ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA selects Dexcom as the first participant in the digital health TEMPO pilot; 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.
Dexcom Sets TEMPO
An AI -powered “glucose health program” from Dexcom was selected as the first participant in FDA’s TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot for digital health devices, the agency announced July 22.
TEMPO was first launched in December alongside CMS’ ACCESS Model in which digital health providers and clinics agree to offer specialized “technology-oriented care” to patients in four chronic disease categories and received an outcomes-based payment rather than traditional fee for service. Under TEMPO, developers of medical device-grade digital health can apply to offer their tool to ACCESS participants before gaining FDA authorization in return for collecting real-world evidence (RWE) that will ultimately support a traditional FDA submission.
Dozens of firms applies for TEMPO earlier this year, and some have heard follow-up question from the agency. But Dexcom is the first to be accepted for its tool that combines AI with glucose data from the Dexcom G7 and Stelo continuous glucose monitors and other health information to help manage patients with diabetes and those who are being screened for the chronic condition. The firm says it will leverage the pilot to collect RWE to assess the tools’ use to advance earlier intervention strategies and to collect evidence for “broader cardiometabolic health outcomes.” The ACCESS Model officially launched July 5, and there are currently about 180 healthcare and technology organizations participating. Dexcom is not an ACCESS participation, which means it will be selling its AI-enabled tool to participants for express use in the alternative payment model program.
“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.
