Humana Cardioverter Defibrillators/Cardiac Resynchronization Therapy Form

Description

Implantable Devices

The implantable (transvenous) cardioverter defibrillator (ICD) is an electronic device that continuously monitors heart rhythm and delivers therapy in response to a ventricular tachyarrhythmia that meets preprogrammed detection rates and duration in an individual who is at high risk of sudden cardiac death (SCD). If the heart develops a sudden life-threatening fast rhythm, the device will either deliver rapid electrical pacing pulses to terminate the arrhythmia or deliver a shock to the inside of the heart to stop the abnormal rhythm. Certain devices will also pace the heart when it beats too slowly. The devices are generally implanted in the subcutaneous tissue with one or more electrodes attached to the heart.

Following implantation, an external interrogation (evaluation) may be performed periodically to ensure the defibrillator is working correctly.

An ICD may be indicated for use in an individual at risk for SCD due to hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens, making it more difficult to pump blood. Risk factors for SCD include, but may not be limited to one or more of the following:

• Personal history of cardiac arrest or sustained (greater than 30 seconds or associated with hemodynamic compromise) ventricular arrhythmias; OR
• Personal history of syncope suspected by clinical history to be arrhythmic; OR
• Family history in first- or second-degree relative of premature HCM-related sudden death, cardiac arrest or sustained ventricular arrhythmias; OR
• Cardiac imaging (echocardiography or coronary magnetic resonance [CMR]) determines maximal left ventricular (LV) wall thickness in all segments of the LV chamber, decreased ejection fraction (EF) or LV apical aneurysm; OR
• Diffuse and extensive late gadolinium enhancement (LGE), representing fibrosis, either quantified or estimated by visual inspection, comprising greater than 15% of LV mass11; OR
• Nonsustained (greater than or equal to 3 premature ventricular complexes terminating spontaneously) ventricular tachycardia (NSVT) episodes on continuous ambulatory electrocardiographic monitoring15

Cardiac resynchronization therapy (CRT) (also known as biventricular pacing) is utilized for the treatment of some cases of advanced heart failure (HF). The CRT device provides electrical stimulation to both sides (left and right) of the heart thereby resynchronizing (coordinating) ventricular contractions. A third lead in the right atrium may also allow for synchronizing atrioventricular (AV) contractions. The device can be utilized with a defibrillator as a cardiac resynchronization therapy/implantable cardioverter defibrillator (CRT-D) or alone (without a defibrillator).

Ventricular dyssynchrony (uncoordinated contractions of the left and right ventricles) increases the risk for developing life-threatening arrhythmias.

Implantation of a CRT-D allows for both coordinating ventricular contractions and terminating life-threatening arrhythmias.

His bundle pacing (HBP) has been proposed as an alternative to traditional CRT therapy and involves placement of a single lead into the right atrium in the area of the His node. The bundle of His is a band of cardiac muscle fibers that transmits signals from the AV node via the bundle branches and eventually to the ventricles of the heart. The electrical conduction causes the contraction of the ventricles at a paced interval (regulated heartbeat). Left bundle branch pacing (LBBP) is another emerging technique that has a physiological pacing effect similar to HBP using lead placement in the septum of the right ventricle. (Refer to Coverage Limitations section)

The WiSE wireless cardiac resynchronization therapy system is a cardiac stimulator for left ventricular pacing used with a conventional pacemaker and/or defibrillator. It is purported to eliminate the need for a left ventricular pacing wire in the coronary sinus. (Refer to Coverage Limitations section)

Hemodynamic (fluid status) monitoring is a feature of certain CRT-Ds that provides continuous monitoring of an individual’s fluid status and is reported to aid in heart failure management. A pressure sensor lead(s) is inserted at the time of the CRT-D implantation and is purported to provide an early indicator of heart failure. An example is the OptiVol 2.0 Fluid Status Monitor, a feature available on some CRT-Ds. (Refer to Coverage Limitations section)

Subcutaneous ICDs (S-ICD) are considered less invasive than transvenous ICDs as there are no leads placed in the heart or vasculature. Instead, an electrode is placed just beneath the skin of the chest which allows sensing of cardiac rhythms and delivery of shocks if necessary. The defibrillator can sense ventricular tachycardia (VT)/ventricular fibrillation (VF) but cannot provide prolonged antibradycardia and antitachycardia pacing.

The extravascular ICD (EV-ICD), also known as a substernal ICD, is another type of device in development which performs pacing and defibrillation functions using an implantable substernal electrode. This novel ICD is reported to treat ventricular tachyarrhythmias while avoiding certain risks of transvenous ICDs because the lead is placed under the sternum (breastbone) outside the heart using a minimally invasive approach. (Refer to Coverage Limitations section)

Antibacterial envelopes (eg, Tyrx) are used to reduce the risk of infection after cardiac devices have been implanted. Prior to implantation, defibrillators or pacemakers can be placed in a bioabsorbable mesh envelope or pocket that elutes rifampin and minocycline to the surgical site for at least seven days. (Refer to Coverage Limitations section)

For information regarding antibacterial envelopes for ventricular assist device placement, please refer to Ventricular Assist Device, Total Artificial Heart Medical Coverage Policy.

Cardiac contractility modulation (CCM) is proposed to treat a symptomatic individual with HF who does not meet the criteria for CRT (eg, normal QRS duration). A pacemaker-sized device with electrodes is implanted into the chest of the individual which delivers electric pulses at regular intervals to modulate (adjust) the contractile strength of the heart muscle. Optimizer Smart is an example of a CCM device.

(Refer to Coverage Limitations section)

External Devices

Wearable cardioverter defibrillators (WCD)

Wearable cardioverter defibrillators (WCD) are vest-like devices that are worn under the clothing 24 hours a day except when bathing or showering. The device monitors and treats abnormal ventricular rhythms in an individual at risk of dying from sudden cardiac arrest (SCA). It consists of a garment with an electrode belt assembly that is worn around the chest next to the skin. This belt is connected to a monitor and alarm, which are worn around the waist. If a life-threatening rhythm is detected, an electric shock is delivered to restore normal rhythm. The ASSURE System and ZOLL LifeVest are examples of WCDs.

Automated external defibrillators (AEDs)

Automated external defibrillators (AEDs) are portable electronic devices that allow a minimally trained individual to provide electric shock to prevent death due to sudden cardiac arrest. These devices monitor heart rhythm and can, if needed, deliver an electric shock to the chest wall much like a traditional (paddle) defibrillator in a hospital. (Refer to Coverage Limitations section)

Cardioverter Defibrillators/Cardiac Resynchronization Therapy

Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 5 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Body surface activation mapping (BSAM)

Body surface activation mapping (BSAM) is an electrocardiographic (ECG) technique that uses multiple leads to create a model that integrates cardiac anatomy, myocardial substrate and epicardial activation. BSAM is purported to improve diagnostic accuracy of acute coronary syndromes and conduction disorders as compared to the standard 12-lead ECG. This is reported to optimize cardioverter-defibrillator synchrony and resynchronization. (Refer to Coverage Limitations section)

Coverage Determination

Any state mandates for cardioverter defibrillators and/or cardiac resynchronization therapy take precedence over this medical coverage policy.

IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Primary Prevention of Sudden Cardiac Death

Humana members may be eligible under the Plan for an FDA-approved ICD for primary prevention of SCD when ALL of the following criteria are met:

• EFs must be measured by angiography, cardiac MRI, echocardiography or radionuclide scanning (waiting periods required)*; AND
• Myocardial infarctions (MIs) must be documented (if applicable) 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; AND
• Absence of ALL of the following:
  • Any disease (eg, cancer, uremia, liver failure), other than cardiac, that is associated with a likelihood of survival less than 1 year; AND
  • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; AND
  • Clinical symptoms or findings that would make the individual a candidate for coronary revascularization;

Cardioverter Defibrillators/Cardiac Resynchronization Therapy Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 6 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.AND ANY of the following indications:

• Documented conditions with a high risk of life-threatening VT, such as Brugada syndrome, cardiac sarcoidosis, catecholaminergic polymorphic VT, Chagas disease, giant cell myocarditis, HCM (with risk factors for SCD events)15, long QT syndrome (LQTS), right ventricular dysplasia or short QT syndrome (SQTS); OR
• Coronary artery disease with a documented prior MI and nonsustained VT, and a measured left ventricular ejection fraction (LVEF) less than or equal to 40% and inducible, sustained VT or VF at electrophysiology (EP) study (waiting periods required)*; OR
• Documented prior MI with measured LVEF less than or equal to 30% and New York Heart Association (NYHA) Class I on guideline-directed medical therapy (GDMT)** (waiting periods required)*; OR
• Ischemic cardiomyopathy (ICM) and documented prior MI and NYHA Class II or III and measured LVEF less than or equal to 35% (waiting periods required)*; OR
• ICM and documented prior MI and NYHA Class I and measured LVEF less than or equal to 30% (waiting periods required)*; OR
• Nonischemic cardiomyopathy (NICM) on GDMT** for greater than or equal to 90 days with NYHA Class II or III and measured LVEF less than or equal to 35% (less than or equal to 50% for HCM)11 (waiting periods required)*

Secondary Prevention of Sudden Cardiac Death

Humana members may be eligible under the Plan for an FDA-approved ICD for secondary prevention of SCD when the following criteria are met:

• Arrhythmogenic cardiomyopathy with high-risk factors for SCD (history of resuscitated SCA, sustained VT, ventricular dysfunction with RVEF or LVEF less than or equal to 45%) or syncope due to ventricular arrhythmia (VA); OR
• Episode of cardiac arrest due to VT/VF or hemodynamically unstable VT not due to a transient or reversible cause; OR
• Sustained VT, either spontaneous or induced by an EP study, not associated with an acute MI and not due to a transient or reversible cause; OR
• Syncope with a history of documented or inducible sustained VA or a diagnosed condition with a high risk of life-threatening VT (eg, familial, inherited or structural heart disease); OR
• NICM with a history of SCA, sustained VT or syncope caused by VA not due to a reversible cause;

AND ALL of the following:

• EFs must be measured by angiography, cardiac MRI, echocardiography or radionuclide scanning; AND
• MIs must be documented (if applicable) 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; AND
• Absence of ALL of the following:
  • Any disease (eg, cancer, uremia, liver failure), other than cardiac, that is associated with a likelihood of survival less than 1 year; AND
  • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; AND
  • Clinical symptoms or findings that would make the individual a candidate for coronary revascularization;

*Waiting periods required. When indicated in the above criteria, an individual must be 40 days post-MI and/or 90 days post-revascularization prior to ICD insertion.

Exceptions to these waiting periods include:

• Cardiac Pacemakers: An individual who meets the criteria listed above for an ICD may receive the combined device in one procedure at the time the pacemaker insertion is clinically indicated; OR
• Interim use of WCD: An individual who meets the criteria listed below for a WCD may receive a WCD when an ICD is not currently indicated or post-MI (the initial 40 days following an MI); OR
• Replacement of ICDs: An individual with an existing ICD may receive an ICD replacement due to the end of battery life, elective replacement indicator (ERI) or device/lead malfunction

Note: The criteria for ICDs are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Subcutaneous Implantable Defibrillators

Humana members may be eligible under the Plan for an FDA-approved subcutaneous implantable defibrillator (S-ICD) when the following criteria are met:

• Criteria listed above for an ICD are met;AND EITHER of the following:
  • High risk for bacteremia (eg, individual on hemodialysis or with chronic indwelling endovascular catheters); OR
  • Limited vascular access;
• AND absence of ALL of the following:
  • Requires pacing or CRT; AND
  • Incessant VT or spontaneous, frequently recurring VT that is reliably terminated with antitachycardia pacing; AND
  • Symptomatic bradycardia

Replacement of S-ICDs: An individual with an existing S-ICD may receive an S-ICD replacement due to the end of battery life, ERI or device malfunction.

Cardiac Resynchronization Therapy

Humana members may be eligible under the Plan for an FDA-approved CRT or CRT-D when the following criteria are met:

• NYHA Class III or (ambulatory) IV; AND
• LVEF less than or equal to 35%; AND
• Left bundle branch block (LBBB) with QRS duration greater than or equal to 120 milliseconds (ventricular dyssynchrony); OR
• Non-LBBB with QRS duration greater than or equal to 150 milliseconds; AND
• Sinus rhythm; AND
• Remains symptomatic despite GDMT**; OR
• NYHA Class II; AND
• LVEF less than or equal to 35%; AND
• LBBB with QRS duration greater than or equal to 120 milliseconds (ventricular dyssynchrony); AND
• Sinus rhythm; AND
• Remains symptomatic despite GDMT**; OR
• NYHA Class II to (ambulatory) Class IV; AND
• Nonobstructive HCM; AND
• LBBB with QRS duration greater than or equal to 120 milliseconds;

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• LVEF less than 50%; AND
• Sinus rhythm¹⁵; OR
• Atrial fibrillation; AND
  • AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT; AND
  • LVEF less than or equal to 35%; AND
  • Remains symptomatic despite GDMT**; AND
  • Requires ventricular pacing or otherwise meets the above CRT criteria

Replacement of CRT or CRT-Ds: Individual with an existing CRT or CRT-D may receive a CRT or CRT-D replacement due to the end of battery life, ERI or device/lead malfunction. **GDMT represents individualized optimal medical therapy for AF, HF and NICM and may include the following:

• Aldosterone antagonists
• Angiotensin-converting enzyme inhibitors (ACEI)
• Angiotensin receptor blockers (ARB)
• Angiotensin receptor-neprilysin inhibitors (ARNI)¹³
• Anticoagulants
• Beta blockers
• Digoxin
• Diuretics
• Ivabradine¹³
• Nitrates¹³
• SLGT2 inhibitors¹³

Note: The criteria for CRT or CRT-Ds are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Cardioverter Defibrillators/Cardiac Resynchronization Therapy

Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 11 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Wearable Cardioverter Defibrillators

Humana members may be eligible under the Plan for an FDA-approved WCD (eg, ASSURE System, ZOLL LifeVest) when the following criteria are met:

• Criteria listed above for an ICD are met (waiting period* exception may apply) and the individual is at high risk for SCD, but an ICD is currently not indicated in any of the following conditions:
  • Awaiting heart transplantation; OR
  • Awaiting ICD reimplantation following infection-related explantation; OR
  • Systemic infectious process or other temporary condition (eg, new or worsening HF or peripartum cardiomyopathy during the GDMT** optimization period) that precludes implantation; OR
• Immediate post-MI period (the initial 40 days following an MI), with either a history of VT or VF at least 48 hours after the acute MI or an LVEF less than or equal to 35%;

AND EITHER of the following:

• Individual is 18 years of age or older for ASSURE System or ZOLL LifeVest; OR
• Individual is 17 years of age or younger with a chest circumference of at least 26 inches and weighs at least 41 pounds for ZOLL LifeVest⁹⁰

Continuation of Coverage

WCDs are initially authorized for 90 days and subject to medical necessity review every 30 days thereafter. Compliance is verified by ordering physician documented attestation. Compliance is defined as usage of the WCD for at least 23 hours per day over a 30 day period. Verification of compliance (physician attestation) may be requested at any time within the first 90 days of therapy and at any time thereafter.

Coverage Limitations

The following are considered integral to the primary device/procedure and not separately reimbursable including, but may not be limited to:

Cardioverter Defibrillators/Cardiac Resynchronization Therapy

Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 12 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Antibacterial envelopes (e.g., Tyrx); OR
• Monitoring features/devices, stand-alone or integrated; OR
• Replacement of the following WCD-related items:
  • Batteries; OR
  • Electrodes; OR
  • Vests/garments

Humana members may NOT be eligible under the Plan for ICDs, CRTs/CRT-Ds or S-ICDs for any indications other than those listed above. These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for WCDs for any indications other than those listed above. All other indications are considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for any of the following:

• Body surface activation mapping; OR
• CCM devices; OR
• CRT-Ds with hemodynamic (fluid status) monitoring lead; OR
• EV-ICDs (substernal implantable defibrillator); OR
• His bundle pacing; OR
• Left bundle branch pacing; OR
• WiSE wireless cardiac resynchronization therapy system

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for AEDs for home use. These are considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition.

Cardioverter Defibrillators/Cardiac Resynchronization Therapy

Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 13 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Background

Additional information about cardiac disease may be found from the following websites:

• American Heart Association
• National Library of Medicine

Medical Alternatives

Alternatives to cardioverter defibrillators include, but may not be limited to, the following:

• Cardioversion
• Prescription drug therapy

Alternatives to CRTs/CRT-Ds include, but may not be limited to, the following:

• Heart transplantation (please refer to Solid Organ Transplants Medical Coverage Policy)
• Prescription drug therapy
• Surgical procedures (coronary revascularization, valvular replacement surgery and cardiac remodeling)
• Ventricular assist device (VAD) placement (please refer to Ventricular Assist Device (VAD), Total Artificial Heart (TAH) Medical Coverage Policy)

Physician consultation is advised to make an informed decision based on an individual's health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Cardioverter Defibrillators/Cardiac Resynchronization Therapy

Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 14 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes.

Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. Provider Claims Codes

Cardioverter Defibrillators/Cardiac Resynchronization Therapy Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 03/01/2023
Policy Number: HUM-0425-035 Page: 15 of 38

Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead system
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Revision Date: 01/01/2024
Review Date: 03/01/2023
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Cardioverter Defibrillators/Cardiac Resynchronization Therapy Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 03/01/2023
Policy Number: HUM-0425-035 Page: 17 of 38
Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Cardioverter Defibrillators/Cardiac Resynchronization Therapy Effective Date: 01/01/2024
Revision Date: 01/01/2024
Review Date: 03/01/2023
Policy Number: HUM-0425-035 Page: 18 of 38
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; atrial electrode only

Cardioverter Defibrillators/Cardiac Resynchronization Therapy

Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 20 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Cardioverter Defibrillators/Cardiac Resynchronization Therapy

Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 21 of 38

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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Cardioverter Defibrillators/Cardiac Resynchronization Therapy Effective Date: 01/01/2024 Revision Date: 01/01/2024 Review Date: 03/01/2023 Policy Number: HUM-0425-035 Page: 24 of 38Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

• Agency for Healthcare Research and Quality (AHRQ). Technology Assessment. Use of cardiac resynchronization therapy in the Medicare population. https://www.ahrq.gov. Published March 24, 2015. Accessed January 26, 2023.
• American College of Cardiology (ACC). 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. https://www.acc.org. Published October 2, 2012. Accessed January 26, 2023.
• American College of Cardiology (ACC). 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction. https://www.acc.org. Published January 29, 2013. Accessed January 26, 2023.
• American College of Cardiology (ACC). 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes. https://www.acc.org. Published December 23, 2014. Accessed January 27, 2023.
• American College of Cardiology (ACC). 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. https://www.acc.org. Published December 2, 2014. Accessed January 27, 2023.
• American College of Cardiology (ACC). 2015 ACC/AHA/HRS guideline for the management of adult patients with supraventricular tachycardia. https://www.acc.org. Published April 5, 2016. Accessed January 27, 2023.
• American College of Cardiology (ACC). 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. https://www.acc.org. Published October 2, 2018. Accessed January 27, 2023.
• American College of Cardiology (ACC). 2018 ACC/AHA/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay. https://www.acc.org. Published August 20, 2019. Accessed January 27, 2023.
• American College of Cardiology (ACC). 2018 AHA/ACC guideline for the management of adults with congenital heart disease. https://www.acc.org. Published April 2, 2019. Accessed January 27, 2023.
• American College of Cardiology (ACC). 2020 ACC/AHA guideline for the management of valvular heart disease. https://www.acc.org. Published February 2, 2021. Accessed January 27, 2023.
• American College of Cardiology (ACC). 2020 AHA/ACC guideline for the diagnosis and treatment of patients with hypertrophic cardiomyopathy. https://www.acc.org. Published December 22, 2020. Accessed January 27, 2023.
• American College of Cardiology (ACC).

2021 update to the 2017 ACC expert consensus decision pathway for optimization of heart failure treatment: answers to 10 pivotal issues about heart failure with reduced ejection fraction. https://www.acc.org. Published February 16, 2021. Accessed January 27, 2023.

Cardioverter Defibrillators/Cardiac Resynchronization Therapy Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 27 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

13. American College of Cardiology (ACC). 2022 AHA/ACC/HFSA guideline for the management of heart failure. https://www.acc.org. Published May 3, 2022. Accessed January 26, 2023.

14. American College of Cardiology (ACC). ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. https://www.acc.org. Published May 27, 2008. Accessed January 27, 2023.

15. American College of Cardiology (ACC). ACCF/HRS/AHA/ASE/HFSA/ SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter- defibrillators and cardiac resynchronization therapy. https://www.acc.org. Published March 26, 2013. Accessed January 30, 2023.

16. American College of Cardiology (ACC). HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. https://www.acc.org. Published September 16, 2014. Accessed January 30, 2023.

17. American College of Cardiology (ACC). Myocardial infarction redefined: a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. https://www.acc.org. Published September 2000. Accessed January 30, 2023.

18. American Heart Association (AHA). 2016 AHA/ACC clinical performance and quality measures for the prevention of sudden cardiac death. https://www.heart.org. Published December 19, 2016. Accessed January 30, 2023.

19. American Heart Association (AHA). 2017 ACC/AHA/HRS guideline for the evaluation and management of patients with syncope. https://www.heart.org. Published August 1, 2017. Accessed January 30, 2023.

20. American Heart Association (AHA). AHA/ACC/AGS Scientific Statement. Knowledge gaps in cardiovascular care of the older adult population. https://www.heart.org. Published May 24, 2016. Accessed January 30, 2023.

Cardioverter Defibrillators/Cardiac Resynchronization Therapy Effective Date: 01/01/2024

Revision Date: 01/01/2024

Review Date: 03/01/2023

Policy Number: HUM-0425-035 Page: 28 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

21. American Heart Association (AHA). AHA Science Advisory. Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. https://www.heart.org. Published April 26, 2016. Accessed January 30, 2023.

22. American Heart Association (AHA). AHA Scientific Statement. Acute myocardial infarction in women. https://www.heart.org. Published March 1, 2016. Accessed January 30, 2023.

23. American Heart Association (AHA). AHA Scientific Statement. Cardiac amyloidosis: evolving diagnosis and management. https://www.heart.org. Published July 7, 2020. Accessed January 30, 2023.

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• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Implantable automatic defibrillators (20.4). https://www.cms.gov. Published February 15, 2018. Accessed January 25, 2023.
• ClinicalKey. Bank AJ, Gage RM, Curtain AE, Burns KV, Gillberg JM, Ghosh S. Body surface activation mapping of electrical dyssynchrony in cardiac resynchronization therapy patients: potential for optimization. J Electrocardiol. 2018;51:534-541. https://www.clinicalkey.com. Accessed January 26, 2023.
• ClinicalKey. Cheung CC, Olgin JE, Lee BK. Wearable defibrillators. In: Jalife J. Stevenson WG. Zipes and Jalife’s Cardiac Electrophysiology: From Cell to Bedside. 8th ed. Elsevier; 2022:1438-1444. https://www.clinicalkey.com. Accessed January 26, 2023.
• ClinicalKey. Chung MK, Daubert JP. Pacemakers and implantable cardioverter- defibrillators. In: Libby P, Bonow RO, Mann DL, Tomaselli FG, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1321-1348. https://www.clinicalkey.com. Accessed January 26, 2023.
• ClinicalKey. Grace A, Mellor G. Subcutaneous implantable cardioverter defibrillators. In Zipes and Jalife’s Cardiac Electrophysiology: From Cell to Bedside. 8th ed. Elsevier; 2022:1427-1437. https://www.clinicalkey.com. Accessed January 26, 2023.
• ClinicalKey. Lindenfeld J, Zile MR. Devices for monitoring and managing heart failure. In: Libby P, Bonow RO, Mann DL, Tomaselli FG, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1107-1118. https://www.clinicalkey.com. Accessed January 26, 2023.

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Accessed January 20, 2023.

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Appendix A Family Relationships

Appendix B New York Heart Association (NYHA) Functional Classification System72

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Appendix C – Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction (MI) Criteria for Acute, Evolving or Recent MI

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Either one of the following criteria satisfies the diagnosis for an acute, evolving or recent MI:

1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
   • Ischemic symptoms;
   • Development of pathologic Q waves on the ECG;
   • ECG changes indicative of ischemia (ST segment elevation or depression);
   • Coronary artery intervention (e.g., coronary angioplasty);