Magnetic Resonance Imaging (MRI)

December 30, 2010

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
Room C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memorandum for Magnetic Resonance Imaging (CAG-00399R2)

Dear Dr. Jacques:

On behalf of St. Jude Medical, Inc., I am submitting these comments in response to the draft Decision Memorandum that was posted on December 1, 2010, with respect to a reconsideration of Medicare coverage policy for Magnetic Resonance Imaging (MRI). This Decision Memorandum addresses national Medicare coverage of MRI for patients with implantable pacemakers and defibrillators. St. Jude Medical appreciates the opportunity to review this draft national coverage determination and to share our views on its content.

We are pleased that the Centers for Medicare & Medicaid Services (CMS) agrees that the use of MRI in patients with pacemakers and implantable cardioverter defibrillators (ICDs) is a clinically-important question for the Medicare population that should be addressed by further research. As pointed out by Dr. Russo, who requested this coverage determination, millions of Medicare beneficiaries have implanted pacemakers and ICDs, and there is a significant risk that they will require an MRI—a procedure that is currently not covered for these patients. Unless an exception to this national coverage policy is made, clinical trials to determine the safety of this procedure for beneficiaries with pacemakers or ICDs may not be feasible.

Over the years, the role that Medicare has played in encouraging and supporting the Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trials and in the generation of evidence to inform coverage decision-making through its clinical trials coverage policies has speeded beneficiary access to state-of-the-art medical care. Our expectation was that CMS would take a similar, progressive stance in encouraging more evidence to be generated for pacemaker and ICD patients who need a clinically-indicated MRI. Our reading of the proposed Decision Memorandum, however, leads us to conclude otherwise.

The proposed national coverage determination appears to be overly prescriptive in the sort of clinical trial it would support. Our concern is that the proposed decision may be implemented in such a way that it will provide coverage only to those clinical trials that are found by CMS to constitute “ideal” evidence—evidence which traces the MRI study to its impact on physician diagnostic thinking, to changes in diagnostic or treatment strategies that are employed, to measurable improvements in patient outcomes. MRI studies are currently covered for Medicare beneficiaries for specified clinical indications when these studies are performed with instruments that have received required FDA pre-market clearances. We do not think that their impact on diagnostic thinking, diagnostic and treatment strategies, and patient outcomes needs be re-proven in Coverage with Evidence Development (CED)/Coverage with Study Participation (CSP) studies.

In our view, the final CMS Decision Memorandum on this matter should invite clinical research on the safety issue at hand by providing Medicare coverage under CED/CSP for the situations under which the current MRI contraindication for pacemakers and ICDs can be dropped, so that beneficiaries will have access to the benefits this diagnostic technology affords.

The final Decision Memorandum should encourage a variety of study designs, including registries and prospective studies, where the current draft Decision Memorandum appears to favor only a single “ideal” trial. We also recommend that CMS encourage pacemaker and ICD manufacturers to address these matters head on by covering Category B FDA IDE clinical trials of pacemakers and ICDs in patients receiving clinically-indicated MRI studies.

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In summary, the proposed Decision Memorandum for Magnetic Resonance Imaging (CAG-00399R2) appears to be overly prescriptive in the sort of clinical trial it would support. Though we agree with CMS on the characteristics of “ideal” evidence, which links a diagnostic intervention to diagnostic thinking, the selection of diagnostic and treatment strategies, and measurable patient outcomes, we do not think that the impact of MRI on patient outcomes needs be re-proven in the clinical research CMS proposes to cover under CED/CSP. This research should focus on the situations under which the current MRI contraindication for pacemakers and ICDs can be dropped so that beneficiaries will have access to the benefits this diagnostic technology affords.

The final Decision Memorandum should cover a variety of study designs, including registries and prospective studies, where the current draft Decision Memorandum appears to favor only a single “ideal” trial. CMS should also encourage pacemaker and ICD manufacturers to address these matters head on by covering Category B FDA IDE clinical trials of pacemakers and ICDs in patients receiving clinically-indicated MRI studies.

We appreciate the opportunity to submit these comments. If you have any questions, please contact me directly at 818-493-3723 or mcarlson@sjm.com.

Sincerely,

Mark Carlson, MD
Chief Medical Officer and Senior Vice President, Research and Clinical Affairs
St Jude Medical, Cardiac Rhythm Management Division

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December 30, 2010

Louis B. Jacques, MD
Director
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD

Re: Magnetic Resonance Imaging (MRI) (CAG-00399R2)

Dear Dr. Jacques:

The American College of Cardiology (ACC) is pleased to submit comments on the proposed coverage memorandum for the second reconsideration of the MRI coverage determination. The College is a 39,000-member nonprofit medical society composed of physicians, nurses, nurse practitioners, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The ACC is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The College provides professional education and operates national registries for the measurement and improvement of quality care. We appreciate the opportunity to comment on the National Coverage Analysis on performing clinically indicated MRI scans of patients with implantable cardioverter defibrillators (ICDs) or pacemakers who are participating in prospective clinical studies designed to determine the risk of the MRI procedure and conducted after an Investigational Device Exemption (IDE) has been approved by the Food and Drug Administration (FDA) for the proposed research.

The number of patients with ICDs or pacemakers has expanded substantially in recent years. Because of its unique capabilities, MRI has become a critical tool for evaluating patients with a variety of diseases or conditions. As a result of these developments, the number of patients who have implantable devices and also present with the standard indications for MRI is increasing. However, patients with pacemakers or ICDs are currently not approved for MR because of potentially life-threatening risks.¹ Pacemakers are one of only two devices specifically contraindicated for MRI scanning in the original policy, which was developed in 1994. Since that time, industry has worked to develop MRI conditional pacemakers and ICDs that address the safety concerns expressed by the FDA in the 2006 editorial in Circulation by Faris and Shein².

There are a number of promising studies that show that MRI, when done with the appropriate safeguards, can be performed safely on patients with pacemakers or ICDs. We agree that a multicenter trial incorporating one method of safety across multiple vendor platforms would be an important contribution to the field.

An equally important initiative would be a registry to document patients that have undergone MRI outside of a multicenter trial. As CMS is aware, all patients scanned cannot be captured in a trial. A registry would allow inclusion and follow-up of patients with implantable devices done in a real-world environment. Not all MRI centers have the staffing or financial resources to participate in a clinical trial yet may be able to contribute valuable patient data. Additionally, the registry would allow providers affiliated with programs that have expertise in MR imaging and electrophysiology to facilitate appropriate patient access to comprehensive care. Central to the design of a registry is the importance of protecting patients from harm. The registry would need to ensure that patients are followed for an appropriate length of time and that recording of adverse events and scanning methods is mandated.

FDA approval should be a minimum requirement for safely imaging pacemaker patients outside of a clinical trial setting. In addition, a registry protocol should comply with the recommendations for the performance of MRI in patients with pacemakers or ICDs made in the American Heart Association Scientific Statement on the safety of MRI in patients with cardiovascular devices.³ The recommendations from this statement are as follows:

• MRI of non–pacemaker-dependent patients and patients with ICDs should only be considered when there is a strong clinical indication and when the benefits clearly outweigh the risks
• MRI of pacemaker-dependent patients should not be performed unless there are highly compelling circumstances and when the benefits clearly outweigh the risks
• Scanning should only be performed at extremely experienced centers with expertise in MR imaging and electrophysiology
• Written informed consent that specifically lists risks of pacemaker or ICD dysfunction or damage, arrhythmia, and death should be obtained
• A physician with advanced cardiac life support and pacemaker and ICD expertise should decide whether it is necessary to reprogram the pacemaker or ICD before the MR examination and should be in attendance for the entire study
• A person with expertise in MR physics and safety should be involved with the scan to optimally plan the scan to minimize risk
• The device needs to be checked immediately before and after the MRI scan
• The patient’s heart rhythm and vital signs should be monitored throughout the MRI
• Appropriate personnel and a "crash cart," including defibrillator, must be available throughout the procedure to address an adverse event.

The combination of a trial and/or registry would provide clinicians with the data necessary to maximize safety in patients with pacemakers or ICDs in need of MRI. Therefore, we recommend that CMS not solely require enrollment in a clinical trial in order for patients to undergo this important procedure. We believe that the second reconsideration of this coverage determination for MRI should provide an exception for patients with cardiac devices who undergo MRI when:

• A clinically indicated MRI is performed as part of a prospective registry to monitor and record the risk of the procedure and the outcomes;
• The registry is implemented after an IDE has been approved by the FDA; and
• CMS ensures that the registry is designed to protect patient safety by complying with the recommendations for the performance of MRI in patients with pacemakers or ICDs made in the American Heart Association Scientific Statement on the safety of MRI in patients with cardiovascular devices.

We would welcome an opportunity to discuss with the Agency options for funding a clinical registry. A collaborative public-private partnership would be most beneficial to the establishment of a meaningful data collection tool.

Thank you for your consideration, we look forward to continued dialogue with CMS. If you have questions, please contact Lisa P. Goldstein at (202) 375-6527 or via e-mail at lgoldstein@acc.org.

Sincerely,

Ralph G. Brindis, MD, MPH, FACC
President, American College of Cardiology

Eike Nagel, MD
President, Society for Cardiovascular Magnetic Resonance

Richard Fogel, MD, FHRS
Chair, Health Policy Committee
Heart Rhythm Society

Bruce Wilkoff, MD, FHRS*
President-Elect
Heart Rhythm Society

* Dr. Wilkoff was a coordinating investigator for the EnRhythm MRI randomized clinical trial, lead author of the publication of the trial results, participated in the presentation before the FDA panel of the PMA application and was an unpaid consultant for Medtronic during the development and testing of the EnRhythm MRI pacemaker.

¹Hayes DL, Lloyd MA, Friedman PA. Cardiac pacing and defibrillation: A clinical approach. 2000 Futura Publishing Company, Inc.

²Faris O, Shein M. Food and Drug Administration Perspective Magnetic Resonance Imaging of Pacemaker and Implantable Cardioverter-Defibrillator Patients. Circulation 2006; 114:1232-1233.

³ Levine GN, Gomes AS, Arai AE, Bluemke DA, Flamm SD, Kanal E, Manning WJ, Martin ET, Smith JM, Wilke N, Shellock FS. Safety of magnetic resonance imaging in patients with cardiovascular devices. An American Heart Association Scientific Statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and Council on Cardiovascular Radiology and Intervention. Circulation 2007; 116: 2878-2891.

REFERENCES:

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December 29, 2010

James Rollins, MD
Director, Division of Items and Devices
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Blvd.
Mail Stop C1-09-06
Baltimore, MD 21244

Dear Dr. Rollins:

Re: Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R) to revise the Contraindication for Cardiac Pacemakers (Section 220.2 of the Medicare NCD Manual)

Thank you for the opportunity to comment regarding the second reconsideration for Magnetic Resonance Imaging to revise the contraindication for cardiac pacemakers. The proposed NCD would extend coverage of MRIs to patients with pacemakers or ICDs when conducted under clinical study. We are pleased with your willingness to consider expanded coverage but wish to comment on some of the CED requirements suggested in the proposed decision.

In the Proposed Decision Memorandum CMS states that:

We agree with the latter portion of the statement, as it refers to safety as a necessary condition for coverage. However, we have very significant concerns with the premise that health outcomes associated with MRI need to be re-proven for pacemaker patients receiving an MRI, as suggested by the inclusion of questions on clinical utility in the NCD. The premise of having to reprove health outcomes of MRI is foundationally wrong given the context of the question on the table - can pacemaker patients safely receive those benefits.

The health outcomes of MRI are already accepted by CMS as suitable for coverage in the National Coverage Determination. As stated in CMS coverage manual section 220.2:

We would note, for example, the use of MRI for the neck has a level 8 appropriateness rating from the American College of Radiology supported by numerous articles including the three listed below.1,2,3 Research of this nature has already been accepted by CMS as sufficient for MRI coverage and should not have to be replicated for each patient population, when provided safely.

A clinical utility approach would also lead to unnecessary research and, in our view, be contrary to condition c in the memorandum:

as the studies necessary for existing coverage of MRIs have already been completed.

Thank you for your consideration

Sincerely,

Bob Thompson, MS., MA.
Senior Director, Reimbursement, Economics and Health Policy
Cardiac Rhythm Disease Management
Medtronic, Inc.
763-526-2928

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July 28, 2010,

Jeffrey Roche, MD
Medical Officer
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Roche:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) national coverage analysis (NCA) tracking sheet for Magnetic Resonance Imaging (MRI) (CAG-00399R2). America’s Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments

AHIP supports CMS''s efforts to ensure that all Medicare beneficiaries receive the most effective and appropriate treatments based on current and valid scientific evidence. CMS received an external request to reconsider and revise the current contraindications section of the MRI national coverage decision (NCD) (220.2). The requestor is asking CMS to permit coverage of MRIs when beneficiaries have implanted devices such as cardiac pacemakers, or other devices containing metal, when the MRI is performed in a clinical study if approved by the Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE). AHIP and our member plans do not support modifying the current contraindications section of the MRI NCD as requested, as there are currently no pacemakers approved for use when patients (with pacemakers) receive MRIs in the U.S., and FDA has not granted an IDE for this use. In order for health plans to consider coverage for a product or device, FDA approval or an approved IDE status is required. Coverage of such a product will then be determined based on a thorough review of the current evidence base. Given that there are currently no such devices approved for use when patients (with pacemakers) receive MRIs or an approved IDE for this use, proposing a revision of the contraindications for coverage of MRI for patients with these devices is premature and may place patients at risk.

In addition, it appears that coverage of MRIs for this population within a clinical study, after an IDE is granted, does not comply with Medicare’s current Clinical Trial Policy (NCD 310.1). The policy states that routine patient care costs that are covered by Medicare do not include: items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan). Our members support CMS policy regarding providing coverage for only items and services that comply with the current CMS Clinical Trial Policy. Thank you for the opportunity to comment on this important issue.

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We routinely obtain MRI studies in patients with pacemakers for our neurosurgery colleagues, for instance in patients with pituitary tumors that cannot be imaged well using any other imaging modality. These patients undergo a dedicated cardiology evaluation prior to the MRI study, and are accompanied by a EEP cardiologists and a EEP nurse prior, during and immediately after the MRI study. Patients are consented prior to the procedure. This approach is safe and needed for our patients. If the new proposed decision is accepted, there would be logistics barriers for our patients to get their MRIs and this would unfavorably impact their care and outcome.

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