ARTICLE SUMMARY:
In this week’s Pathways Picks: Industry and hospital groups call out CMS for tightening its proposed coverage policy language for transcatheter aortic valve replacements; UK issues AI regulation case studies; Health Canada complains of too much information; India finalizes its guidance on medical device software; and more global medtech policy updates.
“Severe” TAVR Proposal From CMS
The Medicare coverage status for transcatheter aortic valve replacement in patients with less-than-severe valve stenosis could be in a gray area based on unexplained wording changes in CMS’ recent national coverage determination (NCD) proposal for TAVR.
The June 15 proposal generally seeks to expand coverage of TAVR by removing coverage-with-evidence development (CED) mandates for the treatment of symptomatic stenosis and adding new CED-based coverage for asymptomatic stenosis. However, industry and hospital groups point out that CMS specifies in the proposal that coverage is limited to “severe” aortic stenosis, while the currently active NCD does not include that modifier. Right now, TAVR devices are only approved by FDA for severe disease, but the existing Medicare policy allows coverage in moderate aortic valve stenosis patients as part of CED studies; it is also worded in a way to immediately allow these patients to be covered once FDA does authorize an expanded TAVR indication.
“We are concerned that the proposed restrictions to the covered population may limit current and future coverage for patients,” writes Amber Stock, AdvaMed’s VP of payment and healthcare delivery policy, in recent comments responding to the proposal. Stock also points out that CMS provides no explanation for the change, along with several other wording adjustments in the new proposal. “This sets a concerning precedent for CMS to limit coverage without appropriate notice and comment,” she notes.
