Magnetic Resonance Imaging (MRI)

February 8, 2018

Tamara Syrek-Jensen, JD
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-00399R4)

Dear Ms. Syrek-Jensen:

In July of 2017, on behalf of a group of experts in the field of MRI with an implanted cardiac device, we the undersigned submitted a formal request to revise the current policy regarding coverage of magnetic resonance imaging (MRI) for Medicare beneficiaries who have a non-MRI-conditional cardiac implantable electronic device (CIED). This category of a non-MRI-conditional device (CIED) includes a permanent pacemaker or implantable cardioverter-defibrillator (ICD) that is not approved by the Food and Drug Administration for MRI scanning (Please see the previous correspondence attached below).

Subsequently, the Centers for Medicare & Medicaid Services (CMS) published the “Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4). In that memo, it was proposed that any MRI examination for patients with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator that does not have FDA labeling specific to use in an MRI environment would be covered only under the following conditions:

1. MRI field strength is ≤ 1.5 Tesla;
2. It has been ≥ 6 weeks since a patient’s device implantation or any lead revision or surgical modification;
3. The patient is not pacemaker-dependent;
4. The implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator system has no fractured, epicardial, or abandoned leads;
5. The facility has implemented a checklist that includes the following:
   • Patient assessment is performed to identify the presence of an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator;
   • Before the scan, benefits and harms of the MRI scan are communicated with the patient or the patient’s delegated decision-maker;
   • Prior to the MRI scan, the implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator is interrogated and programmed into the appropriate MRI scanning mode;
   • A qualified physician, nurse practitioner or physician assistant with expertise with implanted pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, or cardiac resynchronization therapy defibrillators must directly supervise;
   • A discharge plan that includes before being discharged from the hospital/facility, the patient is evaluated and the implanted device is interrogated to detect and correct any abnormalities that might have developed during the MRI.

After a review of the proposed changes to the National Coverage Determination (NCD) contained within Decision Memo CAG-00399R4, we strongly believe that the following three exclusions are not supported by published data, and that these exclusions should not be included in the final version of the Decision Memo for MRI with an implanted cardiac device:

1. It has been ≥ 6 weeks since a patient’s device implantation or any lead revision or surgical modification. We request that this exclusion be removed from the Decision Memo, and that no exclusion is placed on a minimum time since lead or generator placement in the final Decision Memo. In our opinion, this exclusion is not supported by the available data or our cumulative clinical experience (please see below).


2. The patient is not pacemaker-dependent; We request that this exclusion regarding pacing-dependent patients be removed from the Decision Memo. In our opinion, this exclusion is not supported by the available data or our cumulative clinical experience (please see below).


3. The implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator system has no fractured, epicardial, or abandoned leads; We request that the exclusion for abandoned leads be removed from the Decision Memo. In our opinion, this exclusion is not supported by the available data or our cumulative clinical experience (please see below).

Exclusion for a Post CIED Implant Waiting Period of Less Than 6 weeks

The CMS Memo CAG-00399R4 states that “Almost all studies reviewed excluded patients with recently implanted, revised, or modified leads. Investigators stated that this exclusion was due to lead dislodgements being more likely to occur in the immediate post-implantation period. The Canadian Heart Rhythm Society and Canadian Association of Radiologists consensus statement considers a recent CIED implant to be "red flags" for a CIED patient who is scheduled for MR scanning. As stated by that consensus statement and the HRS consensus statement, some CIED manufacturers recommend that a device with FDA labeling specific to use in an MRI environment be implanted > 6 weeks from time of MR imaging and a 6-week waiting period was adopted in clinical trials of PMs with FDA labeling specific to use in an MRI environment to avoid confusion as to whether a lead dysfunction was related to performance of the MRI scan. Only a few studies, including Nazarian, S (2011) and Friedman, H.L. (2013), provided limited observations regarding patients with MRI scans < 42 days after CIED implant. While these studies reported no clinically significant differences in device function observed between patients scanned early or late after CIED implantation, the subsets with earlier scans were very small. Therefore, we propose to cover Medicare beneficiaries with a CIED without FDA-approved labeling for use in an MRI environment only when beneficiaries are ≥ 6 weeks since CIED implantation or any lead revision or surgical modification.”

However, we believe that an exclusion based upon a minimum time since lead implantation is not supported by the available data, or our combined clinical experience.

Pacemaker and ICD leads do not contain ferrous metal components. Thus, exposure to a high-strength, external magnetic field should not result in displacement of a recently implanted cardiac lead. No study of outcomes after MRI with an implanted cardiac device has documented movement of a recently implanted cardiac lead, and no study has noted a correlation between adverse clinical events and the time since implantation of a cardiac lead after MRI.

In addition to the publications of Nazarian, S (2011) and Friedman, H.L. (2013) noted above, CMS has neglected to include and discuss the data obtained from the MagnaSafe Registry. In that study “Among patients who had undergone placement of a new generator or lead within 90 days before the MRI, there were no primary end-point events, and secondary end-point events were limited to a change in pacing lead impedance in 2 of 53 new pacemaker leads and in 1 of 27 new ICD leads.” This data included two patients who underwent MRI of the brain on the day of pacemaker placement without adverse events.

In the 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices³, it is stated that “It is reasonable to perform an MR scan immediately after implantation of a lead or generator of an MR non-conditional CIED system if clinically warranted. ^1,4,5,6,7” The authors of the Expert Consensus Statement support the recommendation with the statement that “Limits have previously been placed on the minimum time between lead and generator implantation and MR imaging for patients with MR conditional CIEDs. Because lead dislodgements are more likely to occur in the immediate post-implantation period, a 6-week waiting period was adopted in clinical trials of MR conditional PMs to avoid confusion as to whether a lead dysfunction was related to performance of the MRI scan. In a single-center prospective cohort of 171 patients that included 8 patients with recently implanted systems (7–36 days), there were no differences in device function observed between patients scanned early or late after CIED implantation.⁶ In the MagnaSafe Registry, there were 63 cases in which MRI was performed within 90 days of implant, 17 cases in which MRI was performed within 30 days of implant, and 5 cases in which MRI was performed within 7 days of implant; there was no correlation between changes in lead performance (sensing, pacing threshold, or impedance) and time from lead implantation.¹ These data support the feasibility of MRI in patients with recently implanted CIEDs.”

Therefore, we request that no restriction be placed within the Final Decision Memo from CMS regarding coverage for MRI in patients with an implanted non-MR-conditional cardiac device based upon the time since lead or generator implantation.

Exclusion for Pacemaker-Dependent Patients

The CMS Memo, CAG-00399R4, states that “Electromagnetic interference (EMI) generated by the gradient magnetic field during MRI may be received by a CIED as a reset signal (Power on Reset, or PoR). This PoR could cause the CIED to revert to its factory default settings. For pacemaker-dependent patients with CIEDs programmed for asynchronous pacing used during MRI, the device may be reset to an inhibited mode. The evidence base, including studies by Higgins, J.V., et al. 2015 and Muehling, O.M., et al. 2014, observed occurrences of PoR which were at times associated with a decrease in heart rate during MRI. All devices functioned normally after completion of the MRI. Therefore, we are proposing to not include pacemaker-dependent patients under the covered population.”

However, we believe that an exclusion based upon pacing-dependence is not supported by the available data, or our combined clinical experience.

The theoretical concerns of the CMS authors included in the Decision Memo CAG-00399R4 regarding the safety of MRI for pacing-dependent patients with an implanted cardiac device, are not supported by the clinical results of the MagnaSafe Registry¹, or the results of Nazarian, S., et al (2017)².

In the MagnaSafe Registry, for patients with a pacemaker or an ICD, pacing dependence was defined as having an intrinsic rhythm lower than 40 beats per minute or having symptoms of presyncope or lightheadedness at a heart rate of 40 beats per minute or higher. In total, 282 patients, or 28.4% of the enrolled pacemaker patients were pacing-dependent. When MRI was performed in these pacing-dependent pacemaker patients, there were no losses of pacing capture noted.

Prior to the performance of MRI for patients with an implanted cardiac device, Nazarian, S, et al² reprogrammed the device “to an asynchronous pacing mode for patients who had an intrinsic heart rate of less than 40 beats per minute. An inhibited pacing mode was used for all other patients.” In this population of 138 pacing-dependent patients, the authors reported no losses of capture.

The CMS authors state that “Power on Reset could cause the CIED to revert to its factory default settings. For pacemaker-dependent patients with CIEDs programmed for asynchronous pacing used during MRI, the device may be reset to an inhibited mode.”

It was noted in the MagnaSafe Registry¹, that “in six cases (five patients), the patient had partial generator electrical reset; in all six cases, the patients had pacemakers that had been implanted 5.7 to 9.7 years before the MRI (Table S5 in the Supplementary Appendix). Settings in the device memory that were reset included patient and device or lead identification information. No appropriately screened and reprogrammed device underwent a full electrical reset.” The low rate of partial electrical reset and the lack of full electrical reset were due to the protocol exclusion of patients with a pacemaker (or ICD) generator with a battery that was near the end of its battery life (with a device interrogation display that read “elective replacement indicator”).”

In addition, within the MagnaSafe Registry pacing-dependent patients with an ICD were excluded, because “not all such patients had a device that was capable of providing pacing function while allowing for inactivation of tachycardia therapy.” The authors of the MagnaSafe Registry add the specific recommendation that their “method should not be applied to pacing-dependent patients with an ICD unless independent programming of the bradycardia and tachycardia functions is possible.”

In the 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices³, it is recommended “that for the patient with an MR non-conditional CIED who is pacing-dependent to program their device to an asynchronous pacing mode with deactivation of advanced or adaptive features during the MRI examination, and the pacing rate should be selected to avoid competitive pacing.” ^1,5,7,8,9 In this Expert Consensus Statement, there is no exclusion for patients who are pacing-dependent.

Remember, that in this Consensus Statement, as well as in all published studies, “It is recommended that continuous MR conditional ECG and pulse oximetry monitoring be used and observed while an MR non-conditional CIED is reprogrammed for imaging, and continued until baseline or until other clinically appropriate CIED settings are restored.”

Therefore, we request that no restriction be placed in the Final Decision Memo from CMS regarding coverage for MRI with an implanted cardiac device based upon pacing-dependence in patients with a non-MR-conditional cardiac device.

Exclusion for Fractured, Epicardial, or Abandoned Leads

The CMS Memo, CAG-00399R4, states that “The HRS consensus statement concluded that, ‘At the present time, however, there are insufficient data to comment on the safety of MRI performance with abandoned, epicardial, or fractured leads. The Canadian Heart Rhythm Society and Canadian Association of Radiologists consensus statement states that, "MR scanning is absolutely contraindicated" in the patients with fractured, epicardial, or abandoned leads. Postsurgical temporary epicardial leads that have been partially removed are not considered to be abandoned pacing leads.’ Patients with fractured, epicardial, or abandoned leads are frequently excluded from studies of CIEDs in the MRI environment. There were no MRI studies specifically on safety and outcomes of these patients that met our inclusion criteria. There is a paucity of evidence to support MRI scans in patients with fractured, epicardial, or abandoned leads. Therefore, we propose not to include patients with these lead conditions under the covered population for those with CIEDs.”

However, we believe that an absolute exclusion based upon the presence of an abandoned lead is not supported by the available data, or our combined clinical experience.

In the MagnaSafe Registry, patients with an abandoned cardiac lead were excluded from study enrollment. However, this exclusion was based on the ability to collect data. An abandoned lead could not be interrogated before and after the MRI procedure to assess a change in lead function as judged by pacing thresholds, measured electrical activity, or a change in lead impedance. The exclusion was not based upon data that suggested a risk to the patient or the device.

Padmanabhan, D., et al¹⁰ evaluated the safety of magnetic resonance imaging in patients with non-MRI-conditional pacemakers and defibrillators who also had abandoned leads. Between 2008 and 2017, 80 patients with 90 abandoned leads underwent 97 MRI examinations. The authors found no evidence of myocardial injury, as measured by paired cTnT in patients who underwent MRI with an abandoned cardiac lead. The authors concluded that the “risk of MRI with abandoned leads appears low, suggesting a favorable risk-benefit profile in patients with CIEDs and abandoned leads who are considered for MRI.”

The performance of MRI in a patient with an implanted cardiac device and an abandoned lead should remain a clinical decision made by the treating physician in collaboration with an electrophysiologist or cardiologist with cardiac device expertise. If MRI is determined to be the imaging modality of choice for a patient with an abandoned lead in the opinion of the treating physician, then coverage should be provided for that patient.

Therefore, we request that no restriction be placed in the Final Decision Memo from CMS regarding the presence of an abandoned cardiac lead for patients with an MR non-conditional device who undergo MRI.

In summary, based upon the available published data and our cumulative clinical experience, we believe very strongly, and request that the following exclusions be removed from the Final Decision Memo regarding coverage for:

• Patients with a non-MR-conditional device and or cardiac leads placed within 6 weeks
• Pacing-dependent patients with a non-MR-conditional pacemaker or ICD
• Patients with an abandoned cardiac lead, as an absolute exclusion

Thank you for your consideration of our request. If you have any questions or require additional information, please feel free to contact Dr. Russo by phone at 858-886-7595, or by email at russo@scripps.edu; Dr. Kramer by email at dkramer@bidmc.harvard.edu, or Dr. Nazarian by email at saman.nazarian@uphs.upenn.edu .

Sincerely,

Robert J. Russo, MD, PhD
The Scripps Research Institute
Author, “Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator (N Engl J Med 2017; 376:755-764); The MagnaSafe Registry

Daniel B. Kramer, MD, MPH
Beth Israel Deaconess Medical Center
Harvard Medical School, Boston
Author, “Coverage of Magnetic Resonance Imaging for Patients with Cardiac Devices (JAMA Cardiol. 2017 Jul 1; 2(7): 711–712)”

Saman Nazarian, MD, PhD
The University of Pennsylvania Perelman School of Medicine
Author, “Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices (N Engl J Med 2017; 377:2555-2564)

References:

1. Russo RJ, Costa HS, Silva PD, et al. Assessing the risks associated with MRI in patients with a pacemaker or defibrillator. N Engl J Med 2017;376:755-64
2. Nazarian S, Hansford R, Rahsepar AA, et al. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med 2017;377:2555-64
3. 2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices. Washington, DC: Heart Rhythm Society, May 11, 2017
4. Martin ET, Coman JA, Shellock FG, et al. Magnetic resonance imaging and cardiac pacemaker safety at 1.5-Tesla. J Am Coll Cardiol 2004;43(7):1315–1324.
5. Cohen JD, Costa HS, Russo RJ. Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. Am J Cardiol 2012;110(11):1631–1636.
6. Friedman HL, Acker N, Dalzell C, et al. Magnetic resonance imaging in patients with recently implanted pacemakers. Pacing Clin Electrophysiol 2013;36(9):1090–1095.
7. Gimbel JR, Bailey SM, Tchou PJ, et al. Strategies for the safe magnetic resonance imaging of pacemaker-dependent patients. Pacing Clin Electrophysiol 2005;28(10):1041–1046.
8. Nazarian S, Roguin A, Zviman MM, et al. Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla. Circulation 2006;114(12):1277–1284.
9. Nazarian S, Hansford R, Roguin A, et al. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med 2011;155(7):415–424.
10. Padmanabhan, D, Kella DK, Metha R, et al. Safety of Magnetic Resonance Imaging in Patients with Legacy Pacemakers and and Defibrillators and Abandoned Leads. Heart Rhythm. 2018 Feb;15(2):228-233

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I support the expansion of coverage for MRIs in patients with cardiac devices. The abundance of evidence, including 2 large NEJM trials, suggests that when screened appropriately, these patients can be scanned safely. We have experienced issues wherein we have made a multidisciplinary decision to proceed with scanning only to have financial burdens preclude imaging of certain patients who would otherwise benefit. The expansion of coverage would go a long way to facilitating necessary medical imaging in this patient population. Thank you for the consideration.

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Tamara Brunker, PA-C, MHS, Department of Electrophysiology, Hospital of University of Pennsylvania

Harold Litt MD-PhD
Associate Professor of Radiology and Medicine
Chief, Division of Cardiothoracic Imaging, Department of Radiology
Perelman School of Medicine of the University of Pennsylvania

Thank you for the opportunity to comment on the proposed changes to coverage of MRI in the presence of implanted pacemaker, implantable cardioverter defibrillator and cardiac resynchronization pacemaker and defibrillator devices. At the Hospital of the University of Pennsylvania, we have had a program in place for performing MR in patients with implanted devices for the past 13 years. We believe that the proposed policy to deny coverage of this procedure in patients who are pacemaker-dependent would deny an important imaging modality to patients while data exists to show this procedure to be safe. Nazarian (2017) describes a group of 1509 MRIs performed, with 137 patients who were pacemaker-dependent. There were no adverse outcomes seen with this patient group. In our cohort of over 1800 patients scanned in the past 4 years, there have been 327 pacemaker-dependent patients who have undergone MRI with pacemaker or ICD without adverse incidents.

In some studies (Russo, 2017) patients with ICDs who were pacemaker-dependent were excluded because of the lack of asynchronous pacing, however this feature is now nearly universally available in modern devices. In our group of 1800 patients, only 1 patient presented with a CRT-pacemaker without asynchronous pacing ability - an older model. We feel that in this unusual situation, it is reasonable to direct the patient to have a newer model implanted if there is a need for MRI scanning without the ability to pace asynchronously.

Concerning the coverage of MRI in the setting of pacemaker, ICD, or resynchronization pacemaker or ICD with abandoned, fractured or epicardial leads, there is no evidence to suggest that this procedure results in adverse outcomes. Padmanabhan (2017) reports on 80 patients, who underwent 97 MRI scans with cardiac implanted electronic devices with abandoned leads in place. There was no injury noted as measured by Cardiac Troponin measurement, nor statistically significant changes in lead measurements. In our own program we have performed 79 MRI scans in 52 patients in these circumstances without incident (Reported as abstract, Heart Rhythm Scientific Sessions, 2017). One patient with an abandoned ICD lead has undergone 10 MRI brain scans for the management of cancer, and 2 other patients have received 4 scans to date.

Nazarian, S., Hansford, R., Rahsepar, A.A., Weltin, V., …Halperin, H.R., Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices, N Engl J Med.2017;377(26):2555-64, doi: 10.1056/NEJMoa1604267

Padmanabhan, D., Kella, D.K., Mehta, R., Kapa, S., …Friedman, P.A., Safety of Magnetic Resonance Imaging in Patients with Legacy Pacemakers and Defibrillators and Abandoned Leads, Heart Rhythm. 15(2):228-233. Doi: 10.1016/j.hrthm.2017.10.022

Russo RJ, Lampert R, & Birgersdotter-Gree, U. Risks of MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017;376(25):2495-2496. doi:10.1056/NEJMc1704179 PMID: 28636860

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February 9, 2018

Tamara Syrek Jensen, JD Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

RE: Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4)

Dear Ms. Syrek Jensen,

As a company dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, Boston Scientific supplies medical devices in many clinical areas, including cardiac implantable electronic devices (CIEDs) which provide Medicare beneficiary care through our Rhythm Management business. We appreciate the opportunity to provide comments regarding the Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for Magnetic Resonance Imaging¹ (MRI).

By updating the MRI NCD to be more closely aligned with the results of the most recent publications and the 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices, CMS will increase access to care for thousands of patients with devices. We offer specific comments on areas of the proposed NCD below.

Revise Condition for MR Non-conditional Devices So That MRI Field Strength Is Aligned with Physician Guideline Recommendations
As in all medical specialties, the fields of radiology and electrophysiology are constantly changing and research is ongoing. We believe it is important for coverage documents such as this NCD to ensure access to care that is appropriate for patients, while also being flexible enough to adapt to changes in medical practice. The pace at which new research is being published is so rapid that even since the issuance of this proposed NCD there has been at least one new publication on the safety of MRI in patients with fractured or abandoned leads.²

Unless regular and frequent updates of this NCD are planned, specifying Tesla strength for MRI scanners used with MR non-conditional devices restricts coverage to scanners that may be outdated in time and may preclude access to higher or lower strength scanners even after guidelines and research support their use. Rather than requiring a particular MRI field strength, and having to update coverage frequently or risk policy obsolescence, Boston Scientific recommends that Section 3.ii.a. read “MRI field strength is aligned with practice guidelines and the most current research.”

Remove Condition Denying Coverage for Certain Pacemaker-Dependent Patients
CMS stated in the analysis for the proposed MRI NCD that “the evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary for the diagnosis or treatment”³ of those patients. In addition to the evidence reviewed by CMS for this proposal and the expert consensus statements issued by the Canadian Heart Rhythm Society⁴ and the Heart Rhythm Society (HRS)⁵, research was recently published by Nazarian et al. that specifically found “no long-term clinically significant adverse events were reported” on 1,509 patients with non-MRI-conditional cardiac implantable devices who underwent clinically indicated thoracic and non-thoracic MRI examinations.⁶

However, in the conditions set forth for patients with CIEDs that do not have FDA labeling specific to use in an MRI environment, CMS is proposing not to cover MRI scans for these patients if they are pacemaker-dependent. Patients who are pacemaker-dependent rely on the pacing ability in their device to avoid serious injuries or death. In some medical circumstances, these patients may also need an MRI if it is deemed to be the most appropriate and accurate test to assist with diagnosis or treatment of other medical conditions. We refer CMS to the 2017 HRS Consensus Statement which presents several Class I recommendations to improve outcomes while performing an MRI in pacemaker-dependent patients with MR non-conditional CIEDs. The HRS consensus statement offers expert opinion related to the appropriate level of medical supervision and programming recommendations for these patients:

• Related to the medical staff who should be present during the MRI:
  "a) Personnel with the skill to program the CIED be in attendance during MR scanning.
  b) A physician with the ability to establish temporary transvenous pacing be immediately available on the premises of the imaging facility.
  c) A physician with the ability to direct CIED programming be immediately available on the premises of the imaging facility.”


• Related to how devices should be programmed to ensure their safety during the scan:
  “It is recommended that for the patient with an MR non-conditional CIED who is pacing-dependent to program their device to an asynchronous pacing mode with deactivation of advanced or adaptive features during the MRI examination, and the pacing rate should be selected to avoid competitive pacing.”

Given that in some cases MRI will be the best test to diagnose or treat medical conditions in pacemaker–dependent patients, Boston Scientific believes that the treating physician(s) should have the opportunity to use medical judgment and discuss with the patient the risk/benefit balance of the MRI scan and the patient’s medical condition in order to make a decision and provide the best possible treatment and clinical outcome. If it is in the patient’s best interest to use an MRI, the physician may determine that the best course of action is to follow the HRS guidelines in preparing the patient for the scan. Based on recently published evidence and the HRS guidelines, Boston Scientific therefore recommends that CMS delete the condition 3.ii.c. “the patient is not pacemaker-dependent.”

Define Proper MRI Scanning Mode for MR Non-conditional Devices
Under Section 3.ii.e., CMS recommends that prior to the scan, MR non-conditional devices must be “programmed into the appropriate MRI scanning mode.” Given that MR non-conditional devices are inherently not MR conditional, they have no clearly defined “appropriate MRI scanning mode.” Instead, Boston Scientific recommends that CMS consider including the recommendation to have the devices programmed in accordance with current professional society recommendations.

Clarify Supervision Requirement
In the CMS manual, CMS has clearly defined direct supervision: “Direct supervision—in the office setting means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.”7 However, the proposed NCD speaks to the need for a qualified physician, nurse practitioner or physician assistant with expertise in implanted CIEDs to directly supervise the procedure for a patient with a MR non-conditional CIED. Because this requirement differs slightly from the definition of “direct supervision” in the CMS manual, there has been some confusion on the need for the physical presence of a CIED-expert health care provider. One interpretation has been that the physicians or their staff must be physically in the room where the MRI is taking place, rather than on the campus, which could be potentially burdensome in daily practice. Therefore, Boston Scientific recommends that CMS clarify the supervision requirement to be consistent with the definitions contained within the CMS manual.

Health Disparities
Boston Scientific applauds CMS for recognizing again in the proposed NCD that there is little data available correlating MRIs with patient demographics such as age, gender, socioeconomic status, race/ethnicity and sexual orientation. We agree that there is an opportunity to develop such data in future research. Our efforts in this area include Close the Gap, a health equity initiative which aims to eliminate cardiovascular care disparities and help ensure that all patients receive optimal cardiac care regardless of age, gender, race, ethnicity or primary language. Additionally, in partnership with physician investigators we have incorporated the WIN-HER Initiative (Women opt IN for HEaRt Research) into the MADIT S-ICD clinical trial. The objectives of WIN-HER are to develop a robust in-study process for recruitment and retention of women in MADIT S-ICD and to provide a foundational knowledge base that can be applied across multiple trials going forward. We remain committed to addressing health disparities in our own research, and we encourage CMS to work with physician societies and industry representatives to explore other new ways like Close the Gap and WIN-HER to reach underserved populations.

We appreciate your consideration of our comments.

Sincerely,

Maria Stewart
Vice-President, Global Health Economics and Market Access

1 Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R2), https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCDId=177&ncdver=3&NCAId=246&ver=3&NcaName=Magnetic+Resonance+Imaging+(MRI)&bc=AEAAAAAAAAAA& (accessed January 30, 2018)
2 Padmanabhan D, Kella DK, Mehta R, et al. Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads. Heart Rhythm 2018; 15(2): 228-233.
3 Ibid.
4 Verma A, Ha, AC, Dennie C, et al. Canadian Heart Rhythm Society and Canadian Association of Radiologists consensus statement on magnetic resonance imaging with cardiac implantable electronic devices. Can J Cardiol. 2014b;30(10):131-1141.
5 Indik JH, Gimbel JR, Abe H, et al. 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices. Heart Rhythm. 2017;14(7):e97-e153.
6 Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, et al. Safety of magnetic resonance imaging in patients with cardiac devices. N Engl J Med. 2017; 377:2555-64. 7 Centers for Medicare and Medicaid Services, Medicare Benefit Policy Manual, CMS Pub. 100-02, Chapter 15 – Covered Medical and Other Health Services, (Rev. 235, 07-11-17); Section 80 - Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests (Rev. 116, Issued: 12-11-09, Effective: 01-01-10, Implementation: 01-04-10), p.91. available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf last accessed February 2, 2018.

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February 9, 2018

Via Electronic Submission

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: National Coverage Analysis (NCA) for Magnetic Resonance Imaging (MRI) (CAG-00399R4)

Dear Ms. Syrek Jensen:

Abbott is pleased that the Centers for Medicare & Medicaid Services' (CMS) has proposed changes to the National Coverage Decision for Magnetic Resonance Imaging (MRI) and welcomes the opportunity to provide comments. Abbott is committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life. Today, 94,000 Abbott employees are working to help people live not just longer, but better, in the more than 150 countries we serve.

As a leading medical technology manufacturer of implantable cardiac devices, Abbott seeks to ensure that Medicare coverage policies promote beneficiary access to high quality healthcare innovations that both address unmet medical needs and improve health outcomes. Abbott supports CMS's proposal to implement measures to ensure patient safety when MRIs are performed on patients with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) that is not FDA labeled for use in an MRI environment. We also believe that changes to the policy to align with clinical evidence and guidelines are important. Therefore, we are providing the following comments to the proposed National Coverage Decision for MRI:

1. Abbott supports the removal of the Coverage with Evidence Development (CED) requirement.
2. Abbott recommends that CMS remove the time limitation (≥ 6 weeks) for coverage of MRIs after device implantation or any lead revision or surgical modification for patients implanted with devices that are not FDA labeled for use in a MRI environment.
3. Abbott recommends that CMS remove the ≤ 1.5T MRI scan requirement for coverage of MRIs for patients implanted with devices that are not FDA labeled for use in a MRI environment.
4. Abbott recommends including coverage for MRIs in pacing-dependent patients with devices that are not FDA labeled for use in a MRI environment when safety protocols outlined in clinical literature and guidelines are met.
5. Abbott recommends re-wording the requirement "programmed into the appropriate MRI scanning mode" to "appropriate programming during the scan based on device and patient characteristics."
6. Abbott recommends the addition of the term "immediately after MRI scan" in the discharge plan requirement to describe when the interrogation of the device should be performed.

1. Removal of the CED requirement
Abbott supports CMS's proposal to remove the Coverage with Evidence Development requirement for MRIs performed on patients with an implanted PM, ICD, CRT-P, or CRT-D that is not FDA labeled for use in an MRI environment. Abbott supports and encourages the development of clinical evidence and acknowledges the importance of CED in certain circumstances where sufficient evidence is lacking to develop a coverage policy. We appreciate that CMS recognizes that sufficient clinical data on MRIs in this patient population has been collected to meet the criteria for CED completion.

2. Removal of the time limitation (≥ 6 weeks) for coverage of MRIs after device implantation or any lead revision or surgical modification
The Expert Consensus Guidelines published in May 2017 by the Heart Rhythm Society (HRS) recommends "it is reasonable to perform an MR scan immediately after implantation of a lead or generator of an MR non-conditional CIED system if clinically warranted." This recommendation is assigned a class II strength with a level A (highest) quality of evidence.¹ Therefore, Abbott recommends that CMS change the policy to align with the HRS recommendation.

Additionally, in the CMS approved MagnaSafe Registry, there was no limitation in the study protocol eligibility criteria for time of MRI after device implant. According to the publication, "there were 63 cases in which MRI was performed within 90 days of implant, 17 cases in which MRI was performed within 30 days of implant, and 5 cases in which MRI was performed within 7 days of implant; there was no correlation between changes in lead performance (sensing, pacing threshold, or impedance) and time from implantation.²" This data supports the feasibility of MRI in patients with recently implanted devices that are not labeled for FDA use in a MRI environment.

3. Removal of the ≤1.5 T requirement
In the proposed memo, CMS requires that MRI field strength is ≤ 1.5T for the coverage of MRIs for patients implanted with non-conditional devices. Abbott recommends that CMS remove this requirement as it does not align with the HRS's Expert Consensus Guidelines to avoid confusion. The HRS expert consensus document does not specify scanner field strength in its recommendations for MRI scans for patients with non-conditional devices.¹ Therefore, we believe the appropriate MRI field strength should be determined by the clinician and patient. This can be achieved through CMS's requirement for coverage to communicate the benefits and harms of the MRI scan with the patient or the patient's delegated decision-maker before the scan.

4. Including coverage for MRIs in pacing-dependent patients with devices that are not FDA labeled for use in a MRI environment when safety protocols outlined in clinical literature and guidelines are met
In the proposed decision memo, CMS specifies that pacing-dependent patients with PMs, ICDs, CRT-Ps, and CRT-Ds that are not labeled for use in a MRI environment are not eligible for MRI coverage. This proposal does not appear to be in line with the clinical evidence and guidelines. Therefore, Abbott recommends that CMS allow coverage for MRIs in this patient population when the safeguards are in place from the MagnaSafe Registry and the HRS Consensus statement.

The MagnaSafe Registry has compelling results including no reported deaths, no lead failures, no losses of capture, and no ventricular arrhythmias occurring during MRI in patients with pacemakers and ICDs. Of the patients that were included in the MagnaSafe study, 28.4% of the pacemaker patients were pacing dependent. This study had a protocol defined specifically for pacemaker patients that were pacing-dependent. Although patients with ICDs were not included in this study, the authors recommend that their method can be applied to pacing-dependent patients with an ICD if independent programming of the bradycardia and tachycardia functions is possible.²

The HRS guidelines also recommend safeguards to ensure that the exposure of the device to an MRI environment neither adversely affects the interpretation of the MRI result nor the proper functioning of the implanted device itself. Two recommendations in this consensus statement specifically address MRIs for pacingdependent patients with devices that are not FDA labeled for use in an MRI environment. Both recommendations are given the highest class of recommendation (I) and provide detailed safety protocols based on clinical evidence.¹

5. Re-wording the requirement "programmed into the appropriate MRI scanning mode" to "appropriate programming during the scan based on device and patient characteristics" CMS requires in its proposed decision memo that prior to the MRI scan, the PM, ICD, CRT-P, or CRT-D is interrogated and programmed into the appropriate MRI scanning mode for patients with devices that are not FDA labeled for use in an MRI environment. Devices that are not FDA labeled for use in an MRI environment are unlikely to have a specific MRI scanning mode available to the user to program. Instead programming changes must be made before and after the scan using a manufacturer-specific device programming system. The HRS states that the workflow for MRI scans on patients with devices that do not have FDA labeling in a MRI environment should include "appropriate programming during the scan based on device and patient characteristics."¹ Therefore, we recommend revising the verbiage to reflect the HRS guidelines.

6. Addition of the term "immediately after MRI scan" in the discharge plan requirement
Abbott recommends that CMS change the wording for this checklist requirement to align with HRS expert consensus. The HRS guidelines recommend that device evaluation be performed immediately post-MRI for devices that do not have FDA labeling for use in a MRI environment. HRS has assigned a strong classification (IB) to this recommendation.¹

Recommended policy changes
Abbott encourages CMS in the final coverage decision to make the following policy changes:

1. Abbott recommends that CMS remove its requirement for it to have been ≥ 6 weeks since a patient's device implantation or any lead revision or surgical modification for patients implanted with devices that are not FDA labeled for use in a MRI environment.
2. Abbott recommends that CMS remove the ≤ 1.5T MRI scan requirement for coverage of MRIs for patients implanted with devices not FDA labeled for use in a MRI environment.
3. Abbott recommends including coverage for MRIs in pacing-dependent patients with devices FDA labeled for use in a MRI environment when safety protocols outlined in clinical literature and guidelines are met.
   Therefore the checklist requirement would read:
   • For pacing-dependent patients with PMs, ICDs, CRT-Ps, and CRT-Ds that are not FDA labeled for use in a MRI environment:
     1. Personnel with the skill to program the device must provide personal supervision for the MRI scanning.
     2. A physician with the ability to establish temporary transvenous pacing be immediately available on the premises of the imaging facility.
     3. A physician with the ability to direct device programming be immediately available on the premises of the imaging facility.
     4. The device must be programmed to an asynchronous pacing mode with deactivation of advanced or adaptive features during the MRI examination, and the pacing rate should be selected to avoid competitive pacing.
4. Abbott recommends re-wording the requirement "programmed into the appropriate MRI scanning mode" with "appropriate programming during the scan based on device and patient characteristics." Therefore the checklist requirement would read:
   • Prior to the MRI scan, the implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator is interrogated and the device is appropriately programmed for the scan based on device and patient characteristics.
5. Abbott recommends the addition of the term "immediately after MRI scan" in the discharge plan requirement to describe when the interrogation of the device should be performed. Therefore the checklist requirement would read:
   • A discharge plan that includes before being discharged from the hospital/facility, the patient is evaluated and the implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator reinterrogated immediately after MRI scan to detect and correct any abnormalities that might have developed during the MRI.

Abbott commends CMS for the proposed changes to the National Coverage Decision for MRIs as we believe the changes will increase patient access to MRI as well as ensure appropriate safety protocols are in place for devices that are not FDA labeled for use in a MRI environment. We appreciate your consideration of our comments. Please feel free to contact me if you have any questions or if you need additional information.

Sincerely,

Barbara J. Calvert
Director, Medical Products Reimbursement

Sources:
1. Indik et al. 2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices. Heart Rhythm 2017; 14(7):97-153.
2. Russo, Robert J et al. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. New England Journal 2017;376(8): 755-764

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Submitted Electronically

February 9, 2018

Joseph Hutter, MD, MA
Medical Officer
Centers for Medicare and Medicaid Services
Attention: CAG-00157R4
7500 Security Boulevard
Baltimore, Maryland 21244-1850

RE: Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4)

Dear Dr. Hutter:

Cardiology Advocacy Alliance (CAA) appreciates the opportunity to comment on the proposed decision memo for MRI coverage. CAA represents more than 5,000 cardiologists in private practice and within integrated organizations who provide care to our nation’s Medicare population. CAA’s mission is to educate the professional cardiovascular community about regulatory and legislative issues that affect their ability to provide high-quality patient care, to represent the common interests of the cardiovascular patient and professional on such issues, and to encourage its members to advocate for their patients and their practices. Our comments on various aspects of the proposed decision memo are listed below.

Coverage with Evidence (CED) Requirement
CMS is proposing to eliminate the requirement of collection of additional information under the Coverage with Evidence Development per section 1862(a)(1)(E) of the Social Security Act for patients implanted with a pacemaker or implantable cardiac defibrillator (ICD). CMS has determined that sufficient published evidence has been published to answer questions originally posed under the CED requirement, and that MRI for these patients is medically reasonable and necessary. Further, while no longer requiring CED, CMS is encouraging the continuation and improvement of a voluntary registry to continue data collection on these patients.

We agree with CMS’ conclusion that the evidence demonstrates that MRI is medically reasonable and necessary for these patients. We further agree that the continuation of a registry should be voluntary for providers as they evaluate the administrative burden and cost associated with participation. We are hopeful that many providers will continue to participate, and appreciate CMS recognizing that each provider should have the ability to determine what is best for their situation.

Expanded Coverage
CMS is proposing to remove the contraindication for coverage of MRI for Medicare beneficiaries with implanted pacemakers and ICDs. In addition, CMS is proposing to add coverage of MRI for beneficiaries with cardiac resynchronization pacemaker (CRT-P) and defibrillator (CRT-D) devices. Finally, CMS is proposing to provide coverage of MRI for patients with these devices that not have MRI-specific FDA labeling specific, under certain criteria.

We strongly support CMS’ proposed decision to remove the contraindication described in the proposed decision memo, and to expand coverage of MRI for patients implanted with these devices. MRI is an invaluable tool in evaluating patient conditions, and these devices have demonstrated, that under the appropriate conditions, conducting an MRI will not impact the performance of these devices or harm patients. Medicare beneficiaries implanted with these devices rely on the therapeutic assistance that they provide, and these proposed changes allow flexibility for Medicare patients to receive MRI when appropriate.

In addition, we appreciate CMS’ willingness to periodically review CED requirements and adjust accordingly when the published evidence is sufficient to warrant updating coverage policies. This helps reduce unnecessary administrative burden on providers.

Thank you for the opportunity to provide our comments on this proposed rule. If you have any questions or require additional information, please do not hesitate to contact me directly at (405) 608-3772 or at pholloway@okheart.com.

Sincerely,

/s/
Patrick H. Holloway
President, Cardiology Advocacy Alliance

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February 9, 2018

Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00399R4

Dear Ms. Syrek Jensen:

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 30 million volunteers and supporters, we appreciate the opportunity to submit comments on the proposed decision memo for magnetic resonance imaging (MRI).

According to the decision memo, the Centers for Medicare and Medicaid Services (CMS) intends to expand Medicare coverage of MRI for beneficiaries with a cardiovascular implantable electronic device (CIED). The new policy would remove the contraindication for Medicare coverage of MRI in a beneficiary with a CIED, and eliminate the existing Coverage with Evidence Development requirement. The policy would apply to patients with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator, and coverage would be available for both MR conditional and non-conditional devices.

AHA strongly supports this proposal.

Expanding Medicare Coverage of MRI
The proposed changes will provide Medicare beneficiaries with improved access to this diagnostic imaging modality. This is extremely important given that millions of Americans have an implanted cardiac device, and it has been estimated that between 50 to 75% of them will have a clinical indication for MRI over the lifetime of their device.¹

Expanding Medicare coverage is also consistent with the science. As we discussed in our August 11, 2017 comments to the Agency, since the national coverage determination was last updated in 2011, several studies have shown that MRIs can be performed safely in patients with a CIED, even if the device does not have Food and Drug Administration labeling specific to use in an MRI environment.

Expanding Medicare coverage is also consistent with current clinical practice guidelines, including the recently released 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices. Eleven organizations, including the American Heart Association, the American College of Cardiology, and the American College of Radiology, among others, collaborated with the Heart Rhythm Society to develop these practical recommendations for how to safely and effectively manage patients with CIEDs who undergo a MRI.

Thus, as stated above, we strongly support expanding Medicare coverage of MRI for patients with a CIED.

Coverage for Non-Conditional Devices
We are also very pleased that the proposed decision memo and the HRS Expert Consensus Statement are largely consistent with one another. There are, however, two areas where the documents do not align.

First, the proposed decision memo would exclude pacemaker-dependent patients from Medicare coverage. The Expert Consensus Statement, however, does not recommend against using MRI in these patients. Instead, the Consensus Statement includes a number of measures to increase safety for these patients during a MRI. The recommendations state:

It is unclear why CMS chose to create a blanket prohibition for this group. We believe that MRI should remain an option for pacemaker-dependent patients if it is considered necessary for diagnosis and management and additional precautions are taken as described in the Expert Consensus Statement.

Second, the proposed coverage policy would require patients to wait at least six weeks after CIED implantation or any lead revision or surgical modification before obtaining a MRI. The Expert Consensus Statement, however, recommends a less restrictive approach based on the individual patient's clinical needs. The recommendation states:

Again, we recommend that CMS reconsider this exclusion. Recent studies^2,3 have shown "no differences in device function observed between patients scanned early or late after CIED implantation"⁴ and "no correlation between changes in lead performance (sensing, pacing threshold, or impedance) and time from implantation."⁵ Thus, it appears that this exclusion is unnecessary; MRI should remain an option for these patients when it is clinically indicated.

Finally, AHA would like to address the requirement that a CIED have no fractured, epicardial, or abandoned leads. This requirement is consistent with the Expert Consensus Statement, which recommends that:

The Consensus Statement further notes that there is insufficient data to comment on the safety of MRI performance with abandoned, epicardial, or fractured leads. We agree that more evidence is needed; however, it is our understanding that evidence is beginning to accumulate that suggests it may be safe to use MRI in these patients. Therefore, we recommend that CMS revisit this exclusion in the future when more data are available.

If you have any questions or require any additional information, please contact Susan Bishop of AHA staff at (202) 785-7908 or susan.k.bishop@heart.org.

Thank you for your consideration of our comments.

Sincerely,

/S/
John J. Warner, MD, FAHA
President
American Heart Association

1 American Heart Association Scientific Statement: Safety of Magnetic Resonance Imaging in Patients with Cardiovascular Disease. Circulation. 2007; 116:2878-2891.
2 Friedman et al. Magnetic resonance imaging in patients with recently implanted pacemakers. Packing Clin Electrophysiol 2013; 36 (9): 1090-1095.
3 Russo RJ, et al. Assessing the risks associated with MRI in patients with a pacemaker or defibrillator. N Engl J Med 2017;376:755-764.
4 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices. http://dx.doi.org/10.1016/j.hrthm.2017.04.025
5 Ibid.

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February 9, 2018

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd
Baltimore MD 21244

Re: CAG-00399R4, Proposed Decision Memo for Magnetic Resonance Imaging (MRI)

Dear Director Jensen:

As the premier trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is submitting the following comments on the referenced Proposed Decision Memo for Magnetic Resonance Imaging (MRI). Bringing innovative medical imaging technologies to healthcare providers and patients, MITA and its member companies have in-depth knowledge of the significant benefits that early and accurate diagnosis through medical imaging provides the healthcare system. MITA would like to serve as a resource to the Agency as it updates its understanding of the role and value of MRI.

Significant advances have been made in MRI technology over the past several years, so it is commendable that the Agency is updating its coverage policy for MRI to reflect current scientific and medical literature.

In the Proposed Decision Memo, the Agency proposes a number of changes to current policy, including:

• Revision of the language in section 220.2(C)(1) to remove the contraindication for Medicare coverage of MRI in a beneficiary who has an implanted pacemaker or implantable cardioverter defibrillator;
• Expansion of coverage to include cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator devices;
• Expansion of coverage for beneficiaries who have an implanted FDA-approved pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator correspondingly under 220.2(B)(3) of the NCD Manual as a Nationally Covered MRI indication;
• Expansion of coverage for beneficiaries with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator device that do not have FDA labeling specific for an MRI with certain criteria; and
• Removal of the Coverage with Evidence Development requirement.

These proposed updates to the Agency's coverage policy for MRI affirm the reasonable and necessary role that this technology plays in diagnosing a wide array of medical conditions which affect Medicare beneficiaries. We support all of the proposed changes.

If you have any questions, please contact Peter Weems at 703-389-1614 or by email at pweems@medicalimaging.org.

Sincerely,

/s/
Patrick Hope
Executive Director, MITA

MITA is the collective voice of medical imaging equipment and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. These technologies include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. Advancements in medical imaging are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. The industry is extremely important to American healthcare and noted for its continual drive for innovation, fast-as-possible product introduction cycles, complex technologies, and multifaceted supply chains. Individually and collectively, these attributes result in unique concerns as the industry strives toward the goal of providing patients with the safest, most advanced medical imaging currently available.

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HCA is a major hospital provider across the United States. We maintain a focus on patients and are engaged in many quality initiatives. These initiatives center on the delivery of high quality patient care, including compliance with local and national coverage determinations. It is in this spirit that we submit these comments on the proposed changes to the Magnetic Resonance Imaging (MRI) National Coverage Determination (NCD).

We commend CMS for:

• expanding coverage to patients with cardiac resynchronization therapy pacemakers and implanted defibrillators,
• removing the registry reporting requirement, and
• expanding coverage to include cardiac implanted electronic devices (CIEDs) that do not have FDA approval for an MRI environment under appropriate safety protocol.

We strongly support the proposed facility “checklist” for CIEDs not FDA-approved for MRI.

Our comments are in regard to Paragraph ii, Line c and Paragraph ii, Line e, Bullet point #4.

A. Paragraph ii, line c excludes pacemaker-dependent patients from MRI scanning when the pacemaker is not FDA-approved for an MRI environment. While we would expect this to be a rare occurrence, there are occasions when a pacemaker-dependent patient requires an MRI study and the benefits to performing the study outweigh the risks.

We note that several studies¹ from the Decision Memo included pacemaker-dependent patients in their protocols with pacemakers programmed to asynchronous pacing and patients appropriately monitored during the MRI scan as recommended in the proposed facility checklist. The investigators concluded that when a standard safety protocol is followed (pre- and post- programming and monitoring patient for arrhythmias during the scan) there were no adverse occurrences for pacemaker-dependent patients with MRI non-conditional pacemakers.

We recommend consideration of coverage for MRI scan of the pacemaker-dependent patient, appropriately programmed prior to the scan, monitored during the scan, and appropriately reprogrammed after the scan prior to discharge, when it is determined that the benefit of the MRI scan results outweigh the risks of performing the MRI scan.

We therefore propose Paragraph ii, Line c be changed to read as follows:
c. For the pacemaker-dependent patient it must be determined by the treating physician ordering the MRI, in consult with an electrophysiologist, that the benefit of obtaining the MRI scan results outweighs the risk of performing the scan. The medical necessity for the MRI scan must be documented in the patient’s medical record, and the safety protocol “checklist” outlined in Line e must be followed.

B. Paragraph ii, line e, bullet point #4 states:

a qualified physician, nurse practitioner or physician assistant with expertise with implanted pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, or cardiac resynchronization therapy defibrillators must directly supervise;

Our interpretation of “must directly supervise” is the CMS definition of physician supervision for hospital diagnostic studies as outlined in 42 CFR §410.28 and 42 CFR §410.32.

For clarity, we propose that bullet point #4 of the checklist be changed to read as follows:

• A qualified physician, nurse practitioner or physician assistant with expertise with implanted pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, or cardiac resynchronization therapy defibrillators must provide direct supervision;

We greatly appreciate your efforts to update this NCD by allowing coverage of all CIEDs for MRI scanning with appropriate safety protocols.

Thank you for your consideration of our comments. Please feel free to contact me with any questions.

References:
1.- Hwang, Y. M., Kim, J., Lee, J. H., et al. (2016). Cardiac Implantable Electronic Device Safety during Magnetic Resonance Imaging. Korean Circ J, 46(6), 804-810. doi:10.4070/kcj.2016.46.6.804
- Kaasalainen, T., Pakarinen, S., Kivisto, S., et al. (2014). MRI with cardiac pacing devices - safety in clinical practice. Eur J Radiol, 83(8), 1387-1395. doi:10.1016/j.ejrad.2014.04.022
- Mason, S., Osborn, J. S., Dhar, R., et al. (2017). Real world MRI experience with non-conditional and conditional cardiac rhythm devices after magnaSafe. J Cardiovasc Electrophysiol. doi:10.1111/jce.13351
- Nazarian, S., Hansford, R., Roguin, A., Goldsher, D., Zviman, M. M., Lardo, A. C., . . . Halperin, H. R. (2011). A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med, 155(7), 415-424. doi:10.7326/0003-4819-155-7-201110040-00004
- Strom, J. B., Whelan, J. B., Shen, C., et al. (2017). Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices. Heart Rhythm, 14(8), 1138-1144. doi:10.1016/j.hrthm.2017.03.039

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February 8, 2018

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd
Baltimore MD 21244

RE: Proposed National Coverage Analysis (NCA) for Magnetic Resonance Imaging (MRI)(CAG-00399R4)

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) offers the following comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for magnetic resonance imaging (MRI).¹

AdvaMed’s member companies produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

AdvaMed appreciates this opportunity to comment on the MRI NCD. AdvaMed supports CMS’ proposals to remove contraindications for Medicare coverage of MRI in beneficiaries with implanted cardiac devices, and to expand coverage to include cardiac resynchronization therapy pacemakers and cardiac resynchronization therapy defibrillator devices. AdvaMed also supports the direction in which CMS seems to be going to align coverage with currently available evidence and guidelines. The proposed NCD protects patients while at the same time allowing access to MRIs where otherwise certain patients might not have access. We suggest ensuring proper protection for patients by requiring that compliance to the conditions listed in section B.3.ii of the draft NCD be documented in the medical record.

Coverage with Evidence Development
AdvaMed is pleased that CMS has proposed to eliminate the mandatory CED associated with MRI for patients with implanted cardiac devices. We support this proposal.

As we have stated in the past, we believe that as CED generates evidence supporting the use of a new innovation or services, Medicare’s coverage policies should reflect these outcomes while minimizing additional administrative burdens and simplifying program requirements where possible.

AdvaMed is pleased that CMS’ proposed revisions align with the clinical evidence and guidelines that have been issued in the years since the last reconsideration of the MRI NCD. Medicare beneficiaries should have safe and appropriate access to MRIs consistent with the available evidence and guidelines.

Health Disparities
AdvaMed agrees that more research is necessary on health disparities relating to MRIs. We note that several of our member companies have conducted and continue to conduct research in this area, including heath equity initiatives that aim to eliminate cardiovascular care disparities and help ensure that all patients receive optimal cardiac care regardless of age, gender, race, ethnicity or primary language. Our companies also engage in partnerships with physician investigators to generate study data in this area. We encourage CMS to work with physician specialty societies and industry representatives to explore new ways to reach these underserved populations, and support efforts to increase the availability of life-saving technologies in underserved areas and underserved populations.

Thank you once again for the opportunity to comment on this important proposed coverage determination. If you have questions regarding these comments or if you require additional information, please contact me or Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

/s/
Donald May
Executive Vice President
Payment and Health Care Delivery Policy

1 Proposed Decision Memo for Magnetic Resonance Imaging (MRI)(CAG-00399R4), https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=289 (accessed January 11, 2018).

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February 7, 2018

Ms. Tamara Syrek Jensen, J.D.
Director, Coverage & Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard, C1-14-15
Baltimore, Maryland 21244

Dear Ms. Syrek Jensen:

Medtronic is the world's leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve patients' health outcomes.

We appreciate the opportunity to comment on Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4) (section 220.2(C)(1)). As the leading manufacturer of Magnetic Resonance (MR) conditional cardiac implantable electronic devices (CIEDs), Medtronic supports the opportunity to update the NCD.

The proposed decision is clear and articulates the considerations for using MRI in patients with CIEDs in a thoughtful and complete manner. Medtronic supports the language in the proposed decision memo that explicitly expands the coverage for MRI beyond implantable pacemakers to implantable cardiac defibrillators, cardiac resynchronization therapy pacemakers, and cardiac resynchronization therapy defibrillators that have been labeled for use in the MR environment by the FDA. We also agree with the approach taken by CMS to protect patients by carefully specifying requirements based on the presence and degree of MRI-specific FDA labeling for each device.

We propose the following changes to the section on MRI for patients with devices that are not FDA labeled for use in an MRI environment (section B.3.ii), in order to provide clarity and consistency with the published evidence, physician society guidelines, and prior national coverage determinations and to assure patent safety:

• To be consistent with the physician consensus document, we propose that the conditions be amended as follows:
  • We propose removing Item b (≥ 6 weeks since device implantation/lead revision/surgical modification). The consensus document addresses this directly with a Class IIa recommendation based on an evidence review: "It is reasonable to perform an MR scan immediately after implantation of a lead or generator of an MR nonconditional CIED system if clinically warranted."
  • We propose the removal of Item c (the patient is not pacemaker dependent). The consensus document does not limit access to MRI in this way, and gives explicit class I recommendations for precautions to be taken for pacemaker dependent patients during the MRI.
  • Additions to the facility checklist (item e)
    • Continuous MR conditional ECG and pulse oximetry monitoring be used while the device is reprogrammed for imaging.
    • Personnel with the skill to perform advanced cardiac life support, including expertise in the performance of CPR, arrhythmia recognition, defibrillation, and transcutaneous pacing, accompany the patient with an MR nonconditional CIED for the duration of time the patient’s device is reprogrammed, until assessed and declared stable to return to unmonitored status.
• As is consistent with previous national coverage determinations, we believe the proposed decision should be amended to require that the necessary criteria and facility checklist items are documented in the medical record.
• As part of the summary of the evidence on MRI use in devices that do not have FDA labeling, the physician consensus statement states: "…the majority of clinical experience of MRI with a CIED has been obtained at 1.5 Tesla with a lesser number of patients imaged at other static magnetic field strengths. In addition, MRI has been primarily performed using Normal Operating Mode of the scanner. This mode restricts the MR technologist from exceeding vendor-determined SAR limits and is intended to promote safety…" To be consistent with the evidence base, we recommend the checklist requirement "MRI field strength is ≤ 1.5 Tesla" should be amended to "MRI field strength is = 1.5 Tesla", and a requirement to be in Normal Operating Mode be added to the checklist.

Thank you for your consideration of these recommendations. We look forward to working closely with CMS throughout the process and providing any additional information that may be needed. Please do not hesitate to contact me at barbara.kay.veath@medtronic.com.

Sincerely,

Barbara K. Veath
Sr. Director, Reimbursement and Health Policy

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February 7, 2018

Ms. Tamara Syrek-Jensen
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) for Magnetic Resonance Imaging (MRI) (CAG-00399R4)

The Heart Rhythm Society (HRS), the American College of Cardiology (ACC), Society for Cardiovascular Magnetic Resonance (SCMR), and the American College of Radiology (ACR) are the non-profit professional societies representing most of the practicing clinicians in the United States who care for patients with cardiac rhythm disorders who will benefit from enhanced access to MRI. Our societies are committed to ensuring access to evidence-based patient care.

We appreciate the opportunity to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) reconsideration of the coverage with evidence development (CED) requirement (section 220.2(C)(1)).

We commend CMS for proposing revisions to the language in section 220.2(C)(1). These modifications generally align with the recent expert consensus statement "HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices".ⁱ

The organizations appreciate CMS’ inclusion of the findings from the MagnaSafe Registry and the previously published findings from the Johns Hopkins Registry, as well as numerous other observational studies demonstrating the safety of performing MRI scans for patients with non-conditional cardiac implantable electronic devices utilizing a 1.5 T magnet.ⁱⁱ We recommend that the Agency include in the final policy the recently published article by Nazarian et. al. that includes a significantly larger observational cohort of 1509 patients with either a pacemaker (58%) or implantable cardioverter defibrillator (ICD, 42%).ⁱⁱⁱ

The following comments are on conditions for coverage for any MRI for patients with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator that does not have FDA labeling specific to use in an MRI environment (Section 3.ii).

In these comments, we make recommendations regarding specific exclusion criteria as well for the requirements for supervision during MRI scanning.

3.ii.a: Less than or equal to 6 weeks since a patient’s device implantation or lead revision or surgical modification:

While pacemaker and ICD generators contain ferromagnetic materials, the extent of force and torque is well below the threshold needed to cause movement in a subcutaneous pocket. Patients with devices implanted within six weeks have been included in published studies. The studies that excluded such patients, did so to avoid confounding of lead parameter measurement bias due to spontaneous lead dislodgements or lead-tissue interface maturation that are known to occur in the sub-acute post-operative period. It is not warranted to apply a 6-week waiting period as an MRI does not increase the risk of lead dislodgement and published evidence has not shown any adverse effects in such patients.

We propose that the requirement "It has been ≥ 6 weeks since a patient’s device implantation or any lead revision or surgical modification" (3.ii.a.) be removed from the coverage policy.

3.ii.a: MRI field strength is ≤ 1.5 Tesla; normal operating mode

MRI in imaging patients with CIEDs has usually been performed at 1.5T field strengths using the Normal Operating Mode of the scanner. This mode restricts the MR technologist from exceeding vendor-determined specific absorption rate (SAR) limits for that scanner, limiting excessive energy deposition with potential to either injure the patient or harm a device.

We recommend adding "normal operating mode" language to section 3.ii.a to help clarify the energy deposition and avoid excessive levels.

3.ii.b: Pacemaker-dependent patients

The draft policy excludes from the covered indications patients who are pacemaker dependent. However, pacemaker dependent patients are well-represented in published cohorts. In the MagnaSafe registry, there were 284 patients who were pacemaker dependent. In the recently published observational cohort by Nazarian et al., there were 137 patients who were pacing dependent, including 22 patients with an ICD. Pacemaker dependent patients with either a pacemaker or an ICD were also included in other published studies.^iv,v

As demonstrated by the clinical evidence, we recommend that the requirement "the patient is not pacemaker-dependent" (3.ii.b) be removed from the policy.

3.ii.c: The CIED has no fractured, epicardial, or abandoned leads

Research is underway on MRI for patients with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator systems with fractured, epicardial, or abandoned leads. This ongoing study conducted by Nazarian and Halperin suggests no evidence of patient harm. So far, no patients have experienced pain, arrhythmia, or other complications in this setting. Additional evidence of safety in this population was recently published by a group from the Mayo Clinic that reported findings for 80 patients with abandoned leads with no adverse events and no evidence for myocardial injury based upon measurements of troponin values.^vi The evidence is promising to suggest overall safety of MRI even in the presence of fractured, epicardial, or abandoned leads as long as a safety protocol is followed.

Until further evidence is available and to ensure continued coverage for patients with abandoned, fractured, or epicardial leads in clinical trials, the societies recommend that CMS revise the NCD to include the language in bold. When evidence regarding the safety of MRIs for patients with fractured, epicardial or abandoned leads is more robust, the Societies will seek the opportunity to share the findings with the Agency.

"The implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator system has no fractured, epicardial, or abandoned leads, unless scans are performed with appropriate consent and/or restrictions for an investigational protocol or registry."

3.ii.e: Facility Check List: Direct Supervision Criteria

The societies recommend that CMS include in section 3.ii.e the definition of "direct supervision" so electrophysiology providers who are unfamiliar with imaging supervision standards can readily understand the term. This will help clarify expectations, avoid confusion and reduce obstacles to this important diagnostic modality.

A qualified physician, nurse practitioner or physician assistant with expertise with implanted pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, or cardiac resynchronization therapy defibrillators must directly supervise the pre-scan interrogation of the device, monitoring the patient’s heart rhythm during the scan, and reprogramming the device and checking to ensure unchanged device function after the scan. Just as the radiology imaging professional must directly supervise the safe acquisition of the MRI imaging data using an appropriate protocol and its interpretation under diagnostic testing rules in 42 CFR § 410.32(b)(3)(ii), the same concepts would apply to the EP professional. In the facility setting, this requires the practitioner be present on the same campus where the services are being furnished. Some facilities have trained EP technologists or nurses who can monitor the patient during the scan. If that is the case, those technologists or nurses must function within their scope of practice and be directly supervised by the qualified physician, nurse practitioner or physician assistant with expertise with implanted cardiac devices. In the office setting direct supervision requires the practitioner be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure.

The societies appreciate CMS’s actions to ensure that Medicare coverage supports evidenced- based medical advances in care, ultimately improving access to health care services for patients with these devices. We would welcome the opportunity to discuss these recommendations with the CMS Coverage Analysis Group. If you have questions about the Societies’ recommendations, please contact Laura Blum at lblum@hrsonline.org.

Sincerely,

Orlando P. Simonetti, PhD
Chief Executive Officer
Society for Cardiovascular Magnetic Resonance

William T. Thorwarth, Jr., MD, FACR
Chief Executive Officer
American College of Radiology

George F. Van Hare, MD, FHRS, FACC
President
Heart Rhythm Society

Mary Norine Walsh, MD, FACC
President
American College of Cardiology

i Indik JH, et al. 2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices. Heart Rhythm 2017; Jul;14(7):e97-e153.
ii Russo RJ, et al. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med 2017;376:755-64.
iii Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, et al. Safety of magnetic resonance imaging in patients with cardiac devices. N Engl J Med 2017; 377:2555-64.
iv Gimbel JR, Bailey SM, Tchou PJ, et al. Strategies for the safe magnetic resonance imaging of pacemaker-dependent patients. Pacing Clin Electrophysiol 2005;28(10):1041–1046.
v Cohen JD, Costa HS, Russo RJ. Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. Am J Cardiol 2012;110(11):1631–1636.
vi Padmanabhan D, Kella DK, Mehta R, et al. Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads. Heart Rhythm 2017; In Press.

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January 27, 2018

Ms. Tamara Syrek-Jensen
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) for Magnetic Resonance Imaging (MRI) (CAG-00399R4)

As a high volume cardiovascular MRI center that has performed research and published in this area, we are pleased to provide comments on the recent CMS coverage proposal regarding magnetic resonance imaging in the presence of CIEDs. Although providing a framework for providing this imaging modality, we find that the language is in need of clarification. Specifically, further delineation of responsibilities is needed with regard to supervision [paragraph ii, line e, bullet #4].

It is our belief that the term “direct supervision” needs to be clearly divided into two separate roles: One person responsible for the process of CIED programming (CIED specialist) and one person for monitoring the entire MRI (monitor). While the programming of the CIED pre-and post-MRI should be performed by a physician or allied health professional with expertise in the field, the responsibility for monitoring the patient throughout should simply require an ACLS certified provider (with easy access to the CIED specialist).

The current proposal does not delineate the two roles and confuses the matter with the term “direct supervision.” It is our experience that an ACLS provider is adequately capable of monitoring for arrhythmias and managing the extremely rare scenario of an emergency once the CIED has been thoughtfully programmed in advance.

We therefore propose that the single bullet point be divided into two bullets as follows:

• A qualified physician or allied health professional (APRN, PA, CNS, etc.) with expertise in cardiac implantable electronic devices (implantable pacemakers, implantable cardioverter-defibrillators, cardiac synchronization therapy devices) evaluate the patient and program the device appropriately for the magnetic resonance environment and be available throughout the duration of imaging
• An ACLS provider must be present and monitor the patients rhythm throughout imaging using telemetry and/or pulse-oximetry

We applaud your attention in addressing the ever-growing need for MR imaging patients with non-MR conditional devices. We hope that you consider our recommendations to provide a clearer delineation of responsibilities for safe imaging.

David A. Sandler, MD, FACC, FHRS
Director, Electrophysiology
Phone: 918-592-0999
Email: d.sandler@oklahomaheart.com

Edward T. Martin, MD, FACC, FACP, FAHA
Director, Cardiovascular MRI
Phone: 918-592-0999
Email: martin@oklahomaheart.com

Oklahoma Heart Institute
1265 S. Utica, Suite 300
Tulsa, OK 74104

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