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”).[1] If the proposed rule becomes final, it would be a significant expansion of the scope of Medicare coverage.

The proposed rule would not establish a bright-line test for Medicare coverage; instead, it would adopt the criteria currently in the Medicare Program Integrity Manual, which is an interpretive guideline for MACs.[3] While this provides a degree of clarity, CMS and the MACs retain a large measure of discretion. 

Source: https://www.jdsupra.com/legalnews/cms-proposes-to-expand-the-scope-of-35902