Researcher reacts to CMS proposal to expand coverage for patients with pacemakers, defibrillators

Two weeks after CMS rolled out a proposal to expand MRI coverage options for patients with unapproved implantable devices, researchers in the field are optimistic—but remain critical.

Saman Nazarian, MD, PhD, led one of the handful of recent studies that have proven magnetic resonance imaging (MRI) screenings to be safe for heart patients with implanted pacemakers or cardioverter defibrillators. He was “delighted” to hear that CMS was loosening its grip on implant-dependent patients, he told Cardiovascular Business, but the proposal doesn’t fix everything.

“Our work was meant to provide access to patients for a necessary exam, which it accomplished directly for 1,509 patients by enrolling them in the safety study and indirectly for many more patients by providing safety data for CMS,” he said. “Hopefully the data will also be used to relax the restrictions further. Based on our work, the proposed continued restriction for pacemaker-dependent patients is unnecessary.”

Prior to Jan. 11’s proposal, patients fitted with defibrillators and pacemakers were restricted from MRI coverage under Medicare and Medicaid policies. Nazarian said he and his colleagues’ work, combined with the publication of the MAGNASAFE registry results, the 2017 HRS expert consensus statement on MRI and radiation exposure in patients with implantable devices, and other investigators’ studies probably pushed CMS to make the change.

“I do believe the proposal will be successful and am confident that it will not only save patients from many unnecessary tests, including ultrasounds, CT scans, painful myelograms, etc., but also from delayed diagnoses and misdiagnoses, and ultimately lead to better and more efficient care,” he said.

Still, according to the CMS proposal, officials are still restricting access to MRI coverage in pacemaker-dependent patients and those with recent implants. Nazarian said the former rule was superfluous; he and his colleagues’ work alone included 130 pacemaker-dependent patients, none of whom had any significant safety issues during the trial.

The latter recommendation, too, is based on misinformation, he said.

“There is a misconception that the magnetic force of MRI could dislodge freshly implanted leads that are not yet attached to cardiac tissue,” he said. “In fact, the leads do not contain any materials that would experience force or torque during the MRI and could not conceivably be dislodged because of a scanner effect.”

Pacemaker and defibrillator generators and batteries do contain materials that would react to magnetic force, Nazarian explained, but the extent of force or torque would fall below the threshold needed to cause movement underneath the skin.

“Outside of a study setting, there is no reason to restrict access to patients with recent pacemaker or ICD implants,” he said.

CMS is accepting comments on its proposed policy changes through Feb. 10.