![]() | Medical Policy |
| Subject: | Implantable Cardioverter-Defibrillator (ICD) | ||
| Policy #: | SURG.00033 | Current Effective Date: | 01/14/2009 |
| Status: | Revised | Last Review Date: | 11/20/2008 |
| Description/Scope |
This document addresses the use of an implantable cardioverter-defibrillator to monitor heart rhythm and deliver an electrical shock when a life threatening ventricular arrhythmia is detected.
| Position Statement |
Medically Necessary:
ADULT Indications:
Implantable cardioverter-defibrillator (ICD) therapy in adults is considered medically necessary for the treatment of ventricular tachyarrhythmias and for the prevention of sudden cardiac death (SCD) in patients who are receiving optimal medical therapy and have a reasonable expectation of survival with a good functional status for more than 1 year when one of the following indications is present:
Note: For use of combined ICD/Biventricular pacing (CRT-ICD) devices, in cases of NYHA Class IV heart failure and for other indications, see SURG.00064 Cardiac Resynchronization Therapy (CRT), with or without an Implantable Cardioverter Defibrillator (CRT/ICD) for the Treatment of Heart Failure.
PEDIATRIC Indications:
Implantable cardioverter-defibrillator (ICD) therapy in children is considered medically necessary for the treatment of ventricular tachyarrhythmias and for the prevention of sudden cardiac death (SCD) in patients who are receiving optimal medical therapy and have a reasonable expectation of survival with a good functional status for more than 1 year when one of the following indications is present:
Investigational and Not Medically Necessary:
The use of an implantable cardioverter-defibrillator is considered investigational and not medically necessary for any other diagnosis not listed above as medically necessary under Adult Indications or Pediatric Indications.
| Rationale |
Implantable cardioverter-defibrillators (ICD) are an important treatment option for patients with a history of life-threatening ventricular arrhythmias. Randomized clinical trials have shown that ICD use significantly reduces mortality rates for those patients with CAD and/or a prior myocardial infarction who have poor ventricular function. Although ICDs for the treatment of atrial fibrillation have been used in studies, evidence on efficacy and long-term outcomes is limited, and thus, clear conclusions concerning the efficacy of this treatment modality cannot be drawn.
Available literature indicates implantable cardioverter-defibrillators (ICDs) are now widely used for the secondary prevention of sudden cardiac death, due to ventricular fibrillation (VF) or ventricular tachycardia (VT). ICD implantation is the generally accepted treatment for patients who have experienced an episode of VF not accompanied by an acute myocardial infarction or other transient or reversible cause. Accepted guidelines prefer this treatment in patients with sustained VT, causing syncope or hemodynamic compromise. As primary prevention, the literature shows that ICD use is superior to conventional antiarrhythmic drug therapy in patients who have survived a myocardial infarction and who have spontaneous, non-sustained VT, a low ejection fraction, and inducible VT at electrophysiological study.
Two prospective, randomized, controlled trials compared the use of ICDs to that of conventional therapy: the Multi-Center Automatic Defibrillator Implantation Trial (MADIT; n=196) and the Multi-Center Automatic Defibrillator Implantation Trial II (MADIT II; n=1,232). Both trials were conducted on patients with coronary artery disease (CAD) who had experienced myocardial infarctions (MIs) and who had reduced left ventricular ejection fractions (LVEFs). Both trials were well designed and of good quality. The observed all-cause mortality rate in the conventionally treated group was somewhat lower in MADIT II (19.8%, with average follow-up at 20 months) than in MADIT (38.6%, with average follow-up at 27 months), suggesting some differences in the baseline mortality risk between these two populations. Both trials reported that ICD treatment resulted in more statistically significant reductions in all-cause mortality (primary endpoint) than conventional therapy did. The MADIT and MADIT II trials provide consistent evidence that patients with CAD, prior MI and reduced LVEF who meet selection criteria for either trial have significantly reduced mortality when treated with ICDs than when given conventional therapy (Moss, 1996).
The Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial was a prospective, randomized study to test the hypothesis that an ICD will reduce the risk of sudden death in patients with non-ischemic cardiomyopathy and moderate-to-severe left ventricular dysfunction. Inclusion criteria were: LVEF < 36%, the presence of ambient arrhythmias, a history of symptomatic heart failure, and the presence of non-ischemic dilated cardiomyopathy (NIDCM). The primary endpoint was death from any cause; the secondary endpoint was sudden death from arrhythmia. A total of 458 patients were enrolled: 229 were randomly assigned to receive standard medical therapy and 229 to receive standard medical therapy plus a single-chamber ICD. Results of the study included 68 deaths, 28 of which occurred in the ICD group, as compared to 40 in the standard therapy group (hazard ratio - 0.65; 95%; confidence interval - 0.40-1.06; p=0.08). The mortality rate at two years was 14.1% in the standard therapy group (annual mortality rate, 7%) and 7.9% in the ICD group. There were 17 sudden deaths from arrhythmia: three in the ICD group and 14 in the standard therapy group (hazard ratio - 0.20; 95% confidence interval - 0.06 to 0.71; P=0.006). The researchers noted that fewer patients died in the ICD group than in the standard therapy group (28 vs. 40), but that the difference in survival was not significant (p=0.08). The researchers concluded that this was still a well-supported study, based on the p value results (Schaechter, 2003). A post-hoc analysis of the DEFINITE trial data was conducted by Kadish and colleagues (2006) which noted that study subjects with reversible causes of left ventricular dysfunction had been excluded from the DEFINITE trial. The authors noted that the time immediately after development of cardiomyopathy may be a time when the disease process and consequent remodeling are in rapid evolution which may stabilize with time. This information would appear to support the medical necessity criterion regarding the duration of NIDCM, (i.e., of greater than nine months), in order to meet medical necessity (Kadish, 2006).
The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) randomized 674 adult patients to receive either an ICD or no ICD within 40 days of a myocardial infarction (Hohnloser, et al. on behalf of the DINAMIT Investigators, 2004). All patients had reduced ejection fractions (ejection fraction ≤ 35%) and impaired cardiac autonomic function. The primary outcome was mortality from any cause, and the secondary outcome was death from arrhythmia. During a mean follow-up of 30 ± 13 months, there was no difference in overall mortality between the two groups. Of 120 patients who died, 62 were in the ICD group, and 58 were in the control group. There were 12 deaths due to arrhythmia in the ICD group and 29 in the control group. There were 50 deaths from nonarrhythmic causes in the ICD group, however, and 29 in the control group. The authors concluded that ICD therapy does not reduce overall mortality in high-risk patients who have recently had an MI. Although ICD therapy was associated with a reduction in arrhythmia-related death, this was offset by an increase in nonarrhythmic-related death.
The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) was conducted to test whether amiodarone therapy or an implantable cardioverter-defibrillator will improve survival, compared to a placebo in adult patients with systolic dysfunction from ischemic dilated cardiomyopathy (IDCM) or non-ischemic dilated cardiomyopathy (NIDCM) who also have NYHA class II or class III heart failure, chronic stable congestive heart failure (CHF) and reduced LVEF less than or equal to 35%. A total of 2,521 patients were randomly assigned: 847 received placebo plus conventional heart failure therapy; 845 received amiodarone plus conventional heart failure therapy; and 829 received single-lead ICD plus conventional heart failure therapy. The results of the trial showed a significant reduction in mortality in the ICD group, compared to the placebo group: (hazard ratio compared to control = 0.77; 97.5% CI = 0.62-0.96; p=0.007).
For patients with IDCM, there was a reduction in the mortality hazard ratio for ICD therapy, compared to the control (hazard ratio=0.79; 97.5% CI=0.60-1.04). For patients with NIDCM, there was a reduction in the mortality hazard ratio for ICD therapy, compared to the control (hazard ratio=0.73; 97.5% CI= 0.50-1.07). Amiodarone therapy did not improve survival. The results of this study showed that overall mortality was lower for patients with NIDCM than for patients with IDCM. The authors concluded that ICD placement is safe and effective for the treatment of ischemic and non-ischemic cardiomyopathy (Bardy, 2005).
In 2006, the American College of Cardiology (ACC), in conjunction with the American Heart Association (AHA), the European Society of Cardiology (ESC), the European Heart Rhythm Association (EHRA), and the Heart Rhythm Society (HRS) published practice guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death (SCD). The guidelines, which were based on published evidence, expert opinion, and medical consensus, provide recommendations for use of ICDs, in addition to other recommendations related to diagnostics and medical/surgical treatment options for a variety of cardiac conditions. In 2008, the American College of Cardiology, American Heart Association and the Heart Rhythm Society (ACC/AHA/HRS) published updated guideline recommendations for Device-Based Therapy of Cardiac Rhythm Abnormalities (Epstein, et al., 2008). These guidelines update the prior 2002 ACC/AHA/NASPE Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices (Gregoratos, et al., 2002). The ACC/AHA/HRS guidelines have been updated due to the expanding body of knowledge and experience related to the treatment of bradyarrhythmias and tachyarrhythmias, as well as the significant advances in the technology of device-based therapy for these conditions. These guidelines are intended to add to the information in the former 2002 ACC/AHA/NASPE guidelines, as well as the 2006 ACC/AHA/ESC Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death (Zipes, et al., 2006). This updated 2008 guidance document reviews available clinical trials data in detail and also provides specific guideline recommendations for use of ICD devices in adults and also in the pediatric population, which have been incorporated into the medical necessity criteria in this document.
According to this ACC/AHA/HRS guideline document (Epstein, 2008):
The indications for ICD implantation in young patients and those with congenital heart disease have evolved over the past 15 years based on data derived primarily from adult randomized clinical trials. Similar to adults, ICD indications have evolved from the secondary prevention of SCD to the treatment of patients with sustained ventricular arrhythmias to the current use of ICDs for primary prevention in patients with an increased risk of SCD. However, in contrast to adults, there are minimal prospective data regarding ICD survival benefit, because fewer than 1% of all ICDs are implanted in pediatric or congenital heart disease patients. Considerations, such as the cumulative lifetime risk of SCD in high-risk patients and the need for decades of antiarrhythmic therapy make the ICD an important treatment option for young patients. Prospective identification and treatment of young patients at risk for sudden death is crucial because compared with adults, a very low percentage of children undergoing resuscitation survive to hospital discharge…Because of concern about drug-induced proarrhythmia and myocardial depression, an ICD (with or without cardiac resynchronization therapy [CRT]) may be preferable to antiarrhythmic drugs in young patients with dilated cardiomyopathy (DCM) or other causes of impaired ventricular function who experience syncope or sustained ventricular arrhythmias…The role of ICDs in primary prevention for children with genetic channelopathies, cardiomyopathies, and congenital heart defects should be defined more precisely and is an area in need of further research (Epstein, 2008).
The Centers for Medicare and Medicaid Services (CMS) expanded its national coverage determination policy (January 27, 2005), to include patients with ischemic dilated cardiomyopathy (IDCM) and non-ischemic dilated cardiomyopathy (NIDCM), subject to additional policy limitations and requirements regarding data collection. This expanded policy is based on the results of recently published trials data, as described above.
| Background/Overview |
Description of Relevant Disease
Sudden cardiac death (also called sudden arrest) is defined as unexpected death, resulting from an abrupt loss of heart function (cardiac arrest). All known heart diseases can lead to cardiac arrest and sudden cardiac death. Most of the cardiac arrests that lead to sudden death occur when the electrical impulses in the diseased heart become rapid (ventricular tachycardia) or chaotic (ventricular fibrillation) or both. This irregular rhythm causes the heart to suddenly stop beating. Some cardiac arrests are due to extreme slowing of the heart (bradycardia). Brain death and permanent death start to occur in just four to six minutes after someone experiences cardiac arrest. Cardiac arrest is reversible in most victims if it is treated within a few minutes with an electrical shock to the heart to restore a normal heartbeat (defibrillation). Cardiovascular mortality as a consequence of VF or VT continues to be a major health problem, despite advances in the overall management of cardiovascular disease. Sudden cardiac death kills approximately 400,000 people per year, with survival rates for cardiac arrest less than 5% in most industrialized countries. If the cardiac arrest was due to ventricular tachycardia or ventricular fibrillation, survivors are at risk for another arrest, especially if they have underlying heart disease.
Description of Implantable Defibrillators (ICD)
Defibrillation is a process in which an electronic device gives an electric shock to the heart. This helps re-establish normal contraction rhythms in a heart having dangerous arrhythmia or in cardiac arrest. A surgically implanted cardioverter-defibrillator (ICD) is a device used in patients at high risk for sudden cardiac death due to arrhythmia, usually due to sustained ventricular tachyarrhythmia. The device is connected to leads positioned inside the heart or on its surface. These leads are used to deliver electrical shocks, sense the cardiac rhythm and sometimes pace the heart, as needed. The various leads are connected to a pulse generator, which is implanted in a pouch beneath the skin of the chest or abdomen. The ICD is designed to continuously monitor an individual's heart rate, recognize ventricular fibrillation or ventricular tachycardia, and deliver an electric shock to terminate these arrhythmias, in order to reduce the risk of sudden death. Multiple ICD devices have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process, subject to FDA-approved labeling indications.
| Definitions |
Arrhythmia: (or dysrhythmia): problems that affect the electrical system of the heart muscle, producing abnormal heart rhythms; may be classified as either atrial or ventricular, depending on which part of the heart they originate from
Atrial Fibrillation: a condition in which the atrium (the heart's two upper chambers) produce uncoordinated electrical signals
Cardiomyopathy: a disease in which the heart muscle becomes inflamed and doesn't work as well as it should; there are three main types of cardiomyopathy:
Congestive heart failure (CHF): or heart failure: a condition in which the heart can't pump enough blood to the body's other organs; the "failing" heart keeps working but not as efficiently as it should; as blood flow out of the heart slows, blood returning to the heart through the veins backs up, causing congestion in the tissues
Coronary Artery Disease (CAD): refers to heart problems caused by narrowed heart arteries; when arteries are narrowed, less blood and oxygen reaches the heart; this can ultimately lead to a heart attack (myocardial infarction)
Defibrillation: a process in which an electronic device (a defibrillator) gives the heart an electric shock, helping to re-establish normal contraction rhythms in a heart that is not properly beating; this may be done using an external device or by a device implanted in the body
Ejection Fraction (EF): the percentage of blood ejected from the left ventricle with each heartbeat; normal readings would be in the 58-70% range and lower values would indicate ventricular dysfunction
Electrophysiology Studies: performed in the cardiac catheterization laboratory; such studies evaluate electro- physiological properties of the heart, such as automaticity, conduction, and whether the condition is refractory to management with medications; additional capabilities of this testing include: ability to initiate and terminate tachycardia; to map activation sequences; and to evaluate patients for various forms of therapy and judge response to therapy
Myocardial Infarction (MI): the medical term for heart attack; a heart attack occurs when the blood supply to part of the heart muscle (the myocardium) is severely reduced or stopped
New York Heart Association (NYHA) Definitions: the NYHA classification of heart failure is a 4-tier system that categorizes patients based on subjective impression of the degree of functional compromise; the four NYHA functional classes are as follows:
QRS Complex: refers to a portion of an electrocardiogram (EKG) reading, which represents the spread of the electrical impulse through the ventricles
Sudden Cardiac Death: (also called sudden death) is death resulting from an abrupt loss of heart function (cardiac arrest)
Ventricular tachyarrhythmias: a medical term for a rapid heartbeat that may be regular or irregular and arises from the ventricle or pumping chamber of the heart; two common tachyarrhythmias are ventricular tachycardia and ventricular fibrillation
Ventricular Fibrillation: (Vfib or VF) a condition in which the heart's electrical activity becomes disordered; when this happens, the heart's lower (pumping) chambers contract in a rapid, unsynchronized fashion, (i.e., the ventricles "flutter" rather than beat), and the heart pumps little or no blood
Ventricular Tachycardia: (Vtach or VT) is a fast regular heart rate that starts in the lower chambers (ventricles); VT may result from serious heart disease and usually requires prompt treatment
| Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage or these services at it applies to an individual member.
When services may be Medically Necessary when criteria are met:
CPT |
|
00534 | Anesthesia for transvenous insertion or replacement of pacing cardioverter-defibrillator |
33202 | Insertion of epicardial electrode(s); open incision (e.g., thoracotomy, median sternotomy, subxiphoid approach) |
33203 | Insertion of epicardial electrode(s); endoscopic approach (e.g., thoracoscopy, pericardioscopy) |
33216 | Insertion of a transvenous electrode; single chamber (one electrode) permanent pacemaker or single chamber pacing cardioverter-defibrillator [when specified as ICD] |
33217 | Insertion of a transvenous electrode; dual chamber (two electrodes) permanent pacemaker or dual chamber pacing cardioverter-defibrillator [when specified as ICD] |
33240 | Insertion of single or dual chamber pacing cardioverter-defibrillator pulse generator |
33249 | Insertion or repositioning of electrode lead(s) for single or dual chamber pacing cardioverter-defibrillator and insertion of pulse generator |
HCPCS |
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C1721 | Cardioverter-defibrillator, dual chamber (implantable) |
C1722 | Cardioverter-defibrillator, single chamber (implantable) |
C1777 | Lead, cardioverter-defibrillator, endocardial single coil (implantable) |
C1882 | Cardioverter-defibrillator, other than single or dual chamber (implantable) |
C1895 | Lead, cardioverter-defibrillator, endocardial dual coil (implantable) |
C1896 | Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable) |
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ICD-9 Procedure |
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37.94 | Implantation or replacement of automatic cardioverter-defibrillator, total system (ICD) |
37.95 | Implantation of automatic cardioverter-defibrillator lead(s) only |
37.96 | Implantation of automatic cardioverter-defibrillator pulse generator only |
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ICD-9 Diagnosis |
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| All diagnoses |
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above specified as ICD, when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
| References |
Peer Reviewed Publications:
Government Agency; Medical Society; and Other Authoritative Publications:
| Web Sites for Additional Information |
| Index |
Automatic Defibrillator
ICD
Implantable Cardioverter-Defibrillator
| Document History |
Status | Date | Action |
Revised | 11/20/2008 | Medical Policy & Technology Assessment Committee (MPTAC) review. The medical necessity criteria have been revised to align with the 2008 ACC/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. Pediatric indications considered medically necessary have now been added to the position statement section. The Rationale section and References were also updated. |
Reviewed | 11/29/2007 | MPTAC review. Criteria for NIDCM were reviewed with consideration for the addition of irreversible disease to the indications considered medically necessary. However, MPTAC approved the document as written with no change to current criteria. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." Rationale and references were updated. Coding section was updated with 01/01/08 CPT/HCPCS changes; removed HCPCS G0297, G0298, G0299, G0300 deleted 12/31/2007. |
Reviewed | 03/08/2007 | MPTAC review. No change to criteria/stance. Rationale, References, and Coding sections have been updated. |
| 01/01/2007 | Updated coding section with 01/01/2007 CPT/HCPCS changes; removed CPT 33245, 33246 deleted 12/31/2006. |
Reviewed | 03/23/2006 | MPTAC review. No change in stance. References were updated to include the recently released updated TEC Assessment Directories (2) and additional published articles. |
| 11/18/2005 | Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD). |
Revised | 04/28/2005 | MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. |
Pre-Merger Organization | Last Review Date | Document Number | Title |
Anthem, Inc.
| 09/19/2003 | SURG.00033 | Automatic Implantable Cardioverter-Defibrillator (AICD), Cardiac Resynchronization Therapy Defibrillator (CRT-D), Biventricular Pacemakers |
WellPoint Health Networks, Inc | 06/24/2004 | 9.04.03 | Implantable Cardioverter-defibrillators |