ARTICLE SUMMARY:
Looking ahead with “Next Picks,” and our regular roundup of global medtech policy news. Topics this week include: the Medicare MCIT program, Europe device regulations, PMA review times, 510(k)s in the courts, telehealth scrutiny, COVID-19 test policies, and more developments from Health Canada, UK NICE, and FDA.
This week’s Pathways’ Picks starts off with a new section, “Next Picks”—a forward-looking segment that will spotlight developments we think will materialize in the coming weeks. Then, our regular news roundup, and dates to remember.
Next Picks
Three things we’re watching for:
- MCIT–will they or won’t they? Look for signs from CMS on whether it plans to stand up the Medicare Coverage for Innovative Technologies (MCIT) program on schedule, on March 15, or whether the automatic coverage program for Breakthrough Devices will be held up by the Biden administration’s general freeze of unimplemented Trump-era policies. The device industry is pressing for an on-time launch, and it recently gained support from four Democratic representatives in the US House who wrote CMS on the matter.
- First MDUFA V readout. User fee reauthorization negotiations between FDA and industry are getting started. The talks are private but FDA will post summary readouts and the first one of those should be coming soon, providing a view into opening positions and how far apart the two sides are.
- FDA commish nomination? When asked at a press briefing this week about nominations for FDA commissioner and several other administration posts, White House Press Secretary Jen Psaki said, “hopefully we’ll have news on that in the coming weeks.” Not very definitive, but there are other reasons to think the FDA nom announcement will happen soon. HHS Secretary nominee Xavier Becerra is expected to be confirmed by the full Senate as early as next week, and there have been reports that one delay in naming an FDA nominee has been that Becerra wants a say in the decision. Also, the first week or two of March aligns with the timing of FDA commissioner nominations at the start of other recent administrations, including Margaret Hamburg by President Obama in 2009 and Scott Gottlieb by President Trump in 2017. It remains an open question who the nominee will be, with current Acting Commissioner Janet Woodcock still in the running, but opposed by some Democratic lawmakers, and reports that the administration has broadened its search to fill the top FDA spot.
