The Centers for Medicare and Medicaid Services is expanding magnetic resonance imaging coverage for Medicare patients with a wide range of implanted cardiac devices.
Previously, patients who have these medical devices have been denied MRI services because of concerns about their safety while undergoing the imaging procedures.
“We determined that the evidence is sufficient to conclude that magnetic resonance imaging (MRI) 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,” states the CMS decision memo.
CMS last reconsidered the national coverage determination at section 220.2 of the Medicare National Coverage Determinations Manual in 2011 and established coverage with an “evidence development” requirement for patients with an implanted pacemaker or implantable cardioverter defibrillator.
However, this time, CMS is taking the following actions:
- Revising 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.
- Expanding coverage to include cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator devices.
- Expanding coverage for beneficiaries who have an implanted FDA-approved pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator correspondingly under 220.2(B)(3) of the NCD Manual as a Nationally Covered MRI indication.
- Expanding coverage for beneficiaries with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator device that do not have FDA labeling specific for an MRI with certain criteria.
- Removing the Coverage with Evidence Development requirement.
A study on the safety of MRIs in patients with cardiac devices published late last year in the New England Journal of Medicine found no long-term clinically significant adverse events.
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