August 11, 2017
Tamara S. Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244
By Online Submission
RE: National Coverage Analysis (NCA) Magnetic Resonance Imaging (MRI) (CAG-00399R4)
Dear Ms. Syrek Jensen,
The American College of Radiology (ACR), representing more than 37,000 diagnostic radiologists, interventional radiologists, radiation oncologists, nuclear medicine physicians and medical physicists, appreciates this opportunity to provide comments on the National Coverage Analysis (NCA) for Magnetic Resonance Imaging (MRI) (CAG-00399R4), posted July 12, 2017. However, there has been confusion surrounding the reason for the internally generated MRI NCA with unclear guidance on the comments CMS is soliciting. Unfortunately, this may result in less robust public comments, with broad reaching incomplete MRI recommendations.
The July 12th, 2017 NCA MRI Tracking Sheet (CAG-00399R4) states:
“CMS is opening this national coverage analysis to reconsider coverage indications for MRI. This reconsideration is limited to MRI and does not include any coverage determination about magnetic resonance (MR) conditional pacemakers, MR conditional ICDs, or any other pacemaker or ICD. See Medicare’s NCD on Cardiac Pacemakers at 20.8 and Implantable Automatic Defibrillators at 20.4 of the NCD Manual”.
On July 17, 2017, CMS provided follow-up clarification to the ACR by email which the ACR recommended CMS make public before the August 11, 2017 comment deadline. Based on the CMS clarification, the ACR comments are focused on the performance of MRI on patients with cardiovascular implantable electronic devices and the MRI NCD language surrounding contra-indications for those patients who have implanted cardiac pacemakers.
“CMS is opening this national coverage analysis (NCA) to reconsider coverage indications for MRI. Since CMS released the NCD covering MRI under CED in February 2011, research in the field of MRI and cardiovascular implantable electronic devices has been rapidly evolving, as documented by a number of publications including a professional society consensus statement from the Heart Rhythm Society (HRS) published May 2017 entitled, “2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices”. As such, we decided that rather than wait for the ongoing CED studies to be completed, which would take a number of years, we would reconsider the NCD now to ensure that our coverage policy is consistent with the currently available evidence base.”
The February 24, 2011 CMS Decision Memorandum for Magnetic Resonance Imaging (CAG-00399R2) limits coverage to those MRI instruments having received FDA premarket approval AND excludes coverage of non-FDA approved cardiac devices (see below) unless studied in a clinical study Coverage with Evidence Development (CED).
“Section 220.2 of Chapter 1 of the Medicare National Coverage Determination (NCD) Manual provides coverage of MRI for a number of clinical indications. Coverage is limited to MRI instruments that have received FDA premarket approval, and such units must be operated within the parameters specified by the approval.
In addition (and as noted by the requester), payment for an MRI examination is not currently covered by Medicare if certain contraindications are present. These include cardiac PMs (as indicated in the following section of the Medicare NCD Manual, Chapter 1, Section 220.2.C.1, as downloaded by CMS staff on November 2, 2010):
C. Contraindications and Nationally Non-Covered Indications
"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. …
(Source: Medicare On-line NCD Manual, available at www.cms.hhs.gov).
….Most recently, a 2009 NCD removed a contraindication from 220.2.C.2 concerning blood flow measurement. Other uses of MRI for which CMS has not specifically indicated national coverage are under local contractor discretion.
The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is not adequate to conclude that the use of magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) or implantable cardioverter defibrillators (ICDs), and thus we determine that it is not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act (the Act). Therefore, subject to one exception, we will retain the current general contraindications at Chapter 1, Section 220.2.C.1 in the NCD Manual.
CMS believes that the evidence is promising although not yet convincing that MRI will improve patient health outcomes if certain safeguards are in place to ensure that the exposure of the device to an MRI environment adversely affects neither the interpretation of the MRI result nor the proper functioning of the implanted device itself. We believe that specific precautions (listed below) could maximize benefits of MRI exposure for beneficiaries enrolled in clinical studies designed to assess the utility and safety of MRI exposure. Therefore, CMS determines that MRI will be covered by Medicare when studied in a clinical study under § 1862(a)(1)(E) (consistent with § 1142 of the Act) if the study meets the criteria…”
MRI of Patients with Implantable Cardiac Devices
The ACR supports the performance of MRI in patients who have MR non-conditional implantable cardiac devices when all of the following are met: (1) there is consensus by the overseeing practitioners involved that is consistent with established consensus criteria, such as the 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices, and (2) when there is no other modality medically appropriate.
Consistent with current guidelines patients are referred to radiologists to be imaged by MRI for numerous indications, including assessment of neurological conditions (to include neoplasia or masses, inflammatory and autoimmune disease, vascular disorders, congenital disorders, dementias, epilepsy and movement disorders, psychiatric disorders, spinal disorders), bone and joint conditions, abdominal and thoracic diseases (to include neoplastic conditions and aortic, pulmonary artery and other vascular conditions), cardiac conditions, and pelvic disorders (to include gynecological and prostate cancers), among others. MRI is especially needed in surveillance of disease response in oncology patients, many of whom require multiple MRI examinations. These are only some of the disorders in patients who require MRI diagnostic examinations and surveillance to examine response to treatment. Patients with these conditions are often elderly and have concomitant cardiovascular disease requiring the presence of a pacemaker or ICD.
Extensive consideration and approval was previously given by the FDA for cardiac conditional devices. Based on recent evidence, it is clear the same patient clinical need exists for non-conditional devices. While MRI may not be necessary for every patient, we strongly believe that clinical need for providing high quality care to the individual patient is critical. MRI coverage should be driven by clinical need. Indeed exclusion of patients with non-conditional devices may adversely affect care in patients with various indications.
The Heart Rhythm Society (HRS) in collaboration with key stakeholder groups including the ACR put forth a current and expert consensus document addressing MRI performed in patients with cardiac implantable electronic devices. The performance of MRI in patients with labeled and non-labeled pacing systems is being done safely and effectively. The criteria used to determine the appropriateness of the requested MRI examination is based on the approval and consensus of the requesting clinical service and the covering radiologic service.
The framework for evaluating risks and benefits as patients consider treatment options are included in the HRS Expert Consensus Statement and attached for your consideration. The ACR encourages CMS to utilize this established consensus document to help implement medically reasonable and necessary coverage and define appropriate policy for both the Medicare beneficiaries and providers in the decision making process.
Thank you for this opportunity to comment and consider appropriate coverage for the performance of MRI in patients with non-conditional cardiac devices. If you have any questions or comments, please contact Anita McGlothlin at 800-227-5463 ext. 4923 or via email at email@example.com.
William T. Thorwarth, Jr, MD, FACR
Chief Executive Officer
Cc: Todd D. Greenberg, MD, Chair, ACR MR Safety Committee
Lincoln Berland, MD, FACR, Chair, ACR Commission on Body Imaging
Ezequiel Silva, III, MD, Chair, ACR Commission on Economics
Pamela Woodard, MD, FACR, Chair, ACR Collaborative Committee, Practice Parameters for the Performance and Interpretation of Cardiac MRI