Organ Transplant Policy Comparison I. Heart 2/9/2016 Full Coverage Details BCBS A. Benefit eligibility is considered for adult patients with end-stage, irreversible, refractory, symptomatic heart disease requiring maximal continuous medical and/or mechanical support and who have: 1. a low functional status, and 2. a poor probability of survival, and 3. one of the following underlying conditions: a. presence of an implanted ventricular assist device, or b. refractory cardiogenic shock, or c. dependency on intravenous inotropic support to maintain adequate organ perfusion, or d. maximal VO2 of 11-14 milliliters/kilogram/minute (or 55% of predicted) and major limitation of activities, or e. severe ischemia (or recurrent unstable ischemia) consistently limiting routine activity not amenable to bypass surgery or percutaneous coronary intervention, or f. recurrent symptomatic ventricular arrhythmias refractory to all therapeutic modalities, or g. ischemic cardiomyopathy not amenable to medical therapy or revascularization procedures. B. Benefit eligibility is considered for pediatric heart transplantation in the following clinical situations: 1. Patients with heart failure with persistent symptoms at rest who require one or more of the following: a. continuous infusion of intravenous inotropic agents, or b. mechanical ventilatory support, or c. mechanical circulatory support. 2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have: a. severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <50% predicted for age and sex), or b. cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease, or c. near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator, or d. restrictive cardiomyopathy with reactive pulmonary hypertension, or Medicaid Each recipient’s condition is evaluated on an individual basis. There may be other conditions that are indications for coverage. The N.C. Medicaid program covers heart transplantation for patients with end-stage heart disease of any etiology who meet indications for transplantation related to the following disease processes. Adult The following list is not all inclusive. a. Symptomatic heart failure (NYHA Class III-IV) refractory to medical therapy: 1. peak VO2 less than 11ml/kg/min (or % predicted peak VO2 less than 45%) 2. peak VO2 = 12–16 ml/kg/min (or % predicted peak VO2 = 45–60%) considered probable indication b. Refractory life-threatening arrhythmias: 1. recurrent symptomatic life-threatening ventricular arrhythmias, which cannot be controlled with all available medical or surgical therapy 2. prolonged episodes of electromechanical disassociation following AICD conversion of VT or VF to sinus rhythm c. Unstable angina with a high risk of myocardial infarction in revascularization is not an option d. Congenital anomalies not amenable to repair or ventricular failure after prior palliative or reconstructive procedures Pediatric The following list is not all inclusive. a. Hypoplastic left heart syndrome, or other lethal congenital heart disease for which there is no standardized treatment b. End-stage cardiomyopathy (including failed palliative surgery) Organ Transplant Policy Comparison Heart 2/9/2016 e. reactive pulmonary hypertension and potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future, or f. anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle, or g. anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction. Retransplantation in patients with graft failure, due to either technical reasons or hyperacute rejection is considered medically necessary. Retransplantation in patients with chronic rejection, moderate graft vasculopathy or recurrent disease is considered medically necessary when the patient meets general patient section criteria as outlined above. II. Not Covered BCBS A. Benefits for Human Heart Transplant are not available when any of the following clinical conditions are present: 1. Alcoholic cardiomyopathy (unless abstinent for at least 6 months), 2. Systemic illness that would limit life expectancy or compromise recovery from cardiac transplantation, 3. Diabetes mellitus with evidence of significant endorgan complications, such as retinopathy, neuropathy, nephropathy, and peripheral or cerebrovascular disease, 4. Severe peripheral vascular disease or cerebrovascular disease, 5. Malignancy, life threatening, current or past (some have suggested a five year window to establish "cure"), 6. Irreversible hepatic (liver) dysfunction (transaminases twice normal, with associated coagulopathy), irreversible renal (kidney) dysfunction (serum creatinine greater than 2 mg/dl or clearance less than 50 cc/min), 9. Chronic bronchitis or chronic obstructive pulmonary disease FEV 1 less than 60% predicted or any irreversible lung disease, 10. Cachexia, even without major end-organ failure, as survival is significantly less favorable, 11. Morbid obesity indicated by a BMI > 40, or a BMI > 35 with comorbid conditions, 12. Absence of documentation of nonsmoking status, Medicaid 4.1 Adult a. Advanced age (generally over 65) b. Elevated and irreversible pulmonary vascular resistance (>6 Woods units, and not responsive to pharmacological manipulation) c. History of malignancy (except certain malignancies considered cured after >5 years) d. Insulin-dependent diabetes, with evidence of organ complications such as 1. Retinopathy 2. Neuropathy 3. Nephropathy 4. Peripheral and cerebrovascular disease e. Severe peripheral vascular disease f. HIV positive g. Smoking/tobacco use—must be abstinent for minimum of one year h. Obesity greater than 130% of ideal body weight i. Chronic bronchitis or chronic obstructive pulmonary disease j. Psychosocial history that would limit ability to comply with medical care pre and post transplant k. Irreversible hepatic function Organ Transplant Policy Comparison Heart 13. Recent substance abuse that will likely impair compliance with post transplant protocols, 14. Psychosocial instability, 15. HIV positivity. B. Pulmonary infarction or embolism during the preceding eight weeks is considered a relative contraindication. C. Heart transplants that require planned concurrent coronary artery bypass graft surgery. This is considered experimental 2/9/2016 l. Systemic illness/disease that would limit life expectancy or compromise recovery from cardiac transplantation m. Current patient and/or caretaker non-compliance that would make compliance with a disciplined medical regime improbable n. Heart transplants that require concurrent coronary artery bypass graft surgery o. History of or active substance abuse—must have documentation of substance abuse program completion plus six months of negative sequential random drug screens 4.2 Pediatric a. Unstable metabolic and hemodynamic status despite receiving supportive measures b. Active clinical infection c. Significant neurological deficit d. Significant renal malformations in infants under one year e. Chromosomal abnormalities or syndromes that would limit survival or benefit from transplantation f. History of or active substance abuse—must have documentation of substance abuse program completion plus six months of negative sequential random drug screen Note: To satisfy the requirement for sequential testing as designated in this policy, DMA must receive a series of test (alcohol and drug) results spanning a minimum six-month period, allowing no fewer than a three-week interval and no more than six-week interval between each test during the given time period. A complete clinical packet for prior approval must include at least one documented test performed within one month of the date of request to be considered. g. Psychosocial history that would limit ability to comply with medical care pre and post transplant h. Current patient and/or caretaker non-compliance that would make compliance with a disciplined medical regime improbable Donors: Living donor expenses are not applicable for a heart transplant. Organ Transplant Policy Comparison III. Heart 2/9/2016 BCBS Policy Guidelines Only those patients accepted for transplantation by a transplantation center and actively listed for transplant should be considered for prior review. Guidelines should be followed for transplant network or consortiums, if available. IV. None. Medicaid Policy Guidelines