Thursday, October 22, 2020
Tuesday, October 20, 2020
It has taken CMS more than 50 years, but the agency has finally proposed a regulatory definition for determining whether an item or service is "reasonable and necessary" for Medicare coverage purposes. Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary," 85 Fed. Reg. 54327 (Proposed Rule, September 1, 2020). This move comes in response to the President's October 3, 2019 Executive Order 13890 directing the Secretary of HHS to ensure that Medicare beneficiaries have access to new cures and technologies that improve health outcomes. While CMS simultaneously seeks to establish a Medicare coverage pathway for medical devices designated as breakthrough by the FDA in this proposed rule, the proposed regulatory definition, including a possible consideration of whether an item or service is covered in the commercial insurance market, marks some progress toward clarifying when Medicare coverage is available. Comments to the proposed rule must be received by November 2, 2020.