The U.S. Centers for Medicare & Medicaid Services (CMS) is on the verge of rescinding a policy that has for years barred heart patients from MRI coverage if they had an implanted pacemaker or cardioverter defibrillator.
The organization published a proposal to change its national coverage determination on its website Jan. 11, citing a growing body of evidence supporting MRIs in patients fitted with cardiac devices.
“We propose that the evidence is sufficient to conclude that magnetic resonance imaging for Medicare beneficiaries with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker or cardiac resynchronization therapy defibrillator is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member under section 1862(a)(1)(A) of the Social Security Act under certain circumstances,” the statement read.
This news comes less than a month after a study published in the New England Journal of Medicine proved MRIs were safe—and often necessary—diagnostic options for patients with pacemakers or defibrillators.
“Given the results of our study and those of the MagnaSafe Trial, it is hard to understand the position of [CMS] to restrict access to patients with MRI-conditional labeling of their leads and ICD systems,” lead author Saman Nazarian, MD, PhD, told Cardiovascular Business. “Given this new data, the idea that access to the potentially lifesaving diagnostic data from MRI would be limited for patients with legacy pacemakers and ICD leads or generators is outdated.”
CMS has proposed altering the language of its policies to include beneficiaries with implantable devices, as well as adding resynchronization therapy pacemakers and defibrillators to its list of approved devices. They are also looking to expand coverage for patients with both FDA-approved and unapproved cardiac apparatuses—a move officials attributed to a “number of studies supporting MRI use” in these patients.