ARTICLE SUMMARY:
In this week’s Pathways Picks: CMS signals its final Transitional Coverage for Emerging Technologies pathway could be published this month; EU makes official several IVDR and MDR reforms; CMS issues its outpatient payment proposed rule, where a device qualifies for a new opioid-alternative payment; FDA addresses opioid disorder treatment devices and misinformation in guidance docs; and more news from Europe, Japan, and China.
Top Picks
TCET timing and final EU reforms:
TCET this month? CMS plans to finalize its Transitional Coverage for Emerging Technologies (TCET) pathway in a notice later this month according to a listing in the US government’s updated regulatory agenda posted this week. If the agency follows that timeline, the notice would come more than year after CMS officially proposed the TCET pathway, in June 2023. TCET is intended as a streamlined path to Medicare coverage for select FDA Breakthrough Devices leveraging the existing national coverage determination (NCD) process. CMS proposed TCET after repealing the Trump-era Medicare Coverage of Innovative Technologies program, which would have established automatic, temporary coverage of Breakthrough Devices under a path distinct from the conventional NCD. In the new agenda listing, CMS says the final notice will respond to public comments on last June’s proposal, but the agency doesn’t indicate whether it will make any substantive updates from the proposal. Device industry groups have ramped up calls for CMS to finalize TCET, which they say is a positive yet insufficient step to address reimbursement gaps for new medtech. Timelines listed in the biannual regulatory agenda are not always accurate, so it’s not guaranteed TCET will be published this month.
