Clinical Policy Title: Home use of non-wearable automatic external defibrillator (AED)

Transcription

1 Clinical Policy Title: Home use of non-wearable automatic external defibrillator (AED) Clinical Policy Number: Effective Date: July 1, 2015 Initial Review Date: March 18, 2015 Most Recent Review Date: February 15, 2017 Next Review Date: February 2018 Related policies: Policy contains: Automatic external defibrillator (AED). Out-of-hospital cardiac arrest (OHCA). Ventricular fibrillation (VF). CP# CP# CP# CP# CP# Wearable cardioverter-defibrillator External counter pulsation (ECP) therapy Real-time outpatient cardiac monitoring Ambulatory blood pressure monitoring Implantable cardiac loop recorder ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Pennsylvania s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Pennsylvania when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Pennsylvania s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Pennsylvania s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Pennsylvania considers the home use of non-wearable automatic external defibrillators (AEDs) to be investigational and, therefore, not medically necessary. Medicare covers this service under certain conditions, as explained in the Local Coverage Determination cited later in this policy. Limitations: All uses of non-wearable AEDs in the home are not medically necessary. Alternative covered services: 1

2 Alternatives to non-wearable AEDs include wearable external cardiac defibrillators (Policy ), implanted cardiac defibrillators, and medication. Background Out-of-hospital cardiac arrest (OHCA) is a common and often fatal occurrence. The American Hospital Association estimates that 326,200 Americans suffered OHCAs in 2011, of whom 10.6 percent survived to hospital discharge (Newman, 2014). This low rate of survival is essentially unchanged in nearly 30 years (Sasson, 2010). Survival rates are low even though 60 percent of OHCA victims are treated by emergency medical services (EMS) personnel. OHCA incidence rates are higher for blacks (10.1 cases per 10,000 population) and Hispanics (6.5) than for whites (5.8). Survival is nearly twice as high for whites as it is for blacks, and higher than for Hispanics. An OHCA is much more likely in persons with a history of heart attack or heart failure (Newman, 2014). Children under age 18 account for a small proportion of OHCA cases (6,328 in 2011). Eighty-two (82) percent of these cases are associated with physical exertion during competition and training. Just 11 percent of children with OHCA are females. Only a small percentage of those individuals would be considered candidates for an implanted automatic cardiac defibrillator. Moreover, 69.5 percent of OHCA events occur at a home or residence. The hope has been that with greater access to AEDs in public areas and in the home, earlier intervention with timed counter-shock would result in higher survival rates. About 1.5 million AEDs exist in the United States (Harris, 2012). An AED is a portable device that can be used in sudden cardiac arrests, which have a high mortality rate. The device diagnoses abnormal arrhythmias of ventricular fibrillation (VF) and ventricular tachycardia (VT) and determines if a shock is needed. About 23 percent of OHCAs have an initial rhythm of VF or VT, and thus these patients could be especially appropriate candidates for treatment with AEDs (Newman, 2014). AEDs can restore a normal rhythm of the heart beat by one or more electric shocks after attaching pads to the patient s chest. Nonprofessionals can be trained to operate AEDs; this is helpful because treatment for patients at home experiencing OHCA can begin rapidly, even before an EMS vehicle can arrive at a patient s home. AEDs in public places such as schools, businesses, and stadiums can also be used for prompt treatment. Over time, it appears that use of public AEDs is increasing. One study in Seattle documented a increase in AED application in public cardiac arrests from 0.6 percent to 2.4 percent, and from 1.8 percent to 8.2 percent in ventricular fibrillation arrests (Rea, 2010). Because of the growing number of public AEDs, each state has enacted laws governing their placement and use by Of 13 elements listed by researchers, nine states had 10 or more, and another 16 had seven to nine; the elements with the most state laws included: 31 required maintenance of the device according to manufacturer specifications. 30 mandated AED seller notification to the EMS system. 28 mandated training for anticipated rescuers (Gilchrist, 2012). 2

3 On January 28, 2015, the U.S. Food and Drug Administration (FDA) issued a news release stating it would take steps to improve reliability of AED devices. The new FDA rule mandates AED manufacturers to submit a premarket approval application. The FDA action took place in reaction to 72,000 medical device reports involving failure of AEDs, which resulted in 111 recalls of over 2 million AED devices in the 10-year period (FDA, 2015). Despite efforts to train members of the public in use of AEDs, few have such knowledge. A recent study from areas with high pedestrian flow in Hong Kong found that 85.3 percent of the public had no training in AED use, and that 77.6 percent did not know the location of an AED near their home or work place (Fan, 2016). Searches AmeriHealth Caritas Pennsylvania searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches were on December 19, Search terms were AED and Automatic External Cardiac Defibrillator. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings The American Heart Association (AHA), along with the National Heart, Lung, and Blood Institute (NHLBI), supported public access AED programs in an attempt to reduce mortality from OHCA (Weisfeldt, 1995a; Weisfeldt, 1995b; Nichol, 1998). The Public Access Defibrillation (PAD) trial included 19,000 volunteers from 993 community units throughout North America, comparing results from those trained in cardiopulmonary resuscitation (CPR) and defibrillation to those trained in CPR alone. The CPR/defibrillation group responded to 128 cardiac arrests, and 30 (23.3 percent) survived to hospital discharge; the CPR-only group responded to 107 arrests, only 15 (14.0 percent) of whom survived to hospital discharge, a significant difference (Hallstrom, 2004). The AHA also provided recommendations for lay rescue AED programs. These include health provider oversight and planning, training of anticipated rescuers in CPR and AED, linkage with EMS, maintenance plans, and quality improvement monitoring (Hazinski, 2005). An early study of low-energy waves in AEDs was conducted by the Mayo Clinic, which placed devices in 12 police squad cars and four paramedic-staffed advanced life support ambulances. The device was used on 10 3

4 patients detected with VF, after a response to a 911 call that averaged 6.6 minutes, and (appropriately) not used after another eight calls for potential VF. Defibrillation was achieved with the first shock in seven of 10 patients, while the others required one to two more shocks (White, 1997). The consensus among those who have studied AED at home is that it has not improved survival for persons with sudden cardiac arrest (Stokes, 2012). A comparison of 12,930 OHCAs found survival to hospital discharge was 34 percent for those that occurred in public, compared to just 12 percent that occurred at home. Moreover, both in public and at home, the incidences of ventricular fibrillation or pulseless ventricular tachycardia were significantly lower when the arrest was witnessed by EMS personnel as opposed to bystanders (Weisfeldt, 2011). In the Home Automatic External Defibrillator Trial (HAT), there were 7,001 patients who had suffered an acute anterior wall myocardial infarction (MI) and were not considered candidates for an implanted cardiac defibrillator. Equivalent percentages of patients died in both the AED arm and the control arm (Bardy, 2008). There is some evidence of improved outcomes with home AED use. For the years , a total of 312,319 Japanese adults who had an OHCA were studied. During this period, the number of public-access AEDs rose from one to four per square kilometer. Of the 12,631 patients with ventricular fibrillation with an arrest of cardiac origin, the proportion of shocks administered by lay persons with public-access AEDs rose from 1.2 to 6.2 percent. Average time to shock fell from 3.7 to 2.2 minutes and the rate of persons who survived with minimal neurologic impairment rose from 2.4 to 8.9 per 10 million (Kitamura, 2010). In Piacenza, Italy, 39 semiautomatic AEDs were placed at various locations in the community, and 1,285 lay volunteers trained in AED use (but not traditional education in CPR) responded to suspected sudden cardiac arrest cases. For 22 months after the installment of AEDs, the survival rate to hospital discharge more than tripled from 3.3 percent to 10.5 percent, based on 354 cases of sudden cardiac arrest (Capucci, 2002). A meta-analysis of three studies (n=1583) of persons with OHCA found that those treated by those with training in CPR and AED had greater chances of survival to hospital admission and hospital discharge than those treated with CPR-only trained personnel (Sanna, 2008). The HAT trial included 1,007 patients with a past acute anterior wall MI who had an OHCA. The group was divided into two groups with similar attributes other than use of AED or not. When studied at 12 months and 24 months post-event, both patient and spouse indicated that by having an AED in the home, the quality of life was not improved for either the patient or the spouse, but there was evidence that both patient and spouse had less anxiety just by having an AED in the home (Mark, 2010). Changes in anxiety and depression of MI patients and their significant others who were trained in CPR and use of AEDs are one concern with home use of the device. A study of 460 patients and their spouses found depression levels were 25 percent and 21 percent for patients and spouses, while anxiety levels were 21 percent and 19 percent. Training in AED use was followed by decreases in depression and anxiety over time, except for anxiety in spouses trained in CPR and AED (Thomas, 2011). Policy updates: This version of the policy includes an additional nine professional guideline/other references, plus an additional 12 peer-reviewed references. Summary of clinical evidence: 4

5 Citation Weisfeldt (2011) Ventricular tachyarrhythmias after cardiac arrest in public vs. at home Mark (2010) Quality of life change in post-ami patients with OHCA, and spouses Kitamura (2010) Effect of AED dissemination on survival of OHCA patients Bardy (2008) Content, Methods, Recommendations Comparison of 2,042 OHCAs in public with at home. Incidence of ventricular fibrillation or pulseless ventricular tachycardia when arrest witnessed by EMS personnel vs. by a bystander, vs. by bystander applying AED. At home, 25% for EMS, 35% for bystander, 36% for bystander/aed. In public, 38% for EMS, 60% for bystander, 79% for bystander/aed. Survival to hospital discharge was 12% for home arrests, 34% for public arrests. 1,007 patients randomized with 94% response rate. Follow-up at 12 and 24 months. For patients with past acute anterior MI, having an AED at home did not improve the quality of life for the patient or spouse. There is evidence of reassurance to patients and spouses by having the AED. Study of 213,319 Japanese adults who had OHCA from 2005 to Number of public-access AEDs increased from one to four per square kilometer. Proportion of shocks administered from lay persons rose from 1.2 percent to 7.2 percent. Mean shock time reduced from 3.7 minutes to 2.2 minutes. Annual number of patients who survived OHCA with minimal neurologic impairment rose from 2.4 to 8.9 per 10 million population. Survival in patients with access to home AED 7,001 patients with hx of acute anterior wall MI, avg. age 62, who were not candidates for automatic implantable cardioverter-defibrillator (AICD). Follow-up for 37.3 months. 450 died: 6.4% in AED group and 6.5% in control group. For survivors of anterior-wall MI who were not candidates for AICD, access to a home AED did not significantly improve overall survival, compared with reliance on conventional resuscitation methods. Cram (2005) Cost-benefit analysis of AED use in adults Hallstrom (2004) Markov decision analysis on four conceptual models. Assuming cardiac arrest survival rates of 15% with EMS-D and 30% with AEDs, the cost per quality-adjusted life-year gained (QALY) of providing in-home AEDs to all adults 60 years of age is $216,000. Costs of providing in-home AEDs to adults with multiple risk factors (2% probability of SCD), previous myocardial infarction (4% probability), and ischemic cardiomyopathy (6% probability) are $132,000, $104,000, and $88,000, respectively. Comparing survival for CPR-trained group vs. CPR/defibrillator-trained group References 19,000 trained volunteers in 993 North American communities. Assessment of survival of persons with OHCAs. 23.3% survived until hospital discharge in CPR/defibrillator-trained group. 14.0% survived until hospital discharge in CPR-only trained group. 5

6 Professional society guidelines/other: American Heart Association. Cardiac arrest statistics. Arrest-Statistics_UCM_448311_Article.jsp. Accessed December 22, American Heart Association. What is an Automated Cardiac Defibrillator? Accessed December 22, Fan KL, Leung LP, Poon HT, Chiu HY, Liu HL, Tang WY. Public knowledge of how to use an automatic external defibrillator in out-of-hospital cardiac arrest in Hong Kong. Hong Kong Med J. 2016;22(6): Harris M. The shocking truth about defibrillators. IEEE Spectrum, February 27, Institute of Electrical and Electronics Engineers. Spectrum.ieee.org/biomedical/devices/the-shocking-truth-aboutdefibrillators/0. Accessed December 22, Hazinski MF, Idris AH, Kerber RE, et al. Lay rescuer automated external defibrillator ( public access defibrillation ) programs: lessons learned from an international multicenter trial: advisory statement from the American Heart Association Emergency Cardiovascular Committee; the Council on Cardiopulmonary, Perioperative, and Critical Care; and the Council on Clinical Cardiology. Circulation. 2005;111(24): Newman MM. AHA releases 2015 heart and stroke statistics. Sudden Cardiac Arrest Foundation, December 30, Accessed December 22, Nichol G, Hallstrom AP, Kerber R, et al. American Heart Association report on the second public access defibrillation conference, April 17-19, Circulation. 1998;97: Thomas SA, Friedmann E, Lee HJ, Son H, Morton PG, HAT Investigators. Changes in anxiety and depression over 2 years in medically stable patients after myocardial infarction and their spouses in the Home Automatic External Defibrillator Trial (HAT): a longitudinal observational study. Heart. 2011;97(5): U.S. Food and Drug Administration (FDA). News Release: FDA takes steps to improve reliability of automated external defibrillators. Rockville MD: FDA. January 28, Accessed December 21, Weisfeldt M, Kerber R, McGoldrick RP, et al. Public access defibrillation: a statement for healthcare professionals from the American Heart Association Task Force on automatic external defibrillation. Circulation. 1995a;92:2763. Weisfeldt ML, Kerber RE, McGoldrick RP, et al. American Heart Association Report on the Public Access Defibrillation Conference, December 8-10, Automatic External Defibrillation Task Force. Circulation. 1995;92: Peer-reviewed references: Bardy GH, Lee KL, Mark DB, et al.; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008;358(17):

7 Capucci A, Aschieri D, Piepoli MF, Bardy GH, Iconomu E, Arvedi M. Tripling survival from sudden cardiac arrest via early defibrillation without traditional education in cardiopulmonary resuscitation. Circulation. 2002;106(9): Cram P, Vijan S, Katz D, Fendrick AM. Cost-effectiveness of in-home automated external defibrillators for individuals at increased risk of sudden cardiac death. J Gen Intern Med. 2005;20(3): England H, Hoffman C, Hodgman T, et al. Effectiveness of automated external defibrillators in high schools in greater Boston. Am J Cardiol. 2005;95(12): Gilchrist S, Schieb L, Mukhtar Q, et al. A summary of public access defibrillation laws, United States, Prev Chronic Dis. 2012;9:E71. Epub March 15, Hallstrom AP, Ornato JP, Weisfeldt M, et al. Public-access defibrillation and survival after out-of-hospital cardiac arrest. N Engl J Med. 2004;351(7): Kitamura T, Iwami T, Kawamura T, Nagao K, Tanaka H, Kiraide A. Implementation Working Group for the All- Japan Utstein Registry of the Fire and Disaster Management Agency. Nationwide public-access defibrillation in Japan. N Engl J Med. 2010;362(11): Mark DB, Anstrom KJ, McNulty SE, et al. Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT). Am Heart J. 2010;159(4): e7. Markenson D. American Academy of Pediatrics Committee on Pediatric Emergency Medicine; American Academy of Pediatrics Section on Cardiology and Cardiac Surgery. Ventricular fibrillation and the use of automated external defibrillators on children. Pediatrics. 2007;120(5): Rea TD, Olsufka M, Bemis B, et al. A population-based investigation of public access defibrillation: role of emergency medical services care. Resuscitation. 2010;81(2): Sanna T, La Torre G, de Waure C, et al. Cardiopulmonary resuscitation alone vs. cardiopulmonary resuscitation plus automated external defibrillator use by non-healthcare professionals: a meta-analysis on 1583 cases of out-of-hospital cardiac arrest. Resuscitation. 2008;76(2): Sasson C, Rogers MA, Dahl J, Kellermann AL. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010;3(1): Stokes NA, Scapigliati A, Trammell AR, Parish DC. The effect of the AED and AED programs on survival of individuals, groups, and populations. Prehosp Disaster Med. 2012;27(5): Thomas SA, Friedmann E, Lee HJ, Son H, Morton PG. Changes in anxiety and depression over 2 years in medically stable patients after myocardial infarction and their spouses in the Home Automatic External Defibrillator Trial (HAT): a longitudinal observational study. Heart. 2011;97(5): Weisfeldt ML, Sitlani CM, Ornato JP, et al.; ROC Investigators. Survival after application of automatic external defibrillators before arrival of the emergency medical system: evaluation in the resuscitation outcomes consortium population of 21 million. J Am Coll Cardiol. 2010;55(16):

8 Weisfeldt ML, Everson-Stewart S, Sitlani C, et al. Ventricular tachyarrhythmias after cardiac arrest in public versus at home. N Engl J Med. 2011;364(4): Weiss TA, Rosenheck S, Gorni S, Katz I, Mendelbaum M, Gilon D. TED Time and life saving External Defibrillator for home-use. Cardiovasc Revasc Med. 2014;15(4): White RD. Early out-of-hospital experience with an impedance-compensating low-energy biphasic waveform automatic external defibrillator. J Interv Card Electrophysiol. 1997;1(3): Winkle RA. The effectiveness and cost effectiveness of public-access defibrillation. Clin Cardiol. 2010;33(7): CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): Automatic External Defibrillators (L33690). Word=automatic+external+defibrillator&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAA AAAAAA%3d%3d&. Accessed December 22, Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment N/A ICD-10 Code Description Comment I25.2 History, myocardial infarction I46.9 Cardiac arrest I49.01 Ventricular fibrillation HCPCS Level II Code K0606 Description Automatic external defibrillator, with integrated EKG analysis, garment type Comment 8