Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)
Policy #:MA05.005c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.


Refer to the following News Article: Waiver of certain requirements during COVID-19 outbreak related to Durable Medical Equipment (DME), prosthetics, orthotics, and supplies for Medicare Advantage members (updated June 30, 2020)

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

WEARABLE

A wearable automatic external defibrillator (AED) HCPCS Code (K0606) 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 (E0617) 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 four weeks prior to receiving an external defibrillator prescription.
      • The EP study must have been performed more that four 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 three 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 one 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 three 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:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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 DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (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 seven 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 five 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 durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy 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

Noridian Healthcare Solutions, LLC. Policy Article(A52458). Automatic external defibrillators. Original 10/01/2015. (Revised 1/1/2019). Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52458&ver=13&Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&DocType=Active&s=All&bc=AhAAAAIAAAAA&. Accessed May 9, 2019.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (L33690) Automatic external defibrillators. Original 10/01/2015. (Revised 01/01/2019) Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Automatic+External+Defibrillators/10f0b92d-0c55-4b5d-aa15-b952b37c70ce. Accessed May 9, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

SEE ATTACHMENT A FOR ICD-10 CODES THAT ARE USED TO REPRESENT INDICATIONS FOR THE NONWEARABLE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED

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

Coding and Billing Requirements


Cross References

Attachment A: Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)
Description: ICD-10 codes used to represent the Wearable Automatic External Defibrillator (AED):

Attachment B: Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)
Description: ICD-10 codes used to represent the Nonwearable Automatic External Defibrillator (AED):







Policy History

MA05.005c
07/17/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Automatic External Cardioverter Defibrillators (Wearable and Nonwearable).
04/25/2018The 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

MA05.005b
10/01017This 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

MA05.005a
09/30/2016In 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.

MA05.005
03/16/2016This 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.
08/19/2015This 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.
01/21/2015The policy has been issued to communicate the Company's continuing position on automatic external and wearable cardioverter defibrillators.






Version Effective Date: 12/27/2017
Version Issued Date: 12/27/2017
Version Reissued Date: 07/17/2019