The CMS has proposed revising its coverage policy to make it easier for Medicare enrollees with implantable cardiac devices to receive an MRI.
While the agency first signed off on covering MRIs for beneficiaries with implantable devices like pacemakers in 2011, the approval included some requirements. Beneficiaries with certain implanted cardiac devices could only receive MRIs if it was part of a clinical trial.
Now, the agency is changing its tune and suggested allowing imaging in these patients without the so-called "coverage with evidence development" requirement.
"The weight of the published literature in this field provides convincing evidence that, with appropriate precautions, MRI can be performed with minimal risk in [these] Medicare beneficiaries," the CMS said in a proposed decision memo posted Thursday.
The decision comes just weeks after a study in the Dec. 28 issue of the New England Journal of Medicine found no long-term clinically significant adverse events for patients with pacemakers and defibrillators that received MRIs.
The new flexibility is needed as seniors with cardiac devices were sometimes not getting the scans they needed, according to Jason Launders, director of operations for ECRI Institute's health devices group.
"The evidence shows that there can be problems, but for a very small number of people. So why are we denying thousands of patients MRI scans?" Launders said. "If you take some basic precautions, you can give them a scan that could save their lives."
Researchers estimate that over 2 million patients in the United States have implanted devices, including pacemakers and implantable cardioverter-defibrillators.
The new coverage decision does have some strings attached. Medicare benficiaries must have their device implanted for at least six weeks and have a qualified physician, nurse practitioner or physician assistant with expertise with implanted cardiac devices directly supervise the scan.
Providers are hoping the CMS will eliminate the six-week waiting period in the final coverage decision.
"The six-week limitation is based on theoretical concerns and is quite arbitrary," said Dr. Henry Halperin, a professor of radiology and biomedical engineering at Johns Hopkins University School of Medicine. "Some patients have a critical need an MRI during that six-week waiting period… the waiting period would deny them the benefit of an MRI that may be needed for timely diagnosis or follow-up of their clinical condition."
The CMS will accept comments on the coverage decision through Feb. 11.
