Inclusion of CT Scans Instead of MRI Scans in WCMSAs for Claimants with Intrathecal Pumps

FDA, Medicare Set-Aside Blog, Medicare Set-Asides on January 12, 2017 | Posted by Erin O'Neill, PA-C, JD

It is commonplace for CT scans to be included in WCMSAs, in lieu of MRI scans, for Claimants with implanted intrathecal pumps; however, little thought is given to the reason for this substitution.

Intrathecal pumps are small implanted programmable battery powered devices that dispense medication which is carried directly to the spinal cord by a catheter which is also implanted under the skin. MRI scanners utilize strong magnets and radiofrequency pulse to produce signals which are converted into images. The magnet found in MRI scanners has the potential to interfere with the intrathecal pump motor; however, recently, certain pumps have been labeled as MRI compatible devices.

Yesterday, the Food and Drug Administration (FDA) issued an FDA MedWatch Alert as part of their Safety Information and Adverse Event Reporting Program, which outlined serious safety concerns regarding potential complications of patients with implanted infusion pumps undergoing MRI scans.

mri

The FDA indicated they have received reports of serious adverse events, including injury and death, in patients who underwent an MRI scan with an implanted infusion device. Complications cited included the intrathecal pump motor stalling or not restarting after the MRI exam and medication dosing issues including under-dosing, over-dosing or unintended bolus release of additional medication due to exposure to the magnet. The FDA issued recommendations aimed at decreasing the likelihood of serious adverse events for those patients where an MRI scan is needed. Additionally, the FDA is working with the implant manufacturers to update their MRI safety information.

Despite the recent development of infusion pumps labeled as MRI compatible, it would appear that CT scans, as opposed to MRI scans, should continue to be included in WCMSAs for diagnostic monitoring in Claimants with intrathecal pumps.