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The automatic implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient's heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias in order to reduce the risk of sudden death.
Indications for ICD implantation can be broadly subdivided into 1) secondary prevention; i.e., their use in patients who have experienced a potentially life-threatening episode of VT (near sudden cardiac death); and 2) primary prevention; i.e., their 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 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 approved by 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 VT associated with cardiac arrest or VT 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 ICD 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 second Multicenter Automatic Defibrillator Implantation Trial (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.
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.
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 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 is considered investigational for all indications in adult and pediatric patients.
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.
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.
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.