Clinical Medical Policy Department Clinical Affairs Division Cardiac Output Monitoring by Thoracic Electrical Bioimpedance (TEB) [For the list of services and procedures that need preauthorization, please refer to www.mcs.com.pr. Go to “Comunicados a Proveedores”, and click “Cartas Circulares”.] Medical Policy: MP-ME-03-10 Original Effective Date: March 18, 2010 Revised: February 9, 2021 Next Revision: February, 2022 This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and Medical Card System, Inc., provider’s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member’s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. DESCRIPTION Cardiac output is a functional measure defined as the amount of blood the heart pumps through the circulatory system in a minute. The amount of blood put out by the left ventricle of the heart in one contraction is called the stroke volume. The stroke volume and the heart rate determine the cardiac output. A normal adult has a cardiac output of 4.7 liters (5 quarts) of blood per minute (MedicinetNet, 2018). The gold standard for measuring cardiac output is use of a thermo-dilution catheter; however, this is an invasive technique that poses a risk to the patient. Thermodilution is an indicator-dilution method of measuring blood flow. This method is based on the premise that when an indicator substance is added to circulating blood, the rate of blood flow is inversely proportional to the change in concentration of the indicator over time. The indicator substance can be a dye (dye-dilution method) or a fluid with a different temperature than blood (thermodilution method). A dextrose or saline solution that is colder than blood is injected through the proximal port of the catheter in the right atrium. The cold fluid mixes with blood in the right heart chambers, and the cooled blood is ejected into the pulmonary artery and flows past the thermistor on the distal end of the catheter. The thermistor records the change in blood temperature with time and sends this information to an electronic instrument that record and displays a temperature-time curve. The area under this curve is inversely proportional to the rate of blood flow in the pulmonary artery. In the absence of intracardiac shunts, this flow rate is equivalent to the (average) cardiac output. (Russell, 2008) Impedance cardiography (ICG), also referred to by the broader term, Thoracic Electrical Bioimpedance (TEB), is a noninvasive means of measuring cardiac output and other functional parameters. A small electric current is applied to the chest through electrodes placed on the neck and sides of the chest. Resistance to the current (impedance) is measured through sensors also placed on the neck and sides of the chest. The pulsatile flow of blood causes fluctuations in the current, and the device calculates cardiac output from the impedance waveform. ICG is used in the management of several heart-related conditions, including CHF, pacemaker calibration, and heart transplant. This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 1 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 1 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits, and coverage. INDICATIONS I. Medical Card System, Inc., (MCS) will consider medically necessary the use of Cardiac Output Monitoring by Thoracic Electrical Bioimpedance (TEB) under the following indications: 1. Differentiation of cardiogenic from pulmonary causes of acute dyspnea when: Medical history, physical examination, and standard assessment tools provide insufficient information; and The treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient. 2. Optimization of atrioventricular (A/V) interval for patients with A/V sequential cardiac pacemakers when: Medical history, physical examination and standard assessment tools provide insufficient information; and The treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient. 3. Monitoring of continuous inotropic therapy for patients with terminal congestive heart failure, when those patients have chosen to die with comfort at home, or for patients waiting at home for a heart transplant. 4. Evaluation for rejection in patients with a heart transplant as a predetermined alternative to a myocardial biopsy. Medical necessity must be documented should a biopsy be performed after TEB. 5. Optimization of fluid management in patients with congestive heart failure when: Medical history, physical examination, and standard assessment tools provide insufficient information; and The treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient. This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 2 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 2 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division 6. Management of drug-resistant hypertension. Drug resistant hypertension is defined as failure to achieve goal blood pressure (BP) in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic. II. The following are examples of appropriate clinical indications for which MCS will consider the assessment of Cardiac Output by Electrical Bioimpedance medically necessary: 1. For patients with structural heart disease (with an ejection fraction £ 40%) associated with the development of congestive heart failure (e.g., valvular and congenital, post myocardial infarction, rheumatic heart disease). 2. For patients with inflammatory heart disease (with an ejection fraction £ 40%) associated with the development of congestive heart failure (e.g., myocarditis and cardiomyopathy, pericarditis and constrictive pericardial scarring, rheumatic heart disease). 3. For patients with ischemic heart disease (with an ejection fraction £ 40%) associated with the development of congestive heart failure (e.g., post myocardial infarction, ischemic cardiomyopathy, ischemic mitral valve or left ventricular dysfunction). 4. For patients with cardiac disease resulting in congestive heart failure (CHF) with normal left ventricular function (e.g., diastolic dysfunction, restrictive cardiomyopathy/infiltrative such as amyloidosis or cancer of the heart). 5. For patients with pulmonary disease associated with congestive heart failure (e.g., cor - pulmonale and the need to distinguish between pulmonary and cardiac disease as the cause, pulmonary hypertension). 6. For acute conditions for which the patient might present to an outpatient setting and in which a decision regarding intervention is necessary (e.g., pericardial effusion with possible tamponade, myocardial infarction, cardiac trauma). 7. For patients with recent pacemaker implants who demonstrate clinical manifestations of unexplained fatigue, symptomatic hypotension, or congestive heart failure. 8. For the titration of therapeutic agents in the setting of symptomatic congestive heart failure. 9. For acute heart rejection during outpatient follow-up of heart transplant patients (as a supplement to invasive endomyocardial biopsy); and/or 10. For patients with acute/chronic renal failure or end stage renal disease/dialysis who demonstrate clinical manifestations of unexplained shortness of breath, unexplained reduced access flow, and symptomatic hypotension/hypertension. LIMITATIONS 1. Cardiac output by Electrical Bioimpedance is NOT COVERED for the following indications: This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 3 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 3 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division a. Monitoring of patients with proven or suspected disease involving severe regurgitation of the aorta. b. Patients with minute ventilation (MV) sensor function pacemakers (since the device may adversely affect the functioning of that type of pacemaker). c. During cardiac bypass surgery and/or d. In the management of all other forms of hypertension (with the exception of drug- resistant hypertension as outlined below, and Indication #6 from Part 1): o Drug resistant hypertension is defined as failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic (CMS NCD 20.16, 2007). e. All other uses of TEB not otherwise specified (CMS NCD 20.16, 2007). CODING