In a fact sheet published June 22, the agency said it plans to introduce the Transitional Coverage for Emerging Devices pathway. The program, which is voluntary for devicemakers, would allow Medicare coverage of new devices while evidence about their effectiveness is gathered.
The rule is aimed at speeding up a slow approval process for Medicare coverage — a 2022 survey of medical device industry professionals found it took an average of 4.7 years for new devices to receive national Medicare coverage after they are approved by the FDA.
In 2021, CMS repealed a previous rule expediting coverage for breakthrough devices, saying the process did not adequately assess devices’ effectiveness.
The proposed rule is open for comment for the next 60 days.
At the Becker's 5th Annual Fall Payer Issues Roundtable, taking place November 17–19 in Chicago, payer executives and healthcare leaders will come together to discuss value-based care, regulatory changes, cost management strategies and innovations shaping the future of payer-provider collaboration. Apply for complimentary registration now.
