• The Centers for Medicare and Medicaid Services have delayed the implementation of the Medicare Coverage of Innovative Technology (MCIT) program until December 15, 2021. 
  • The MCIT will provide immediate, national coverage for breakthrough devices or diagnostics approved by the FDA.
  • The Foundation and our partners including MITA have expressed disappointment in this delay.

Key Points

  • The Centers for Medicare and Medicaid Services (CMS) have delayed the implementation of the Medicare Coverage of Innovative Technology (MCIT) program until December 15, 2021. 
  • The MCIT will provide immediate, national coverage for breakthrough devices or diagnostics approved by the FDA.
  • The Foundation and our partners, including MITA, have expressed disappointment in this delay.

CMS logoOn May 18, the Centers for Medicare and Medicaid Services (CMS) published a final rule opting to further delay implementation of the Medicare Coverage of Innovative Technology (MCIT) program until December 15, 2021. The Foundation and our partners, including the Medical Imaging & Technology Alliance (MITA), have expressed disappointment in this delay.

“This additional delay by CMS could unfortunately prolong the time for patients to gain access to innovative new treatments, and we encourage CMS to consider this impact on patients as they ultimately implement this new program,” said the Foundation’s Chief Scientific Officer, Jessica Foley, PhD. “The proposed MCIT pathway would create a more efficient adoption path for noninvasive technologies, such as focused ultrasound, improving the health and well-being of countless people in the US.”

In January 2021, CMS issued a final rule that provided 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 was expected to take effect beginning March 15, but it was delayed until May 15 and then until December 15 to allow the new Administration the opportunity for a more thorough review and assessment.

The Foundation will continue our advocacy in collaboration with the focused ultrasound community and our other partners to encourage implementation of an MCIT pathway that reduces the barriers to commercialization for our industry and provides patients with the innovative treatments they deserve. To get involved in our advocacy initiatives please contact Jessica Foley, PhD.

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