Print Automatic Implantable Cardioverter Defibrillator (AICD)

Automatic Implantable Cardioverter Defibrillator (AICD)

 

DESCRIPTION

The Automatic Implantable Cardioverter Defibrillator (AICD) is a device designed to monitor a patient'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.

Indications for AICD implantation can be broadly subdivided into 1) secondary prevention; i.e., their use in patients who have experienced a potentially life-threatening episode of ventricular tachyarrhythmia; and 2) primary prevention; i.e., their use in patients who are considered at high risk for sudden cardiac death but who not yet experienced life-threatening ventricular tachycardia (VT) or ventricular fibrillation (VF).

The standard ICD involves placement of a generator in the subcutaneous tissue of the chest wall. Transvenous leads are attached to the generator and threaded intravenously into the endocardium. The leads sense and transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces an electrical shock when a malignant arrhythmia is recognized.

A totally subcutaneous ICD (S-ICD®) has also been developed. This device does not employ transvenous leads and thus avoids the need for venous access and complications associated with the venous leads. Rather, the S-ICD® uses a subcutaneous electrode that is implanted adjacent to the left sternum. The electrodes sense the cardiac rhythm and deliver countershocks through the subcutaneous tissue of the chest wall.

Several automatic implantable cardioverter defibrillators are approvedby the U.S. Food and Drug Administration (FDA) through the premarket application approval process. FDA-labeled indications generally include patients who have experienced life-threatening ventricular tachyarrhythmia associated with cardiac arrest or ventricular tachyarrhythmia associated with hemodynamic compromise and resistance to pharmacologic treatment. Devices manufactured by Guidant are approved by the FDA for use in "patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced at least one of the following: an episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (VT); or a prior myocardial infarction, left ventricular ejection fraction of less than or equal to 35%, and a documented episode of nonsustained ventricualr tachycardia (VT), with an inducible ventricular tachyarrhythmia." On July 18, 2002, the FDA expanded the approved indications for the Guidant AICD devices to include the prophylactic use of Guidant ICDs for cardiac patients who have had a previous heart attack and have an ejection fraction that is less than or equal to 30%. This expanded indication is based on the results of the MADIT II trial. Medtronic devices are approved "to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias." Other devices have approval language similar to Medtronic.

On September 28, 2012, the S-ICD® system by Cameron Health, Inc. was approved by FDA “to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, continual (incessant) ventricular tachycardia, or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.”

NOTE: AICDs may be combined with other pacing devices, such as pacemakers for atrial fibrillation, or biventricular pacemakers designed to treat congestive heart failure. This policy addresses AICDs alone, when used solely to treat patients at risk for ventricular arrhythmias.

See also Biventricular Pacemakers for the Treatment of Congestive Heart Failure.

 

POLICY

For Coding Guidelines see the Anesthesia Coding Policy.

Adults

The use of the automatic implantable cardioverter defibrillator (AICD) may be considered medically necessary in adults who meet the following criteria:

Primary Prevention:

  • Ischemic cardiomyopathy with New York Heart Association (NYHA) functional class II or class III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 35% or less; or
  • Ischemic cardiomyopathy with NYHA functional class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30% or less; or
  • Nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined; or
  • Hypertrophic cardiomyopathy (HCM) with one or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in 1 or more first-degree relatives younger than 50 years; left ventricular hypertrophy greater than 30 mm; 1 or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.

Secondary Prevention:

  • Patients with a history of life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (eg, acute ischemia) have been excluded.

The use of the AICD is considered investigational in primary prevention patients who:

  • Have had an acute myocardial infarction (i.e. less than 40 days before AICD treatment);
  • Have New York Heart Association  (NYHA) Class IV congestive heart failure (unless patient is eligible to receive a combination cardiac resynchronization therapy ICD device);
  • Have had cardiac revasculization procedure in past 3 months (coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) or are candidates for a cardiac revascularization procedure; or
  • Have noncardiac disease that would be associated with life expectancy less than 1 year.

Pediatrics

The use of the ICD may be considered medically necessary in children who meet any of the following criteria:

  • Survivors of cardiac arrest, after reversible causes have been excluded; or
  • Symptomatic, sustained ventricular tachycardia in association with congenital heart disease in patients who have undergone hemodynamic and electrophysiologic evaluation; or
  • Congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias.

The use of the ICD is considered investigational for all other indications in pediatric patients.

The use of a subcutaneous ICD is considered investigational for all indications in adult and pediatric patients.

 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

 

POLICY GUIDELINES

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

6/1997: Approved by the Medical Policy Advisory Committee (MPAC)

4/18/2002: Type of Service and Place of Service deleted

9/2/2003: Code Reference section updated, CPT 33247 deleted

11/2003: Reviewed by MPAC, policy coverage aligned to be consistent with Centers for Medicare & Medicaid Services, "Description" section revised to be consistent with BCBSA, FEP Exception added

2/27/2004: Code Reference section updated

11/16/2005: Code Reference section updated, ICD9 diagnosis code 426.82 added

5/18/2006: Policy revised. Revisions approved by the Medical Policy Advisory Committee (MPAC)

12/27/2006: Code Reference section updated per the 2007 CPT revisions

12/13/2007: Policy reviewed and hypertorphic cardiomyopathy section added

7/18/2008: Anesthesia Coding Policy hyperlink added

12/19/2008: Policy reviewed, no changes

06/03/2010: Policy description and policy statement unchanged. Added the definition of investigative service to the policy guidelines. Deleted outdated references from the Sources sections. FEP verbiage added to the Policy Exceptions section. Added CPT codes 33216 and 33217.

08/23/2011: Policy statement revised to clarify the indications in ischemic cardiomyopathy, with separate indications for class II/III and class I patients. Policy statement regarding waiting time in nonischemic cardiomyopathy was revised to remove the specification of a 9-month waiting period.  Added policy statement to outline coverage criteria for ICD in pediatric patients.  

01/09/2013:  Added policy statement to indicate that the use of a subcutaneous ICD is considered investigational for all indications in adult and pediatric patients. Added 0319T - 0328T to the Code Reference section as non-covered.

05/06/2013:  Added ICD-9 codes 414.8, 425.4, and V12.53 to the Covered Codes table.

12/13/2013: Policy reviewed; no changes.

03/19/2014: Policy reviewed; no changes.

05/07/2014: Policy reviewed; description updated regarding standard and subcutaneous ICDs. Moved the first medically necessary policy statement under the adults section and replaced the word "patients" with "adults." Deleted the word "symptomatic" from the statement in the primary prevention criteria. It previously stated: Symptomatic nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined.  Added "after reversible causes (eg, acute ischemia) have been excluded" to the policy statement on secondary prevention in adults.

 

SOURCE(S)

Blue Cross Blue Shield Association Policy #7.01.44

 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.  

For Coding Guidelines see the Anesthesia Coding Policy.

Covered Codes

Code Number

Description

CPT-4

33216

Insertion of a single transvenous electrode, permanent pacemaker or cardioverter-defibrillator

33217

Insertion of 2 transvenous electrodes, permanent pacemaker or cardioverter-defibrillator

33240

Insertion or replacement of implantable cardioverter-defibrillator pulse generator only

33241

Removal of implantable cardioverter-defibrillator pulse generator only

33242

Repair of implantable cardioverter-defibrillator pulse generator and/or leads

33243

Removal of implantable cardioverter-defibrillator pulse generator and/or lead system; by thoracotomy

33244

by other than thoracotomy

33249

Insertion or replacement of implantable cardioverter-defibrillator lead(s) by other than thoracotomy, with insertion of cardio-defibrillator pulse generator

ICD-9 Procedure

37.94

Implantation or replacement of automatic cardioverter/defibrillator, total system (AICD), code includes pocket formation, thoracotomy

37.95

Implantation, AICD leads only

37.96

Implantation, AICD pulse generator only

37.97

Replacement, AICD leads only

37.98

Replacement, AICD pulse generator only

37.99

Other, removal of cardioverter/defibrillator pulse generator with replacement

ICD-9 Diagnosis

414.8

Other specified forms of chronic ischemic heart disease 

425.11  

Hypertrophic obstructive cardiomyopathy 

425.4

Other primary cardiomyopathies 

426.81 

Lown-Ganong-Levine syndrome

426.82

Long QT syndrome

426.89 

Other specified conduction disorder (nonparoxysmal AV nodal tachycardia)

427.0 

Paroxysmal supraventricular tachycardia

427.1

Paroxysmal ventricular tachycardia

427.41

Ventricular fibrillation

427.42 

Ventricular flutter

427.81 

Sinoatrial node dysfunction

427.89 

Other specified cardiac dysrhythmias

427.9

Cardiac dysrhythmia, unspecified (ventricular arrhythmia code)

V12.53     

Sudden cardiac arrest 

HCPCS

 

 

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure.

Non- Covered Codes

Code Number

Description

CPT-4

0319T - 0328T

Insertion, replacement, and programming of  subcutaneous implantable defibrillator code range (Added 01-09-2013)

ICD-9 Procedure

 

 

ICD-9 Diagnosis

 

 

HCPCS

 

 

 

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