Pathways' Pick of the Week: TCET Criticized on the Hill
Market Pathways
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ARTICLE SUMMARY:
Congress hears feedback on CMS’ “emerging technologies” coverage proposal. Excerpted from Pathways' Picks July 19: TCET on the Hill, MDR Q&A, CDRH “Transformation” Chief, and More.
Device company executives from? Edwards Lifesciences ?and? PAVmed Inc. ?testified in Congress yesterday about CMS’?recently proposed Transitional Coverage for Emerging Technologies?(TCET) plan.
They said the TCET proposal is an incremental positive but raised several overarching complaints about the plan, arguing that it is too narrow and under-resourced, with only five devices per year estimated for the program; that it incorporates ambiguous timelines instead of the more automatic process that had been envisioned by the repealed MCIT program; and that it excludes diagnostics, among other concerns.
The House Energy and Commerce Health Subcommittee convened the hearing on Medicare coverage pathways to discuss TCET, as well as controversies persisting about coverage of monoclonal antibodies for Alzheimer’s disease.
The hearing also served as an unofficial kickoff for renewed efforts by industry and allies in Congress to move legislation that would enact the automatic MCIT framework instead of CMS’ less aggressive proposals.
“We’re going to shift our focus more aggressively on the Hill now,” AdvaMed CEO Scott Whitaker told?Market Pathways.
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