Magnetic Resonance Imaging (MRI)

July 30, 2009

Ross Brechner, MD, MS, MPH
Medical Officer
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard Baltimore, MD 21244

RE: CAG 00399R (Proposed Decision Memo for Magnetic Resonance Imaging)

The American College of Cardiology (ACC), American College of Radiology (ACR), North American Society for Cardiovascular Imaging (NASCI) and the Society for Cardiovascular Magnetic Resonance (SCMR), are pleased to submit comments in response to the Proposed Decision Memo for Magnetic Resonance Imaging (CAG 00399R). We appreciate CMS’ acceptance and opening of the MRI NCD and agree with the Proposed Decision Memo.

Our societies fully support CMS’ Proposed MRI Decision to remove the phrase “blood flow measurement”, from the Nationally Noncovered Indications at 220.2©(2) of the National Coverage Determinations Manual. Additionally, we agree with section 220.2(D) regarding local Medicare contractor discretion to cover this use. We further agree with CMS that blanket noncoverage of MRI for blood flow determinations is no longer supported by the available evidence. This positive coverage decision for MRI flow quantification will lead to better treatment decisions than alternative or more invasive diagnostic techniques.

Thank you for the opportunity to provide further comments on this important coverage determination for MRI and blood flow measurements. If you have any questions or need additional information, please contact either Denise Garris at denise@korrisgroup.com; Rebecca Kelly at rkelly@acc.org; or Anita McGlothlin at amcglothlin@acr-arrs.org.

Sincerely,

Harvey L. Neiman, MD, FACR Executive Director, American College of Radiology [Endorsed copies to be submitted via email]

Alfred A. Bove, MD, PhD, FACC
President, American College of Cardiology

[Endorsed copies to be submitted via email]

Pamela Woodard, MD
President, North American Society for Cardiovascular Imaging[Endorsed copies to be submitted via email]

Christopher Kramer, MD
President, Society for Cardiovascular Magnetic Resonance

[Endorsed copies to be submitted via email]

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July 30, 2009

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

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)

Dear Dr. Jacques:

Thank you for considering our request to revise the NCD for Magnetic Resonance Imaging (MRI) to include coverage for pacemakers and ICDs that have been designed, tested, and FDA-labeled for use in the MRI environment. Though we are disappointed that CMS did not propose to remove the contraindications for implantable pacemakers and ICDs at this time, we appreciate that the proposed decision memorandum expresses CMS’s willingness to reconsider the request when an MRI-safe pacemakers and ICDs is approved by the FDA.

In anticipation of FDA approval, we have carefully reviewed the Proposed Decision Memo (DM) and would like to seek clarification on a specific point raised in the memo. We would also like to recommend and work with CMS on ways in which coverage can be expedited for pacemakers or ICDs approved by FDA for use in the MRI.

Safety and Health Outcomes of Pacemakers and ICDs approved by FDA for Use in the MRI

The proposed decision memorandum states:

The contraindication in the current NCD exists not because patients with implantable pacemakers and ICDs are inherently unable to derive a benefit from MRIs, but because the presence of implantable pacemakers and ICDs make it potentially unsafe for patients to undergo an MRI and to derive such benefit. As the NCD demonstrates, there are in fact a number of indications for which MRIs have been determined to improve patient health outcomes for Medicare beneficiaries who are not otherwise contraindicated for MRIs, and thus MRIs are considered reasonable and necessary for them.

The purpose of the study we are conducting on these new pacemakers is not to show that MRIs improve outcomes per se (many other studies on MRI have in fact done that). It is to show that such devices are in fact safe for use during an MRI, and that the contraindication against implantable pacemakers should be removed for devices found safe by the FDA for use in the MRI environment – thus enabling patients with such devices to benefit from MRI.

Given the statements in the proposed decision-memorandum, we ask that CMS clarify in the final DM that the standard it will be considering in reviewing the studies on these pacemakers and ICDs is not whether such studies demonstrate that MRIs improve outcomes in beneficiaries with such devices. Rather it is whether such studies demonstrate that the devices are in fact safe and thus allow patients with pacemakers and ICDs, that have been approved by the FDA for use in the MRI, to benefit from the already-proven outcomes of MRI.

We note that the bibliography for the DM includes only one article regarding the use of MRI on patients with a pacemakers or implantable Cardioverter-defibrillators (ICDs). It is a 2006 editorial in Circulation by Faris and Shein that provides the perspective of the FDA on this issue. We wish to make CMS aware of the fact that Medtronic is working to address the FDA concerns described in this editorial. As reported in Clintrials.gov, the EMRI SureScan™ Clinical Study is a randomized trial of 467 patients to demonstrate the safety of pacemakers in the MRI environment.

Subsequent Actions on Pacemakers and ICDs that Have Been FDA-Approved for Use in the MRI

We believe the development of pacemakers and ICDs that have been approved by the FDA for use in the MRI is an important advancement in technology, enabling access to advanced diagnostics and imaging not previously available to these patients. There is likely to be significant clinical and patient interest in such devices upon approval by the FDA. Recognizing the potential for such interest, we would like to request that CMS consider approaches for removing barriers to MRI coverage to ensure clinicians and patients can access this important new advancement in technology as soon as possible upon FDA approval. We suggest the following approaches in order of preference, and would be happy to work with you further on any of these options.

1. As noted above, we believe the key consideration regarding the contraindication against implantable pacemakers and ICDs is whether safety is established for devices FDA-approved for use in the MRI. Since safety is a central component of the FDA’s review, we believe it would be reasonable for CMS to amend the coverage policy at this point, in the context of the current national coverage analysis (NCA), to prospectively remove the contraindication for any implantable pacemakers and ICDs found by the FDA to be safe for use in the MRI environment.
2. If CMS does not wish to completely remove the national contraindication, language could be added to the existing policy to provide explicit authority for local coverage decisions to be made regarding implantable pacemakers and ICDs found by the FDA to be safe for use in the MRI environment. Broader reconsideration of the national contraindication could be undertaken at a later date.
3. Finally, if CMS does not pursue either of the first two options, we would request that CMS consider an expedited review such that MRI coverage for implantable pacemakers and ICDs that have been FDA-approved for use in the MRI could be granted within three months after approval. This would assure that any delays in access to the technology are kept to a minimum.

As noted above, we would be happy to work with you further on any of these approaches.

Thank you for your consideration of these options. If you have any questions or require additional information, please feel free to contact me or Franceen Horin, Senior Reimbursement Manager at 763-526-2938 or franceen.horin@medtronic.com.

Sincerely,

/s/
Bob Thompson,MS., MA.
Senior Director, Reimbursement, Economics and Health Policy
Cardiac Disease Rhythm Management
Medtronic, Inc.
8200 Coral Sea Street NW, MVS23
Mounds View, MN 55112
Office: 763-526-2936; Fax: 651-367-0808
bob.thompson@medtronic.com

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July 30, 2009

Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8017
Baltimore, Maryland 21244-8017

Attention: Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group

We appreciate the opportunity to comment on the Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R).

The following comments are offered for your consideration on behalf of the Mayo Clinic MRI/Pacemaker practice.

Over the past several years, Mayo Clinic Radiology has implemented a program, working closely with Cardiology, to perform magnetic resonance imaging (MRI) examinations in carefully selected pacemaker (PM) patients. This addresses a significant public health issue in that over 3,000,000 Americans now have a permanently implanted cardiac pacemaker and there are clearly situations in which these patients would benefit from the unparalleled imaging and diagnostic capabilities of MRI.

Whereas MRI of PM patients was considered an absolute contraindication for many years, recent data from several centers performing these exams in a similar manner to us have indicated that in properly controlled circumstances, MRI can be performed with optimized safety conditions, particularly with newer generation better shielded pacemakers (1-3). The most recent MRI Safety White Paper report from the American College of Radiology (4) states that MRIs in pacemaker patients remain a relative (but not absolute) contraindication, and that scanning is not routine, and should be done on a case-by-case basis employing appropriate knowledgeable staff.

We believe we fulfill these criteria for PM patients seen at Mayo Clinic. First, when an MRI is requested in a PM patient, a radiologist carefully triages the case to determine if alternative imaging methods are available that can answer the clinical question without resorting to MRI. For a considerable number of such patients, we recommend other imaging approaches, without pursuing the MRI. Second, if the patient is deemed to be a candidate for MRI, they then are seen in Cardiology where their PM is characterized and the extent of their cardiac and general health is assessed. In particular, their degree of PM dependence is carefully assessed. Third, if our Cardiology colleagues agree that the patient is a suitable candidate for MRI, the exam is performed under the direction of a radiologist in a carefully controlled environment after the patient has been part of a thorough risk / benefit discussion and informed consent process. Cardiology personnel are also present during the entire MRI exam. Prior to the MRI exam they program the PM, and then reprogram it after the MRI. They carefully monitor the patient’s ECG, pulse oximetry, and other physiological parameters throughout the exam. A Radiology MRI physicist (PhD level) is also present to assist with the monitoring equipment and to assist the radiologist in tailoring their MRI exam in the safest way possible for the patient. This includes limiting the radiofrequency energy deposition and ensuring proper coils are used.

It is important to note that previously for a PM patient to have undergone an MRI scan, the PM pulse generator had to be explanted, with the cardiac leads remaining in place. After the MRI exam, the pulse generator was reimplanted. This procedure was subsequently found to not afford any tangible safety benefit to the patient, and the operative risks of bleeding, infection, and anesthesia, as well as the expense of the operative procedure, was deemed to outweigh the benefits. This practice has been discontinued at most other centers as well.

We have now performed MR scans in approximately 35 PM patients and have had no significant complications. The clinical benefit to a number of these patients has been extremely significant. MRI has been found to be critical to patient management in 77% of our patients, either resulting in surgical treatment or significantly altering patient clinical management.

Some specific patient examples follow. One patient had been wheelchair bound with an unknown condition until a radiologist diagnosed with the MRI that he had a rare spinal dural arteriovenous fistula, which was subsequently successfully operated upon. Another patient had a previously unknown large tumor at the junction of his brain and spinal cord, which was compressing them. These patients are now greatly improved after surgery. Prior CT’s did not disclose the abnormality in either patient. In another patient, a radiologist used the MRI to diagnose likely demyelination or multiple sclerosis in the spinal cord. Another patient had the full extent of a multifocal brain tumor revealed. The superior imaging capabilities of MRI made these diagnoses possible; these were unattainable with CT or other imaging modalities. We have multiple other examples.

Patients come to Mayo Clinic and similar benchmark institutions often as a “last stop” in their healthcare – often when they have been unable to get answers and diagnoses elsewhere. We believe that we approach PM MRI exams in a safe and conservative manner. Like so much in medicine, the decision to scan a patient revolves around a risk-benefit analysis; we believe that we are employing the best available means to minimize the patient’s risk in the MRI environment, while we are maximizing the benefit to the patient by giving them access to the unparalleled imaging capabilities of MRI. These exams are labor and personnel intensive, but we believe performing them is critical to our commitment to our patients and the mission of the Mayo Clinic. Thank you for the opportunity to comment. We sincerely appreciate your consideration of these comments. Please contact me at (507) 284-6969 if you have any questions.

Very truly yours,

Robert E. Watson, Jr. M.D., Ph.D
Mayo Clinic

References
1. Sommer T, Naehle CP, Yang A, Zeijlemaker V, Hackenbroch M, Schmiedel A, Meyer C, Strach K, Skowasch D, Vahlhaus C, Litt H, Schild H. Strategy for safe performance of extrathoracic magnetic resonance imaging at 1.5 Tesla in the presence of cardiac pacemakers in non-pacemaker-dependent patients. A prospective study with 115 examinations. Circulation 114:1285, 2006.
2. Gimbel JR, Wilkoff BL, Kanal E, Rozner MA. Safe, sensible, sagacious: responsible scanning of pacemaker patients. European Heart Journal 26(16):1683-1684, 2005.
3. Levine GN, Gomes AS, Arai AE, Bluemke DA, Flamm SD, Kanal E, et al., 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 the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. American Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Radiology and Intervention. Circulation 116: 2878-2891, 2007.
4. Kanal E, Barkovich AJ, Bell C, et al., ACR guidance document for safe MR practices: 2007. Report of the American College of Radiology Blue Ribbon Panel on MR Safety. Am J. Radiology 188: 1447-1474, 2007.
5. Miller GM, Campeau NG, Shen W, Felmlee JP, Watson RE. The clinical impact of 1.5T MRI in patients with a permanently implanted pacemaker: A necessary procedure for indicated cases. Presented at International Society for Magnetic Resonance in Medicine annual meeting 2009. Also accepted for presentation at European Society of Neuroradiology 2009.

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July 30, 2009

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Ms. Syrek Jensen:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage determination (NCD) for Magnetic Resonance Imaging (MRI) (CAG-00399R). 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
We support CMS's efforts to review all current and available clinical evidence in order to determine appropriate coverage for procedures and treatments that are best shown to be safe, effective, and improve the health outcomes of Medicare beneficiaries. As previously stated within our previous comments on this issue during the public comment period for the national coverage analysis (NCA) tracking sheet (February 2009), AHIP and our member plans agree that the MRI NCD (220.2) should be revised due to the significant advances in the ability of MRIs to quantify blood flow and assess velocity, which are requisite for determining a variety of cardiac functions and/or impairments. In addition, the current magnetic resonance angiography (MRA) NCD (220.3, finalized in 2003) states that MRA is an application of MRI and "provides images of normal and diseased blood vessels as well as visualization and quantification of blood flow through the vessels (italics added)." Therefore, AHIP supports "blood flow measurement" as a covered indication within the MRI NCD (220.2).

In addition, AHIP remains supportive of CMS's simultaneous decision to not expand coverage of MRIs for Medicare beneficiaries with implanted devices, such as cardiac pacemakers, which have been designed, tested and FDA labeled for use in the MRI environment. Our members consider both premarket review and approval by the FDA as minimum pre-requisites for consideration of coverage, as we detailed within our comments submitted to CMS on this issue in response to the NCA tracking sheet comment period in April 2009. Given that there are currently no such devices approved for use in the MRI environment, our members believe that revising the contraindications for coverage of MRI for patients with these devices is premature and may place patients at risk.

Thank you for the opportunity to provide these comments.

Sincerely,

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July 30, 2009

Tamara Syrek Jensen
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Magnetic Resonance Imaging (MRI) (CAG-00399R)

Dear Ms. Jensen:

The Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services'(CMS) Proposed Decision Memorandum for Magnetic Resonance Imaging (MRI) (CAG-00399R) (the "Proposed Decision").¹ As the leading trade association representing companies whose sales comprise over ninety five percent of the global market for medical imaging and radiotherapy, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provides. MITA looks forward to working with you to continue to improve the healthcare of Medicare beneficiaries through appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases.

Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, radiation therapy, related image acquisitions, diagnostic ultrasound, and nuclear medical imaging (including positron emission tomography (PET)), and MRI. Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures.² In addition, medical imaging equipment often is used to select, guide and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions.³ MITA's members also develop and manufacture innovative radiotherapy equipment used in cancer treatment.

In the Proposed Decision, CMS announces that it intends to end Medicare's blanket noncoverage of MRI for blood flow determination at section 220.2 of the National Coverage Determinations (NCD) Manual.⁴ As requested by the American College of Radiology, the American College of Cardiology, North American Society for Cardiovascular Imaging, and the Society for Cardiovascular Magnetic Resonance, CMS proposes to remove the phrase "blood flow measurement" from the Nationally Noncovered Indications at section 220.2(C)(2) of the NCD Manual.⁵ This change would give local Medicare contractors the discretion to cover this use.⁶

MITA supports this approach to coverage of MRI for blood flow determination, and we urge CMS to finalize this proposal. We agree with CMS's conclusion that the existing noncoverage policy no longer is supported by the available evidence, and we are pleased that CMS proposes to move toward greater coverage of this technology. As CMS recognizes in the Proposed Decision, physicians "use MRI for assessment of cardiac blood flow to manage the care of patients who have one or several cardiovascular diseases" and "this management leads to therapeutic interventions, e.g., valve replacement, that improve patient health outcomes."⁷ Allowing Medicare's local contractors to decide whether and when to cover this valuable diagnostic test will expand beneficiaries' access to this diagnostic option. The proposed change also will help to reduce confusion among physicians, providers, and contractors about the interaction of the MRI policy at section 220.2 and the magnetic resonance angiography policy at section 220.3 of the NCD Manual that permits coverage of certain uses of MRI related to blood flow.

CMS does not propose to permit coverage for MRI when a beneficiary has an implanted device that has been designed, tested, and Food and Drug Administration (FDA) labeled for use in the MRI environment.⁸ CMS notes that there currently are no such devices, and it concludes that this request is "premature."⁹ If the FDA approves such a device, however, CMS "expect[s] to receive a request to reconsider this NCD and review such evidence that may be available at that time."¹⁰ We urge CMS to reconsider this NCD promptly upon approval of such a device to allow beneficiaries to benefit from advancements in care.

We appreciate this opportunity to submit these comments and urge CMS to move forward with the proposed change in coverage of MRI for blood flow determination. If you have any questions or would like to discuss these matters further, please contact me at 703-841-3279. Thank you for consideration of these comments.

Respectfully submitted,

/s/
Ilyse Schuman
Vice President, NEMA
Managing Director, Medical Imaging & Technology
Alliance

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July 28, 2009

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

Re: Proposed Decision of the National Coverage Determination (NCD) of the Magnetic Resonance Imaging (MRI) (CAG-00399R)

Dear Dr. Jacques:

Boston Scientific Corporation would like to thank CMS for their decision to maintain the non-coverage decision in the use of MRI for cardiac pacemaker and implantable defibrillator patients. As a cardiac pacemaker and implantable defibrillator manufacturer, Boston Scientific believes the risks associated with the use ofMRI in this patient population have not been completely characterized or mitigated to justify routine use of this diagnostic tool.

Until technical and procedural standards and guidelines are completed, communicated and validated we believe this is the best decision to ensure patient safety is maintained. Boston Scientific would support reconsideration of this rule once these standards have been developed by the ISO/IEC Joint Working Group and AHA's guidelines have been changed to support the safe use ofMRI in these patient populations.

Thank you for providing us the opportunity to comment on this proposal.

Sincerely,

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The premise of not covering MRI in face of a pacemaker/ Defibrillator, denies an important test that is often the final diagnostic test in the list of non-diagnostic tests. Not only does the MRI have the capability of assessing the structure but also the function and flow. The vascular disease that is prevalent in medicare beneficiaries that also have cardiac, cerebrovascular and renal disease. A non-contrast MRI sometimes lends more to the diagnosis than a contrast CT that also involves the risk of nephrotoxicity. In essence, keeping the door open to the use of MRI in patients with pacemakers and defibrillators and keeping a registry open to add any untoward events may be a better strategy.

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Implanted pacemakers and defibrillators were once thought to be an absolute contraindication for MRI. However, the peer reviewed literature now contains data from multiple centers, demonstrating that MRI has been safely performed in hundreds of these patients without serious adverse event.

In fact, I can add a case from my own personal experience. I recently performed a brain MRI on a woman with a pacemaker who had a recurrent pituitary tumor which was documented by rising blood hormone levels. Two prior head CT''s had been nondiagnostic. The MRI was necessary to demonstrate the recurrent tumor and to allow preoperative planning by the neurosurgeon.

CMS''s reasoning for denial of coverage is internally inconsistent. CMS states that there is "not evidence that MRI improves health outcomes in beneficiaries who have an implanted cardioverter-defibrillator or cardiac pacemaker." However, these devices are not unique. CMS routinely covers MRI scans in patients with all sorts of implanted devices that have not "been designed, tested and FDA labeled for use in the MRI environment." Examples of such devices include prosthetic heart valves, coronary artery bypass clips, coronary stents, as well as all kinds of orthopedic hardware, and metallic shrapnel for that matter. Should CMS deny coverage of all MRIs performed on veterans with shrapnel because no study has shown improved health outcomes in this population? I think not. The idea that a brain MRI is less efficacious in a patient with a pituitary tumor because he or she has a pacemaker just doesn''t make sense.

Rather than denying all Medicare beneficiaries access to this technology with a blanket noncoverage determination, CMS should recognize that the procedure should be covered when the potential benefit to the patient outweighs the potential risk, the patient is monitored appropriately during the MRI scan, and no other imaging alternative is suitable. This kind of thoughtful response will ensure the best patient care.

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