Here are three notes on the coverage expansion.
1. In 2011, CMS said MRIs for Medicare beneficiaries with cardiac devices could only be covered in “evidence development” cases, or clinical trials.
2. Medicare will now cover an MRI when used according to labeling from the Food and Drug Administration in an MRI environment suitable for patients with cardiac devices. Patients with cardiac devices lacking FDA labeling for use in an MRI environment will only be covered under certain conditions.
3. The decision affects beneficiaries with an implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator device.
For the full decision memo, click here.
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