ARTICLE SUMMARY:
In this week’s roundup: Eyeing next week’s CMS advisory committee meeting on coverage with evidence development; an industry petition urging FDA to rescind its clinical decision support software guidance; digital health reimbursement updates from Germany and the UK; EU MDR news; and more.
Next Picks: Medicare CED chat
What we’re watching for:
MEDCAC meets. CMS’ Medicare Evidence Development and Coverage Advisory Committee will meet next Monday and Tuesday to consider proposed updates to the criteria for clinical studies under Coverage with Evidence Development (CED) policies, in which national coverage is conditioned on data collection. The new criteria don’t necessarily represent a major shift in practice for the CED program, but its an opportunity for CMS to modernize and tighten up the framework it has been employing officially for the past 18 or so years. Industry is always looking for more predictability and data flexibility in CED policies, but one big open question is to what extent this effort will feed into CMS’s upcoming Transitional Coverage for Emerging Technologies (TCET) proposed rule. Industry groups hope CED and TCET stay on separate tracks, but CMS seems to have different ideas. To read more, see “Never the Twain Shall Meet? Medicare CED Meeting Precedes TCET Rule.”
