Commercial

Medical Policy

Notification

Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)

Notification Issue Date:

This version of the policy will become effective 07/20/2020.

In accordance with the Final Rule 1713 (84 Fed. Reg Vol 217), a face-to-face encounter is required for specified HCPCS codes:

E0617 External defibrillator with integrated electrocardiogram analysis

K0606 Automatic external defibrillator with integrated electrocardiogram analysis, garment type

K0609 Replacement electrodes for use with automated external defibrillator, garment type only, each

Title:

Automatic External Cardioverter Defibrillators (Wearable and Nonwearable)

Policy #:

05.00.29o

Policy

An automatic external defibrillator (AED) is considered medically necessary and, therefore, covered when an individual has a prescription for the device from a professional provider, purchases the device from a durable medical equipment (DME) provider, and meets the following criteria.

ADULTS

WEARABLE
A wearable AED 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 (VT). 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 VT 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 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:

All other uses for AEDs (wearable or nonwearable) by adults are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

CHILDREN

WEARABLE
A pediatric wearable AED (i.e., Zoll LifeVest) is considered medically necessary and, therefore, covered for individuals who are at high risk for SCD and have all of the following indications:

Individuals under the age of 18 must have a chest circumference of 26 inches
Individuals who weigh at least 18.75 kg (approximately 43 pounds), the average size of an 8-year-old child

The LifeVest system should not be used in individuals who have an active ICD.

NONWEARABLE
A pediatric nonwearable AED is considered medically necessary and, therefore, covered for children 1 to 8 years of age who weigh less than 55 pounds (25 kilograms) and meet one or more of the medically necessary adult criteria listed above.

An adult nonwearable AED is considered medically necessary and, therefore, covered for children over 8 years of age or who weigh more than 55 pounds (25 kilograms) when they meet one or more of the medically necessary adult criteria listed above.

ADULTS AND CHILDREN

Professional provider charges related to AED set-up, programming, evaluation, and analysis are eligible for reimbursement when the device is considered medically necessary.

Because the available published peer-reviewed literature does not support its use in the diagnosis or treatment of illness or injury, requests for the following are considered not medically necessary and, therefore, not covered:

Technological advancements or newly released upgrades to equipment, when the original equipment still functions properly and/or there are no significant changes in the individual's condition

Carrying cases or mounting hardware for the AED are not covered by the Company because they are not primarily medical in nature and are considered comfort or convenience items. Therefore, these items are not eligible for reimbursement consideration.

REQUIRED DOCUMENTATION

MIs must be documented by elevated cardiac enzymes or Q-waves on an electrocardiogram. LVEFs must be measured by angiography, radionuclide scanning, or echocardiography.

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.

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

PROOF OF DELIVERY REQUIREMENTS
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 durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The 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 7 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 5 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 DME supplier may be required to reimburse the Company for overpayments.

Guidelines

Automatic external defibrillators (AEDs) should be ordered by an attending physician who will provide usage instructions. It is advisable that any individual potentially using an AED receive formal training in the use of the device and in basic life support techniques.

An AED should be used as stated in the manufacturer's labeling, and the device should be compatible with the corresponding manufacturer's defibrillation pads.

Transient or reversible causes of cardiac arrest may include conditions such as, but not limited to, drug toxicity, severe hypoxia, acidosis, hypokalemia, hypercalcemia, hyperkalemia, systemic infections, and myocarditis.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, AEDs are covered as durable medical equipment (DME) under the medical benefits of most of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

WEARABLE AUTOMATIC CARDIOVERTER DEFIBRILLATORS (WEARABLE AUTOMATIC EXTERNAL DEFIBRILLATORS)
A wearable AED was approved by the FDA on December 18, 2001, for adults who are at risk for sudden cardiac arrest and who either are not candidates for, or refuse, an implantable cardioverter-defibrillator (ICD).

A wearable AED was approved by the FDA on December 17, 2015, for children who are at risk for sudden cardiac arrest.

AUTOMATIC EXTERNAL DEFIBRILLATORS (AEDs)/NONWEARABLE
There are numerous automatic external defibrillators approved by the FDA.

Description

Sudden cardiac death, or cardiac arrest, is usually caused by cardiac arrhythmia. The most common arrhythmias that result in cardiac arrest are ventricular fibrillation (VF) and ventricular tachycardia (VT). VF is an erratic, disorganized firing of impulses from the ventricles that affect the heart's pumping and contracting ability, thereby cutting off blood flow to the brain and other vital organs. VT is a rapid heartbeat initiated within the ventricles, characterized by three or more consecutive premature ventricular beats that critically reduce the heart's ability to effectively pump blood throughout the body.

The treatment for VF and VT is defibrillation, a process in which an electronic device (defibrillator) gives an electric shock to the heart. The electric shock resets the electrical state of the heart, thereby enabling the heart to beat to a rhythm controlled by its own natural pacemaker cells. Defibrillation helps re-establish normal contraction rhythms in a heart that has a dangerous arrhythmia or is in cardiac arrest. Left untreated, VF and VT can lead to cardiac arrest that is fatal within minutes. Studies have shown that individuals who survive severe cardiac arrhythmias do so because defibrillation is performed almost immediately.

Although the focus of this policy is automatic (automated) external defibrillators (AEDs), it should be noted that for most individuals at high risk for cardiac arrhythmias, an implantable cardioverter-defibrillator (ICD) is the treatment of choice. The surgically implanted ICD is designed to constantly monitor an individual's heart rate, recognize VF or VT, and deliver an electric shock to terminate these arrhythmias in order to reduce the risk of sudden death. When an ICD is not an option for an individual at risk for sudden death due to cardiac arrhythmias, an AED is necessary.

An 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 VF or VT, the AED can automatically or manually deliver a defibrillating shock to restore normal heart rhythm.

A wearable AED is a vest-like garment (worn under clothing) that automatically defibrillates an individual's heart. A nonwearable AED is a portable device that is used by someone other than the affected individual to effect defibrillation. Both types of AEDs consist of a monitor, electrodes, and a small alarm module.

The US Food and Drug Administration (FDA) has approved several AEDs that can be used by individuals outside of a health care facility. On May 2, 2001, the FDA approved the first external defibrillators to be used on children who experience cardiac arrest. The device, known as the Heartstream HeartStart FR2 AED (Agilent Technologies, Inc., Santa Clara, CA), is equipped with pediatric-sized attenuated electrode pads and cables that emit a shock suitable for children. Both the American Heart Association (AHA) and the Pediatric Advanced Life Support Task Force of the International Liaison Committee on Resuscitation (ILCOR) have recommended using an AED only when it can deliver a pediatric dose and when the child is between 1 and 8 years of age who have no signs of circulation. According to the ILCOR, an AED should not be used on children under 1 year of age.

Other manufacturers, such as Welch Allyn, maker of the Pediatric Energy Reducer for AED 10®, provide the pediatric attenuator as a separate accessory. According to the manufacturer, the Energy Reducer for AED 10® facilitates the use of less costly nonattenuating electrodes for all individuals, eliminating the potential to confuse attenuating electrodes with nonattenuating electrodes, as well as the need to ensure sufficient stock of the two styles of electrodes.

On December 18, 2001, the FDA approved the Wearable Cardioverter Defibrillator (WCD®) 2000 LifeVest (Lifecor, Inc., Pittsburgh, PA) for individuals over 18 years of age. The WCD® is an external device, worn 24 hours a day (except when bathing or showering) that functions like an ICD. It is a noninvasive, vest-like garment (worn under clothing) that consists of a monitor, electrodes, and a small alarm module that constantly checks and analyzes heart rhythm. If an abnormal shockable heart rhythm (i.e., VT or VF) is detected, a shock will be delivered. The device displays a message prior to delivering the shock, and an individual is able to prevent the shock by holding and pressing the response buttons. But if the individual loses consciousness while holding the buttons, the release of the buttons will automatically trigger the defibrillator to deliver the shock in an attempt to restore normal heart rhythm.

On December 17, 2015, the FDA approved a new indication for the LifeVest (Zoll Manufacturing Corporation, Pittsburgh, PA) wearable cardioverter defibrillator. The LifeVest is approved for children who are at risk for sudden cardiac arrest but who are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.

Weighing less than 2 pounds, the LifeVest consists of two main components: an electrode belt and garment that surround the patient’s chest, and a monitor that the patient wears around his or her waist. This device is intended only for children that weigh at least 41 pounds and have a chest size of 26 inches or more (about the size of an average 8 year old).

The pediatric approval was based on published studies and a company registery containing clinical information from 248 patients, ages 3 to 17, at risk for sudden cardiac arrest. No additional safety concerns were identified during the study. Four individuals who experienced sudden cardiac arrest received a shock that successfully restored a life-sustaining heartbeat.

On July 28, 2021, the FDA approved the ASSURE® Wearable Cardioverter Defibrillator (WCD) System for adult individuals at risk for sudden cardiac arrest who are not candidates for (or refuse) an ICD. (Kestra Medical Technologies, Inc., Kirkland, WA).

Cardiopulmonary resuscitation and the use of a portable AED are emergency techniques that assist an individual in the management of cardiac arrest until emergency personnel arrive. It is advisable that any individual potentially using these techniques have formal training in the use of the device and in basic life support.

References

American Heart Association (AHA). AED programs Q&A. [AHA Web site]. 04/2018 Available at: A-E-D Program Questions and Answers (heart.org). Accessed May 16, 2023.

American Heart Association (AHA). AHA/ASA newsroom. Wearable defibrillators may be an alternative to surgically implanted device for children with certain heart rhythm disorders. [AHA Web site]. 06/26/18. Available at: https://newsroom.heart.org/news/wearable-defibrillators-may-be-an-alternative-to-surgically-implanted-device-for-children-with-certain-heart-rhythm-disorders. Accessed May 16, 2023.

Cardiology Advisor. LifeVest Wearable Defibrillator for Children FDA Approved. [Cardiology Advisor Web site]. 12/18/15. Available at: https://www.thecardiologyadvisor.com/home/topics/pediatric-cardiology/lifevest-wearable-defibrillator-for-children-fda-approved. Accessed May 16, 2023.

Centers for Medicare & Medicaid Services (CMS). Federal Register. Medicare Program; End-stage renal disease prospective payment system, payment for renal dialysis services furnished to individuals with acute kidney injury, end-stage renal disease quality incentive program, durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) fee schedule amounts, DMEPOS competitive bidding program (CBP) amendments, standard elements for a DMEPOS order, and master list of DMEPOS items potentially subject to a face-to-face encounter and written order prior to delivery and/or prior authorization requirements for calendar year (CY) 2020; Final Rule. [Federal Register Web site]. 01/01/2020. Available at: https://www.federalregister.gov/documents/2019/11/08/2019-24063/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis. Accessed May 16, 2023.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (L33690) Automatic external defibrillators. Original 10/01/2015. (Revised 01/01/2020) Available at:https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33690&ver=20. Accessed May 16, 2023.

Noridian Healthcare Solutions, LLC. Policy Article (A52458). Automatic external defibrillators. Original 10/01/2015. (Revised 10/01/2020). Available at: Article - Automatic External Defibrillators - Policy Article (A52458) (cms.gov). Accessed May 16, 2023.

Noridian Healthcare Solutions. Local Coverage Article.A55426: Standard documentation requirements for all claims submitted to DME MACs. [Noridian Healthcare Solutions Web site]. Original 01/01/2017. Revised 04/06/2020. Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleid=55426. Accessed May 16, 2023.

Philips HeartStart FR2/FR2+ Defibrillator. [Philips Web site]. Available at: https://www.heartsmart.com/Philips-AEDs-s/1862.htm. Accessed May 16, 2023.

Spar DS, Bianco NR, et al. The US Experience of the cardioverter-defibrillator in pediatric patients. Circ Arrhythm Electrophysiol. 2018;11(7):e006163. doi:10.1161/CIRCEP.117.006163. Available at: https://www.ncbi.nlm.nih.gov/pubmed/29945928. Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. HeartSine Samaritan® PAD. 510(k) summary. [FDA Web site]. 05/25/04. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041067.pdf. Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Philips Heartstream Heartstart FR2 AED. 510(k) summary. [FDA Web site]. 10/03/05. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf5/K051632.pdf. Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Medtronic Physio-Control Infant/Child Reduced Energy Electrodes. 510(k) summary. [FDA Web site]. 12/13/02. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K022732.pdf. Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. LIFECOR Wearable Cardioverter Defibrillator (WCD®) 2000 System for Adults. Summary of safety and effectiveness data. [FDA Web site]. 12/18/01. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010030b.pdf. Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Assure® Wearable Cardioverter Defibrillator (WCD) System (Assure System). Summary of safety and effectiveness data. [FDA Web site]. 07/28/21. Available at:P200037 SSED (fda.gov). Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Pediatric energy reducer for AED 1®; pediatric energy reducer for AED 2O®. Premarket approval letter. [FDA Web site]. 09/14/04. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040479.pdf. Accessed May 16, 2023.

US Food and Drug Administration (FDA). IDE Review Memorandum. Summary of Safety and Effectiveness Data (SSED). LifeVest® Wearable Cardioverter Defibrillator in Pediatric Patients. [FDA Web site]. 12/17/15. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/p010030s056b.pdf. Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. LIFEPAK® 500 Biphasic Automated External Defibrillator (Non-Wearable). 510(k) summary. [FDA Web site]. 05/05/99. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/K983393.pdf. Accessed May 16, 2023.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Medtronic LIFEPAK® 500 Automated External Defibrillator (AED). 510(k) summary. [FDA Web site]. 02/17/06. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf5/K052057.pdf. Accessed May 16, 2023.

Coding

CPT Procedure Code Number(s)

93292, 93745

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

SEE ATTACHMENT A FOR ICD-10 CODES THAT ARE USED TO REPRESENT INDICATIONS FOR THE WEARABLE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED), REPLACEMENT SUPPLIES, AND ACCESSORIES.

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

HCPCS Level II Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT NONWEARABLE AUTOMATIC EXTERNAL DEFIBRILLATOR (AED):

E0617 External defibrillator with integrated electrocardiogram analysis

THE FOLLOWING CODE IS USED TO REPRESENT WEARABLE AED:

K0606 Automatic external defibrillator, with integrated electrocardiogram analysis, garment type

THE FOLLOWING CODES ARE USED TO REPRESENT REPLACEMENT SUPPLIES AND ACCESSORIES FOR AN AED:

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

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

10/1/2023

Version Issued Date:

9/29/2023

Version Reissued Date: