In a decision memo posted on its website, CMS proposed that it remove the coverage with evidence development (CED) requirement for MRI scans of patients with devices that include implanted pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers, or cardiac resynchronization therapy defibrillators. The proposal would modify the agency's national coverage determination (NCD) for these scans.
The CED framework was designed to allow CMS to provide Medicare payments for technologies that might be considered more experimental, while collecting data that could be used to determine if more liberal reimbursement policies were justified. The process has been used in medical imaging to enable payment for FDG-PET scans for oncology applications, for example.
CMS set up the CED framework for coverage of MRI scans of patients with implantable pacemakers and cardioverter defibrillators in a national coverage determination issued in February 2011. At the time, the agency said that "the evidence is promising although not yet convincing" that MRI was beneficial for these patients as long as safeguards were taken to ensure that exposure of these devices to MRI fields would hinder neither the scan itself nor the operation of the device.
Since then, a number of studies have been published pointing to the safety of MRI scans for patients with implantable cardiac devices. Most recently, a study published in the December 28 issue of the New England Journal of Medicine found no long-term clinically significant adverse events in a group of nearly 1,000 patients with pacemakers and defibrillators that were older and not considered to be MRI-conditional for use in the MRI environment.
Before that, a study published in September 2017 in the Journal of Cardiovascular Electrophysiology found no problems in a group of 178 patients with implantable devices who received MRI scans, and another New England Journal of Medicine study in February 2017 found no device or lead failures, even with devices that weren't certified for use with MR imaging.
The latter study noted that some 2 million people in the U.S. have implants that aren't conditional for use in an MRI scanner. What's more, at least half of these patients are expected to have a clinical indication for an MRI scan during the lifetime of their devices.
CMS acknowledged this growing body of research in this week's proposed decision memo. The agency said it reviewed literature from 2011 to 2017 to "reassess the contraindications" for those with a pacemaker or defibrillator, and to determine if the questions raised by the CED process have been answered. The agency said it found 18 relevant studies, which taken together point to the safety of MRI for this application.
"The evidence generated and reviewed since the 2011 NCD sufficiently answers the CED questions ... and we believe that additional data collection is no longer needed for Medicare coverage purposes," the proposal concludes.
The issuance of the memo on the new rule starts a 30-day comment period. To comment, click here.
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