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National Coverage Analysis (NCA) Tracking Sheet

Magnetic Resonance Imaging (MRI)

CAG-00399R

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Issue

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 CT scanning in various parts of the body.

Section 220.2 of the National Coverage Determination (NCD) Manual, effective since 1985, 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. In addition, the services must be reasonable and necessary for the diagnosis or treatment of the specific patient involved. The NCD states that blood flow measurement, imaging of cortical bone and calcifications, and procedures involving spatial resolution of bone and calcifications, are not considered reasonable and necessary indications within the meaning of section 1862(a)(1)(A) of the Social Security Act, and are therefore noncovered.

The requestors have asked CMS to reconsider Section 220.2 and specifically remove the reference to blood flow measurement in the nationally non-covered indications.

We have received public input requesting CMS to also revise the current language on contraindications. That language states:

  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. In addition, the long imaging time and the enclosed position of the patient may result in claustrophobia, making patients who have a history of claustrophobia unsuitable candidates for MRI procedures.

The requestor has asked us to modify the Contraindications section to permit coverage of MRI when devices such as cardiac pacemakers have been designed, tested and FDA labeled for use in the MRI environment. We have broadened the scope of this review to include this request and are soliciting additional public comment.

National Coverage Determinations

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
American College of Radiology (ACR), American College of Cardiology (ACC), North American Society for Cardiovascular Imaging (NASCI), and the Society for Cardiovascular Magnetic Resonance (SCMR) View Letter
Medtronic, Inc. View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
01/20/2009
Expected NCA Completion Date
09/28/2009
Public Comment Period
03/16/2009 - 04/15/2009
Proposed Decision Memo Due Date
Proposed Decision Memo Released
06/30/2009
Proposed Decision Memo Public Comment Period
06/30/2009 - 07/30/2009
Decision Memo Released
09/28/2009
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Kimberly Long
kimberly.long@cms.hhs.gov
410-786-5702
Brijet Burton Coachman
Lead Medical Officers
Ross Brechner, MD

Medicare Benefit Category Determination Date

Actions Taken

January 20, 2009

CMS opens this reconsideration of the NCD on Magnetic Resonance Imaging (MRI). CMS has been asked to ensure the cardiac MRI is covered under Section 220.2 by specifically removing the phrase "blood flow measurement" from the nationally non-covered indications. CMS is requesting public comments as to whether that, in fact, would accomplish the requestor's goal. We would also like public comments on whether cardiac imaging and functioning is included under Magnetic Resonance Angiography (MRA) Section 220.3 of the NCD Manual and whether imaging of the cardiac chambers and cardiac function is noncovered as a result of the "all other uses of MRA noncovered" statement in that NCD. In addition, we are interested in the evidentiary support for the use of MRI in cardiac imaging and functioning. 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 technology under review.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html. 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.

March 16, 2009

During the initial 30-day comment period, CMS received a request [PDF, 2MB] from Medtronic, Inc. to revise the current language on contraindications as described above.  We are soliciting additional public comment for 30 days on this aspect of the request.

To submit a comment, please use the orange "COMMENT" button at the top of the page.

June 30, 2009

CMS is requesting public comments on the proposed decision. The 30-day public comment period begins with this posting date, and ends after 30 calendar days. Instructions on submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

To submit a comment, please use the orange COMMENT button at the top of the page.

September 28, 2009
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