The Centers for Medicare and Medicaid Services (CMS) is rethinking its coverage for magnetic resonance imaging (MR) for Medicare beneficiaries with implanted cardiac devices, and may ease requirements, according to a website posting by the agency.

The devices at issue include implanted pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy pacemakers (CRT-P), and cardiac resynchronization therapy defibrillators (CRT-D).

The evidence that Medicare patients with these devices benefit from MR “is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” the agency said in a statement, adding that, “we are proposing to modify our national coverage determination (NCD) to eliminate the collection of additional information under the Coverage with Evidence Development (CED) paradigm.”
The agency explained that it proposes to revise 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; expand coverage to include cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator devices; expand coverage for beneficiaries who have an implanted FDA-approved pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator,” it advised billers.

In addition it proposes to expand coverage for those with the implanted devices “that do not have FDA labeling specific for an MRI with certain criteria.”

It will also remove the “Coverage with Evidence Development” requirement.

The agency had begun to pay for MR in patients with “MR-friendly” implants in 2011.

The CED paradigm, also set up in 2011, was established, according to CMS, when evidence was promising but not yet convincing.

Since that time researchers have continued to find that MR is safe with non-MR-conditional cardiac devices that are implanted, when proper precautions are observed.

In late 2017, in fact, a study published in The New England Journal of Medicine confirmed “that pretty much anybody who has a pacemaker or implanted defibrillator can, with very few restrictions, safely get an MRI scan if they need it,” as long as settings for the devices are correct for scanning and adequate precautions are taken, co-author Dr. Henry Halperin, professor of medicine, radiology and biomedical engineering at Johns Hopkins University told Reuters.

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