Key Points
- A new program for the Centers for Medicare and Medicaid Services (CMS) may expedite Medicare reimbursement national coverage determinations for devices with breakthrough device designation.
- October 31 is the first quarterly deadline to apply to the Transitional Coverage for Emerging Technologies (TCET) program.
The Centers for Medicare and Medicaid Services (CMS) has established a new program called the Transitional Coverage for Emerging Technologies (TCET) that can help expedite Medicare reimbursement for some medical devices with breakthrough device designation.
Up to five devices will participate in the program each year. The goal of the TCET program is to enable a more efficient and transparent Medicare coverage review process with enhanced communications between CMS and industry before the device earns US Food and Drug Administration (FDA) authorization. Clear evidence requirements and defined timelines for final coverage actions will also be available. CMS has stated that the goal is to secure a national coverage determination for TCET products within six months after FDA authorization, which is three to six months faster than the regular process. For TCET products needing additional data to support a CMS coverage determination, a coverage with evidence development path may allow additional studies with transitional CMS coverage for five or more years while the evidence is gathered.
At least six focused ultrasound devices have earned Breakthrough Device designation: Carthera for its SonoCloud-9 device for glioblastoma, Cordance Medical for its NeuroAccess liquid biopsy device, EDAP TMS for its Focal One high-intensity focused ultrasound (HIFU) platform for treating deep infiltrating rectal endometriosis, HistoSonics for its EdisonTM histotripsy platform, Acoustiic for its ultrasound arrays, and SONIRE Therapeutics Inc’s HIFU therapy system for the treatment of pancreatic cancer.
“Collective advocacy of our focused ultrasound and medical device community and our various partners have made a positive influence in the adoption of new programs like the TCET program,” said Jessica Foley, PhD, the Foundation’s Chief Scientific Officer and Managing Director for Government Affairs. “It is a good start and we encourage CMS to consider making this pathway available more broadly than its current limit of five devices per year.”
Apply for the TCET Program
Nomination applications are accepted quarterly, and the next deadline is October 31. Device manufacturers are encouraged (but not required) to submit a voluntary, non-binding letter of intent 18 to 24 months before FDA authorization.
Learn More
For more information about the program, see the CMS notice, watch the CMS webinar, or contact FUS Partners if you need connections to third-party reimbursement experts who can assist you on a fee-for-service basis.