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CMS to cover MRIs for patients with pacemakers, ICDs
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CMS has issued a decision memo stating that the evidence is sufficient for the coverage of MRI in Medicare beneficiaries with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy defibrillator or cardiac resynchronization therapy pacemaker.
This decision, written by Tamara Syrek Jensen, JD, director of the coverage and analysis group for CMS, and colleagues, removes the contraindication of MRI for Medicare in the four types of devices and expands coverage to now include devices that are either FDA-approved or do not have FDA labeling for MRI.
MRI in patients with devices that do not have FDA labeling for use in an MRI environment would only be covered if certain criteria are met, including:
- MRI field strength of 1.5 T while using normal operating mode;
- No epicardial, fractured or abandoned leads in the device, and
- A facility checklist that is comprised of patient assessment, discussion about benefits and harms of the scan, appropriate interrogation and programming of the device, patient observation during the scan, the presence of an advanced cardiac life support provider and a discharge plan.
This national coverage determination was last reconsidered by CMS in 2011, when coverage with evidence development was established for patients with an ICD or implanted pacemaker.
In this reconsideration, CMS reviewed published literature from 2011 to 2017 and focused on whether to remove the coverage with evidence development for patients with Medicare who had these devices. CMS attempted to answer questions on whether MRIs can inform clinical management or diagnosis of patients with pacemakers or ICDs and if they can improve health outcomes.
This decision was also based on two expert consensus statements from the Canadian Heart Rhythm Society and Canadian Association of Radiologists.
CMS considered 31 public comments from two separate periods, which were predominately made by professional societies, medical groups, physicians and medical technology manufacturers.
“A valid MRI scan is important to guide clinical decision making and subsequent treatment based upon the results,” Syrek Jensen and colleagues wrote. “If image quality is unaffected by the presence of [cardiac implantable electronic devices], then it would be likely that MRI test parameters such accuracy, sensitivity and specificity would be maintained and comparable to patients that do not have [cardiac implantable electronic devices] as previously reported.” – by Darlene Dobkowski
Reference:
CMS. Decision Memo CAG-00399R4.
Perspective
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Robert J. Russo, MD, PhD
The recent Final CMS Decision Memo (change to the National Coverage Determination) addresses all of the questions that we raised with CMS in a recent letter, and I believe that the decision is fair. The change to the NCD allows for coverage in most patients with a pacemaker or defibrillator who require MRI.
The impact of the chance to the NCD will be to open access to the hundreds of thousands of patients with an implanted device who have an indication for MRI but have been previously denied access based on CMS coverage. Now that the last hurdle has been cleared, that is coverage by Medicare, the problem that remains is access to MRI in an imaging facility. The lack of access is not due to issues regarding coverage or safety, but the lack of access is due to institutional programs that deny patients’ entry into the MRI scanner.
The cardiology community has carried the ball as far as we can, and now it’s the responsibility of the radiology community and hospital administrators to implement programs that will streamline the process of ordering and performing an MRI with an implanted cardiac device.
The cardiology community has always taken care of these patients, and we’ve tried to move this issue forward as best we can. We have provided robust data on the risk for MI with an implanted device. We have developed protocols for the performance of MRI and we have successfully petitioned for a change to Medicare coverage. However, a cardiologist alone cannot get a patient into the scanner, we cannot change the decision-making process of a radiologist, we cannot change the training of an MRI technologist and we cannot change an institutional program implemented by a hospital or clinic. Despite the excellent published data regarding the safety of MRI, the patient with an implanted cardiac device and with the need for imaging may still not have access to MRI.
In San Diego, we recently performed an MRI of the brain for a patient from Australia with a pacemaker who could not get an MRI performed in her country. As principal investigator of the MagnaSafe trial, almost every week, I receive a call or email from a patient who has a device, but cannot find an institution to perform the scan.
The future of MRI with an implanted cardiac device will include providing an online patient and institutional resource of centers that provide MRI services for patients with MR-conditional and MR-nonconditional cardiac device and working to provide industry with guidelines and recommendations for an autonomous pacemaker that will sense the MRI environment, make appropriate programming changes and, as a result, greatly limit the number of non-radiology personnel required to oversee the procedure.
Lastly, while the CMS guidelines change coverage, this change has not increased coverage for physician, nurse practitioner and physician assistant observation and device programming time before, during and after MRI. Coverage is provided to the radiologist to interpret the images and to the facility to perform the scan, but not to the cardiologist, the physician assistant, nurse practitioner or other qualified physician who is present for the examination. This effort by the cardiology community is still a volunteer effort, which we provide in the interest of patient care.
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