The implantation of an automatic defibrillator is a covered service when medically necessary. Implantable automatic cardioverter-defibrillators (ICDs) are covered only if they have received FDA approval. Each device should be used in accordance with FDA-approved indications.

The implantation of an automatic defibrillator is a covered service for patients with any of the following:

1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause.
2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause.
3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy.
4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) < 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.)
5. Documented prior MI and a measured LVEF < 0.30, and additionally, patients must not have the following:
   
   • New York Heart Association (NYHC) classification IV heart failure;
   • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
   • Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months;
   • Patients must not have an acute MI in the past 40 days;
   • Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
   • Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.
     
6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF < 35%;
7. Patients with non-ischemic dilated cardiomyopathy (NIDCM) >3 months, NYHA Class II and III heart failure, and measured LVEF < 35%;
8. Patients with NYHA Class IV heart failure. Patients must also meet all coverage requirements for a cardiac resynchronization therapy (CRT) device. (See Medical Policy Bulletin S-153 Biventricular Pacemakers for the Treatment of Congestive Heart Failure.)

For all covered indications above, patients must not have the following:

1. Irreversible brain damage from preexisting cerebral disease;
2. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
3. Had a CABG or PTCA within the past 3 months;
4. Had an acute MI within the past 40 days;
5. Clinical symptoms or findings that would make them a candidate for coronary revascularization;
6. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

ICD therapy is not indicated for patients with NYHA Class IV symptoms, who are not candidates for a cardiac resynchronization therapy device. (See Medical Policy Bulletin S-153 Biventricular Pacemakers for the Treatment of Congestive Heart Failure.)

ICD therapy is not indicated for patients with newly diagnosed heart failure.

ICD therapy is not indicated for patients recovering from an acute MI or CABG surgery.

Services performed for indications other than those listed above are considered not medically necessary and, therefore, are not covered. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

The wearable cardioverter-defibrillator is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable cardiac defibrillator.

Analysis of Cardioverter-Defibrillator
Analysis of cardioverter-defibrillator systems is required for long-term routine follow-up care. Cardioverter-defibrillator monitoring (including analysis, evaluation, and interrogation) is an eligible service.

Device evaluation includes review of programmed parameters, lead(s), battery, capture and sensing function, presence or absence of therapy for ventricular tachyarrhythmias and underlying heart rhythm. Often, various components, e.g., AV intervals, pacing voltage, and diagnostics are adjusted.

Codes 93282-93284 represent a programming device evaluation with physician review and analysis. This is an "in person" service.

Code 93287 represents a periprocedural analysis with physician review and analysis.

This is an "in person" service which involves adjustment of the cardioverter-defibrillator prior to surgery, procedure, or test and is normally performed before and after the procedure. It can be done by the same provider, in which case the code is reported twice, or by different providers where each reports the procedure code once.

Codes 93289 and 93292 represent an "in person" interrogation device evaluation which involves the retrieval of stored and measured information to determine the current programming and settings.

Codes 93295 and 93296 represent a "remote" interrogation device evaluation. These codes can be reported only once in 90 days. Charges billed more frequently within the 90-day period are not eligible for separate payment. Additional monitoring during the 90-day period is considered part of the global allowance. A participating, preferred, or network provider cannot bill the member for the denied service(s).

Implantable Cardiovascular Monitor (ICM)
An implantable cardiovascular monitor (ICM) is used to assist the doctor in the management of non-rhythm related cardiac conditions such as heart failure. An ICM can be used in addition to an implantable cardioverter-defibrillator (ICD). ICM data and the ICD heart rhythm data such as sensing, pacing, and tachycardiac detection therapy are separate and distinct services.

ICM services should be reported under procedure codes 93290, 93297, or 93299, as appropriate. Codes 93297 and 93299 should be reported and reimbursed only once in a 30-day period. Additional monitoring during the 30-day period is considered part of the global allowance. A participating, preferred, or network provider cannot bill the patient separately for additional monitoring during the 30-day period.

Electrophysiologic assessment is a more complex evaluation of newly or chronically implanted cardioverter-defibrillators. This is a covered service when medically necessary and should be processed under codes 93640, 93641, or 93642.

Place of Service: Inpatient/Outpatient

An elective, percutaneous implantation of an automatic cardioverter-defibrillator is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to, unstable angina, current therapeutic anticoagulant therapy, and symptomatic congestive heart failure.

Description

The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

InterQual® Level of Care Criteria 2010. Acute Care Adult. McKesson Health Solutions, LLC.

CMS Pub. 100-3, Medicare National Coverage Determinations Manual, Implantable Automatic Defibrillators, Section 20.4

Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;51:1-62.

 Al-Khatib SM, Hellkamp A, Curtis J, et al. Non–Evidence-Based ICD Implantations in the United States. JAMA. 2011;305(1):43-49.