www.fdanews.com/articles/132567-cms-proposes-coverage-for-trials-involving-mris-and-pacemakers
CMS Proposes Coverage for Trials Involving MRIs and Pacemakers
December 9, 2010
Although the Centers for Medicare & Medicaid Services (CMS) is holding to its decision to not cover MRI for patients with implanted pacemakers or implantable cardioverter defibrillators, it is proposing an exception for some clinical trials. To qualify for coverage, trials must meet several safety conditions. For instance, radiology and cardiology personnel, as well as a fully stocked crash cart, must be available throughout the MRI scan. CMS is seeking comments on the proposed exemption.
Devices & Diagnostics Letter
Devices & Diagnostics Letter