Physician groups are expressing overwhelming support for CMS' proposal to cover magnetic resonance imaging in patients with FDA-approved MRI-safe pacemakers, and some are pushing for the agency to go much further.

In May 24 comments to CMS, the Society for Cardiovascular Magnetic Resonance, representing physicians and technologists, urged the agency to cover MRI scans on patients with any type of pacemaker or implanted defibrillator – not just those deemed MRI-safe by FDA.

"There are numerous recent studies that show that MRI, when done with the appropriate safeguards, can be performed safely on patients with virtually any make or model of pacemakers or ICDs," the group wrote.

Four physicians from Utah-based Intermountain Medical Center submitted similar remarks. In the past six years, they said, their center has safely performed MRIs in more than 100 patients with cardiac implants. The patients, who were being evaluated for such serious conditions as brain tumors and central nervous system abscesses, gave written informed consent, and clinicians followed a clearly defined protocol.

Under the program, "There has not been a single instance of device injury requiring replacement or significant patient injury," the Utah physicians said. "The benefit to risk ratio in our own experience is clearly positive.”

CMS' current policy, finalized just a few months ago, covers MRI in patients with pacemakers and implanted defibrillators only in the context of CMS-approved clinical trials. (See “ Also see "Study Resumes Site Recruitment To Test MRIs On Pacemaker/ICD Patients" - Medtech Insight, 4 April, 2011. ” – “The Gray Sheet” April 4, 2011.)

On April 25, however, CMS loosened up slightly, proposing to cover MRIs for pacemaker patients whose implants are approved by FDA as safe for use in the MRI environment. The new coverage analysis was requested by Medtronic, which recently received FDA approval for its Revo MRI SureScan pacemaker, specially designed to withstand the strong magnetic fields generated during an MRI scan. (See “ Also see "CMS Changes Gears On MRI Coverage In Pacemaker Patients" - Medtech Insight, 2 May, 2011. ” – “The Gray Sheet” May 2, 2011.)

Registry Suggested

Even if CMS finalizes, without changes, its April 25 proposal on MRI-safe implants, its underlying restriction on MRIs in patients with all other types of implanted pacers and defibrillators will still stand: only those cardiac-implant patients who agree to be part of a clinical trial will be eligible for Medicare reimbursement of an MRI scan.

Registries, as opposed to randomized, controlled clinical trials, would allow data collection on safe use of MRI without denying scans to patients who need them, a group of doctors argues.

Addressing that restriction, the Intermountain Medical Center physicians suggested that instead of requiring clinical trials, CMS could set up formal patient registries – a solution that would preserve access to needed MRIs while still allowing evidence collection on the safest ways to conduct the imaging procedure in patients with electrical cardiac implants.

Such registries could come in handy for patients who do not initially receive MRI-safe implants but who later develop a condition for which MRI is indicated, the Intermountain specialists said.

They pointed out that if pacemaker patients do not have acceptable coverage options through registries, "then physicians may be forced to implant an unduly high percentage of these new-generation, higher-cost, often lower-functionality MRI-approved devices, because predicting everyone who will need MRI scans in their future is an impossible task.”

Medtronic does not yet have U.S. competition for its MRI-compatible pacemaker, but other companies have such devices under development or on the market overseas.

Other Comments: HRS, ACC, MITA

Unlike the Society for Cardiovascular Magnetic Resonance and the Intermountain Medical Center group, the Heart Rhythm Society and the American College of Cardiology support both CMS coverage policies: In joint May 25 comments, they agreed MRIs should be covered in patients with FDA-approved MRI-safe pacemakers, and expressed continuing support for clinical research to investigate the safety of MRIs for patients with implants not specifically approved for the MRI environment.

The American Heart Association, the American College of Radiology and the trade group Medical Imaging and Technology Alliance also wrote May 25 in support of MRI coverage for patients with MRI-safe pacers.

The American Heart Association added that although practical experience shows that MRI can be done safely in patients with various types of cardiac implants, clinical trial data on specially designed MRI-safe implants "will provide health care providers and their patients with additional assurance."

CMS plans to issue a final decision on the topic by July 24.

By Monica Hogan, Mary Houghton

Physicians Push For Less Restricted MRI Coverage For Pacemaker-Implanted Patients

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