Medicare Advantage

Medical Policy

Notification

Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)

Notification Issue Date:

This version of the policy will become effective 07/20/2020.

In accordance with the Final Rule 1713 (84 Fed. Reg Vol 217), a face-to-face encounter is required for specified HCPCS codes:

E0617 External defibrillator with integrated electrocardiogram analysis

K0606 Automatic external defibrillator with integrated electrocardiogram analysis, garment type

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

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

Revisions From MA05.005g:

10/01/2023

Inclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

This policy has been identified for the ICD-10 code update, effective 10/01/2023.

The following ICD-10 code has been added to Attachments A and B of this policy:

I21.B Myocardial infarction with coronary microvascular dysfunction

Revisions From MA05.005f:

06/14/2023	The policy has been reviewed and reissued to communicate the Company’s continuing position on Automatic External Cardioverter Defibrillators (Wearable and Nonwearable).
11/21/2022	This version of the policy will become effective 11/21/2022. The intent of this policy remains unchanged, however, the Face-to-Face Requirements have been deleted for the following HCPCS codes: E0617 External defibrillator with integrated electrocardiogram analysis K0606 Automatic external defibrillator with integrated electrocardiogram analysis, garment type K0609 Replacement electrodes for use with automated external defibrillator, garment type only, each

06/14/2023

The policy has been reviewed and reissued to communicate the Company’s continuing position on Automatic External Cardioverter Defibrillators (Wearable and Nonwearable).

11/21/2022

This version of the policy will become effective 11/21/2022.

The intent of this policy remains unchanged, however, the Face-to-Face Requirements have been deleted for the following HCPCS codes:

E0617 External defibrillator with integrated electrocardiogram analysis
K0606 Automatic external defibrillator with integrated electrocardiogram analysis, garment type
K0609 Replacement electrodes for use with automated external defibrillator, garment type only, each

Revisions From MA05.005e:

10/01/2022

Inclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

This policy has been identified for the ICD-10 code update, effective 10/01/2022.

The following ICD-10 code has been termed and removed from Attachments A and B of this policy:

I47.2 Ventricular tachycardia

The following ICD-10 codes have been added to Attachments A and B of this policy:

I47.20 Ventricular tachycardia, unspecified

I47.21 Torsades de pointes

I47.29 Other ventricular tachycardia

Revisions From MA05.005d:

08/25/2021

The policy has been reviewed and reissued to communicate the Company’s continuing position on Automatic External Cardioverter Defibrillators (Wearable and Nonwearable).

07/20/2020

This version of the policy will become effective 07/20/2020.

In accordance with the Final Rule 1713 (84 Fed. Reg Vol 217), a face-to-face encounter is required for specified HCPCS codes:

E0617 External defibrillator with integrated electrocardiogram analysis

K0606 Automatic external defibrillator with integrated electrocardiogram analysis, garment type

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

Revisions From MA05.005c:

07/17/2019	The policy has been reviewed and reissued to communicate the Company’s continuing position on Automatic External Cardioverter Defibrillators (Wearable and Nonwearable).
04/25/2018	The policy has been reviewed and reissued to communicate the Company’s continuing position on Automatic External Cardioverter Defibrillators (Wearable and Nonwearable).
12/27/2017	This version of the policy will become effective 12/27/2017. The following ICD-10 codes were added for the wearable AED (K0606): I21.4, I22.0, I22.1, I22.2, I22.8, I22.9, I25.2, I42.0, I42.1, I42.2, I42.3, I42.4, I42.5, I42.6, I42.7, I42.8, I42.9, I43 The following ICD-10 codes were removed for the non-wearable AED (E0617): I42.0 Dilated cardiomyopathy I42.3 Endomyocardial (eosinophilic) disease I42.4 Endocardial fibroelastosis I42.5 Other restrictive cardiomyopathy I42.6 Alcoholic cardiomyopathy I42.7 Cardiomyopathy due to drug and external agent I42.8 Other cardiomyopathies I42.9 Cardiomyopathy, unspecified I43 Cardiomyopathy in diseases classified elsewhere The following ICD-10 codes were removed for both E0617 and K0606: T82.827A Fibrosis due to cardiac prosthetic devices, implants and grafts, initial encounter T82.827D Fibrosis due to cardiac prosthetic devices, implants and grafts, subsequent encounter T82.827S Fibrosis due to cardiac prosthetic devices, implants and grafts, sequela T82.837A Hemorrhage due to cardiac prosthetic devices, implants and grafts, initial encounter T82.837D Hemorrhage due to cardiac prosthetic devices, implants and grafts, subsequent encounter T82.837S Hemorrhage due to cardiac prosthetic devices, implants and grafts, sequela T82.847A Pain due to cardiac prosthetic devices, implants and grafts, initial encounter T82.847D Pain due to cardiac prosthetic devices, implants and grafts, subsequent encounter T82.847S Pain due to cardiac prosthetic devices, implants and grafts, sequela T82.867A Thrombosis due to cardiac prosthetic devices, implants and grafts, initial encounter T82.867D Thrombosis due to cardiac prosthetic devices, implants and grafts, subsequent encounter T82.867S Thrombosis due to cardiac prosthetic devices, implants and grafts, sequela T82.897A Other specified complication of cardiac prosthetic devices, implants and grafts, initial encounter T82.897D Other specified complication of cardiac prosthetic devices, implants and grafts, subsequent encounter T82.897S Other specified complication of cardiac prosthetic devices, implants and grafts, sequela

Revisions From MA05.005b:

10/01017

This policy has been identified for the ICD-10 CM code update, effective 10/01/2017.

The following ICD-10 CM codes have been added to this policy:

I21.9 Acute myocardial infarction, unspecified
I21.A1 Myocardial infarction type 2
I21.A9 Other myocardial infarction type

Revisions From MA05.005a:

09/30/2016

In accordance with the 10/01/2016 ICD 10 code update, the following changes occurred in this policy:

The following codes have narrative revisions: T82.827A, T82.827D, T82.827S, T82.837A, T82.837D, T82.837S, T82.847A, T82.847D, T82.847S, T82.867A, T82.867D, T82.867S.

Revisions From MA05.005:

03/16/2016	This policy has been reviewed and reissued to reflect the Company's continuing position on automatic external and wearable cardioverter defibrillators. ICD 10 codes have been added to Attachment A.
08/19/2015	This policy has been reviewed and reissued to reflect the Company's continuing position on automatic external and wearable cardioverter defibrillators. ICD 10 codes were added to the policy.
01/21/2015	The policy has been issued to communicate the Company's continuing position on automatic external and wearable cardioverter defibrillators.

Version Effective Date:

10/1/2023

Version Issued Date:

9/29/2023

Version Reissued Date: