Implantable Cardioverter Defibrillator
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 Type July 1993 July 1993 January 1998 December 1998 September 2012
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.
For Coding Guidelines see the Anesthesia Coding Policy.
The use of the automatic implantable cardioverter defibrillator (ICD) may be considered medically necessary in adults who meet the following criteria:
The use of the ICD is considered investigational in primary prevention patients who:
The use of the ICD for secondary prevention is considered investigational for patients who do not meet the criteria for secondary prevention.
The use of the ICD may be considered medically necessary in children who meet any of the following criteria:
The use of the ICD is considered investigational for all other indications in pediatric patients.
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:
The use of a subcutaneous ICD is considered investigational for individuals who do not meet the criteria outlined above.
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.
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
Indications for consideration for ICD implantation for each cardiac ion channelopathy are as follows:
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.
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.
Blue Cross Blue Shield Association Policy # 7.01.44
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.