant: Removal of an individual's heart and replacing it with a donor heart.

New York Heart Association (NYHA) definitions:

The NYHA classification of heart failure is a tiered system that categorizes subjects based on subjective impression of the degree of functional compromise; the class III and IV NYHA functional classes are as follows:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

 

00580

Anesthesia for heart transplant or heart/lung transplant

33940

Donor cardiectomy (including cold preservation)

33944

Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation

33945

Heart transplant, with or without recipient cardiectomy

 

 

ICD-10 Procedure

 

02YA0Z0

Transplantation of heart, allogeneic, open approach

02YA0Z1

Transplantation of heart, syngeneic, open approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Investigational and Not Medically Necessary:
For the codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Bauer J, Thul J, Kramer U, et al. Heart transplantation in children and infants: short-term outcome and long-term follow-up. Pediatr Transplant. 2001; 5(6):457-462.
  2. Boucek MM, Waltz DA, Edwards LB, et al. International Society for Heart and Lung Transplantation. Registry of the International Society for Heart and Lung Transplantation: ninth official pediatric heart transplantation report--2006. J Heart Lung Transplant. 2006; 25(8):893-903.
  3. Canter CE, Shaddy RE, Bernstein D, et al. Indications for heart transplantation in pediatric heart disease: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young; the Councils on Clinical Cardiology, Cardiovascular Nursing, and Cardiovascular Surgery and Anesthesia; and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007; 115(5):658-676.
  4. Costanzo MR, Augustine S, Bourge R, et al. Selection and treatment of candidates for heart transplantation. A statement for health professionals from the Committee on Heart Failure and Cardiac Transplantation of the Council on Clinical Cardiology, American Heart Association. Circulation. 1995; 92(12):3593-3612.
  5. Dearani GA, Razzouk AJ, Gundry SR, et al. Pediatric cardiac retransplantation: intermediate-term results. Ann Thorac Surg. 2001; 71(1):66-70.
  6. Dellgren G, Koirala B, Sakopoulus A, et al. Pediatric heart transplantation: improving results in high-risk patients. J Thorac Cardiovasc Surg. 2001; 121(4):782-791.
  7. Gandhi SK, Canter CE, Kulikowska A, Huddleston CB. Infant heart transplantation ten years later – where are they now? Ann Thorac Surg. 2007; 83(1):169-171.
  8. Groetzner J, Reichart B, Roemer U, et al. Cardiac transplantation in pediatric patients: fifteen-year experience of a single center. Ann Thorac Surg. 2005; 79(1):53-61.
  9. Gronda E, Bourge RC, Costanzo MR, et al. Heart rhythm considerations in heart transplant candidates and considerations for ventricular assist devices: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates – 2006. J Heart Lung Transplant. 2006; 25(9):1043-1056.
  10. Hosenpud JD, Pamidi SR, Fiol BS, et al. Outcomes in patients who are hepatitis B surface antigen-positive before transplantation: an analysis and study using the joint ISHLT/UNOS thoracic registry. J Heart Lung Transplant. 2000; 19(8):781-785.
  11. Jessup M, Banner N, Brozena S, et al. Optimal pharmacologic and non-pharmacologic management of cardiac transplant candidates: approaches to be considered prior to transplant evaluation: International Society for Heart and Lung Transplantation Guidelines for the care of cardiac transplant candidates – 2006. J Heart Lung Transplant. 2006; 25(9):1003-1023.
  12. Kobashigawa, J. What is the optimal prophylaxis treatment of cardiac allograft vasculopathy? Curr Control Trials Cardiovasc Med. 2000; 1(3):166-171.
  13. Mudge GH, Goldstein S, Addonizio LJ, et al. 24th Bethesda Conference: Cardiac transplantation. Task Force 3: Recipient guidelines/prioritization. J Am Coll Cardiol. 1993; 22(1):21-31.
  14. Rosenthal D, Chrisant MR, Edens E, et al. International Society for Heart and Lung Transplantation: Practice guidelines for management of heart failure in children. J Heart Lung Transplant. 2004; 23(12):1313-1333.
  15. Ross M, Kouretas P, Gamberg P, et al. Ten- and 20-year survivors of pediatric orthotopic heart transplantation. J Heart Lung Transplant. 2006; 25(3):261-270.
  16. Srivastava R, Keck BM, Bennett LE, Hosenpud JD. The results of cardiac retransplantation: an analysis of the Joint International Society for Heart and Lung Transplantation/United Network for Organ Sharing Thoracic Registry. Transplantation. 2000; 70(4):606-612.
  17. Steinman TI, Becker BN, Frost AE, et al. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001; 71(9):1189-1204.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Centers for Medicare and Medicaid Services. National Coverage Determination for Heart Transplants. NCD #260.9. Effective May 1, 2008. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=112&ncdver=3&DocID=260.9&SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed on February 05, 2018.
  2. Colvin M, Smith JM Skeans MA, et al. OPTN/SRTR 2015 Annual data report: Heart. 2017; Available at: http://onlinelibrary.wiley.com/doi/10.1111/ajt.14128/full. Accessed on February 05, 2018.
  3. Gersh BJ, Maron BJ, Bonow RO. et al. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American Association for Thoracic Surgery, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2011; 124(24):e783-831. Available at: http://circ.ahajournals.org/content/124/24/e783.full.pdf+html. Accessed on February 05, 2018.
  4. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused Update Incorporated Into the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Available at: http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.109.192065v1. Accessed on February 05, 2018.
  5. International Society for Heart & Lung Transplantation. ISHLT Transplant Registry quarterly reports for heart in North America.  June 30, 2017. Available at:
    http://www.ishlt.org/registries/quarterlyDataReportResults.asp?organ=HR&rptType=all&continent=4. Accessed on February 05, 2018.
  6. Medicare/HCFA. Heart Transplants. Medicare Medical Policy Guidelines. 1999; 2.
  7. Mehra MR, Canter CE, Hannan MM, et al.; International Society for Heart Lung Transplantation (ISHLT) Infectious Diseases Council; International Society for Heart Lung Transplantation (ISHLT) Pediatric Transplantation Council; International Society for Heart Lung Transplantation (ISHLT) Heart Failure and Transplantation Council. The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: A 10-year update. J Heart Lung Transplant. 2016; 35(1):1-23. Available at: http://www.jhltonline.org/article/S1053-2498(15)01484-9/pdf. Accessed on February 05, 2018.
  8. Mehra MR, Kobashigawa J, Starling R, et al. Listing criteria for heart transplantation: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates – 2006. J of Heart and Lung Transplantation. 2006; 25(9):1024-1042. Available at: http://www.jhltonline.org/article/S1053-2498(06)00460-8/fulltext. Accessed on February 05, 2018.
  9. Steinman TL, Becker BN, Frost AE, et al. Clinical Practice Committee, American Society of Transplantation. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001; 71(9):1189-1204.
  10. United Network for Organ Sharing (UNOS). Policy 6 Organ Distribution: Allocation of Hearts and Heart-Lungs. Updated February 05, 2018. Available at: http://optn.transplant.hrsa.gov/governance/policies/. Accessed on February 05, 2018.
  11. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013; 128:e240-e327. Available at: http://circ.ahajournals.org/content/128/16/e240.full.pdf+html. Accessed on February 05, 2018.
Websites for Additional Information
  1. American Heart Association. Available at: http://www.americanheart.org. Accessed on February 05, 2018.
  2. National Heart, lung, And Blood Institute. What is a heart transplantation? Last updated December 9, 2016. Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/ht/. Accessed on February 05, 2018.
  3. The International Society for Heart & Lung Transplantation. Available at: http://www.ishlt.org. Accessed on February 05, 2018.
  4. United Network for Organ Sharing. Available at: http://www.unos.org/. Accessed on February 05, 2018.
Index

 

Heart Transplantation

Human Heart Transplantation

Transplantation, Human Heart

 

Document History

Status

Date

Action

Reviewed

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated formatting in MN position statement. Updated Background, References and Websites sections.

Reviewed

11/02/2017

MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, Background, References and Websites sections.

Reviewed

11/03/2016

MPTAC review. Updated formatting in Position Statement section. Updated Rationale, Background, References and Websites sections.

Revised

11/05/2015

MPTAC review. Defined abbreviation in investigational and not medically necessary statement. Updated Background, References and Websites sections. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Updated Description. Rationale, Background, References and Websites sections.

Reviewed

11/14/2013

MPTAC review. Updated Rationale, Background, References and Websites.

Reviewed

11/08/2012

MPTAC review. Updated Definitions, References and Websites.

Revised

02/16/2012

MPTAC review. Revised adult heart transplant medically necessary statement to include presence of intra-aortic balloon pump (IABP) as an underlying condition. Updated Background, References and Websites.

Reviewed

02/17/2011

MPTAC review. Removed “and/or” phrase from medically necessary statement. Rationale updated. Updated References and Websites.

Revised

02/25/2010

MPTAC review. Clarified medically necessary statement and adult medically necessary criteria for heart transplant. References updated.

Reviewed

02/26/2009

MPTAC review. References updated.

Reviewed

02/21/2008

MPTAC review. No change in position statement. Updated references. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary” at the November 29, 2007 MPTAC meeting. 

Revised

03/08/2007

MPTAC review. Medical necessity criteria updated to align with ACC, AHA and ISHLT criteria. Added retransplantation criteria. Updated references, background, websites and coding.

Reviewed

03/23/2006

MPTAC review. No changes to criteria. References were updated to include the 2005 updated ACC/AHA Guideline for the Diagnosis and Management of Chronic Heart Failure in the Adult.

 

11/18/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Revised

04/28/2005

MPTAC review. Revision based on: Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

10/09/2001

TRANS.00005H

Heart Transplant

 

 

Archived

 

WellPoint Health Networks, Inc.

03/11/2004

7.04.02

Heart Transplantation-Adult

 

03/11/2004

7.04.03

Heart Transplantation-Pediatric