CMS further delays new technology pathway

WASHINGTON – CMS in a final rule filed last week further delayed the effective date for a Medicare coverage pathway to provide beneficiaries access to new, innovative medical devices designated as breakthrough technology by the U.S. Food and Drug Administration. 

The effective date for Medicare Coverage of Innovative Technology, as well as implementing regulatory standards to be used in making reasonable and necessary determinations under the Social Security Act for items and services that are furnished under Medicare Part A and B, has been delayed until Dec. 15, 2021. 

“The final rule would further delay the effective date of the MCIT/R&N final rule until Dec. 15, 2021, to provide CMS an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment as noted previously,” CMS states. “During the delay, we will determine appropriate next steps that are in the best interest of all Medicare stakeholders, and beneficiaries in particular.” 

Earlier this year, CMS filed an interim final rule delaying the effective date of the MCIT/R&N final rule for 60 days to ensure that the rulemaking process was procedurally adequate; that it properly considered all relevant facts; that it considered statutory or other legal obligations; and that it had adequately considered public comments objecting to certain elements of the rule. 

CMS says it received about 215 comments in response to the IFR delaying the effective date of the MCIT/R&N final rule.