Print Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

 

POLICY NUMBER

A.7.01.44

 

DESCRIPTION

The automatic implantable cardioverter defibrillator (ICD) 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. A subcutaneous ICD (S-ICD) has been developed that does not employ transvenous leads, with the goal of reducing lead-related complications.

Indications for ICD implantation can be broadly subdivided into 1) secondary prevention; i.e., use in patients who have experienced a potentially life-threatening episode of VT (near sudden cardiac death); and 2) primary prevention; i.e., use in patients who are considered at high risk for sudden cardiac death but who have not yet experienced life-threatening VT or 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 subcutaneous ICD (S-ICD®) has 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 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 approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. FDA-labeled indications generally include patients who have experienced life-threatening VT associated with cardiac arrest or VT associated with hemodynamic compromise and resistance to pharmacologic treatment. In addition, devices typically have approval in the secondary prevention setting in patients with a previous myocardial infarction and reduced injection fraction.

Transvenous Implantable Cardioverter Defibrillators

FDA has approved a large number of ICDs through the PMA process (FDA product code: LWS). A 2014 review of FDA approvals of cardiac implantable devices reported that, between 1979 and 2012, FDA approved 19 ICDs (7 pulse generators, 3 leads, 9 combined systems) through new PMA applications. Many originally-approved ICDs have undergone multiple supplemental applications. A summary of some currently available ICDs is provided below (list not exhaustive).

Implantable Cardioverter Defibrillators With FDA Approval

Device

Manufacturer

Originial PMA
Approval Date

Type

Ellipse/Fortify Assura Family (originally:
Cadence Tiered Therapy Defibrillation
System)
St. Jude Medical (St. Paul, MN)

July 1993

Transvenous
Current Plus ICD (originally: Cadence
Tiered Therapy Defibrillation System)
St. Jude Medical (St. Paul, MN)

July 1993

Transvenous
Dynagen, Inogen, Origen, and Teligen
Family (originally: Ventak, Vitality,
Cofient family)
Boston Scientific (Marlborough, MA)

January 1998

Transvenous
Evera Family (originally: Virtuosos/
Entrust/Maximo/ Intrisic/ Marquis family)
Medtronic (Minneapolis, MN)

December 1998

Transvenous
Subcutaneous Implantable Defibrillator
System
Cameron Health (San Clemente, CA);
acquired by Boston Scientific

September 2012

Subcutaneous

Subcutaneous ICDs

In September 2012, FDA approved the Subcutaneous Implantable Defibrillator (S-ICD®) System (Cameron Health, San Clemente, CA; acquired by Boston Scientific, Marlborough, MA), through the PMA process for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

In March 2015, the Emblem S-ICD™ (Boston Scientific), which is smaller and longer-lasting than the original S-ICD, was cleared for marketing through a PMA supplement process.

NOTE: ICDs may be combined with other pacing devices, such as pacemakers for atrial fibrillation, or biventricular pacemakers designed to treat heart failure. This policy addresses ICDs 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 (ICD) 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.
  • Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see Policy Guidelines section):
    • congenital long QT syndrome; OR
    • Brugada syndrome; OR
    • short QT syndrome; OR
    • catecholaminergic polymorphic ventricular tachycardia.

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 ICD is considered investigational in primary prevention patients who:

  • Have had an acute myocardial infarction (i.e. less than 40 days before ICD 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 a cardiac revascularization 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.

The use of the ICD for secondary prevention is considered investigational for patients who do not meet the criteria for secondary prevention.

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.
  • Hypertrophic cardiomyopathy (HCM) with one or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years; massive left ventricular hypertrophy based on age-specific norms; 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.
  • Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see Policy Guidelines):
    • congenital long QT syndrome; OR
    • Brugada syndrome; OR
    • short QT syndrome; OR
    • catecholaminergic polymorphic ventricular tachycardia.

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

Subcutaneous ICD

The use of a subcutaneous ICD may be considered medically necessary for adults or children who have an indication for ICD implantation for primary or secondary prevention for any of the above reasons and meet all of the following criteria:

  • Have a contraindication to a transvenous ICD due to one or more of the following: (1) lack of adequate vascular access; (2) compelling reason to preserve existing vascular access (ie, need for chronic dialysis; younger patient with anticipated long-term need for ICD therapy); or (3) history of need for explantation of a transvenous ICD due to a complication, with ongoing need for ICD therapy.
  • Have no indication for antibradycardia pacing; AND
  • Do not have ventricular arrhythmias that are known or anticipated to respond to antitachycardia pacing.

The use of a subcutaneous ICD is considered investigational for individuals who do not meet the criteria outlined above.

 

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

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

This policy addresses the use of implantable cardioverter defibrillator (ICD) devices as stand-alone interventions, not as combination devices to treat heart failure (ie, cardiac resynchronization devices) or in combination with pacemakers. Unless specified, the policy statements are referring to transvenous ICDs.

Indications for pediatric ICD use are based on American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) guidelines published in 2008, which acknowledged the lack of primary research in this field on pediatric patients. These indications derive from nonrandomized studies, extrapolation from adult clinical trials, and expert consensus.

Criteria for ICD Implantation in Patients With Cardiac Ion Channelopathies

Individuals with cardiac ion channelopathies may have a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes, in which case they should be considered for ICD implantation for secondary prevention, even if they do not meet criteria for primary prevention.

Criteria for ICD implantation in patients with cardiac ion channelopathies are derived from results of clinical input, a 2013 consensus statement from the HRS, European Heart Rhythm Association (EHRA), and the Asia-Pacific Heart Rhythm Society on the diagnosis and management of patients with inherited primary arrhythmia syndromes, 2013 guidelines from the ACC, AHA, HRS, the American
Association of Thoracic Surgeons, and the Society of Thoracic Surgeons on device-based therapy of cardiac rhythm abnormalities, and a report from the HRS/EHRA’s Second Consensus Conference on Brugada syndrome.

Indications for consideration for ICD implantation for each cardiac ion channelopathy are as follows:

  • Long QT syndrome (LQTS):
    • Patients with a diagnosis of LQTS who are survivors of cardiac arrest.
    • Patients with a diagnosis of LQTS who experience recurrent syncopal events while on beta-blocker therapy.
  • Brugada syndrome (BrS):
    • Patients with a diagnosis of BrS who are survivors of cardiac arrest.
    • Patients with a diagnosis of BrS who have documented spontaneous sustained ventricular tachycardia (VT) with or without syncope.
    • Patients with a spontaneous diagnostic type 1 ECG who have a history of syncope, seizure, or nocturnal agonal respiration judged to be likely caused by ventricular arrhythmias (after noncardiac causes have been ruled out).
    • Patients with a diagnosis of BrS who develop ventricular fibrillation (VF) during programmed electrical stimulation.
  • Catecholaminergic polymorphic ventricular tachycardia (CPVT):
    • Patients with a diagnosis of CPVT who are survivors of cardiac arrest.
    • Patients with a diagnosis of CPVT who experience recurrent syncope or polymorphic/bidirectional ventricular tachycardia (VT) despite optimal medical management, and/or left cardiac sympathetic denervation.
  • Short QT syndrome (SQTS):
    • Patients with a diagnosis of SQTS who are survivors of cardiac arrest.
    • Patients with a diagnosis of SQTS who are symptomatic and have documented spontaneous VT with or without syncope.
    • Patients with a diagnosis of SQTS or are asymptomatic or symptomatic and have a family history of sudden cardiac death.

NOTE: For congenital LQTS, patients may have one or more clinical or historical findings other than those outlined above that may, alone or in combination, put them at higher risk for sudden cardiac death. These may include patients with a family history of sudden cardiac death due to LQTS, infants with a diagnosis of LQTS with functional 2:1 atrioventricular block, patients with a diagnosis of LQTS in conjunction with a diagnosis of Jervell and Lange-Nielsen syndrome or Timothy syndrome, and patients with a diagnosis of LQTS with profound QT prolongation (>550 ms). These factors should be evaluated on an individualized basis by a clinician with expertise in LQTS when considering the need for an ICD implantation.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

 

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.

12/03/2014: Policy title changed from "Automatic Implantable Cardioverter Defibrillator (AICD)" to "Implantable Cardioverter Defibrillator." Wording changed throughout policy to be consistent with policy title. Policy description updated regarding FDA approval of ICDs. Policy statements unchanged.

12/31/2014: Code Reference section updated to revise the description of the following CPT codes: 33216, 33217, 33240, 33241, 33243, 33244, and 33249. Effective 01/01/2015. Added the following new 2015 CPT codes to the Code Reference section: 33270, 33271, 33272, 33273, 93260, 93261, and 93644.

08/28/2015: Code Reference section updated for ICD-10. Removed deleted CPT code 33242.

06/08/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions. Removed deleted CPT codes 0319T - 0328T from the Investigational Codes table.

08/15/2016: Policy description updated regarding subcutaneous ICDs. Primary prevention for adults policy statement updated to state that AICD may be medically necessary for the diagnosis of cardiac ion channelopathies with conditions. Added investigational statement for the use of the ICD for secondary prevention for patients who do not meet criteria. Policy statement for pediatrics updated to add hypertrophic cardiomyopathy and the diagnosis of cardiac ion channelopathies with conditions as medically necessary indications. Subcutaneous ICD policy statement changed from investigational to medically necessary with certain conditions. Revised policy statement to state that the use of subcutaneous ICD is considered investigational for individuals who do not meet the criteria outlined above. Policy guidelines updated regarding criteria for ICD implantation in patients with cardiac ion channelopathies. Moved the following CPT codes from investigational to covered: 33270, 33271, 33272, 33273, 93260, 93261, and 93644. Added ICD-10 procedure codes 0JH60PZ, 0JH63PZ, and 0JWT0PZ. Removed Investigational Codes table.

   

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 implantable defibrillator

33217

Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator

33240

Insertion of implantable defibrillator pulse generator only; with existing single lead

33241

Removal of implantable defibrillator pulse generator only

33243

Removal of single or dual chamber implantable defibrillator electrode(s); by thoracotomy

33244

Removal of single or dual chamber implantable defibrillator electrode(s); by transvenous extraction

33249

Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber

33270Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed
33271Insertion of subcutaneous implantable defibrillator electrode
33272Removal of subcutaneous implantable defibrillator electrode
33273Repositioning of previously implanted subcutaneous implantable defibrillator
electrode
93260Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system
93261Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system
93644Electrophysiologic evaluation of subcutaneous implantable defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters)

HCPCS

  

ICD-9 Procedure

ICD-10 Procedure

 

 

0JH60PZ

Insertion of Cardiac Rhythm Related Device into Chest Subcutaneous Tissue and Fascia, Open Approach

  0JH63PZInsertion of Cardiac Rhythm Related Device into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach
  0JWT0PZRevision of Cardiac Rhythm Related Device in Trunk Subcutaneous Tissue and Fascia, Open Approach

37.94

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

02H60KZ, 02H63KZ, 02H64KZ, 02H70KZ, 02H73KZ, 02H74KZ, 02HK0KZ, 02HK3KZ, 02HK4KZ, 02HL0KZ, 02HL3KZ, 02HL4KZ

Insertion of Defibrillator Lead into Heart and Great Vessels (Right/Left Atrium, Right/Left Ventricle), By Approach

0JH608Z, 0JH638Z, 0JH808Z, 0JH838Z

Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, By Approach

37.95

Implantation, AICD leads only

02H40KZ, 02H44KZ, 02H60KZ, 02H63KZ, 02H64KZ, 02H70KZ, 02H73KZ, 02H74KZ, 02HK0KZ, 02HK3KZ, 02HK4KZ, 02HL0KZ, 02HL3KZ, 02HL4KZ, 02HN0KZ, 02HN3KZ, 02HN4KZ

Insertion of Defibrillator Lead into Heart and Great Vessels, By Approach

37.96

Implantation, AICD pulse generator only

0JH608Z, 0JH638Z, 0JH808Z, 0JH838Z

Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, By Approach

37.97

Replacement, AICD leads only

02PA0MZ, 02PA3MZ, 02PA4MZ, 02PAXMZ

Removal of Cardiac Lead from Heart, By Approach

37.98

Replacement, AICD pulse generator only

0JPT0PZ, 0JPT3PZ

Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and Fascia, By Approach

37.99

Other, removal of cardioverter/defibrillator pulse generator with replacement

ICD-9 Diagnosis

ICD-10 Diagnosis

414.8

Other specified forms of chronic ischemic heart disease

I25.5

Ischemic cardiomyopathy

425.4

Other primary cardiomyopathies

I42.0

Dilated cardiomyopathy

425.11

Hypertrophic obstructive cardiomyopathy

I42.1

Obstructive hypertrophic cardiomyopathy

426.81

Lown-Ganong-Levine syndrome

I45.6

Pre-excitation syndrome (Lown-Ganong-Levine syndrome)

426.82

Long QT syndrome

I45.81

Long QT syndrome

426.89

Other specified conduction disorder (nonparoxysmal AV nodal tachycardia)

I45.89

Other specified conduction disorder (nonparoxysmal AV nodal tachycardia)

427.0

Paroxysmal supraventricular tachycardia

I47.1

Supraventricular tachycardia

427.1

Paroxysmal ventricular tachycardia

I47.2

Ventricular tachycardia

427.41

Ventricular fibrillation

I49.01

Ventricular fibrillation

427.42

Ventricular flutter

I49.02

Ventricular flutter

427.81

Sinoatrial node dysfunction

I49.5

Sick sinus syndrome

427.89

Other specified cardiac dysrhythmias

I49.8

Other specified cardiac arrhythmias

 

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