CMS revises policy on pacemakers and MRI

Dec 12, 2010

The U.S. Centers for Medicare and Medicaid Services (CMS) has revised its policy on reimbursement for the use of MRI in patients with pacemakers to support coverage of the exams in clinical studies.

Previously, CMS did not cover payment for an MRI examination for patients with cardiac pacemakers. The FDA has decided to continue that policy for most Medicare beneficiaries; it stated that it is not convinced that the use of MRI improves health outcomes for patients with implanted permanent pacemakers (PMs) or implantable cardioverter defibrillators (ICDs).

However, the agency has proposed that MRI be reimbursed by CMS for patients participating in some clinical studies. To receive reimbursement, these studies must address whether the devices affect physician decision-making or affect patient outcomes. In addition, studies must include safety criteria for all patients.

In the document announcing the new policy, CMS stated that the agency believes the evidence is "promising" -- although not yet convincing -- that MRI will improve patient health outcomes "if certain safeguards are in place to ensure that the exposure of the device to an MRI environment adversely affects neither the interpretation of the MRI result nor the proper functioning of the implanted device itself."

FDA warns of pacemaker, MRI issues, December 17, 2009

MRI OK for patients with newer implanted cardiac devices, November 25, 2007

MRI of cardiac devices OK, but requires following strict guidelines, January 30, 2007

Radiologists should discuss cardiac implant disposal with patients, January 1, 2007