CMS Proposes to Expand the Scope of Medicare Coverage Determinations

On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would, for the first time, establish formal criteria to define the “reasonable and necessary” standard for Medicare coverage, and would make Medicare coverage available immediately for medical devices deemed to be breakthrough devices by the Food and Drug Administration (“FDA”). If the proposed rule becomes final, it would be a significant expansion of the scope of Medicare coverage. CMS has...<BR />By: <a href="https://www.jdsupra.com/profile/epstein_becker_green/">Epstein Becker & Green</a>