In a victory for medical device maker Medtronic, the U.S. Centers for Medicare and Medicaid Services (CMS) said on April 26 that it would pay for MRI studies performed in patients with pacemakers, provided the pacemakers have been approved by the U.S. Food and Drug Administration (FDA) for use in an MRI environment.
The CMS decision is a refinement of a new agency policy on MRI and pacemakers announced just two months ago, in which the agency said it would only pay for MRI scans in patients with pacemakers if they were enrolled in a clinical trial. CMS said it is revising that policy in response to a petition from Medtronic, which received FDA approval for its Revo MRI SureScan pacemaker in February. Revo is designed for use in MRI environments under certain conditions.
In announcing the new decision, CMS said it received a letter from Medtronic on February 25 that asked the agency to remove the contraindication in the new MRI policy for devices that have been approved by the FDA for use with MRI -- a change that would specifically apply to the Revo MRI device.
CMS acknowledged that Medtronic had brought to its attention new evidence about the use of MRI with certain types of pacemakers, and it reopened its previously issued national coverage determination. The agency said it received 15 public comments during a period from March 4 to April 2.
While CMS rejected the language that Medtronic suggested be used to replace the current policy, it did note that the company had conducted a randomized clinical trial in support of the Revo MRI regulatory application. The results of the study indicated that patients who had the pacemaker and who received an MRI scan did not have higher complication rates than patients who were not exposed to MRI.
Therefore, CMS stated that it plans to change the language in section 220.2.C.1 of the National Coverage Determinations Manual, because "the evidence is adequate to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) when the PMs are used according to the FDA-approved labeling for use in an MRI environment."
