HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 
Medical Policy:
E-58-012
Topic:
Wearable Cardioverter-Defibrillator
Section:
Durable Medical Equipment
Effective Date:
September 2, 2019
Issued Date:
September 2, 2019
Last Revision Date:
August 2019
Annual Review:
August 2019
 
 

A wearable cardioverter-defibrillator (WCD) is a temporary, external device that is an alternative to an implantable cardioverter-defibrillator (ICD). It is primarily intended for temporary conditions for which an implantable device is contraindicated, or for a period of time during which the need for a permanent implantable device is uncertain.

Policy Position

A WCD may be considered medically necessary for a period of up to three (3) months and when the following criteria are met:

 

  • At least one (1) year of age or older; and
  • At high risk for sudden cardiac death (SCD); and
  • Requires the WCD as interim treatment for those who meet the criteria for an ICD; and
  • Device must be worn for at least 22 hours per day (greater than 90% wear time); and ANY ONE of the following criteria:

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.  Transient or reversible causes including but not limited to:

  • Drug toxicity; or
  • Severe hypoxia; or
  • Acidosis; or
  • Hypokalemia; or
  • Hypercalcemia; or
  • Hyperkalemia; or
  • Systemic infections.

OR

A previously implanted defibrillator now requires explantation.

OR

As a bridge to left ventricular (LV) improvement for ANY ONE of the following indications:

  • LV ejection fraction (EF) less than or equal to 35% in adults, and one to two standard deviations below a normal EF (or fractional shortening) of 55% for children, after cardiac events such as:
    • After recent acute myocardial infarction (MI) during the 40-day period under which ICD implantation is not indicated or deferred. Reevaluation of LVEF must occur no later than three (3) months after a MI.  If LVEF remains less than or equal to 35%, an ICD is indicated; or
    • Coronary revascularization procedures such as before and after coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) during the 90-day ICD waiting period; or
    • Recently diagnosed non-ischemic cardiomyopathy during the three (3)-month to nine (9)-month period awaiting LV improvement or ICD implantation; or
  • Heart transplantation; or
  • As an alternative to an ICD in an individual who has a documented contraindication to an ICD (e.g., systemic infection, lack of vascular access).

OR

Inherited or familial conditions with a high risk for life-threatening ventricular tachyarrhythmias.

High-risk factors as evidenced by ANY ONE of the following:

  • Hypertrophic cardiomyopathy; or
  • Long QT Syndrome; or
  • A family history of ANY ONE of the following:
    • SCD in a first degree relative (e.g., sibling, parent or child) less than 40; or
    • SCD in a first degree relative (e.g., sibling, parent or child) with hypertrophic cardiomyopathy; or
    • LV/septal thickness greater than three (3) cm in adults; or
    • LV/septal thickness greater than two (2) standard deviations outside of normal parameters in children, or
    • Abnormal exercise blood pressure (BP) including failure BP to rise greater than 25mmHg from baseline or decrease less than10mmHg from the maximal BP during exercise.

WCD for any other indications will be considered not medically necessary.

93292

93745

K0606

 

 

 

 


New York Heart Association Functional Classification (NYHA) of Heart Disease

Classification   

Characteristics

Class I (mild)

No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, rapid/irregular heartbeat (palpitation) or shortness of breath (dyspnea).

Class II (mild)

Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, rapid/irregular heartbeat (palpitation), or shortness of breath (dyspnea). 

Class III (moderate)

Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, rapid/irregular heartbeat (palpitation), and shortness of breath (dyspnea).

Class IV (severe)

Inability to carry on any physical activity without discomfort. Symptoms of fatigue, rapid/irregular heartbeat (palpitation) or shortness of breath (dyspnea) are present at rest. If any physical activity is undertaken, discomfort increases.

 

Modified Ross Heart Failure Classification for Children

Classification   

Characteristics

Class I

No limitations or symptoms.

Class II

Infants: Mild tachypnea or diaphoresis with feeding.

Older children: Mild to moderate dyspnea on exertion.  

Class III

Infants: Growth failure and marked tachypnea or diaphoresis with feeding.

Older children: Marked dyspnea on exertion.

Class IV

Symptoms at rest such as tachypnea, retractions, grunting, or diaphoresis.

 

*All documentation include daily wear time must be maintained in the medical record and be available upon request. Beginning with the initial date the device was worn for continuous monitoring; the Cardiologist must reevaluate the need for continued use of the WCD at three (3) months and again at 90 day intervals until the device is discontinued. Documentation requirements including but not limited to the following must be maintained in the medical record: the date the device was first worn for continuous monitoring, the initial indication establishing medical necessity, member tolerance and compliance throughout the use of the WCD as documented by Cardiologist evaluations.

The Cardiologist may access the Zoll LifeVest Network on-line patient management system allowing for monitoring of the individual’s data reports downloaded from a the LifeVest wearable defibrillator.

Professional Statements and Societal Positions Guidelines

2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.

Removal of an ICD for a period of time, most commonly due to infection, exposes the patient to risk of untreated VT/SCD unless monitoring and access to emergency external defibrillation is maintained. In 1 series of 354 patients who received the wearable cardioverter-defibrillator, the indication was infection in 10%. For patients with a history of SCA or sustained VA, the wearable cardioverter-defibrillator may allow the patient to be discharged from the hospital with protection from VT/SCA until the clinical situation allows reimplantation of an ICD.

The patients listed in this recommendation are represented in clinical series and registries that demonstrate the safety and effectiveness of the wearable cardioverter-defibrillator. Patients with recent MI, newly diagnosed NICM, recent revascularization, myocarditis, and secondary cardiomyopathy are at increased risk of VT/SCA. However, the wearable cardioverter-defibrillator is of unproven benefit in these settings, in part because the clinical situation may improve with therapy and time. In patients awaiting transplant, even with anticipated survival <1 year without transplant, and depending on clinical factors such as use of intravenous inotropes and ambient VA, a wearable cardioverter-defibrillator may be an alternative to an ICD.


Covered Diagnosis Codes for Procedure Codes 93292, 93745, K0606:

I25.2

I40.0

I40.1

I40.8

I40.9

I42.0

I42.1

I42.2

I42.3

I42.4

I42.5

I42.6

I42.7

I42.8

I42.9

I43

I45.81

I47.0

I47.1

I47.2

I47.9

I49.01

I49.02

I49.1

I49.2

I49.3

T82.110A

T82.111A

T82.118A

T82.119A

T82.120A

T82.121A

T82.128A

T82.129A

T82.190A

T82.191A

T82.198A

T82.199A

T82.6XXA

T82.7XXA

 

 


Place of Service: Outpatient

WCD is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator. 

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. 

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: 

U.S. Department of Health and Human Services 
200 Independence Avenue, SW 
Room 509F, HHH Building 
Washington, D.C. 20201 
1-800-368-1019, 800-537-7697 (TDD) 

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.