Magnetic Resonance Angiography and Magnetic Resonance Imaging

The Centers for Medicare and Medicaid Services (CMS) issued a 2010 National Coverage Decision (NCD) that merged the Magnetic Resonance Angiography (MRA) and the Magnetic Resonance Imaging (MRI) NCDs. Currently, coverage is limited to MRI units that have received Food and Drug Administration (FDA) premarket approval, and such units must be operated within the parameters specified by the approval. Other uses of MRI for which CMS has not specifically indicated national coverage or national non-coverage are at the discretion of Medicare’s local contractors.

On February 8, 2011, the FDA granted approval of the first pacemaker designed for use in the MR environment for certain MRI exams. On February 24, 2011, CMS issued a NCD that provided coverage of MRI for beneficiaries with implanted pacemakers (PMs) or implantable cardiac defibrillators through Coverage with Evidence Development (CED)/Coverage with Study Participation (CSP) in approved clinical studies of MRI. The NCD was updated in July 2011 to remove the contraindication for Medicare coverage of MRI in beneficiaries with implanted PMs when the PMs are used according to the FDA-approved labeling for use in an MRI environment. Other contraindications that may be present in any given beneficiary continue to apply in patients with PMs.

Decision memo

Approved Studies

Study Title: Safety of MRI for Patients with Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICD
Sponsor: Lancaster General Hospital
ClinicalTrials.gov Number: NCT02318550
CMS Approval Date: 03/17/2015

Study Title: Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
Sponsor: Medtronic
ClinicalTrials.gov Number: NCT02117414
Investigational Device Exemption (IDE) Number: G140039
CMS Approval Date: 07/10/2014