The U.S. Centers for Medicare & Medicaid Services (CMS) has posted a proposed rule for coverage of FDA-designated breakthrough devices, a programmatic objective that has been front and center for the agency for several years. However, Tamara Syrek Jensen, director of the Coverage and Analysis Group (CAG) at CMS, said the proposal to redefine the term “reasonable and necessary” may be the more critical piece of the proposed rule because it would give the agency unprecedented flexibility in covering a broad swath of medical technologies.