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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
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On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and necessary” under section 1862(a)(1)(A) of the Social Security Act (SSA) and sets the stage for commercial insurance coverage to be considered in assessing such coverage in prescribed circumstances. In addition, the final rule establishes a “Medicare Coverage of Innovative Technology” (MCIT) pathway, which is a voluntary and expedited mechanism to obtain national Medicare coverage for medical devices designated with “breakthrough” device status by the Food and Drug Administration (FDA).