IMPLANTABLE CARDIODEFIBRILLATORS (ICDS)

Transcription

1 IMPLANTABLE CARDIODEFIBRILLATORS (ICDS) Protocol: CAR024 Effective Date: June 1, 2018 Table of Contents Page DESCRIPTION... 1 COMMERCIAL & MEDICAID COVERAGE RATIONALE... 1 MEDICARE COVERAGE RATIONALE... 3 BACKGROUND... 6 U.S. FOOD AND DRUG ADMINISTRATION (FDA)... 7 APPLICABLE CODES... 7 REFERENCES... 7 PROTOCOL HISTORY/REVISION INFORMATION... 8 INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice. This policy does not govern Medicare Group Retiree members. UnitedHealthcare may also use tools developed by third parties, such as the MCG Care Guidelines, to assist us in administering health benefits. The MCG Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. DESCRIPTION An implantable cardioverter-defibrillator (ICD) is a small battery-powered electrical impulse generator which is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. The device is programmed to detect ventricular arrhythmias and correct them by delivering ventricular anti-tachycardic overdrive pacing and/or direct current shock. Some models also have biventricular synchronized pacing capabilities. COMMERCIAL & MEDICAID COVERAGE RATIONALE Automatic Implantable Cardioverter-Defibrillator (ICD) is medically necessary for any of the following indications: A. Known cardiac arrest likely or definitely due to ventricular tachycardia or fibrillation Implantable Cardiodefibrillators (ICDs).doc Page 1 of 8

2 1. Reversible causes such as electrolyte imbalance and coronary artery disease amenable to revascularization have been excluded B. Ventricular tachycardia or ventricular fibrillation documented on electrophysiologic study 1. Reversible causes such as electrolyte imbalance and coronary artery disease amenable to revascularization have been excluded C. Syncope and one of the following: 1. Ventricular fibrillation or sustained ventricular tachycardia was induced on electrophysiologic testing 2. Ventricular fibrillation or sustained ventricular tachycardia was documented on electrocardiography 3. Left ventricular dysfunction 4. Primary electrical disease and one of the following: a. Long QT syndrome with syncope while on B-blocker therapy and one of the following: i. Syncope while on B-blockers ii. Ventricular tachycardia or fibrillation while on B-blockers iii. Family history of sudden cardiac death iv. Type 3 long QT syndrome genotype v. QTc interval > 500 milliseconds b. Brugada syndrome c. Catecholamine induced ventricular tachycardia with syncope while on B-blocker therapy D. Prior myocardial infarction and known coronary artery disease and one of the following: 1. An indication for a pacemaker during the 40 day lockout period is present and ejection fraction 35 percent or less 2. Myocardial infarction 40 or more days ago and one of the following: a. Ventricular fibrillation or sustained ventricular tachycardia induced on electrophysiologic testing [And b, or c] b. Left ventricular ejection fraction percent i. Class II or III congestive heart failure despite maximal medical therapy* c. Left ventricular ejection fraction 30 percent or less ii. Class I, II, or III congestive heart failure despite maximal medical therapy* E. Dilated cardiomyopathy with no known coronary disease 1. Left ventricular ejection fraction 35 percent or less a. Class I, II, or III congestive heart failure is present after maximal medical therapy* * Patient must have had an adequate trial of pharmacologic agents (oral loop diuretics, cardiomyopathy-indicated beta-blockers, ACE inhibitors or angiotensin receptor blockers, vasodilators, and behavioral modification (dietary guidelines regarding salt and fluid intake) for 90 days. F. Structural heart disease and one of the following: 1. Congenital heart disease and one of the following: a. Syncope with left ventricular dysfunction b. Ventricular fibrillation or sustained ventricular tachycardia documented on electrocardiography or induced on electrophysiologic study Implantable Cardiodefibrillators (ICDs).doc Page 2 of 8

3 2. Hypertrophic obstructive cardiomyopathy and ANY of the following a. Prior cardiac arrest b. Ventricular tachycardia or ventricular fibrillation on electrocardiography c. Family history of sudden cardiac death d. Left ventricular thickness of three centimeters or greater e. Hypotensive blood pressure response to exercise testing 3. Arrhythmogenic right ventricular dysplasia 4. Documented cardiac sarcoid, giant cell myocarditis, Chagas disease or non-compaction 5. Outpatient awaiting cardiac transplantation G. Primary electrical disease and one of the following: 1. Long QT syndrome and ONE of the following a. Syncope while on B-blockers b. Ventricular tachycardia or fibrillation while on B-blockers c. Family history of sudden cardiac death d. Type 3 long QT syndrome genotype e. QTc interval > 500 milliseconds 2. Brugada syndrome and ANY of the following a. Syncope b. Ventricular tachycardia on electrophysiologic study c. Family history of sudden cardiac death 3. Catecholamine induced ventricular tachycardia and ANY of the following a. Syncope while on B-blockers b. Ventricular tachycardia while on B-blockers NOTE: For patients being considered for ICD implantation for primary prevention, the following criteria must also be met: Individuals must NOT have: o Life expectancy <1 year from cardiac or noncardiac conditions o Significant psychiatric illness that maybe aggravated by device implantation or that may preclude regular follow up o Ongoing illicit drug use o Noncompliance with medical therapy and follow up There is insufficient evidence in the clinical literature to conclude that implantable cardio-defibrillators in these patient populations will improve clinical outcomes. MEDICARE COVERAGE RATIONALE Medicare has a National Coverage Determination for Implantable Automatic Defibrillators (20.4). Local Coverage Determinations (LCDs) for Nevada do not exist at this time. Accessed April Implantable Automatic Defibrillators (20.4) General The implantable automatic defibrillator is an electronic device designed to detect and treat lifethreatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating. Implantable Cardiodefibrillators (ICDs).doc Page 3 of 8

4 Indications and Limitations of Coverage Implantable cardiodefibrillators are considered medically necessary under the following criteria Covered Indications 1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause. 2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause. 3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy. 4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) < 0.35%, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.) 5. Documented prior MI and a measured LVEF < 0.30% and a QRS duration of >120 milliseconds (the QRS restriction does not apply to services performed on or after January 27, 2005). Patients must not have: New York Heart Association (NYHA) classification IV; Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months; Had an enzyme positive MI within past month (Effective for services on or after January 27, 2005, patients must not have an acute MI in the past 40 days); Clinical symptoms or findings that would make them a candidate for coronary revascularization; or Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year. 6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF 35%; 7. Patients with non-ischemic dilated cardiomyopathy (NIDCM) >9 months, NYHA Class II and III heart failure, and measured LVEF 35%; 8. Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure; All indications must meet the following criteria: Patients must not have irreversible brain damage from preexisting cerebral disease; MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction; Indications 3-8 (primary prevention of sudden cardiac death) must also meet the following criteria: a. Patients must be able to give informed consent; b. Patients must not have: Implantable Cardiodefibrillators (ICDs).doc Page 4 of 8

5 Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; Had a CABG or PTCA within the past 3 months; Had an acute MI within the past 40 days; Clinical symptoms or findings that would make them a candidate for coronary revascularization; Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; d. The beneficiary receiving the defibrillator implantation for primary prevention is enrolled in either a Food and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial (42 CFR ), a trial under the CMS Clinical Trial Policy (National Coverage Determination (NCD) Manual 310.1) or a qualifying data collection system including approved clinical trials and registries. Initially, an implantable cardiac defibrillator (ICD) database will be maintained using a data submission mechanism that is already in use by Medicare participating hospitals to submit data to the Iowa Foundation for Medical Care (IFMC) a Quality Improvement Organization (QIO) contractor for determination of reasonable and necessary and quality improvement. Initial hypothesis and data elements are specified in this decision (Appendix VI) and are the minimum necessary to ensure that the device is reasonable and necessary. Data collection will be completed using the ICDA (ICD Abstraction Tool) and transmitted via QNet (Quality Network Exchange) to the IFMC who will collect and maintain the database. Additional stakeholder-developed data collection systems to augment or replace the initial QNet system, addressing at a minimum the hypotheses specified in this decision, must meet the following basic criteria: i. Written protocol on file; ii. Institutional review board review and approval; iii. Scientific review and approval by two or more qualified individuals who are not part of the research team; iv. Certification that investigators have not been disqualified. For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria. e. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient's medical record. 9. Patients with NIDCM >3 months, NYHA Class II or III heart failure, and measured LVEF 35%, only if the following additional criteria are also met: a. Patients must be able to give informed consent; b. Patients must not have: Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; Had a CABG or PTCA within the past 3 months; Had an acute MI within the past 40 days; Clinical symptoms or findings that would make them a candidate for coronary revascularization; Irreversible brain damage from preexisting cerebral disease; Implantable Cardiodefibrillators (ICDs).doc Page 5 of 8

6 Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; d. MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction; e. The beneficiary receiving the defibrillator implantation for this indication is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR ), a trial under the CMS Clinical Trial Policy (NCD Manual 310.1), or a prospective data collection system meeting the following basic criteria: Written protocol on file; Institutional Review Board review and approval; Scientific review and approval by two or more qualified individuals who are not part of the research team; Certification that investigators have not been disqualified. For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria. f. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient's medical record. Other Indications All other indications for implantable automatic defibrillators not currently covered in accordance with this decision will continue to be covered under Category B IDE trials (42 CFR ) and the CMS routine clinical trials policy (NCD 310.1). (This NCD last reviewed July 2011.) Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage database on the Centers for Medicare and Medicaid Services Website. BACKGROUND Cardiovascular disease is the single most common cause of death in the United States. Sudden cardiac death (SCD) is estimated to account for approximately 50% of all cardiovascular deaths. This represents an estimated 350,000 cases per year and only about 20% survive to hospital discharge. Ventricular tachyarrhythmias are the mechanism responsible for 75-80% of cases. The other events are precipitated by bradycardia, asystole, or electromechanical dissociation. Only 20% present with an acute MI though 75% have had a prior MI. Of the 1,100,000 MIs that occur each year in the US, 5-6% have heart failure with an ejection fraction < 30% (CMS, 2005). Ventricular tachyarrhythmias include VT and VF. Ventricular tachycardia may be defined as three or more consecutive, ventricular ectopic beats at a rate of more than 120 beats per minute. The VT is considered sustained if it lasts longer than 30 seconds. VF may be defined as a fibrillatory state of the heart without coordinated contraction of the ventricle. There are a number of potential causes of Implantable Cardiodefibrillators (ICDs).doc Page 6 of 8

7 ventricular tachyarrhythmias, including acute myocardial infarction and transient or reversible causes such as drug toxicity, severe hypoxia, acidosis, hypokalemia, hypercalcemia, hyperkalemia, systemic infections and myocarditis (CMS, 2005). U.S. FOOD AND DRUG ADMINISTRATION (FDA) Numerous ICD devices have gained premarket approval from the FDA. Manufactures of FDA approved implantable cardio-defibrillator devices include: Biotronic, Boston Scientific, Sorin Group, Medtronic, and St. Jude Medical. A new subcutaneous ICD device (S-ICD System, Cameron Health, Inc.) obtained FDA clearance September 28, Additional information available at: (Accessed April 2018). APPLICABLE CODES CPT Code Description Insertion of implantable-defibrillator pulse generator only; with existing single lead Insertion or replacement of permanent implantable-defibrillator system with transvenous lead(s) single or dual chamber Removal of implantable-defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead system Removal of implantable-defibrillator pulse generator with replacement of implantable defibrillator pulse generator; dual lead system Removal of implantable-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; multiple lead system CPT is a registered trademark of the American Medical Association. REFERENCES Ellenbogen KA, Estes NAM III, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices). J Am Coll Cardiol 2008; 51:e1 62. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NAM III, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO. ACC/ AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/vNASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices). Heart Rhythm 2008; 5:e1 e62. Implantable Cardiodefibrillators (ICDs).doc Page 7 of 8

8 Gabriel Gregoratos, MD, FACC, FAHA, Chair; Jonathan Abrams, MD, FACC, FAHA; Andrew E. Epstein, MD, FACC, FAHA; Roger A. Freedman, MD, FACC;David L.Hayes, MD, FACC, FAHA; Mark A. Hlatky, MD, FACC, FAHA;Richard E. Kerber, MD, FACC, FAHA; Gerald V. Naccarelli, MD, FACC, FAHA; Mark H. Schoenfeld, MD, FACC, FAHA; Michael J. Silka, MD, FACC; Stephen L. Winters, MD, FACC ACC/AHA/NASPE 2002 Guideline Update for Implantation of Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). Circulation. 2002;106: Cardiac Pacemakers and Antiarrhythmia Devices: Summary Article Moss AJ, Hall WJ, Cannom DS, et al; MADIT-CRT Trial Investigators. Cardiac resynchronization therapy for the prevention of heart-failure events. N Engl JMed.2009;361(14): NCD National Coverage Determination for AICD or ICD (CV-104). PROTOCOL HISTORY/REVISION INFORMATION Date 04/26/ /27/ /28/2016 Action/Description Corporate Medical Affairs Committee The foregoing Health Plan of Nevada/Sierra Health & Life Health Operations protocol has been adopted from an existing UnitedHealthcare policy or coverage determination guideline that was researched, developed and approved by the UnitedHealthcare Coverage Determination Committee. Implantable Cardiodefibrillators (ICDs).doc Page 8 of 8