• The Medicare Coverage of Innovative Technologies Pathway (MCIT) was set to take effect March 15, but is delayed.
  • The MCIT provides immediate, national coverage for ‘breakthrough’ devices or diagnostics approved by the FDA.
  • We encourage focused ultrasound companies to submit comments in support of the rule.

Key Points

  • The Medicare Coverage of Innovative Technologies Pathway (MCIT) set to take effect March 15 has now been delayed.
  • The MCIT provides immediate, national coverage for breakthrough devices or diagnostics approved by the FDA.
  • We encourage focused ultrasound companies to submit comments in support of the rule.

CMS logoIn January 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that provides immediate national Medicare coverage for four years for any new device or diagnostic designated as a Breakthrough Technology and approved by the US Food and Drug Administration (FDA). The Foundation as well as our partners MITA and AdvaMed praised this rule as a big win for Medicare patients. The rule could potentially eliminate the lag time between regulatory approval and reimbursement for many focused ultrasound therapies.

This new rule – called the Medicare Coverage of Innovative Technologies Pathway (MCIT) – was expected to take effect beginning March 15, but was delayed to allow the new Administration the opportunity for a more thorough review and assessment. CMS has opened an additional public comment period that ends April 16, and the Foundation will send comments in support of the rule. We encourage focused ultrasound companies to submit their own comments, as this rule could have significant impact on their timelines for receiving Medicare coverage for their products. We anticipate the new rule to take effect May 15, 2021.

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