ARTICLE SUMMARY:
In this week’s Pathways Picks: AdvaMed CEO Scott Whitaker is increasingly optimistic on legislative prospects for jumpstarting Medicare coverage of Breakthrough Devices; FDA officially rescinds the laboratory developed test rule, and refines its emergency policies for diagnostics; EU industry weighs in on short- and long-term MDR and IVDR reform; Malaysia joins the Medical Device Single Audit Program; China adds flexibility on device lab testing; and more news from Asia, Europe, and the US.
US Picks
Medicare optimism, diagnostic news, and software guidelines:
Industry optimistic on Breakthrough bill. AdvaMed CEO Scott Whitaker says he is increasingly optimistic about the prospects of Congress establishing an automatic, temporary path to national Medicare coverage for most FDA Breakthrough Devices. “Am I optimistic? More so than I was last year,” Whitaker said in an interview on the Market Pathways Podcast. House Ways and Means passed the Ensuring Patient Access to Critical Breakthrough Products Act (HR 5343) out of committee last week with only three “no” votes. “It moved from a mostly partisan vote in the past to a 38-3 vote that was overwhelmingly in support of the same basic bill,” the AdvaMed chief underscored during the September 22 episode. The Energy and Commerce Committee discussed the bill last week, but didn’t vote on it yet, and similar legislation is pending in the Senate. “It's a very positive sign and an encouraging trend right now,” Whitaker said.
