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Public Policy Newsletter Article

CMS Extends MCIT Implementation Delay

  • 2021-05-20T15:00:00.000+0000
  • Author: Izzie Omer

On Friday, May 15, the Centers for Medicare and Medicaid Services (CMS) released their responses to a second round of comments on the interim final rule Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” and further delayed the start of the pathway until December 15, 2021.

The MCIT program, developed in 2020, provides four years of automatic Medicare coverage for breakthrough-designated devices approved by the FDA. This pathway would provide coverage for critical devices for at-risk patient populations. The pathway was slated to begin on March 15, 2021 and had already been delayed to May 15, 2021.

CMS stated this additional time would 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. This delay is disappointing news for Medicare patients and industry.

Biocom California has commented on this issue multiple times, including most recently in April 2021, urging the agency to implement the pathway on May 15. We will continue to monitor this issue and advocate for the pathway’s implementation at the end of this year.