Humana Cardioverter Defibrillators/Cardiac Resynchronization Therapy - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals. Type Title ID Number Jurisdiction Medicare Applicable States/Territories Cardioverter Defibrillators/Cardiac Resynchronization Therapy Page: 2 of 21 NCD LCD LCA LCD LCA Implantable Cardioverter Defibrillators (ICDs) Cardiac Resynchronization Therapy (CRT) Cardiac Resynchronization Therapy (CRT) 20.4 L39080 A58821 L39080 A58821 LCD LCA Automatic External Defibrillators L33690 A52548 Administrative Contractors (MACs) JJ - Palmetto GBA (Part A/B MAC) JM - Palmetto GBA (Part A/B MAC) DME A - Noridian Healthcare Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) DME C - CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC) AL, GA, TN NC, SC, VA, WV All States 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 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. Cardioverter Defibrillators/Cardiac Resynchronization Therapy Page: 3 of 21 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. • Personal history of syncope suspected by clinical history to be arrhythmic. • Family history in first- or second-degree relative of premature HCM-related sudden death, cardiac arrest or sustained ventricular arrhythmias. • 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. • Diffuse and extensive late gadolinium enhancement (LGE), representing fibrosis, either quantified or estimated by visual inspection, comprising greater than 15% of LV mass.11 • Nonsustained (greater than or equal to 3 premature ventricular complexes terminating spontaneously) ventricular tachycardia (NSVT) episodes on continuous ambulatory electrocardiographic monitoring.15 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.44 Cardiac resynchronization therapy (CRT) (also known as biventricular pacing) is used to treat 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 of developing life-threatening arrhythmias. Implantation of a CRT-D allows for both coordinating ventricular contractions and terminating life-threatening arrhythmias. 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. External Devices Cardioverter Defibrillators/Cardiac Resynchronization Therapy Page: 4 of 21 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) 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. Coverage Determination Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Automated External Defibrillators Please refer to the above Medicare guidance for automated external defibrillators. Implantable Cardioverter Defibrillators Please refer to the above Medicare guidance for implantable cardioverter defibrillators. Subcutaneous Implantable Defibrillators An FDA-approved subcutaneous implantable defibrillator (S-ICD) will be considered medically reasonable and necessary when the following requirements are met: • Criteria 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 the following: • Requires pacing or CRT; AND • Incessant VT or spontaneous, frequently recurring VT that is reliably terminated with antitachycardia Cardioverter Defibrillators/Cardiac Resynchronization Therapy Page: 5 of 21 pacing; AND • Symptomatic bradycardia74 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 if the S-ICD continues to be medically necessary. Wearable Cardioverter Defibrillators Please refer to the above Medicare guidance for wearable cardioverter defibrillators. Cardiac Resynchronization Therapy (CRT-P or CRT-D) An FDA-approved CRT or CRT-D will be considered medically reasonable and necessary when the following requirements are met: • NYHA Class III or (ambulatory) IV; AND o 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 o Sinus rhythm; AND o Remains symptomatic despite GDMT*; OR • NYHA Class II; AND o LVEF less than or equal to 35%; AND o LBBB with QRS duration greater than or equal to 120 milliseconds (ventricular dyssynchrony); AND o Sinus rhythm; AND o Remains symptomatic despite GDMT*; OR • NYHA Class II to (ambulatory) Class IV; AND o Nonobstructive HCM; AND o LBBB with QRS duration greater than or equal to 120 milliseconds; AND o LVEF less than 50%; AND o Sinus rhythm15; OR • Atrial fibrillation; AND Cardioverter Defibrillators/Cardiac Resynchronization Therapy Page: 6 of 21 o AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT; AND o LVEF less than or equal to 35%; AND o Remains symptomatic despite GDMT*; AND o 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 if the CRT/CRT-D continues to be medically necessary. *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 • Sodium-glucose cotransporter-2 inhibitors (SLGT2i)13 The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage Cardiac Resynchronization Therapy (CRT or CRT-D) The following indications for CRT or CRT-D will not be considered medically reasonable and necessary: • Individual with a QRS less than 130 ms (Exception to this non-coverage criterion would be in the case of an individual undergoing AV nodal ablation or in need of RV pacing [due to second- or third-degree block or very long first-degree block] that is expected to occur a majority of the time.)33; OR Cardioverter Defibrillators/Cardiac Resynchronization Therapy Page: 7 of 21 • Individual with an EF greater than or equal to 50%33; OR • CRT in an individual with nonambulatory NYHA IV HF symptoms or on chronic inotropic HF therapy or with LV assist device in place33 A review of the current medical literature shows that the evidence is insufficient to determine that these services are standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management. Cardiac Contractility Modulation (CCM) Cardiac contractility modulation will not be considered medically reasonable and necessary. A review of the current literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term outcomes establishing the value of this service in clinical management. Summary of Evidence Long-term study results comparing CRT-D therapy with ICD therapy alone for individuals with NYHA Class II and III heart failure symptoms and requiring an ICD showed a statistically significant risk reduction in mortality or heart failure events in the CRT-D group.48 Individuals with a QRS less than 130 ms, an EF greater than 30% and nonambulatory NYHA IV HF symptoms were excluded from the randomized controlled trials (RCTs). Extension of benefit to individuals with narrow QRS has been attempted but generally failed and studies have shown no benefit to this group. Studies have shown no clinical benefit for those with normal ejection fraction or whose conditions or frailty (eg, nonambulatory NYHA IV) limit survival to less than one year.13 While clinical studies supported the US Food & Drug Administration (FDA) approval of the Optimizer Smart cardiac contractility modulation system, there continues to be a lack of RCTs with data supporting long- term clinical outcomes and associated complications.66 An overall low-quality body of evidence suggests that CCM with the Optimizer Smart System as an adjunct to optimal medical therapy (OMT) may improve outcomes related to functional heart class severity and quality of life; however, uncertainty remains regarding clinical benefit versus OMT alone.43 Independent, randomized, blinded comparative clinical studies are needed to determine whether CCM with the Optimizer Smart System is safe, more effective than OMT alone and has durable benefits.45