CMS Updates MRI and Implanted Cardiac Devices Coverage

CMS does not specify effective date for new changes.

The Centers for Medicare and Medicaid Services (CMS) has published a decision memo for Magnetic Resonance Imaging (MRI). The decision memo, posted on Tuesday by CMS, reviewed the proposed updates to the National Coverage Determination (NCD) 220.2 (C )(1) and 220.2 (B) (3) policy. It is important to note that the decision memo did not identify an effective date for these changes.

An MRI is an imaging techniquethat uses powerful magnets, radio waves, and a computer, according to WebMD. The benefit of this testing is that it does not use a form of radiation, unlike Computer Tomography (CT) or X-rays.

The memo provides revised language which removes the contraindication for MRI for Medicare beneficiaries that have an implanted pacemaker or implanted cardioverter defibrillator. Coverage is expanded to include cardiac resynchronization therapy pacemakers or cardiac resynchronization therapy defibrillator devices. This memo also expands coverage to Medicare beneficiaries who have a Federal Drug Administration (FDA)-approved or non-FDA-labeled pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator which meet specific MRI criteria. This memo also removes the Coverage with Evidence Development (CED) requirement.

Initially, MRIs were not covered for Medicare beneficiaries who had a pacemaker or metal clips for vascular aneurysm repairs. In July 2011, the pacemakers with FDA labeling or that met the Coverage with Evidence Development criteria were included in Medicare coverage. The Coverage with Evidence Development is the acknowledgement that the testing is used for data gathering in conjunction with a clinical trial. This requirement of Coverage with Evidence Development has been removed.

A significant number of clinical trial summaries were reviewed to determine that MRIs are appropriate for patients with implanted cardiac devices. (The study citations are provided at the end of the memo.) This decision memo indicates that MRI has been approved for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

The non-FDA-approved devices must continue to meet this set of criteria:

1. MRI field strength is 1.5 Tesla using Normal Operating Mode;
2. The implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy, or cardiac resynchronization therapy defibrillator system has no fractured, epicardial, or abandoned leads;
3. The facility has completed a specified checklist which includes a patient assessment, potential benefits and harms are discussed, the device is interrogated prior to MRI, and qualified personnel supervise the test; observation of patient is completed throughout test; advanced cardiac life support is available; and a discharge plan is completed which includes device re-interrogation and discharge from the facility.

The thirty-day comment period yielded fourteen public comments which included support from physicians, medical device manufacturers, professional organizations, and medical societies. Clinical trial summaries were reviewed which supported the use of MRI technology with the implanted cardiac devices.

Continue to watch the NCD updates for an effective date of this revised policy. The website for the NCD Index is listed in the Resources.

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