FEP Medical Policy Manual

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1 FEP Medical Plicy Manual Effective Date: Octber 15, 2018 Related Plicies: Nne Wearable Cardiverter Defibrillatrs Descriptin A wearable cardiverter defibrillatr (WCD) is a temprary, external device that is an alternative t an implantable cardiverter defibrillatr (ICD). It is primarily intended fr temprary cnditins fr which an implantable device is cntraindicated, r fr the perid during which the need fr a permanent implantable device is uncertain. OBJECTIVE The bjective f this evidence review is t assess whether the use f a wearable cardiverter defibrillatr imprves net health utcme in patients with a temprary cntraindicatin t implantable cardiverter defibrillatr r as a bridge t implantable cardiverter defibrillatr placement r heart transplantatin, r recvery. POLICY STATEMENT Use f wearable cardiverter defibrillatrs (WCDs) fr the preventin f sudden cardiac death is cnsidered medically necessary as interim treatment fr thse wh: meet the criteria fr an implantable cardiverter defibrillatr (see plicy guidelines); and have a temprary cntraindicatin t receiving an ICD, such as a systemic infectin, at the current time; and have been scheduled fr an ICD placement r wh had an ICD remved and have been rescheduled fr placement f anther ICD nce the cntraindicatin is treated. Use f WCDs fr the preventin f sudden cardiac death is cnsidered nt medically necessary fr the fllwing indicatins when they are the sle indicatin fr a WCD: Patients in the immediate (ie, <40 days) perid fllwing an acute mycardial infarctin Patients pst crnary artery bypass graft surgery High-risk patients awaiting heart transplant Patients with newly diagnsed nnischemic cardimypathy Wmen with peripartum cardimypathy. Use f WCDs is cnsidered nt medically necessary fr all ther indicatins. Original Plicy Date: December 2011 Page: 1

2 Effective Plicy Date: Octber 15, 2018 Page: 2 f 7 POLICY GUIDELINES It is uncmmn fr patients t have a temprary cntraindicatin t implantable cardiverter defibrillatr placement. The mst cmmn reasn will be a systemic infectin that requires treatment befre the implantable cardiverter defibrillatr can be implanted. The wearable cardiverter defibrillatr shuld nly be used shrt-term while the temprary cntraindicatin (eg, systemic infectin) is being clinically managed. Once treatment is cmpleted, the permanent implantable cardiverter defibrillatr shuld be implanted. Criteria fr Implantable Defibrillatr in adults: Primary Preventin Ischemic cardimypathy with New Yrk Heart Assciatin (NYHA) functinal class II r III symptms, a histry f mycardial infarctin at least 40 days befre ICD treatment, and left ventricular ejectin fractin f 35% r less; r Ischemic cardimypathy with NYHA functinal class I symptms, a histry f mycardial infarctin at least 40 days befre ICD treatment, and left ventricular ejectin fractin f 30% r less; r Nnischemic dilated cardimypathy and left ventricular ejectin fractin f 35% r less, after reversible causes have been excluded, and the respnse t ptimal medical therapy has been adequately determined; r Hypertrphic cardimypathy (HCM) with 1 r mre majr risk factrs fr sudden cardiac death (histry f premature HCM-related sudden death in 1 first-degree relatives yunger than 50 years; left ventricular hypertrphy >30 mm; 1 runs f nnsustained ventricular tachycardia at heart rates f 120 beats per minute n 24-hur Hlter mnitring; prir unexplained syncpe incnsistent with neurcardigenic rigin) and judged t be at high risk fr sudden cardiac death by a physician experienced in the care f patients with HCM. Diagnsis f any ne f the fllwing cardiac in channelpathies and cnsidered t be at high risk fr sudden cardiac death (see Plicy Guidelines sectin): cngenital lng QT syndrme; OR Brugada syndrme; OR shrt QT syndrme; OR catechlaminergic plymrphic ventricular tachycardia. Secndary Preventin Patients with a histry f a life-threatening clinical event assciated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (eg, acute ischemia) have been excluded. Criteria fr Implantable Defibrillatr in children: survivrs f cardiac arrest, after reversible causes have been excluded; symptmatic, sustained ventricular tachycardia in assciatin with cngenital heart disease in patients wh have undergne hemdynamic and electrphysilgic evaluatin; r cngenital heart disease with recurrent syncpe f undetermined rigin in the presence f ventricular dysfunctin r inducible ventricular arrhythmias. HCM with 1 r mre majr risk factrs fr sudden cardiac death (histry f premature HCMrelated sudden death in 1 first-degree relatives <50 years; massive left ventricular hypertrphy based n age-specific nrms; prir unexplained syncpe incnsistent with

3 Effective Plicy Date: Octber 15, 2018 Page: 3 f 7 neurcardigenic rigin) and judged t be at high risk fr sudden cardiac death by a physician experienced in the care f patients with HCM. diagnsis f any ne f the fllwing cardiac in channelpathies and cnsidered t be at high risk fr sudden cardiac death: cngenital lng QT syndrme; OR Brugada syndrme; OR shrt QT syndrme; OR catechlaminergic plymrphic ventricular tachycardia. BENEFIT APPLICATION Experimental r investigatinal prcedures, treatments, drugs, r devices are nt cvered (See General Exclusin Sectin f brchure). FDA REGULATORY STATUS In 2001, the Lifecr WCD 2000 system was apprved by FDA thrugh the premarket apprval prcess fr adult patients wh are at risk fr cardiac arrest and are either nt candidates fr r refuse an implantable defibrillatr. The vest was renamed the Zll LifeVest. In 2015, FDA apprved the LifeVest fr certain children wh are at risk fr sudden cardiac arrest, but are nt candidates fr an implantable defibrillatr due t certain medical cnditins r lack f parental cnsent. FDA prduct cde: MVK. RATIONALE Summary f Evidence Temprary Cntraindicatins Fr individuals wh have a temprary cntraindicatin t an ICD wh receive a WCD, the evidence includes prspective chrt studies. Relevant utcmes are verall survival, mrbid events, functinal utcmes, and treatment-related mrbidity. A small number f patients meet established criteria fr an ICD but have a transient cntraindicatin fr an implantable device, mst cmmnly an infectius prcess. The available data have established that the WCD device can detect lethal arrhythmias and can successfully deliver a cuntershck in mst cases. In patients scheduled fr ICD placement, the WCD will imprve utcmes as an interim treatment. The evidence is sufficient t determine that the technlgy results in a meaningful imprvement in the net health utcme. Immediate Pst Mycardial Infarctin Fr individuals wh are in the immediate pst mycardial infarctin perid wh receive a WCD, the evidence includes RCTs and a technlgy assessment that assess ICD devices, given the absence f evidence n WCD devices. Relevant utcmes are verall survival, mrbid events, functinal utcmes, and treatment-related mrbidity. Tw RCTs have reprted that verall survival did nt imprve after treatment with a permanent ICD. While bth trials reprted a decrease in sudden cardiac death, there was a crrespnding increase in nn-sudden cardiac death events, resulting in n net survival benefit. Analysis f data frm a retrspective pst market registry with WCD reprted a success rate f 82% but interpretatin f registry data is limited in absence f a cntrl grup. Given the lack f evidence that a permanent ICD imprves utcmes in the immediate pst mycardial infarctin perid, a WCD wuld nt be expected t imprve utcmes. The evidence is insufficient t determine the effects f the technlgy n health utcmes.

4 Effective Plicy Date: Octber 15, 2018 Page: 4 f 7 Other High-Risk Cnditins Fr individuals wh are pst crnary artery bypass graft surgery and are at high risk fr lethal arrhythmias, awaiting heart transplantatin and at high risk fr lethal arrhythmias, have newly diagnsed nnischemic cardimypathy, r have peripartum cardimypathy wh receive a WCD, the evidence includes an RCT evaluating early ICD placement after crnary artery bypass graft, and case series and registry data fr ther indicatins that assess ICD devices, given the absence f evidence n WCD devices. Relevant utcmes are verall survival, mrbid events, functinal utcmes, and treatmentrelated mrbidity. Fr high-risk pst crnary artery bypass graft patients, an RCT reprted n difference in verall survival assciated with early ICD placement. Fr ther indicatins, there are n RCTs that demnstrate benefit f an ICD placement. Because f absence f any benefit f ICD and lack f any RCTs t demnstrate benefit f a WCD, the evidence des nt currently permit cnclusins that a WCD will imprve patient utcmes. The evidence is insufficient t determine the effects f the technlgy n health utcmes. SUPPLEMENTAL INFORMATION Practice Guidelines and Psitin Statements American Heart Assciatin In 2016, the American Heart Assciatin (AHA) published a scientific advisry n the wearable cardiverter defibrillatr (WCD). 27 AHA stated that because there is a paucity f prspective data supprting the use f the WCD, particularly in the absence f any published, randmized, clinical trials, the recmmendatins prvided in this advisry are nt intended t be prescriptive r t suggest an evidence-based apprach t the management f patients with FDA-apprved indicatins fr use. The specific recmmendatins are summarized in Table 1. Table 1. Guidelines fr WCD Therapy Recmmendatin COR LOE Use f WCDs is reasnable when there is a clear indicatin fr an implanted/permanent device accmpanied by IIa C a transient cntraindicatin r interruptin in ICD care such as infectin. Use f WCDs is reasnable as a bridge t mre definitive therapy such as cardiac transplantatin IIa C Use f WCDs may be reasnable when there is cncern abut a heightened risk f SCD that may reslve ver IIb C time r with treatment f left ventricular dysfunctin/ fr example, in ischemic heart disease with recent revascularizatin, newly diagnsed nnischemic dilated cardimypathy in patients starting guideline-directed medical therapy, r secndary cardimypathy (tachycardia mediated, thyrid mediated, etc) in which the underlying cause is ptentially treatable. WCDs may be apprpriate as bridging therapy in situatin assciated with increased risk f death in which ICDs IIb C have been shwn t reduce SCD but nt verall survival such as within 40 D f MI. WCDs shuld nt be used when nnarrhythmic risk is expected t significantly exceed arrhythmic risk, particularly in patients wh are nt expected t survive >6 m. III C COR: class f recmmendatin; ICD: implantable cardiverter defibrillatr; LOE: level f evidence; MI: mycardial infarctin; SCD: sudden cardiac death; WCD: wearable cardiverter defibrillatr. American Cllege f Cardilgy et al The American Cllege f Cardilgy, AHA, and the Heart Rhythm Sciety jintly published guidelines n the management f adults wh have ventricular arrhythmias r wh are at risk fr sudden cardiac death, including diseases and syndrmes assciated with a risk f sudden cardiac death frm ventricular arrhythmias. 28 Recmmendatins related t the use f WCDs are prvided in Table 2. Table 2. Guidelines fr WCD Therapy Recmmendatins COR LOE In patients with an implantable cardiverter defibrillatr and a histry f sudden cardiac arrest r sustained IIa B-NR ventricular arrhythmia in whm remval f the implantable cardiverter defibrillatr is required (as with infectin), the wearable cardiverter defibrillatr is reasnable fr the preventin f sudden cardiac death. a In patients at an increased risk f sudden cardiac death but wh are nt ineligible fr an implantable cardiverter IIb B-NR

5 Effective Plicy Date: Octber 15, 2018 Page: 5 f 7 defibrillatr, such as awaiting cardiac transplant, having an LVEF f 35% r less and are within 40 days frm an MI, r have newly diagnsed nnischemic cardimypathy, revascularizatin within the past 90 days, mycarditis r secndary cardimypathy r a systemic infectin, wearable cardiverter defibrillatr may be reasnable. b B-NR: data derived frm 1 nnrandmized trials r meta-analysis f such studies; COR: class f recmmendatin; ICD: implantable cardiverter defibrillatr; LOE: level f evidence; LVEF: left ventricular ejectin fractin; MI: mycardial infarctin; WCD: wearable cardiverter defibrillatr. a Remval f an ICD fr a perid f time, mst cmmnly due t infectin, expses the patient t risk f untreated ventricular tachycardia/sudden cardiac death unless mnitring and access t emergency external defibrillatin is maintained. In 1 series f 354 patients wh received the WCD, the indicatin was infectin in 10%. 29 Fr patients with a histry f sudden cardia arrest r sustained ventricular arrhythmia, the WCD may allw the patient t be discharged frm the hspital with prtectin frm ventricular tachycardia/sudden cardiac death until the clinical situatin allws reimplantatin f an ICD. b The patients listed in this recmmendatin are represented in clinical series and registries that demnstrate the safety and effectiveness f the WCD. Patients with recent MI, newly diagnsed nnischemic cardimypathy, recent revascularizatin, mycarditis, and secndary cardimypathy are at increased risk f ventricular tachycardia r sudden cardiac death. Hwever, the WCD is f unprven benefit in these settings, in part because the clinical situatin may imprve with therapy and time. In patients awaiting transplant, even with anticipated survival <1 year withut transplant, and depending n clinical factrs such as use f intravenus intrpes and ambient ventricular arrhythmia, a WCD may be an alternative t an ICD. Internatinal Sciety fr Heart and Lung Transplantatin In 2006, the Internatinal Sciety fr Heart and Lung Transplantatin issued guidelines n the care f cardiac transplant candidates that addressed use f implantable cardiverter defibrillatrs r WCDs. 30 Recmmendatins n the use f WCDs are prvided in Table 3. Table 3. Guidelines n Management f Cardiac Transplant Candidates with ICDs Recmmendatin COR LOE An implanted r wearable ICD shuld be prvided fr Status 1B patients [ie, dependent n intravenus I C medicatins r a mechanical assist device] wh are discharged hme given that the wait fr transplantatin remains significant. It is reasnable t cnsider placement f a defibrillatr in patients with Stage D failure wh are candidates fr transplantatin r LVAD destinatin therapy (see subsequent cnsideratins fr MCSD referral: bridge r destinatin). IIa C COR: class f recmmendatin; ICD: implantable cardiverter defibrillatr; LOE: level f evidence; LVAD: left ventricular assist device; MCSD: mechanical circulatry supprt device. Nt applicable. U.S. Preventive Services Task Frce Recmmendatins Medicare Natinal Cverage There is n natinal cverage determinatin (NCD). In the absence f an NCD, cverage decisins are left t the discretin f lcal Medicare carriers. REFERENCES 1. Fd and Drug Administratin. Summary f Safety and Effectiveness Data, P010030, Lifecr, Inc. WCD 2000 System. 2001; Accessed April 20, Beauregard LA. Persnal security: Clinical applicatins f the wearable defibrillatr. Pacing Clin Electrphysil. Jan 2004;27(1):1-3. PMID Blue Crss and Blue Shield Assciatin Technlgy Evaluatin Center (TEC). Wearable cardiverter-defibrillatr as a bridge t implantable cardiverter-defibrillatr treatment. TEC Assessments. 2010;Vlume 25:Tab Auricchi A, Klein H, Geller CJ, et al. Clinical efficacy f the wearable cardiverter-defibrillatr in acutely terminating episdes f ventricular fibrillatin. Am J Cardil. May ;81(10): PMID Chung MK, Szymkiewicz SJ, Sha M, et al. Aggregate natinal experience with the wearable cardiverterdefibrillatr: event rates, cmpliance, and survival. J Am Cll Cardil. Jul ;56(3): PMID Tanawuttiwat T, Garist JD, Salw A, et al. Prtectin frm utpatient sudden cardiac death fllwing ICD remval using a wearable cardiverter defibrillatr. Pacing Clin Electrphysil. May 2014;37(5): PMID

6 Effective Plicy Date: Octber 15, 2018 Page: 6 f 7 7. Mitrani RD, McArdle A, Slane M, et al. Wearable defibrillatrs in uninsured patients with newly diagnsed cardimypathy r recent revascularizatin in a cmmunity medical center. Am Heart J. Mar 2013;165(3): PMID Ka AC, Krause SW, Handa R, et al. Wearable defibrillatr use in heart failure (WIF): results f a prspective registry. BMC Cardivasc Disrd. Dec ;12:123. PMID Feldman AM, Klein H, Tchu P, et al. Use f a wearable defibrillatr in terminating tachyarrhythmias in patients at high risk fr sudden death: results f the WEARIT/BIROAD. Pacing Clin Electrphysil. Jan 2004;27(1):4-9. PMID Kutyifa V, Mss AJ, Klein H, et al. Use f the wearable cardiverter defibrillatr in high-risk cardiac patients: data frm the Prspective Registry f Patients Using the Wearable Cardiverter Defibrillatr (WEARIT-II Registry). Circulatin. Oct ;132(17): PMID Gregrats G, Cheitlin MD, Cnill A, et al. ACC/AHA guidelines fr implantatin f cardiac pacemakers and antiarrhythmia devices: a reprt f the American Cllege f Cardilgy/American Heart Assciatin Task Frce n Practice Guidelines (Cmmittee n Pacemaker Implantatin). J Am Cll Cardil. Apr 1998;31(5): PMID Hhnlser SH, Kuck KH, Drian P, et al. Prphylactic use f an implantable cardiverter-defibrillatr after acute mycardial infarctin. N Engl J Med. Dec ;351(24): PMID Steinbeck G, Andresen D, Seidl K, et al. Defibrillatr implantatin early after mycardial infarctin. N Engl J Med. Oct ;361(15): PMID Epstein AE, Abraham WT, Bianc NR, et al. Wearable cardiverter-defibrillatr use in patients perceived t be at high risk early pst-mycardial infarctin. J Am Cll Cardil. Nv ;62(21): PMID Uyei J, Braithwaite RS. Effectiveness f wearable defibrillatrs: systematic review and quality f evidence. Int J Technl Assess Health Care. Apr 2014;30(2): PMID Bigger JT, Jr. Prphylactic use f implanted cardiac defibrillatrs in patients at high risk fr ventricular arrhythmias after crnary-artery bypass graft surgery. Crnary Artery Bypass Graft (CABG) Patch Trial Investigatrs. N Engl J Med. Nv ;337(22): PMID Zishiri ET, Williams S, Crnin EM, et al. Early risk f mrtality after crnary artery revascularizatin in patients with left ventricular dysfunctin and ptential rle f the wearable cardiverter defibrillatr. Circ Arrhythm Electrphysil. Feb 2013;6(1): PMID Opreanu M, Wan C, Singh V, et al. Wearable cardiverter-defibrillatr as a bridge t cardiac transplantatin: A natinal database analysis. J Heart Lung Transplant. Oct 2015;34(10): PMID Wässnig NK, Gunther M, Quick S, et al. Experience with the wearable cardiverter-defibrillatr in patients at high risk fr sudden cardiac death. Circulatin. Aug ;134(9): PMID Ra M, Gldenberg I, Mss AJ, et al. Wearable defibrillatr in cngenital structural heart disease and inherited arrhythmias. Am J Cardil. Dec ;108(11): PMID Kadish A, Schaechter A, Subacius H, et al. Patients with recently diagnsed nnischemic cardimypathy benefit frm implantable cardiverter-defibrillatrs. J Am Cll Cardil. Jun ;47(12): PMID Salehi N, Nasiri M, Bianc NR, et al. The wearable cardiverter defibrillatr in nnischemic cardimypathy: A US natinal database analysis. Can J Cardil. Oct 2016;32(10):1247 e e1246. PMID Duncker D, Knig T, Hhmann S, et al. Ventricular arrhythmias in patients with newly diagnsed nnischemic cardimypathy: Insights frm the PROLONG study. Clin Cardil. Aug 2017;40(8): PMID Duncker D, Knig T, Hhmann S, et al. Aviding untimely implantable cardiverter/defibrillatr implantatin by intensified heart failure therapy ptimizatin supprted by the wearable cardiverter/defibrillatr-the PROLONG Study. J Am Heart Assc. Jan ;6(1). PMID Saltzberg MT, Szymkiewicz S, Bianc NR. Characteristics and utcmes f peripartum versus nnperipartum cardimypathy in wmen using a wearable cardiac defibrillatr. J Card Fail. Jan 2012;18(1): PMID Duncker D, Haghikia A, Knig T, et al. Risk fr ventricular fibrillatin in peripartum cardimypathy with severely reduced left ventricular functin-value f the wearable cardiverter/defibrillatr. Eur J Heart Fail. Dec 2014;16(12): PMID Piccini JP, Sr., Allen LA, Kudenchuk PJ, et al. Wearable cardiverter-defibrillatr therapy fr the preventin f sudden cardiac death: a science advisry frm the American Heart Assciatin. Circulatin. Apr ;133(17): PMID Al-Khatib SM, Stevensn WG, Ackerman MJ, et al AHA/ACC/HRS guideline fr management f patients with ventricular arrhythmias and the preventin f sudden cardiac death: a reprt f the American Cllege f

7 Effective Plicy Date: Octber 15, 2018 Page: 7 f 7 Cardilgy/American Heart Assciatin Task Frce n Clinical Practice Guidelines and the Heart Rhythm Sciety. Circulatin. Oct PMID Klein HU, Meltendrf U, Reek S, et al. Bridging a temprary high risk f sudden arrhythmic death. Experience with the wearable cardiverter defibrillatr (WCD). Pacing Clin Electrphysil. Mar 2010;33(3): PMID Grnda E, Burge RC, Cstanz MR, et al. Heart rhythm cnsideratins in heart transplant candidates and cnsideratins fr ventricular assist devices: Internatinal Sciety fr Heart and Lung Transplantatin guidelines fr the care f cardiac transplant candidates J Heart Lung Transplant. Sep 2006;25(9): PMID POLICY HISTORY Date Actin Descriptin December 2011 New Plicy December 2012 Update Plicy Plicy updated with literature review, reference 6 updated, reference 14 added. Wrding have all f the fllwing stricken frm medically necessary plicy statement. N ther changes t plicy statement. March 2014 Update Plicy Plicy updated with literature review thrugh August 2013, references 6-7, 13 and 15 added. N change t plicy statement. Remved as a Bridge t Implantable Cardiverter-Defibrillatr Placement frm the title. March 2015 Update Plicy Plicy updated with literature review thrugh Nvember 30, References 17, 23, and added. Investigatinal plicy statements changed t nt medically necessary. September 2016 Update Plicy Plicy updated with literature review, references 13, 20, added. FDA regulatry status updated. Plicy statements and guideline revised. September 2018 Update Plicy Plicy updated with literature review thrugh March 14, 2018; reference added; reference 1 updated. High-risk patients awaiting heart transplant was added t the nt medically necessary plicy statement; and an additinal plicy statement that use f wearable cardiverterdefibrillatrs is cnsidered nt medically necessary fr all ther indicatins was added