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Public Policy Newsletter Article

Biocom CA Requests Comments on CMS’ Delay of the MCIT Final Rule

  • 2021-03-25T15:00:00.000+0000
  • Author: Izzie Omer

On January 12, CMS released the final rule for the Medicare Coverage of Innovative Technology (MCIT) pathway. The rule provides four years of automatic national Medicare coverage for medical devices that have been designated as breakthrough by the Food and Drug Administration (FDA), starting on the date of FDA market authorization. Biocom had submitted a comment letter on the draft regulation, expressing our support for the policy, with recommended changes.

On March 12, the Friday before the rule was slated to come into effect, CMS delayed the final rule to May 15 and reopened the comment period. The interim final rule cited areas of concern for additional comments, including benefit category determinations, coding, and payment levels, the overlapping of the DMEPOS and MCIT rules, and considerations over the volume of breakthrough devices.

Biocom is looking for feedback from members. Please email Izzie Omer, Biocom’s Regulatory Policy Associate, at [email protected] if you would like to share feedback and concerns.