Automatic external defibrillators (AED) are covered for patients at high risk for sudden cardiac death (SCD) due to one of the conditions described below. It is expected the ordering physician be experienced in the management of patients at risk for SCD.

Wearable Defibrillator

A wearable defibrillator (K0606) is covered for patients if they meet one of the following criteria:

1. A documented episode of ventricular fibrillation or a sustained (lasting 30 seconds or longer) ventricular tachyarrhythmia. These dysrhythmias may be either spontaneous or induced during an electrophysiologic (EP) study, but may not be due to a transient or reversible cause and not occur during the first 48 hours of an acute myocardial infarction; or
   
   
2. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrhythmia such as long QT syndrome (426.82) or hypertrophic cardiomyopathy; or
   
   
3. Either documented prior myocardial infarction or dilated cardiomyopathy, and a measured left ventricular ejection fraction less than or equal to 0.35; or
   
   
4. A previously implanted defibrillator now requires explantation.

Nonwearable Automatic Defibrillator

A nonwearable automatic defibrillator (E0617) is covered for patients in two circumstances. They meet either (1) both criteria A and B or (2) criteria C, described below.

1. The patient has one of the following conditions (1-8):
   
   
   1. A documented episode of cardiac arrest due to ventricular fibrillation, not due to a transient or reversible cause.
      
      
   2. A sustained (lasting 30 seconds or longer) ventricular tachyarrhythmia, either spontaneous or induced during an electrophysiologic (EP) study, not associated with acute myocardial infarction, and not due to a transient or reversible cause.
      
      
   3. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrythmias such as long QT syndrome or hypertrophic cardiomyopathy.
      
      
   4. Coronary artery disease with a documented prior myocardial infarction, with a measured left ventricular ejection fraction less than or equal to 0.35, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) during an EP study. To meet this criterion:
      
      
      • The myocardial infarction must have occurred more than 4 weeks prior to the external defibrillator prescription; and,
      • The EP test must have been performed more than 4 weeks after the qualifying myocardial infarction.
        
        
   5. Documented prior myocardial infarction and a measured left ventricular ejection fraction less than or equal to 0.30. Patients must not have:
      
      
      • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or
      • Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; or
      • Had an enzyme-positive MI within past month; or
      • Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
      • Irreversible brain damage from preexisting cerebral disease; or
      • Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year.
        
        
   6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction (LVEF) ≤ 35%.
      
      
   7. Patients with nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%.
      
      
   8. Patients who meet one of the previous criteria (1-7) and have NYHA Class IV heart failure.
      
      
2. Implantation surgery is contraindicated.
   
   
3. A previously implanted defibrillator now requires explantation.

Claims for defibrillators for other indications will be denied as not medically necessary. Effective January 26, 2009, 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.

NOTE:

See Medical Policy Bulletin I-18 for more information on the New York Heart Association classifications of functional capacity.

Myocardial infarctions are defined by elevated cardiac enzymes or Q-waves on an electrocardiogram.

Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography.

Transient or reversible causes include, but are not limited to, conditions such as drug toxicity, severe hypoxia, acidosis, hypokalemia, hypercalcemia, hyperkalemia, systemic infections, and myocarditis (not all-inclusive).

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and be available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier (No physician or other health care provider order for this item or service) added to each affected procedure code. These items will be denied as not medically necessary. Effective January 26, 2009, 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 diagnosis code that justifies the need for these items must be included on the claim.

Suppliers must add a KX modifier (Specific required documentation on file) to a code only if all of the criteria in the “Indications and Limitations of Coverage” section of this policy have been met.

Other types of defibrillators are coded as A9270.

No separate payment is made for carrying cases or mounting hardware.

Code 93745 should be reported when billing for the initial set-up and programming by a physician of a wearable cardioverter-defibrillator (includes initial programming of system, establishing baseline electronic ECG, transmission of data to data repository, patient instruction in wearing system, and patient reporting of problems or events).

Codes K0607–K0609 are used for replacement supplies and accessories for use with K0606.

Code A9999 is used for replacement supplies and accessories for use with E0617.

Coverage for DME is determined according to individual or group customer benefits.

NOTE:

Total payments for a rental item may not exceed its allowable purchase price, except for those items identified as life sustaining DME. For information on continuous rental of life sustaining DME, see Medical Policy Bulletin E-38, Continuous Rental of Life Sustaining Durable Medical Equipment (DME).

Description

Automatic defibrillators are devices that are capable of monitoring cardiac rhythms, detecting dysrhythmias, and delivering a defibrillation shock to the heart when appropriate without any user decision-making.

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.

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.