For at least 4-5 years, there have been perennial rumors about some new Breakthrough Technology innovative coverage rule at CMS. (I wrote a blog a couple years ago that was an update of the past several years, to that timepoint.) President Trump had an executive order including this topic in Fall 2019, and CMS added some special statuses for breakthrough technologies in NTAP in 2019/2020.
Here's OMB from August 2020.
https://www.reginfo.gov/public/do/eoDetails?rrid=129365
Here's a rulemaking reference tied to Fall 2019, from the RIN 0938 AT88 link above.
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0938-AT88
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