Pathways’ Picks November 2: Medicare Pay, Breakthrough Stats, CE Mark Times, and More

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In this week’s roundup: CMS 2023 payment rules, updated numbers on FDA’s Breakthrough program, year-plus timelines reported for CE mark reviews, a new guidance on EU Authorized Representative practices, and more from FDA, China, and Malaysia.

Top Picks

CMS rule bonanza and FDA breakthrough stats:

Medicare in 2023. CMS made final rulings for next year on medtech bonus payments, clinical trial coding, and algorithm-based software reimbursement among an array of other payment policies in a series of regulations published October 31 and November 1. For a roundup of some of the medtech decisions in the final rules, see:Medicare Moves: CMS Settles 2023 Medtech Pay Policies.

Breakthrough stats. The number of FDA designations of Breakthrough Devices dropped in FY 2022 but the number of Breakthrough Devices authorized for marketing by the agency inched up in the fiscal year that ended September 30, according to updated numbers posted on FDA’s website October 28. A few key data points:

  • FDA made 164 Breakthrough designations in FY 2022, down from 206 last year. The drop resulted from a reduction in company requests for designations during that period, possibly due to commercial COVID-19 backlogs, according to CDRH Director Jeff Shuren, who cited the trend last week during a panel discussion at The MedTech Conference in Boston.
  • On the other hand, the agency authorized 17 Breakthrough Devices during the same period, up from 15 in FY 2021 and 10 in FY 2020.
  • Seven of the FY 2022 authorizations were 510(k)s, almost double the number of 510(k)s authorized via the Breakthrough program previously.
  • In total from 2016 through September 30, FDA has designated 722 Breakthrough Devices and authorized 56 of them, with a relatively even split between PMA, De Novo, and 510(k) authorizations: 


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