CMS Delays Rule Codifying Medicare’s Definition of “Reasonable and Necessary”
The Centers for Medicare & Medicaid Services (CMS) delayed the effective date for its final rule codifying how it defines “reasonable and necessary” coverage for items and services furnished under Medicare Parts A and B, through December 15, 2021. The rule also establishes a Medicare coverage pathway for innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA).
This final rule delays the effective date of the final rule entitled, “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary”, published in the January 14, 2021, Federal Register. CMS said the delay would allow it to address issues raised by stakeholders and determine appropriate next steps. It previously delayed the rule from March 15 to May 15 as part of the Biden administration’s review of new and pending rules and requested public comment on the rule’s underlying facts, law and policy. To review the MCIT and R&N Final Rule, click here.
