Medicare Coverage Issues Manual - Transmittal 173
Section 35-85, Implantable Automatic Defibrillators, is revised to specify that we have expanded the coverage policy for: Coronary artery disease with a documented prior myocardial infarction (MI), a measured left ventricular ejection fraction < 0.35, and inducible, sustained ventricular tachyarrhythmia or ventricular fibrillation at electrophysiology study; or documented prior MI and a measured left ventricular ejection fraction < 0.30 and a QRS duration of > 120 milliseconds. Also in CIM §§ 35-85, we specify that: all other indications for defibrillators not otherwise specified in this section of the CIM remain noncovered except when furnished in accordance with Food and Drug Administration-approved protocols governing Category B Investigational Device Exemption (IDE) clinical trials as stated in 60 FR 48417.
This section of the CIM is the National Coverage Determination (NCD). The NCDs are binding on all carriers, intermediaries, peer review organizations, health maintenance organizations, competitivemedical plans, and health care prepayment plans. Under 42 CFR 422.256(b), and NCD that expands Medicare coverage is also binding on a Medicare+Choice Organization. In addition, an Administrative Law Judge may not review an NCD. (See §1869(f)(1)(A)(i) of the Social Security Act.)
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: August 22, 2003
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