To embed, copy and paste the code into your website or blog: On January 14, 2021, CMS finalized 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," 86 Fed. Reg. 2987 (Final Rule, January 14, 2021). In response to President Trump's October 3, 2019 Executive Order 13890 directing the Secretary of HHS to clarify the application of coverage standards, CMS explained that codifying "reasonable and necessary" will "provide greater certainty to stakeholders seeking coverage for innovative items and services and to ensure that this substantive legal standard is codified." The effective date of the final rule is listed as