Local Coverage Determination (LCD)

Automatic External Defibrillators

L33690

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Contractor Information

LCD Information

Document Information

LCD ID
L33690
LCD Title
Automatic External Defibrillators
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 01/01/2020
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

NONE

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • Refer to the Supplier Manual for additional information on documentation requirements.

  • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Automatic external defibrillators are covered for beneficiaries at high risk for sudden cardiac death (SCD) due to one of the conditions described under I or II. It is expected the treating practitioner be experienced in the management of beneficiaries at risk for SCD.

  1. A wearable defibrillator (K0606) is covered for beneficiaries if they meet one of the criteria (1-4), described below:
    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 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

    Refer to the ICD-10 Codes section in the LCD-related Policy Article for applicable diagnoses.

  2. A nonwearable automatic defibrillator (E0617) is covered for beneficiaries in two circumstances. They meet either (1) both criteria A and B or (2) criteria C, described below:
    1. The beneficiary 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;
        1. The myocardial infarction must have occurred more than 4 weeks prior to the external defibrillator prescription; and,
        2. 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. Beneficiaries must not have:
        1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or,
        2. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; or,
        3. Had an enzyme-positive MI within past month; or,
        4. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or,
        5. Irreversible brain damage from preexisting cerebral disease; or,
        6. Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year.
      6. Beneficiaries 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. Beneficiaries with nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%
      8. Beneficiaries 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

Refer to the ICD-10 Codes section in the LCD-related Policy Article for applicable diagnoses.

Claims for defibrillators for other indications will be denied as not reasonable and necessary.


GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Coding Information

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

GA – Waiver of liability statement issued as required by payer policy, individual case

GZ – Item or service expected to be denied as not reasonable and necessary

KF – Item designated by FDA as class III device

KX – Requirements specified in the medical policy have been met

HCPCS CODES:

Group 1 Codes
CodeDescription
A9999 MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED
E0617 EXTERNAL DEFIBRILLATOR WITH INTEGRATED ELECTROCARDIOGRAM ANALYSIS
K0606 AUTOMATIC EXTERNAL DEFIBRILLATOR, WITH INTEGRATED ELECTROCARDIOGRAM ANALYSIS, GARMENT TYPE
K0607 REPLACEMENT BATTERY FOR AUTOMATED EXTERNAL DEFIBRILLATOR, GARMENT TYPE ONLY, EACH
K0608 REPLACEMENT GARMENT FOR USE WITH AUTOMATED EXTERNAL DEFIBRILLATOR, EACH
K0609 REPLACEMENT ELECTRODES FOR USE WITH AUTOMATED EXTERNAL DEFIBRILLATOR, GARMENT TYPE ONLY, EACH

General Information

Associated Information

DOCUMENTATION REQUIREMENTS

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 beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner'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.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO

  • Medical Record Information (including continued need/use if applicable)

  • Correct Coding

  • Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

Miscellaneous

Appendices

Myocardial infarctions are defined by elevated cardiac enzymes or Q-waves on an electrocardiogram. Refer to the ICD-10 Codes section in the LCD-related Policy Article for applicable diagnoses.

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

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

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information
N/A
Bibliography

N/A

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
01/01/2020 R7

Revision Effective Date: 01/01/2020
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”

As required by CR 10901, the ICD-10 information has been moved to all Policy Articles. There is no change in coverage.

  • Other
01/01/2020 R6

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: “ordering physician” to “treating practitioner”
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 code section in the LCD-related Policy Article
Revised: Order information as a result of Final Rule 1713
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO
APPENDICES:
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 code section in the LCD-related Policy Article

02/06/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.

  • Provider Education/Guidance
01/01/2019 R5

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statement to refer to diagnosis code section below
Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statement about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction
APPENDICES:
Revised: Reference to the applicable diagnosis code section

  • Other (ICD-10 code relocation per CMS instruction)
01/01/2017 R4 Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Supplier Manual reference from Miscellaneous
Removed: PIM reference from Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
07/01/2016 R3 Revision Effective Date 07/01/2016
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation language - ACA order requirements – Effective 04/28/16
DOCUMENTATION REQUIREMENTS:
Revised: Standard documentation language for orders, ACA requirements, and Proof of delivery instructions; added New order requirements, and Correct coding instructions – Effective 04/28/16
  • Provider Education/Guidance
07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
10/01/2015 R1 Revision Effective Date: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for Equipment Retained from a Prior Payer
Revised: Repair to beneficiary-owned DMEPOS
  • Provider Education/Guidance

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
02/13/2020 01/01/2020 - N/A Currently in Effect You are here
01/31/2020 01/01/2020 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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