Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that the implantable automatic defibrillator is an electronic device designed to detect and treat 
life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and 
defibrillating. 
 
Additional indications effective for services performed on or after October 1, 2003: 
 
    Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible 
cause (effective July 1, 1991). 
    Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an 
electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient 
or reversible cause (effective July 1, 1999). 
    Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT 
syndrome or hypertrophic cardiomyopathy (effective July 1, 1999). 
    Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) = 
0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to 
defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.) 
    Documented prior MI and a measured LVEF = 0.30 and a QRS duration of >120 milliseconds (the QRS 
restriction does not apply to services performed on or after January 27, 2005) . Patients must not have: 
        New York Heart Association (NYHC) classification IV; 
        Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; 
        Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) 
within past 3 months; 
        Had an enzyme positive MI within past month  (Effective for services on or after January 27, 2005, 
patients must not have an acute MI in the past 40 days); 
        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. 
    
Additional indications effective for services performed on or after January 27, 2005: 
    Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart 
failure, and measured LVEF = 35%; 
    Patients with non-ischemic dilated cardiomyopathy (NIDCM) >9 months, NYHA Class II and III heart 
failure, and measured LVEF = 35%;     Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a 
cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure; 
 
    All indications must meet the following criteria: 
 
        Patients must not have irreversible brain damage from preexisting cerebral disease; 
        MIs must be documented and defined according to the consensus document of the Joint European Society 
of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction; 1 
 
    Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria: 
        Patients must be able to give informed consent; 
        Patients must not have: 
            Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; 
            Had a CABG or PTCA within the past 3 months; 
            Had an acute MI within the past 40 days; 
            Clinical symptoms or findings that would make them a candidate for coronary revascularization; 
            Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood 
of survival less than 1 year; 
        Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; 
        The beneficiary receiving the defibrillator implantation for primary prevention is enrolled in either a Food 
and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial (42 
CFR 405.201), a trial under the CMS Clinical Trial Policy (National Coverage Determination (NCD) Manual 
310.1) or a qualifying data collection system including approved clinical trials and registries. Initially, an 
implantable cardiac defibrillator (ICD) database will be maintained using a data submission mechanism that is 
already in use by Medicare participating hospitals to submit data to the Iowa Foundation for Medical Care 
(IFMC) a Quality Improvement Organization (QIO) contractor for determination of reasonable and necessary 
and quality improvement. Initial hypothesis and data elements are specified in this decision (Appendix VI) and 
are the minimum necessary to ensure that the device is reasonable and necessary. Data collection will be 
completed using the ICDA (ICD Abstraction Tool) and transmitted via QNet (Quality Network Exchange) to 
the IFMC who will collect and maintain the database. Additional stakeholder-developed data collection 
systems to augment or replace the initial QNet system, addressing at a minimum the hypotheses specified in 
this decision, must meet the following basic criteria: 
 
            Written protocol on file; 
            Institutional review board review and approval; 
            Scientific review and approval by two or more qualified individuals who are not part of the research 
team; 
            Certification that investigators have not been disqualified. 
 
        For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials 
meet these criteria. 
 
        Providers must be able to justify the medical necessity of devices other than single lead devices. This 
justification should be available in the patient's medical record. 
 
You can find these rules in the National Coverage Determination (NCD) Implantable Automatic Defibrillators 
20.4. 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.