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 medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
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. All indications must meet the following criteria: 
 
        a. Patients must not have irreversible brain damage from preexisting cerebral disease; 
        b. 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. 
 
    Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria: 
        a. Patients must be able to give informed consent; 
        b. 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; 
        c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; 
        d. 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. 
 
        e. 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 this information in the 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.