Pathways’ Picks January 11: Codifying CED, Moving MDR Dates, and More from US, Europe, and Asia

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ARTICLE SUMMARY:

In this week’s roundup: CMS discloses plans to codify coverage with evidence development in Medicare regulations; European Commission follows through with proposal to extend MDR compliance timelines; EMA plans scientific advice pilot for high-risk combo products; China approvals spiked in December; single US-Canada submissions tested; the problem of recalled 510(k) products; and more global medtech policy news and insights.

Top Pick: CMS Emphasizes CED

CMS wants to formalize long-used program:

Codifying CED? CMS plans to use its upcoming Transitional Coverage for Emerging Technologies (TCET) proposed rule to codify its coverage with evidence development pathway into Medicare regulations, the agency disclosed in a January 5 regulatory agenda update. “This rule is necessary to codify the Coverage with Evidence Development (CED) coverage pathway in regulation and aims to increase predictability, transparency, and timeliness of Transitional Coverage for Emerging Technologies (TCET),” according to an entry in the new HHS Unified Agenda posted January 5. In the agenda item, CMS sticks with its previously listed April 2023 estimate for releasing the TCET rule. The agency also reiterates its four underlying principles for TCET that it laid out in a journal article last year.

Notably, CMS has been employing the CED policy to condition national coverage policies with data-collection requirements since about 2005 by relying on indirect regulatory citations. The legality of CED has been challenged on multiple occasions—most recently by the Trump administration’s HHS Office of General Counsel, which posted an advisory opinion in January 2021 concluding CMS didn’t have the authority to require evidence collection as part of a coverage policy. But the Biden administration quickly took that opinion down, and now CED will be a central part of CMS’ long-term plan to streamline coverage for innovative medtech under TCET. Notably, CMS’ Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) is set to meet February 13 and 14 to weigh in on updated criteria for establishing, reporting, and completing CED study requirements.

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