Humana Cardiac Electrophysiological Studies and Cardiac Catheter Ablation - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Applicable States/Territories Cardiac Electrophysiological Studies and Cardiac Catheter Ablation Page: 2 of 7 Contractors (MACs) NCD Diagnostic Endocardial Electrical Stimulation (Pacing) NCD HIS Bundle Study 20.12 20.13 Description Cardiac electrophysiological studies (EPS) are tests that help determine an arrhythmia’s (abnormal rhythm) area of origin in the heart. Arrhythmias are caused by damage to the heart related to disease, genetics or injury which changes the electrical signals that control cardiac activity. This damage may result from myocardial infarction (heart attack), aging, high blood pressure or abnormal electrical pathways created by certain congenital defects. EPS usually take place in an electrophysiology (EP) lab or a cardiac catheterization lab while the individual is mildly sedated. A catheter (thin tube) is inserted into a blood vessel leading to the heart. This catheter contains specialized electrodes enabling the physician to send programmed electrical stimulation to the heart and record its electrical activity. The physician may also attempt to induce an arrhythmia to determine the cause or origin. Pacing can be accomplished via these electrodes if arrhythmias arise. EPS are used to diagnose arrhythmias, evaluate the effectiveness of antiarrhythmic medication, assess the risk of cardiac arrest or determine the need for potential treatment (eg, implantation of a pacemaker or implantable cardioverter defibrillator [ICD]). Cardiac catheter ablation is a procedure which may be performed in conjunction with EPS. Radiofrequency energy (heat) or cryoablation (cold) is used via catheter to restore the heart’s regular rhythm by destroying a small area of heart tissue that is causing an arrhythmia. During this procedure, three-dimensional (3D) mapping (eg, CARTO 3 System, EnSite Precision System) may be used to define the cardiac anatomy and provide guidance for ablation. Cardiac focal ablation using radiation therapy, also known as stereotactic arrhythmia radioablation (STAR), is proposed to treat ventricular arrhythmias (eg, ventricular tachycardia [VT]) when medication or catheter ablation are ineffective or contraindicated. This investigational therapy fuses noninvasive electrocardiogram (ECG) and imaging (eg, computed tomography, magnetic resonance, positron emission tomography) data to pinpoint the area in the heart that is triggering the arrhythmia. High dose stereotactic radiation therapy is used to render the targeted area electrically inactive to purportedly reduce VT episodes. Transcatheter pulmonary artery denervation (PADN) is a catheter ablation technique proposed to treat pulmonary artery hypertension (PAH), a condition which may lead to right heart failure. Novel PAH treatments under investigation include thermal and ultrasound catheter ablation used to target sympathetic nerve fibers in the pulmonary artery and its bifurcation. Thermal pulmonary artery denervation uses radiofrequency ablation to apply thermal energy to destroy a small area of the targeted nerve tissue. Ultrasound pulmonary artery denervation uses high frequency nonfocused ultrasound energy Cardiac Electrophysiological Studies and Cardiac Catheter Ablation Page: 3 of 7 to ablate the targeted nerve bundles. These transcatheter procedures are purported to decrease sympathetic nervous system (SNS) activity and reduce pulmonary artery pressure. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Please refer to the above CMS guidance for diagnostic endocardial electrical stimulation (pacing) and HIS bundle study. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Cardiac Electrophysiological Studies and Cardiac Catheter Ablation The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage