SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Transcription

1 SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Protocol: CAR044 Effective Date: December 1, 2017 Table of Contents Page COMMERCIAL & MEDICAID COVERAGE RATIONALE... 1 MEDICARE COVERAGE RATIONALE... 2 DESCRIPTION OF SERVICES... 4 CLINICAL EVIDENCE... 5 U.S. FOOD AND DRUG ADMINISTRATION (FDA)... 6 APPLICABLE CODES... 7 REFERENCES... 7 POLICY HISTORY/REVISION INFORMATION... 9 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. COMMERCIAL & MEDICAID COVERAGE RATIONALE Subcutaneous implantable cardioverter-defibrillators (S-ICD) are proven and medically necessary for treating ventricular arrhythmias in patients who meet ALL of the following criteria : A. Are candidates for a conventional transvenous implantable cardioverterdefibrillator (ICD); AND B. Do not have symptomatic bradycardia, incessant ventricular tachycardia, spontaneous arrhythmias, or frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; AND Subcutaneous Implantable Cardioverter Defibrillators Page 1 of 9

2 C. Have ONE or more of the following medical contraindications to a conventional transvenous ICD: 1. Lack of adequate venous access due to occlusion or congenital anomaly 2. High risk of complications for transvenous access (e.g., patient is on dialysis or immunocompromised) 3. Infection associated with a conventional transvenous ICD. Subcutaneous implantable cardioverter-defibrillators (S-ICD) are unproven and not medically necessary for all other indications due to insufficient evidence supporting safety and efficacy. MEDICARE COVERAGE RATIONALE Medicare does not have a National Coverage Determination (NCD) that specifically addresses subcutaneous implantable cardioverter defibrillators; however there is a NCD (20.4) for implantable automatic defibrillators. Implantable Automatic Defibrillators (20.4) Item/Service Description 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. Indications and Limitations of Coverage Covered Indications 1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause (effective July 1, 1991). 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 (effective July 1, 1999). 3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy (effective July 1, 1999). Additional indications effective for services performed on or after October 1, 2003: 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: a. New York Heart Association (NYHC) classification IV; b. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; c. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; d. 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); e. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or Subcutaneous Implantable Cardioverter Defibrillators Page 2 of 9

3 f. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year. Additional indications effective for services performed on or after January 27, 2005: 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: a. Patients must not have irreversible brain damage from preexisting cerebral disease; b. 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: c. Patients must be able to give informed consent; d. 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; Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year; e. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; f. 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. g. 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; Subcutaneous Implantable Cardioverter Defibrillators Page 3 of 9

4 Clinical symptoms or findings that would make them a candidate for coronary revascularization; Irreversible brain damage from preexisting cerebral disease; 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; 2 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). For Medicare and Medicaid Determinations Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. 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. DESCRIPTION OF SERVICES Implantable cardioverter defibrillators (ICD) detect and correct arrhythmias such as ventricular tachycardia and ventricular defibrillation. They may also have pacing capabilities. The subcutaneous implantable cardioverter defibrillator (S-ICD) does not require transvenous insertion. The S-ICD is inserted under the skin and implanted outside the ribcage under local anesthesia and sedation; insertion does not require fluoroscopy or contrast. The device delivers 80 Joule shocks after detecting and confirming the arrhythmia (Hayes, 2013). Subcutaneous Implantable Cardioverter Defibrillators Page 4 of 9

5 CLINICAL EVIDENCE Conventional implantable cardioverter-defibrillators (ICDs) require the placement of electrode leads through major veins and into the heart s ventricular chambers. Subcutaneous ICD leads are placed just beneath the skin. These devices cannot provide long-term pacing so are therefore not an alternative to transvenous ICDs when antibradycardia pacing is required. Evidence suggests that subcutaneous ICDs work to restore normal cardiac rhythm and provide protection against sudden cardiac arrest in patients with life-threatening ventricular tachycardia (VT) who do not have symptomatic bradycardia, incessant VT or spontaneous, frequently recurring VT that is reliably terminated with antitachycardia pacing. Registry data suggests that subcutaneous ICDs produce fewer lead complications but more major infections than transvenous ICDs; however, no direct comparison studies have been completed (ECRI, 2014). Weiss et al. conducted a prospective, nonrandomized, multicenter trial evaluating the safety and efficacy of a subcutaneous ICD in 330 patients with an indication for an ICD but not for pacing. A total of 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. The 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock. This study is limited by a lack of randomization and control. Bardy et al. (2010) designed and tested an entirely subcutaneous ICD system (Cameron Health). The authors conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements. Four subcutaneous ICD configurations were evaluated in 78 patients with the best configuration tested in 49 additional patients. The goal was to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. Next, the authors evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6 patients, followed by a trial of 55 patients. The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator. This configuration was as effective as a transvenous ICD for terminating induced ventricular fibrillation, albeit with a significantly higher mean energy requirement (36.6+/ J vs /-8.5 J). Among patients who received a permanent subcutaneous ICD, ventricular fibrillation was successfully detected in 100% of 137 induced episodes. Clinically significant adverse events included two pocket infections and four lead revisions. After a mean of 10+/-1 months, the device had successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia. A potential for bias exists due to manufacturer sponsorship of the study. This study is limited by small sample size and lack of randomization and control. Further results from large, longterm, randomized, prospective, multicenter trials are needed to determine if this technology is comparable to conventional ICDs in selected patients who do not require long-term pacing. In a multicenter case-control study, Köbe et al. (2013) reported the results of patients with an entirely subcutaneous implantable-cardioverter defibrillator (ICD) system (S-ICD( )) compared to a matched conventional transvenous ICD group. Sixty-nine patients (50 male, 19 female, mean age 45.7±15.7 Subcutaneous Implantable Cardioverter Defibrillators Page 5 of 9

6 years) received an S-ICD in three centers and were randomly assigned to 69 sex and age matched conventional ICD patients. Conversion rates of induced ventricular fibrillation were 89.5% for 65 Joules (15J safety-margin) and 95.5% including reversed shock polarity (15J safety-margin) in the study group. Termination of induced ventricular fibrillation was successful in 90.8% (10J safetymargin device dependant) of the control patients. Procedural complications were similar between the two groups. The mean follow-up is 217±138 days. During follow-up, three patients with S-ICD were appropriately treated for ventricular arrhythmias. Three inappropriate episodes occurred (5.2%) in three S-ICD patients due to T-wave oversensing, whereas atrial fibrillation with rapid conduction was the predominant reason for inappropriate therapy in conventional devices. The authors concluded that the S-ICD system could safely be implanted with similar perioperative adverse events compared to standard transvenous devices. This observational study is limited by its retrospective design, small sample size and lack of randomization. Further results from large, long-term, randomized, prospective, multicenter trials are needed to determine if this technology is comparable to conventional ICDs in selected patients who do not require long-term pacing. Several retrospective studies assessed the safety and efficacy of subcutaneous ICDs. The studies generally support the efficacy of the technology, showing that the device delivers appropriate shocks to a high proportion of patients experiencing spontaneous ventricular tachycardias, achieving successful conversion of the arrhythmia to a normal cardiac rhythm. The rate of patients who received an appropriate shock ranged from 7% to 25%, with a successful conversion rate of 96% to 100%. The rates of patients receiving an inappropriate shock ranged from 5% to 25%. No major adverse events were observed perioperatively or during follow-up; however, the device is associated with a moderate rate of infectious complications. These studies are limited by retrospective design and lack of randomization and control (Jarmon and Todd, 2013; Olde Nordkamp et al., 2012; Aydin et al., 2012; Dabiri Abkenari et al., 2011). On September 28, 2012, the U.S. Food and Drug Administration (FDA) approved a premarket approval application (P110042) for the S-ICD device. The device is approved to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing. Available at: Accessed October A National Institute for Health and Care Excellence (NICE) report states that the current evidence on the efficacy of subcutaneous ICDs for the prevention of sudden cardiac death in the short and medium term is adequate. Evidence on its safety in the short term is adequate but there are uncertainties about long-term durability. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. (NICE, 2013) U.S. FOOD AND DRUG ADMINISTRATION (FDA) A premarket approval application (P110042) was approved by the FDA on 9/28/12 for the S-ICDTM device. The EmblemTM S-ICD system, a next-generation leadless ICD received FDA approval under the same PMA. Subcutaneous Implantable Cardioverter Defibrillators Page 6 of 9

7 APPLICABLE CODES The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state or contractual requirements and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Coverage Determination Guidelines may apply. CPT Code Description Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed Insertion of subcutaneous implantable defibrillator electrode Removal of subcutaneous implantable defibrillator electrode Repositioning of previously implanted subcutaneous implantable defibrillator electrode Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system Electrophysiologic evaluation of subcutaneous implantable defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters) CPT is a registered trademark of the American Medical Association. REFERENCES Aydin A, Hartel F, Schlüter M, et al. Shock efficacy of subcutaneous implantable cardioverterdefibrillator for prevention of sudden cardiac death: initial multicenter experience. Circ Arrhythm Electrophysiol Oct;5(5): Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverterdefibrillator. N Engl J Med Jul 1;363(1): Boston Scientific website. Available at: Accessed October Subcutaneous Implantable Cardioverter Defibrillators Page 7 of 9

8 Burke MC, Gold MR, Knight BP, et al. Safety and efficacy of the totally subcutaneous implantable defibrillator: 2-Year results from a pooled analysis of the IDE study and EFFORTLESS registry. J Am Coll Cardiol Apr28;65(16): Dabiri Abkenari L, Theuns DA, Valk SD, et al. Clinical experience with a novel subcutaneous implantable defibrillator system in a single center. Clin Res Cardiol Sep;100(9): ECRI Institute. Emerging Technology Evidence Report. Subcutaneous implantable cardioverter defibrillator for treating life-threatening ventricular tachyarrhythmia. September ECRI Institue. Health Technology Forecast. Subcutaneous implantable cardioverter-defibrillator for preventing sudden cardiac arrest. November May ECRI Institute. Product Brief. Subcutaneous implantable cardioverter-defibrillator (Boston Scientific Corp.) for preventing sudden cardiac arrest. March Gold MR, Weiss R, Theuns DA, et al. Use of a discrimination algorithm to reduce inappropriate shocks with a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm Aug;11(8): Hayes, Inc. Hayes Health Technology Brief. S-ICD (subcutaneous implantable cardioverter defibrillator; Boston Scientific Corp.) for prevention of sudden cardiac death. Lansdale, PA: Hayes, Inc.; December Updated October Jarman JW, Todd DM. United Kingdom national experience of entirely subcutaneous implantable cardioverter-defibrillator technology: important lessons to learn. Europace Aug;15(8): Köbe J, Reinke F, Meyer C, et al. Implantation and follow-up of totally subcutaneous versus conventional implantable cardioverter-defibrillators: A multicenter case-control study. Heart Rhythm Jan;10(1): Lambiase PD, Barr C, Theuns DA, et al.; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J Jul 1;35(25): National Institute for Health and Care Excellence. IPG 454. Insertion of a subcutaneous implantable cardioverter defibrillator for prevention of cardiac death. April Available at: Accessed October Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol Nov 6;60(19): Pettit SJ, McLean A, Colquhoun I, et al. Clinical experience of subcutaneous and transvenous implantable cardioverter defibrillators in children and teenagers. Pacing Clin Electrophysiol Dec;36(12): Subcutaneous Implantable Cardioverter Defibrillators Page 8 of 9

9 Theuns DA, Crozier IG, Barr CS, et al. Longevity of the subcutaneous implantable defibrillator: longterm followup of the European Regulatory Trial Cohort. Circ Arrhythm Electrophysiol Oct;8(5): Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantablecardioverter defibrillator. Circulation Aug 27;128(9): POLICY HISTORY/REVISION INFORMATION Date 10/26/ /27/2016 Action/Description Corporate Medical Affairs Committee The foregoing Health Plan of Nevada/Sierra Health & Life Healthcare Operations protocol has been adopted from an existing UnitedHealthcare coverage determination guideline that was researched, developed and approved by the UnitedHealthcare Coverage Determination Committee. Subcutaneous Implantable Cardioverter Defibrillators Page 9 of 9