Key Points
- A new program proposed by the Centers for Medicare & Medicaid Services (CMS) would allow breakthrough medical devices to secure Medicare reimbursement.
- The Transitional Coverage for Emerging Technologies pathway would expedite coverage for up to five devices each year.
- Submit your public comments to CMS by August 28.
A new pathway proposed by the Centers for Medicare & Medicaid Services (CMS), Transitional Coverage for Emerging Technologies (TCET), would allow some qualifying breakthrough medical devices to secure Medicare reimbursement.
Each year, the voluntary program would expedite Medicare coverage for up to five designated breakthrough* devices. If approved, the selected devices would gain an estimated three to five years of transitional CMS coverage. The goal would be to finalize coverage for the medical device no later than six months after FDA clearance. Then, ideally, the device would generate enough evidence on the market to achieve a longer-term Medicare coverage determination.
“Medical devices, including those in the focused ultrasound space, often experience a significant gap between FDA clearance and reimbursement by CMS,” explains the Foundation’s Chief Scientific Officer and Managing Director for Government Affairs, Jessica Foley, PhD. “This ‘valley of death’ can impact the success of a medical device because patients are unable to afford treatment out-of-pocket. The proposed TCET pathway could help alleviate this burden for devices that qualify. It is a good start, and we are proud that the collective advocacy of our focused ultrasound and medical device community and our various partners over the past few years has made a positive difference. However, we encourage CMS to consider making this pathway available more broadly than its current limit of five devices per year.”
The TCET pathway comes after CMS repealed a similar program, the Medicare Coverage of Innovative Technology (MCIT), in 2021, citing concerns that it may have covered devices without adequate evidence of their impact in a Medicare population.
CMS will be taking public comments on the notice until 5 pm on August 28, 2023.
“The Foundation encourages all relevant stakeholders in the focused ultrasound field to submit comments in response to the proposed TCET pathway,” said Dr. Foley.
*The FDA’s Breakthrough Devices Program was established in 2008 to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval. Devices must meet specific criteria to be considered for the breakthrough pathway.