CurrentNew York State Department of HealthPolicy N/A

New York State Medicaid Wearable Automatic External Defibrillator Guidelines

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These New York State Medicaid guidelines establish coverage criteria, non-covered indications, prior approval, documentation, and rental requirements for wearable automatic external defibrillators (WAEDs) provided to Medicaid beneficiaries. WAED coverage is governed under the Medicaid Home Health Benefit and applies to providers, ordering practitioners, and beneficiaries.

Policy Summary

PayerNew York State Department of Health

PolicyNew York State Medicaid Wearable Automatic External Defibrillator Guidelines

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOctober 2015

Next Review DateN/A

Key ActionObtain prior approval supported by the required clinical documentation and the original signed written order from a qualified licensed prescriber.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

K0606WAED procedure code

4Required coverage criteria

120 + 180 daysTreatment periods

10 monthsMaximum rental period

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CurrentNew York State Department of HealthPolicy N/A

New York State Medicaid Wearable Automatic External Defibrillator Guidelines

Customize your policy alerts

Sign up for all New York State Department of Health policy alerts

Know when New York State Department of Health releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerNew York State Department of Health

PolicyNew York State Medicaid Wearable Automatic External Defibrillator Guidelines

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOctober 2015

Next Review DateN/A

Key ActionObtain prior approval supported by the required clinical documentation and the original signed written order from a qualified licensed prescriber.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

K0606WAED procedure code

4Required coverage criteria

120 + 180 daysTreatment periods

10 monthsMaximum rental period

30 daysNon-covered post-MI period

WAED Coverage Criteria

Initial WAED Coverage

The WAED is covered for patients at high risk of sudden cardiac death when all four criteria are met.

All coverage requirements

High risk of sudden cardiac death
- Documented ventricular arrhythmia: A documented episode of ventricular fibrillation or sustained ventricular tachyarrhythmia lasting 30 seconds or longer is present. The dysrhythmia may be spontaneous or reproducible during an electrophysiologic study, but must not be due to a transient or reversible cause and must not occur during the first 48 hours of an acute myocardial infarction, the first 72 hours after coronary bypass, or within 5 days of a transplant.30 seconds or longer
- Familial or inherited high-risk condition: The patient has a familial or inherited condition with a high risk of life-threatening ventricular tachyarrhythmia, such as long QT syndrome or hypertrophic cardiomyopathy.
- Reduced ejection fraction with qualifying history: The patient has a documented prior myocardial infarction or dilated cardiomyopathy and a measured left ventricular ejection fraction less than or equal to 0.35.LVEF ≤ 0.35
Implantation contraindication or temporary barrier: Either implantation surgery is contraindicated because of a systemic infectious process or another temporary condition precludes initial implantation, or a previously implanted defibrillator requires explantation because of infection or an inflammatory process involving the implant graft, with a waiting period before ICD reinsertion and documentation that severe infection is not due to poor patient compliance.
Alternatives explored: The provider and ordering practitioner have assured that all less costly medically appropriate alternatives have been explored. If alternatives are inadequate, the ordering practitioner must clearly document why.
18 NYCRR 513.4
Qualified ordering practitioner: The ordering practitioner is a cardiologist experienced in managing patients at risk for sudden cardiac death.

The WAED is not covered for indications outside the stated coverage criteria, including a history of acute myocardial infarction within 30 days; drug-refractory class IV congestive heart failure when the patient is not a candidate for heart transplantation; psychiatric disorders that interfere with necessary care and follow-up; ventricular tachyarrhythmia with a definitively identifiable reversible trigger, such as drug therapy, definitive therapy, ablation, evolving acute myocardial infarction, or electrolyte abnormalities; and terminal illness or another disease process that clearly and severely limits life expectancy.

For the listed non-covered indications and all other indications outside the coverage criteria, the wearable cardioverter defibrillator is considered investigational, not medically necessary, medically contraindicated, and not covered.

Coding and Clinical Thresholds

Covered WAED Procedure CodeHCPCSCovered

K0606

Automatic external defibrillator, with integrated electrocardiogram analysis, garment type

Sustained ventricular tachyarrhythmia

Qualifying duration30 seconds or longer

Qualifying rhythmSustained ventricular tachyarrhythmia

Clinical limitationThe dysrhythmia must not be due to a transient or reversible cause or occur during the first 48 hours of an acute myocardial infarction, the first 72 hours after coronary bypass, or within 5 days of a transplant.

Left ventricular ejection fraction

Qualifying thresholdLess than or equal to 0.35

Required historyDocumented prior myocardial infarction or dilated cardiomyopathy

Provider Requirements and Denial Risks

Prior Authorization

Prior Approval Required

Prior approval is required for WAED rental coverage. The request must include the required clinical documentation and the original signed written order specific to the item requested.

Procedure code: K0606 — automatic external defibrillator with integrated electrocardiogram analysis, garment type.
If approved, WAED is furnished as a rental, with reimbursement for a maximum of 10 months.

Prior Authorization

Continuation Approval After 120 Days

After the initial 120 days of treatment, obtain a new fiscal order for the remaining 180 days and submit a continuation prior approval request. Continued coverage remains subject to the coverage criteria in Section II.

The continuation request must document compliance with the treatment plan.
Include the defibrillator readout and other required continuation documentation.

Policy Background

A wearable automatic external defibrillator (WAED) is a vest-like device worn by the patient that continuously monitors cardiac rhythms, detects dysrhythmias, and delivers a defibrillation shock when appropriate without requiring patient decision-making. It is categorized as durable medical equipment and is covered under the Medicaid Home Health Benefit for patients at high risk of sudden cardiac death who meet the stated criteria.

Definitions

Wearable automatic external defibrillator (WAED)

Device formA vest-like device worn by the patient

Monitoring functionMonitors cardiac rhythms and detects dysrhythmias

Therapeutic functionDelivers a defibrillation shock to the heart when appropriate without patient decision-making

Durable medical equipment

Ordering requirementOrdered by a practitioner to treat a specific medical condition

DurabilityCan withstand repeated use for a protracted period

Medical purpose

Medical Necessity Determination

Medical Necessity for WAED

Medical necessity is established only when the patient meets all four requirements for WAED coverage.

All four medical necessity requirements

Qualifying high risk of sudden cardiac death
- Ventricular arrhythmia: A documented episode of ventricular fibrillation or sustained ventricular tachyarrhythmia lasting 30 seconds or longer is present; it may be spontaneous or reproducible during an electrophysiologic study, but must not result from a transient or reversible cause or occur during the first 48 hours of an acute myocardial infarction, the first 72 hours after coronary bypass, or within 5 days of a transplant.30 seconds or longer
- Familial or inherited condition: A familial or inherited condition with a high risk of life-threatening ventricular tachyarrhythmia is present, such as long QT syndrome or hypertrophic cardiomyopathy.

Rental and Purchase Rules

Equipment	Billing method	Maximum reimbursement period	Included in monthly rental
Wearable automatic external defibrillator (K0606)	Rental, if approved	Up to 10 months	Necessary equipment, delivery, maintenance and repair costs, parts, supplies, setup services, and replacement of worn essential accessories or parts

Replacement of Accessories and Parts

WAED and essential accessories or parts

Replacement timingAs needed for worn essential accessories or parts

Payment inclusionReplacement of worn essential accessories or parts is included in the monthly rental payment

Related rental coverageThe monthly rental payment also includes necessary equipment, delivery, maintenance, repair, parts, supplies, and setup services.

Required Documentation

Documentation Required

Include an item-specific signed order

The original signed written order must identify the WAED being requested and must be signed by a qualified licensed prescriber.

Specify the requested item.
Obtain the signature of a qualified licensed prescriber.

Documentation Required

Support ongoing eligibility and continuation

Maintain records supporting continued eligibility under the coverage criteria and compliance with the treatment plan. For continuation after the initial 120 days, include the downloaded defibrillator readout and documentation that coverage criteria remain satisfied.

Document the qualifying high-risk condition and other applicable coverage requirements.
Include treatment-plan compliance documentation.
Submit the defibrillator readout download for continuation approval.

Non-Covered Indications

The WAED is not covered for indications outside the stated coverage criteria, including acute myocardial infarction within 30 days; drug-refractory class IV congestive heart failure when the patient is not a candidate for heart transplantation; psychiatric disorders that interfere with necessary care and follow-up; ventricular tachyarrhythmia caused by a definitively identifiable reversible trigger, such as drug therapy, definitive therapy, ablation, evolving acute myocardial infarction, or electrolyte abnormalities; and terminal illness or another disease process that clearly and severely limits life expectancy.

Policy Summary

PayerNew York State Department of Health

PolicyNew York State Medicaid Wearable Automatic External Defibrillator Guidelines

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOctober 2015

Next Review DateN/A

Key ActionObtain prior approval supported by the required clinical documentation and the original signed written order from a qualified licensed prescriber.

SourceLink

On This Page

Measured left ventricular ejection fraction

Recent acute myocardial infarction

Non-covered timingWithin 30 days of an acute myocardial infarction

Affected patientsPatients with a history of an acute myocardial infarction

Coverage statusInvestigational, not medically necessary, medically contraindicated, and not covered

Initial and continuation treatment periods

Initial treatment period120 days

Continuation periodRemaining 180 days

Step Therapy

Explore Less Costly Alternatives

The provider and ordering practitioner must assess whether less costly, medically appropriate alternatives are available. If alternatives are inadequate, the ordering practitioner must clearly document why they are not adequate.

Providers must assure that adequate and less costly alternatives have been explored.
Where appropriate and cost effective, the alternatives must be provided.
Requirement under 18 NYCRR 513.4 and 18 NYCRR 513.

Documentation Required

Clinical Eligibility Documentation

Maintain clinical documentation supporting the patient's qualifying high risk of sudden cardiac death and the other coverage requirements. Documentation must establish at least one qualifying clinical pathway and the applicable implantation-related circumstance.

Documented ventricular fibrillation or sustained ventricular tachyarrhythmia lasting 30 seconds or longer, not attributable to a transient or reversible cause and not occurring during the specified post-MI, post-bypass, or post-transplant exclusion periods.
A familial or inherited high-risk condition, such as long QT syndrome or hypertrophic cardiomyopathy.
Prior myocardial infarction or dilated cardiomyopathy with measured left ventricular ejection fraction <= 0.35.
Documentation that implantation is contraindicated or temporarily precluded, or that an implanted defibrillator requires explantation with a waiting period before reinsertion.
The ordering practitioner must be a cardiologist experienced in managing patients at risk for sudden cardiac death.

Documentation Required

Signed Written Order

Maintain an original, signed written order from a qualified licensed prescriber for every service. The order must be specific to the WAED or other item being requested.

A general or non-item-specific order does not satisfy the requirement.
The original signed order must support the service through billing and audit.

Documentation Required

Continuation Documentation

For continuation beyond the initial 120 days, document that the patient has complied with the treatment plan and continues to meet the Section II coverage criteria.

Submit the readout downloaded from the defibrillator.
Include documentation of continued clinical eligibility and coverage criteria.
The continuation request covers the remaining 180 days and requires a new fiscal order.

Unsupported block type: denial_riskุvariant

Denial Risk

Non-Covered Indications

WAED is investigational, not medically necessary, medically contraindicated, and not covered for non-covered indications, including the following.

Acute myocardial infarction within the previous 30 days.
Drug-refractory class IV congestive heart failure when the patient is not a candidate for heart transplantation.
Psychiatric disorders that interfere with necessary care and follow-up.
A definitely identifiable reversible trigger for ventricular tachyarrhythmia, including evolving acute myocardial infarction or electrolyte abnormalities.
Terminal illness or another disease process that clearly and severely limits life expectancy.

Denial Risk

Inappropriate or Unsupported Services

Do not order or furnish inappropriate, improper, unnecessary, or excessive services. Unsupported or non-medically necessary services may result in claim denial and provider or practitioner liability.

Providers may be liable for overpayments or penalties and may face administrative action affecting continued Medicaid participation.
The financial liability of the ordering practitioner and DME provider for services found on audit not to be medically necessary is addressed in 18 NYCRR 518.
Monthly rental includes necessary equipment, delivery, maintenance and repair, parts, supplies, setup, and replacement of worn essential accessories or parts; do not bill duplicatively.

Primarily and customarily used for medical purposes and generally not useful in the absence of illness or injury

CustomizationNot usually fitted, designed, or fashioned for a particular individual's use; equipment intended for one beneficiary may be custom-made or customized.

Prior myocardial infarction or dilated cardiomyopathy with reduced ejection fraction: A documented prior myocardial infarction or dilated cardiomyopathy is present, with a measured left ventricular ejection fraction less than or equal to 0.35.LVEF ≤ 0.35

Implantation contraindication or temporary barrier: Implantation surgery is contraindicated because of a systemic infectious process or another temporary condition precludes initial implantation; alternatively, a previously implanted defibrillator requires explantation because of infection or an inflammatory process involving the implant graft, with a waiting period before ICD reinsertion and documentation that severe infection is not due to poor patient compliance.

Less costly alternatives explored: The provider and ordering practitioner have assured that all less costly medically appropriate alternatives have been explored. If alternatives are inadequate, the ordering practitioner must clearly document why.

18 NYCRR 513.4

Qualified cardiologist ordering practitioner: The ordering practitioner is a cardiologist experienced in managing patients at risk for sudden cardiac death.