HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 
Medical Policy:
S-59-008
Topic:
Implantable Automatic Cardioverter-Defibrillator
Section:
Surgery
Effective Date:
October 1, 2017
Issued Date:
October 2, 2017
Last Revision Date:
October 2016
 
 

The automatic implantable cardioverter defibrillator (AICD) is a device designed to monitor a patient’s heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death.

The Subcutaneous Implantable Cardioverter-Debrillator (S-ICD) administers an electric shock without the use of wires implanted in the heart thereby leaving the heart and blood vessels untouched and intact. It was designed to prevent sudden death as a result of ventricular fibrillation.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

The implantation of an automatic defibrillator is a covered service when medically necessary. Implantable automatic cardioverter-defibrillators (ICDs) are covered only if they have received FDA approval. Each device should be used in accordance with FDA-approved indications.

Adult Indications for Heart Failure

The use of the automatic implantable cardioverter defibrillator (AICD) may be considered medically necessary in patients who meet ONE or more of the following criteria:

Primary Prevention:

  • Ischemic cardiomyopathy with New York Heart Association (NYHA) functional Class II or Class III symptoms, and
    • If patient has had an myocardial infarction (MI) at least 40 days before implantable cardioverter defibrillator (ICD) treatment; or
    • Left ventricular ejection fraction of 35% or less.
  • Ischemic cardiomyopathy with NYHA functional Class I symptoms;
    • If patient has had an MI at least 40 days before ICD treatment; or
    • Left ventricular ejection fraction of 30% or less.
  • Nonischemic dilated cardiomyopathy:
    • Left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined.
  • Hypertrophic cardiomyopathy (HCM) with ONE or more of the following major risk factors for sudden cardiac death:
    • History of premature HCM and related sudden death in one (1) or more first-degree relatives younger than 50 years; or
    • Left ventricular hypertrophy greater than 30 mm; or
    • One or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; or
    • Prior unexplained syncope inconsistent with neurocardiogenic origin.
  • Judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.

Secondary Prevention:

  • Patient’s with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia (VT) after reversible causes have been excluded; or
  • Patient’s with familial or inherited conditions with a high risk of life-threatening VT’s such as:
    • Long QT syndrome; or
    • Brugada syndrome; or
    • Short QT syndrome; or
    • Catecholaminergic polymorphic ventricular tachycardia; or
    • Hypertrophic cardiomyopathy.

AICD implantation is considered not medically necessary when ANY of the following indications are documented:

  • Irreversible brain damage from preexisting cerebral disease; or
  • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; or
  • Had an acute MI within the past 40 days; or
  • Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
  • Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

AICD therapy is not indicated for patients with NYHA Class IV symptoms, who are not candidates for a cardiac resynchronization therapy device.

AICD therapy is not indicated for patients with newly diagnosed heart failure.

AICD therapy is not indicated for patients recovering from an acute MI or CABG surgery.

The use of an AICD is considered not medically necessary for any condition not listed above.

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Pediatric Indications

AICD therapy in children may be considered medically necessary for the treatment of ventricular tachyarrhythmia’s and for the prevention of sudden cardiac death (SCD) in patients who are receiving optimal medical therapy and have a reasonable expectation of survival with a good functional status for more than 1 year when ONE of the following indications is present:

  • For survivors of cardiac arrest after evaluation to define the cause of the event and to exclude any reversible causes; or
  • For patients with symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation. (Catheter ablation or surgical repair may offer possible alternatives in carefully selected patients); or 
  • For patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias at electrophysiological study.

The use of an AICD is considered not medically necessary for any condition not listed above.

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Subcutaneous Implantable Cardioverter-Defibrillators (S-ICD)

A subcutaneous ICD (S-ICD) may be considered medically necessary when an adult or child has met ANY of the clinical criteria for an AICD AND met ANY of the following criteria:

  • Congenital heart disease; or 
  • Hypertrophic cardiomyopathy; or
  • Inherited channelopathies; or
  • Obstructed venous access; or
  • High-risk for bacteremia due to:
    • Chronic indwelling catheters; or
    • Patients on hemodialysis; or
  • Immunocompromised.

S-ICD is considered not medically necessary for the following:

  • Patients that would require anitbradycardia pacing; or
  • Patients that would require antitachycardia pacing; or
  • Patients that has previous documentation of endocarditis; or
  • Patients that require bi-ventricular pacing.

S-ICD is considered experimental/investigational for all other indications and and therefore non-covered; due to effectiveness and safety has not been established.

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Analysis of Cardioverter-Defibrillator

Long-term routine follow-up care for cardioverter-defibrillator monitoring (including analysis, evaluation, and interrogation) is an in person or a remote evaluation service that is eligible for reimbursement.

Device evaluation includes the following:

  • review of programmed parameters; and
  • lead(s), battery; and
  • capture and sensing function; and
  • presence or absence of therapy for ventricular tachyarrhythmia’s and underlying heart rhythm.

Often, various components, e.g., AV intervals, pacing voltage, and diagnostics are adjusted.

Remote interrogation evaluation can be reported only once in 90 days; more frequent remote evaluations is part of the global allowance and not eligible for separate payment.

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Electrophysiological Assessment 

Electrophysiological assessment is a more complex evaluation of newly or chronically implanted cardioverter-defibrillators; this is a covered service when medically necessary.

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Implantable Cardiovascular Monitor (ICM)  

An implantable cardiovascular monitor (ICM) may be considered medically necessary to assist the doctor in the management of non-rhythm related cardiac conditions such as heart failure. An ICM can be used in addition to an implantable cardioverter-defibrillator (ICD); reimbursement is allowed once in a 30 day period. Additional monitoring is considered part of the global allowance and not eligible for separate payment.

ICM data and the ICD heart rhythm data such as sensing, pacing, and tachycardia detection therapy are separate and distinct services.

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Related Policies

Refer to medical policy S-153 Biventricular Pacemakers for the Treatment of Congestive Heart Failure for additional information.

Refer to medical policy E-58 Wearable Cardioverter-Defibrillators for additional information.


Place of Service: Inpatient/Outpatient

The use of an implantable automatic cardioverter-defibrillator 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.

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.

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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.