LCD for Automatic External Defibrillators (L13613)


 

Contractor Information

 

Contractor Name 

TriCenturion 

Contractor Number 

77011 

Contractor Type 

DME PSC 

DME MAC/DMERC this DME PSC is affiliated with 

AdminaStar Federal, Inc (Region B), National Heritage Insurance Company (Region A)  

 

LCD Information

 

LCD ID Number 

L13613 

LCD Title 

Automatic External Defibrillators 

Contractor's Determination Number 

AED20070701 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.  

CMS National Coverage Policy 

 

 

Primary Geographic Jurisdiction 

Connecticut
District of Columbia
Delaware
Illinois
Indiana
Kentucky
Massachusetts
Maryland
Maine
Michigan
Minnesota
New Hampshire
New Jersey
New York - Entire State
Ohio
Pennsylvania
Rhode Island
Virginia
Vermont
Wisconsin
West Virginia 

Oversight Region 

Central Office 

DME Region LCD Covers 

Jurisdiction A/B 

Original Determination Effective Date 

For services performed on or after 01/01/2004  

Original Determination Ending Date 

 

Revision Effective Date 

For services performed on or after 07/01/2007  

Revision Ending Date 

 

Indications and Limitations of Coverage 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. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

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

  1. A wearable defibrillator (K0606) is covered for patients 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 (ICD-9 427.1, 427.42, 427.5); or
    2. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrhythmia such as long QT syndrome (ICD-9 426.82) or hypertrophic cardiomyopathy (ICD-9 425.1); or
    3. Either documented prior myocardial infarction (ICD-9 410.00-410.92, 412) or dilated cardiomyopathy (ICD-9 425.0-425.9) and a measured left ventricular ejection fraction less than or equal to 0.35; or
    4. A previously implanted defibrillator now requires explantation (ICD-9 996.04, 996.61)

 

  1. 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

 

A.     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 (ICD-9 427.41, 427.42, 427.5).
      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 (ICD-9 427.1).
      3. Familial or inherited conditions with a high risk of life-threatening ventricular tachyarrythmias such as long QT syndrome (ICD-9 426.82) or hypertrophic cardiomyopathy (ICD-9 425.1).
      4. Coronary artery disease with a documented prior myocardial infarction, (ICD-9 410.00 – 410.92, 412) 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.

 

      1. Documented prior myocardial infarction (ICD-9 410.00-410.92, 412) and a measured left ventricular ejection fraction less than or equal to 0.30. Patients 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.

 

      1. 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%.
      2. Patients with nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%.
      3. Patients who meet one of the previous criteria (1-7) and have NYHA Class IV heart failure.

 

B.      Implantation surgery is contraindicated.

C.     A previously implanted defibrillator now requires explantation (ICD-9 996.04, 996.61).



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

Coverage Topic 

Durable Medical Equipment
 

 

Coding Information

CPT/HCPCS Codes 

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

HCPCS MODIFIERS:

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

KX – Specific required documentation on file

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

 

ICD-9 Codes that Support Medical Necessity 

The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on “Indications and Limitation of Coverage and/or Medical Necessity” for other coverage criteria and payment information.

For HCPCS Code E0617

410.00 - 410.92

ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL EPISODE OF CARE UNSPECIFIED - ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE SUBSEQUENT EPISODE OF CARE

412

OLD MYOCARDIAL INFARCTION

425.1

HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY

426.82

LONG QT SYNDROME

427.1

PAROXYSMAL VENTRICULAR TACHYCARDIA

427.41

VENTRICULAR FIBRILLATION

427.42

VENTRICULAR FLUTTER

427.5

CARDIAC ARREST

996.04

MECHANICAL COMPLICATION OF AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR

996.61

INFECTION AND INFLAMMATORY REACTION DUE TO CARDIAC DEVICE IMPLANT AND GRAFT

For HCPCS Codes K0606-K0609


410.00 - 410.92

ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL EPISODE OF CARE UNSPECIFIED - ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE SUBSEQUENT EPISODE OF CARE

412

OLD MYOCARDIAL INFARCTION

425.0 - 425.9

ENDOMYOCARDIAL FIBROSIS - SECONDARY CARDIOMYOPATHY UNSPECIFIED

426.82

LONG QT SYNDROME

427.1

PAROXYSMAL VENTRICULAR TACHYCARDIA

427.41

VENTRICULAR FIBRILLATION

427.42

VENTRICULAR FLUTTER

427.5

CARDIAC ARREST

996.04

MECHANICAL COMPLICATION OF AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR

996.61

INFECTION AND INFLAMMATORY REACTION DUE TO CARDIAC DEVICE IMPLANT AND GRAFT

 

Diagnoses that Support Medical Necessity 

Refer to the previous section. 

ICD-9 Codes that DO NOT Support Medical Necessity 

All ICD-9 codes that are not specified in the previous section.

 

 

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation 

 

Diagnoses that DO NOT Support Medical Necessity 

All diagnoses that are not specified in the previous section. 

 

General 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 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.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

The ICD-9 code that justifies the need for these items must be included on the claim.

Suppliers must add a KX modifier to a code only if all of the criteria in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy have been met.

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

Appendices 

Myocardial infarctions (ICD-9 410.00-410.92, 412) 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 conditions such as drug toxicity, severe hypoxia, acidosis, hypokalemia, hypercalcemia, hyperkalemia, systemic infections, and myocarditis (not all-inclusive).
 

Utilization Guidelines 

Refer to Indications and Limitations of Coverage and/or Medical Necessity. 

Sources of Information and Basis for Decision 

 

Advisory Committee Meeting Notes 

 

Start Date of Comment Period 

09/06/2002 

End Date of Comment Period 

10/25/2002 

Start Date of Notice Period 

09/01/2003 

Revision History Number 

AED005 

Revision History Explanation 

Revision Effective Date: 07/01/2007
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added ICD-9 412 to HCPCS code E0617 and K0606-K0609
Removed DMERC references
ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:
Added ICD-9 412 to HCPCS code E0617 and K0606-K0609
DOCUMENTATION REQUIREMENTS:
Removed DMERC references
APPENDICES:
Added ICD-9 412 to definition of myocardial infarction.

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TriCenturion (77011) from DMERC Tricenturion (77011).

Revision Effective Date: 10/01/2005
INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY:
Added ICD-9 996.04 and 996.61
Replaced ICD-9 426.89 with 426.82
ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:
Added ICD-9 996.04 and 996.61
Replaced ICD-9 426.89 with 426.82
DOCUMENTATION REQUIREMENTS:
Removed KX language about additional documentation

Revision Effective Date: 07/01/2005
INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY:
Revised criteria to include expanded ICD NCD.
ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised codes to reflect new coverage criteria
SOURCES OF INFORMATION AND BASIS FOR DECISION:
Removed. Not relevant to this revision.
ADVISORY COMMITTEE MEETING NOTES:
Removed. Not relevant to this revision.

Revision Effective Date: 01/01/2005
LMRP converted to LCD and Policy Article
INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY:
Revised coverage criteria for K0606
HCPCS CODES:
Added A9999 

Last Reviewed On Date 

 

Related Documents 

Article(s)
A23905 - Automatic External Defibrillators - Policy Article - Effective January 2005

LCD Attachments 

There are no attachments for this LCD

 

 

 

Article for Automatic External Defibrillators - Policy Article - Effective January 2005 (A23905)

 

Contractor Information

Contractor Name, Number, and Type 

DME PSC: TriCenturion (77011)
DME MAC: AdminaStar Federal, Inc (17003) , National Heritage Insurance Company (16003)  

 

Article Information

Article ID Number 

A23905 

Article Type 

Article

Key Article 

Yes

Article Title 

Automatic External Defibrillators - Policy Article - Effective January 2005 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction 

Connecticut
District of Columbia
Delaware
Illinois
Indiana
Kentucky
Massachusetts
Maryland
Maine
Michigan
Minnesota
New Hampshire
New Jersey
New York - Entire State
Ohio
Pennsylvania
Rhode Island
Virginia
Vermont
Wisconsin
West Virginia
 

DME Region Article Covers 

Jurisdiction A/B 

Original Article Effective Date 

01/01/2005

Article Revision Effective Date 

03/01/2006

Article Text 

CODING GUIDELINES

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.

Non-wearable, automatic external defibrillators with integrated electrocardiogram capability are coded using HCPCS code E0617.

Wearable, automatic, external defibrillators with integrated electrocardiogram analysis are coded using HCPCS code K0606.

Other types of defibrillators are coded as A9270.No separate payment is made for carrying cases or mounting hardware.

Replacement supplies and accessories for use with K0606 are coded using K0607 – K0609 as appropriate.

Replacement supplies and accessories for use with K0617 are coded using A9999.

Suppliers should contact the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) for guidance on the correct coding of these items.

Coverage Topic 

Durable Medical Equipment
 

 

 

Other Information

Revision History Explanation 

Effective Date: 01/01/2005
LMRP converted to LCD and Policy Article

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this article was transitioned to DME PSC TriCenturion (77011) from DMERC Tricenturion (77011).

Related Documents 

 

LCD(s)
L13613 - Automatic External Defibrillators