Medicare Advantage

Medical Policy

Notification

Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)

Notification Issued Date:

Title:

Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)

Policy #:

MA05.005g

Policy

WEARABLE

A wearable automatic external defibrillator (AED) is considered medically necessary and, therefore, covered for individuals who are at high risk for sudden cardiac death (SCD) and have any of the following conditions:

A documented episode of ventricular fibrillation (VF) or a sustained (lasting 30 seconds or longer) ventricular tachyarrhythmia. These dysrhythmias may be either spontaneous or induced during an electrophysiologic (EP) study, but they may not be due to a transient or reversible cause (e.g., hyperkalemia, systemic infections, severe hypoxia) and may not occur during the first 48 hours of an acute myocardial infarction (MI).
Familial or inherited conditions with a high risk for life-threatening ventricular tachyarrhythmia such as long-QT syndrome or hypertrophic cardiomyopathy
Either documented prior MI or dilated cardiomyopathy and a measured left ventricular ejection fraction (LVEF) less than or equal to 0.35
A previously implanted defibrillator that now requires explantation
As an alternative to an implantable cardioverter-defibrillator (ICD) in an individual who has a documented contraindication to an ICD (e.g., systemic infection, lack of vascular access)

NONWEARABLE

A nonwearable AED is considered medically necessary and, therefore, covered for individuals who are at high risk for SCD and have either of the following conditions:

A previously implanted defibrillator that now requires explantation
When implantation surgery is contraindicated AND the individual has one of the following:
- A documented episode of cardiac arrest due to ventricular fibrillation (VF) and not due to a transient or reversible cause
- A sustained (lasting 30 seconds or longer) ventricular tachyarrhythmia, either spontaneous or induced during an EP study, that is not associated with acute MI and not due to a transient or reversible cause
- Familial or inherited conditions with a high risk for life-threatening ventricular tachyarrhythmia such as long-QT syndrome or hypertrophic cardiomyopathy
- Coronary artery disease with a documented prior MI, a measured LVEF less than or equal to 0.35, and inducible, sustained ventricular tachycardia (VT) or VF during an EP study. To meet this criteria, both of the following must apply:
  - The MI must have occurred more than 4 weeks prior to receiving an external defibrillator prescription.
  - The EP study must have been performed more than 4 weeks after the qualifying MI.
- A documented prior MI, a measured LVEF less than or equal to 0.30, AND the individual must not have or have had any of the following:
  - Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm
  - Coronary artery bypass graft (CABG) surgery or percutaneous transluminal coronary angioplasty within the past 3 months
  - An enzyme-positive MI within the past month
  - Clinical symptoms or findings that would make the individual a candidate for coronary revascularization
  - Irreversible brain damage from pre-existing cerebral disease
  - A disease other than cardiac disease (e.g., cancer, uremia, liver failure) that is associated with a likelihood of survival of less than 1 year
- Ischemic dilated cardiomyopathy (IDCM), a documented prior MI, New York Heart Association (NYHA) Class II or III heart failure, and a measured LVEF less than or equal to 0.35
- Nonischemic dilated cardiomyopathy (NICDM) for longer than 3 months, NYHA Class II or III heart failure, and a measured LVEF less than or equal to 0.35
- NYHA Class IV heart failure and one of the medically necessary criteria above

All other uses for AEDs (wearable or nonwearable) are considered not medically necessary and, therefore, not covered.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.

Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, automatic external defibrillators (AEDs) are covered as durable medical equipment (DME) under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

An automatic external defibrillator (AED) is a wearable or nonwearable device that monitors cardiac rhythms. AEDs are used to treat potentially lethal dysrhythmias by delivering an electric shock to the heart through monitoring electrodes that are attached to an affected individual's chest. The AED collects information about the heart's rhythm that is immediately analyzed. If the analyzed rhythm is interpreted to be ventricular fibrillation (VF) or ventricular tachycardia (VT), the AED can automatically or manually deliver a defibrillating shock to restore normal heart rhythm.

References

Centers for Medicare & Medicaid Services (CMS). Medicare Program; End-stage renal disease prospective payment system, payment for renal dialysis services furnished to individuals with acute kidney injury, end-stage renal disease quality incentive program, durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) fee schedule amounts, DMEPOS competitive bidding program (CBP) amendments, standard elements for a DMEPOS order, and master list of DMEPOS items potentially subject to a face-to-face encounter and written order prior to delivery and/or prior authorization requirements for calendar year (CY) 2020; Final Rule. [Federal Register Web site]. 01/01/2020. Federal Register 2019;84(217). Rules and Regulations Available at: https://www.federalregister.gov/documents/2019/11/08/2019-24063/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis. Accessed May 16, 2023.

Noridian Healthcare Solutions. Local Coverage Article. A55426. Standard Documentation Requirements for All Claims Submitted to DME MACs . [Noridian Healthcare Solutions Web site]. Original 01/01/2017. Revised 04/06/2020. Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleid=55426. Accessed May 16, 2023.

Noridian Healthcare Solutions, LLC. Policy Article (A52458). Automatic external defibrillators. Original 10/01/2015. (Revised 10/01/2022). Available at: Article - Automatic External Defibrillators - Policy Article (A52458) (cms.gov). Accessed May 16, 2023.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (L33690) Automatic external defibrillators. Original 10/01/2015. (Revised 01/01/2020) Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33690. Accessed May 16, 2023.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

SEE ATTACHMENT A FOR ICD-10 CODES THAT ARE USED TO REPRESENT INDICATIONS FOR THE WEARABLE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED), REPLACEMENT SUPPLIES, AND ACCESSORIES.

SEE ATTACHMENT B FOR ICD-10 CODES THAT ARE USED TO REPRESENT INDICATION FOR THE WEARABLE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED).

HCPCS Level II Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT THE NONWEARABLE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED):

E0617 External defibrillator with integrated electrocardiogram analysis

THE FOLLOWING CODE IS USED TO REPRESENT THE WEARABLE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED):

K0606 Automatic external defibrillator, with integrated electrocardiogram analysis, garment type

THE FOLLOWING CODES ARE USED TO REPRESENT REPLACEMENT SUPPLIES AND ACCESSORIES FOR THE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED):

K0607 Replacement battery for automated external defibrillator, garment type only, each

K0608 Replacement garment for automatic external defibrillator, each

K0609 Replacement electrodes for use with automated external defibrillator, garment type only, each

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

1/1/2024

Version Issued Date: