National Coverage Analysis (NCA) Tracking Sheet

Magnetic Resonance Imaging (MRI)



Magnetic resonance imaging (MRI) is a noninvasive method of graphically representing the distribution of water and other hydrogen-rich molecules in the human body. MRI is a useful diagnostic imaging modality that is capable of demonstrating a wide variety of soft-tissue lesions with contrast resolution equal or superior to computerized tomography (CT) scanning in various parts of the body.

Section 220.2 of the National Coverage Determination (NCD) Manual, as recently updated, establishes coverage of MRI for a number of uses. Coverage is limited to MRI units that have received FDA premarket approval, and such units must be operated within the parameters specified by the approval. However, payment for an MRI examination is not covered by Medicare for patients with cardiac pacemakers (Section 220.2, C.1):

  1. "Contraindications

    "The MRI is not covered when the following patient-specific contraindications are present. It is not covered for patients with cardiac pacemakers or with metallic clips on vascular aneurysms. MRI during a viable pregnancy is also contraindicated at this time. The danger inherent in bringing ferromagnetic materials within range of MRI units generally constrains the use of MRI on acutely ill patients requiring life support systems and monitoring devices that employ ferromagnetic materials. … "

CMS has received a request to reconsider the NCD for MRI. The requestor has asked that the contraindication to coverage for MRI be modified for patients with cardiac devices who undergo MRI if: (1) a clinically-indicated MRI is performed as part of a prospective clinical trial designed to determine the risk of the procedure, and (2) the study is conducted after an Investigational Device Exemption (IDE) has been approved by the Food and Drug Administration (FDA) for the proposed research.

National Coverage Determinations

Benefit Category

Diagnostic Services in Outpatient Hospital
Diagnostic Tests (other)

Requestor Information

Requestor NameRequestor Letter
Robert Russo, MD, PhD, FACC, Director, Intravascular Imaging Program, Director, Cardiac MRI Program, Division of Cardiovascular Diseases, Scripps Clinic, Adjunct Assistant Professor in Molecular and Experimental Medicine, The Scripps Research Institute View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
06/28/2010 - 07/28/2010
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
12/01/2010 - 12/31/2010
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Brijet Burton Coachman
Lead Medical Officers
Jeffrey Roche, MD

Actions Taken

June 28, 2010

CMS opens this NCA for MRI for Patients with Implanted Cardioverter Defibrillators or Pacemakers who are in Clinical Studies. CMS is requesting public comments on the evidence regarding the effects of MRI on health outcomes in patients with these implanted devices. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review. We are particularly interested in obtaining public comment on the clinical study designs that would provide sufficient methodologic rigor to answer questions on the benefits and harms attributable to the use of of implanted cardiac pacemakers and ICDs in an MRI environment.

Instructions on submitting public comments can be found at You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

December 1, 2010

February 24, 2011

CMS posts the final decision memo.