L13877-LCD

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Local Coverage Determination (LCD) for Automatic External Defibrillators (L13877)

Contractor Information

Contractor Name CGS Administrators, LLC

Contractor Number 18003

Contractor Type DME MAC

Jurisdiction J - G

LCD Information

Document Information

LCD ID Number L13877

LCD Title Automatic External Defibrillators

Contractor's Determination Number AED

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Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

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 08/05/2011

Revision Ending Date

CMS National Coverage Policy

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 local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, 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 reasonable and 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.

I. 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).

5. 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;

a. The myocardial infarction must have occurred more than 4 weeks prior to the external defibrillator prescription; and

b. The EP test must have been performed more than 4 weeks after the qualifying myocardial infarction.

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

1.30. Patients must not have:

a. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or

b. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; or

c. Had an enzyme-positive MI within past month; or

d. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or

e. Irreversible brain damage from preexisting cerebral disease; or

f. Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than one year.

6. 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%.

7. Patients with nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%.

8. 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 reasonable and necessary.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

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:

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 opens in new window

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

412 OLD MYOCARDIAL INFARCTION

425.11 HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY

425.18 OTHER HYPERTROPHIC 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 coded 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

Documentations 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.

KX, GA, AND GZ MODIFIERS:

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.

If all of the criteria in the Indications and Limitations of Coverage and/or Medical Necessity section have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.

Claim lines billed without a GA, GZ or KX modifier will be rejected for missing information.

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 007

Revision History Explanation 08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Revision Effective Date: 01/01/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Preamble language HCPCS CODES AND MODIFIERS:

Added: KF modifier Revised: GA modifier

Revision Effective Date: 09/01/2009 HCPCS CODES AND MODIFIERS:

Added : GA and GZ modifiers Revised: KX Modifier

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Separated range: 996.04 - 996.61 DOCUMENTATION REQUIREMENTS:

Added: Instructions for use of GA and GZ modifiers

03/01/2008 In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

Revision Effective Date: 07/01/2007 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: ICD-9 code 412 to HCPCS code E0617

Added: ICD-9 code 412 to HCPCS codes K0606-K0609 Removed: DMERC references

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Added: ICD-9 code 412 to HCPCS code E0617

Added: ICD-9 code 412 to HCPCS codes K0606 - K0609 DOCUMENTATION REQUIREMENTS:

Removed: DMERC references

06/01/2007 In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

03/01/2006 In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

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

Reason for Change Maintenance (annual review with new changes, formatting, etc.)