Clinical Policy Title: Heart transplants

Transcription

1 Clinical Policy Title: Heart transplants Clinical Policy Number: Effective Date: January 1, 2016 Initial Review Date: June 16, 2013 Most Recent Review Date: October 19, 2017 Next Review Date: October 2018 Related policies: Policy contains: Heart transplant. Donor heart. Cardiomyopathy. Coronary artery disease. Heart failure. CP# Heart valve transplant ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of heart transplantation to be clinically proven and, therefore, medically necessary when the following criteria are met (Huang J-F. 2016, Conway 2013, Yeen 2013, Milla 2012, Mastrobuoni 2012, Moosdorf 2012, Jung 2011): Adults with end-stage, irreversible, refractory, symptomatic heart failure requiring maximal continuous medical or mechanical support. Children with end-stage heart disease characterized by intractable symptoms and heart failure that cannot be treated with conventional medical or surgical methods. Heart failure of irreversible underlying etiology in children (age newborn to 12 years), adolescents (age 12 years to 18 years) and adults (age >18 years) is treatable with heart transplantation and includes, but is not limited to: Cardiac arrhythmia. Cardiac re-transplantation due to graft failure. 1

2 Cardiomyopathy due to nutritional, metabolic, hypertrophic or restrictive etiologies. Congenital heart disease. o Severe stenosis or atresia in proximal coronary arteries. o Moderate to severe stenosis or insufficiency of the atrioventricular or systemic semilunar valve(s). o Severe ventricular dysfunction. o Pulmonary hypertension and a potential risk of developing fixed, irreversible elevated pulmonary vascular resistance (PVR) that may preclude future orthotopic heart transplant. o Severe aortic insufficiency not amenable to surgical correction. o Severe arterial oxygen desaturation. End-stage ventricular failure. Idiopathic dilated cardiomyopathy. Inability to be weaned from temporary cardiac-assist devices after myocardial infarction or nontransplant cardiac surgery. Intractable coronary artery disease. Myocarditis. Post-partum cardiomyopathy. Right ventricular dysplasia/cardiomyopathy. Valvular heart disease. Assessment of heart failure severity requires a minimum of the following examinations and tests: Electrocardiogram. Echocardiogram. Right heart catheterization. VO 2 max. HbA1C for diabetics. Serum creatinine <2.5 mg/dl ( 1.5 mg/dl in children) or glomerular filtration rate >35 ml/min. Carotid Doppler ultrasound when indicated or age >50 years. 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, cardiac allograft vasculopathy, or recurrent disease is considered medically necessary. Limitations: All other uses of heart transplantation are not medically necessary. Relative contraindications for transplant recipients include, but are not limited to, the following: 2

3 Pulmonary hypertension as evidenced by: o Pulmonary vascular resistance greater than 5 Wood units. o Trans-pulmonary gradient greater than or equal to 16 mm/hg. Absolute contraindications for transplant recipients include, but are not limited to: Metastatic cancer. Ongoing or recurring infections that are not effectively treated. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured. Active, systemic lupus erythematosus or sarcoid with multisystem involvement. Any systemic condition with a high probability of recurrence in the transplanted heart. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations. Potential complications from immunosuppressive medications are unacceptable to the patient. 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: CD4 count greater than 200 cells/mm3 for greater than six months. HIV-1 undetectable. On stable anti-retroviral therapy greater than 3 months. Meeting all other criteria for heart transplantation. Alternative covered services: None. Background The merits of heart transplantation as a standard treatment for individuals with end-stage heart disease that is not amenable to medical or surgical therapies are many. In the 2013 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) guideline for the management of heart failure the authors opined that cardiac transplantation is considered the gold standard for the treatment of refractory end-stage heart failure. About 2,000 heart transplants are performed each year in the United States. This number has remained relatively stable for over two decades due to a lack of donors. Current results indicate one, three, and five-year post-transplant survival rates of 87.8, 78.5, and 71.7 percent in adults, respectively. Moreover, 90 percent of cardiac transplant patients lead a relatively 3

4 normal lifestyle, having no limitations in their activity, and 40 percent return to work. Infant heart recipients (less than one year old) have a poorer survival rate during the first post-transplant year (74 percent compared to >85 percent for all other age groups), but those who survive the first year have better long-term outcomes than adults. Elderly recipients (aged 65 years or older) have survival rates comparable to younger patients through about eight years, when survival rates began to fall more rapidly. The major indications for cardiac transplant 20 years ago were coronary artery disease and dilated cardiomyopathy, but epidemiological data from the turn of the century to the present indicates that dilated cardiomyopathy has supplanted coronary artery disease as the major cause of heart failure leading to cardiac transplantation. Survival rates have improved even further with the advent and implementation of contemporary immunosuppressive agents (e.g., tacrolimus and mycophenolate). Searches AmeriHealth Caritas searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on September 19, Search terms were: "transplantation (MeSH)," "heart transplant (MeSH)," and "immunosuppression." We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings There is a great deal of evidence regarding cardiac transplantation that dates back to 1967, when the first such procedure was performed. The current trend in this area is long-term analysis of results and treatment of complications (i.e., cardiac allograft vasculopathy), which follows from the procedure, along with the perfection of technique associated with the surgical procedure of cardiac transplantation and fine-tuning of immunosuppression. There is also great interest in, though as yet not a lot of practical 4

5 information about, mechanical devices that may someday obviate the need of a human donor heart for transplantation. The state-run health system of China, after international pressure to end the practice of death penalty prisoner mandatory organ donation for transplantation, established the China Organ Transplant Response System (COTRS) to regulate the world s third-largest system of organ transplantation (over 10,000 procedures in 2015). A narrative review of the country s experience with transition to a system of voluntary donor organ (i.e., heart, lung, kidney and liver) acquisition is related by Huang (2016). Policy updates: A systematic review (Conway 2013) considered psychosocial and psychological health post-heart transplant. The most consistent findings across all the studies (7) were related to the importance of social support. Faith, optimism and sense of control were also perceived as positive influences on outcome. The authors opined that the act of facilitation for support socially permits heart transplant recipients to progress more successfully back to full lifestyle independence. Summary of clinical evidence: Citation Huang J-F.(2016) Content, Methods, Recommendations The new era of organ transplantation in China Conway (2013) The psychological experiences of adult heart transplant recipients: a systematic review and metasummary of qualitative findings China Organ Transplant Response System is the sole legitimate official organ allocation computer system in China. According to the China Organ Transplant Response System and scientific registries documentation (as of February 3, 2016), there were 2766 community-based deceased organ donations between January 1, 2015 and December 31, 2015, which accounted for 2150 liver, 4931 kidney, 279 heart, and 118 lung transplantations in the same period. With 470 living donor liver transplantations and 2109 living donor kidney transplantations, there were a total of 10,057 organ transplantations in China in The number of organ donation in China ranked as No. 3 in the world in 2015, marked the successful transition of China's organ transplantation system from the old practice to a brand-new alternative system that is consistent with the international standard. A systematic review considered psychosocial and psychological health post-heart transplant. The most consistent findings were related to the importance of social support. Faith, optimism and sense of control were also perceived as positive influences on outcome. The authors opined that the act of facilitation for support socially permits heart transplant recipients to progress more successfully back to full lifestyle independence. 5

6 Citation Yeen (2013) Content, Methods, Recommendations Outcomes of adult orthotopic heart transplantation with extended allograft ischemic time Milla (2012) Indications for heart transplantation in current era of left ventricular assist devices Mastrobuoni (2012) Long-term survival (>20 years) following heart transplantation Moosdorf (2012) Artificial heart and heart transplantation Retrospective review of cardiac ischemia times on survival of orthotopic heart transplantation. Found that ischemia beyond four and five hours is associated with increased mortality. Editorial opinion on left ventricular assist (LVA) device therapy s impact on the management of severe heart failure patients. Traditional use of left ventricular assist devices has been temporizing until transplant could be effected. Smaller, more durable left ventricular assist devices are obviating the need for the total artificial heart. Observational study over 20 years of cardiac transplant experience. Survival was 77.8%, 64.4% and 48.9% at 1-, 5-, and 10-year marks. Cardiac allograft vasculopathy was the main cause of death in the group. Donor organ shortage has prompted the development of so-called artificial heart. Most of these systems are no longer replacing but mainly assisting the heart, which remains in place. Further miniaturization and a decrease of the costs will eventually make these devices a realistic alternative to donor hearts, in terms of survival as well as rehospitalization rates. However, at present they are still not an alternative to heart transplantation. Jung (2011) Mortality in adult orthotopic heart transplant recipients Observational study over 16 years of cardiac transplantation. A total of 201 consecutive patients, 154 (76.6%) males, aged 17 years underwent heart transplantation between November 1992 and December Two patients (1%) died in-hospital due to sepsis caused by infection. Late death occurred in 39 patients (19.4%), with the most common cause being sepsis due to infection. The 1-, 5-, and 10-yr survival rates in these patients were 95.5% ± 1.5%, 86.9% ± 2.6%, and 73.5% ± 4.1%, respectively. The surgical results of heart transplantation in adults were excellent, with late mortality due primarily to infection, malignancy, and rejection. Cardiac deaths related to cardiac allograft vasculopathy were very rare. References 6

7 Professional society guidelines/other: Gersh BJ, Maron BJ, Bonow RO, et al ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy. Circulation. 2011;124(24): Yancy CW, Jessup M, Bozkurt B, et al ACCF/AHA Guideline for the Management of Heart Failure. Circulation. 2013;128(16): Peer-reviewed references: Chinnock R and Bailey L. Heart Transplantation for Congenital Heart Disease in the First Year of Life. Curr Cardiol Rev. 2011; 7(2): Conway A, Schadewaldt V, Clark R, Ski C, Thompson DR, Doering L. The psychological experiences of adult heart transplant recipients: a systematic review and meta-summary of qualitative findings. Heart Lung. 2013;42(6): Huang J-F. The New Era of Organ Transplantation in China. Chinese Medical Journal. 2016;129(16): Jung S, Kim J, Choo S, Yun T, Chung C,and Lee J. Mortality in Adult Orthotopic Heart Transplant Recipients. J Korean Med Sci May; 26(5): Lund, LH, Edwards, LB, Kucheryavaya, AY et al. The Registry of the International Society for Heart and Lung Transplantation: thirty-first official adult heart transplant report J Heart Lung Transplant. 2014; 33: Mastrobuoni S, Dell'Aquila AM, Azcarate PM, Rabago G, Herreros J. Long-term survival (>20 years) following heart transplantation. J Cardiovasc Surg. 2012;53(5): Milla F, Pinney SP, Anyanwu AC. Indications for heart transplantation in current era of left ventricular assist devices. Mt Sinai J Med. 2012;79(3): Moosdorf R. Artificial heart and heart transplantation. Herz. 2012;37(8): Russo, MJ, Iribarne, A, Hong, KN, et al. Factors associated with primary allograft failure after heart transplantation. Transplantation. 2010; 90: Yeen, W, Polgar, A, Guglin, M et al. Outcomes of adult orthotopic heart transplantation with extended allograft ischemic time. Transplant Proc. 2013; 45:

8 CMS National Coverage Determination (NCDs): National Coverage Determination for Heart Transplants. CMS Medicare Coverage Database Web site. KeyWord=heart+transplant&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAAAA %3d%3d& Accessed September 19, Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Heart transplant, with or without recipient cardiectomy ICD 10 Codes Description Comments I11.0 Hypertensive heart disease with heart failure I42.0-I42.9 Cardiomyopathy I43 Cardiomyopathy in diseases classified elsewhere I50.1-I50.9 Heart failure I51.0-I51.7 Complications and ill-defined descriptions of heart disease Q20.0-Q20.9 Congenital malformations of cardiac chambers and connections Q21.0-Q21.9 Congenital malformations of cardiac septa Q22.0-Q22.9 Congenital malformations of pulmonary and tricuspid valves Q23.0-Q23.9 Congenital malformations of aortic and mitral valves Q24.0-Q24.9 Other congenital malformations of heart T86.20-T Complications of heart transplant Z94.1 Heart transplant status HCPCS Level II Code N/A Description Comments 8