MMRI Pacemaker & ICD Policy Revised

	Coding & Reimbursement
	Quality/Outcomes Reporting
	Device & Drug Safety
	Research & NIH Funding
	Legislation/ Take Action

Home > Health Policy > Coding & Reimbursement > Coverage > ICD

MRI Pacemaker & ICD Policy Revised

The Centers for Medicare and Medicaid Services (CMS) has updated its policy prohibiting payment for MRIs on patients who have pacemakers or ICDs, following the FDA’s approval of Medtronic’s Revo MRI SureScan Pacing System.

CMS Revises Policy on MRIs for Patients with Pacemakers
and ICDs

The U.S. Food and Drug Administration (FDA) approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams — the Revo MRI SureScan Pacing System — on February 8, 2011 (learn more). Following that approval, the Centers for Medicare and Medicaid Services (CMS) updated its reimbursement policy for MRIs on patients who have pacemakers or ICDs on March 4, included in the March 11 issue of the agency's MLN Matters®.

Effective for claims with dates of service on or after February 24, 2011, CMS will now allow for coverage of MRI for Medicare beneficiaries with implanted pacemakers or ICDs when those beneficiaries are enrolled in clinical studies that are approved by CMS for the purpose of gaining further evidence about the utility and safety of MRI exposure. Read CMS transmittal (PDF, 327K)

In its decision memo, CMS stated that “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...CMS determines that MRI will be covered by Medicare when studied in a clinical study...if the study meets [certain] criteria.”

About half of all patients with pacemakers may require an MRI, but have been advised not to have one because an MRI’s magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage. The Revo pacemaker, manufactured by Medtronic, includes a function that is turned on before a scan to prepare patients for the MRI.

The pacemaker’s use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. As part of its approval, the FDA requires training for cardiologists and radiologists who use the Revo MRI SureScan Pacing System.