Skip to Main Content

Magnetic Resonance Angiography and Magnetic Resonance Imaging

The Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) in 2010 that merged the Magnetic Resonance Angiography (MRA) and the Magnetic Resonance Imaging (MRI) NCDs. At that time, coverage was 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 had not specifically indicated national coverage or national non-coverage were at the discretion of Medicare’s local contractors. 

On February 24, 2011, CMS issued an NCD that provided coverage of MRI for beneficiaries with implanted pacemakers (PMs) or implantable cardiac defibrillators through Coverage with Evidence Development in approved clinical studies of MRI.  Effective April 10, 2018, CMS issued an NCD that eliminated the CED data collection requirement.  For historical purposes, the studies listed below are those that were approved by CMS while the CED requirement was in effect.

Decision memo

Approved Studies

Study Title: Assessment Of MRI In Patients With Implanted Cardiac Devices
Sponsor: University of Arizona
Clinicaltrials.gov number: NCT02815384
CMS Approval Date: 10/12/2017

Study Title: Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
Sponsor: Banner Health
ClinicalTrials.gov Number: NCT02906189
CMS Approval Date: 03/29/2017

Study Title: Safety and Clinical Outcomes of Magnetic Resonance Imaging on CMS Beneficiaries with Cardiac Implantable Electrical Devices:  A Prospective Study
Sponsor: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Number:  NCT03016429
CMS Approval Date: 11/30/2016

Study Title: Determining Risks of MRI in the Presence of Cardiac Implantable Electronic Devices (CIEDs)
Sponsor: Mayo Clinic
ClinicalTrials.gov Number: NCT02357082
CMS Approval Date: 09/07/2016

Study Title: An Expanded Evaluation of the Safety of Clinically Indicated Magnetic Resonance Imaging in Patients with Permanent Pacemakers (PPM's) and Implanted Cardioverter Defibrillators (ICD's)
Sponsor: Johns Hopkins University
ClinicalTrials.gov Number: NCT02888353
CMS Approval Date: 7/26/2016

Study Title: Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds (ENABLE MRI)
Sponsor: Boston Scientific Corporation
ClinicalTrials.gov Number: NCT02652481
CMS Approval Date: 04/05/2016

Study Title:  Prospective Observational Study:  Evaluating the use of MRI on CMS beneficiaries with pacemakers and/or Implantable Cardioverter Defibrillators
Sponsor:  Penn Medicine
ClinicalTrials.gov Number:  NCT02513056
CMS Approval Date: 07/23/2015

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

.