ARTICLE SUMMARY:
In this week’s roundup: Medicare inpatient new technology proposals contend with COVID, European documents continue to roll out in the runup to MDR, Saudi artificial intelligence device guidance, Taiwan reforms, India regulatory extension, a cost analysis of the VALID Act for diagnostics, and more from FDA and UK NICE.
Top Pick: Inpatient Proposal Contends with COVID
Emergency Use Authorization devices are not eligible for new technology add-on payments (NTAPs). That is one takeaway from Medicare’s fiscal year 2022 hospital inpatient prospective payment system (IPPS) proposed rule, issued April 27. (Note: We previewed the IPPS release in the March 31 "Next Picks".) The document contends with the impacts of COVID-19 throughout its almost 2,000 pages, including the EUA/NTAP policy and CMS’ proposal to grant a one-year extension to expiring NTAPs to make up for the depression in medical procedures in 2020. For more about the NTAP policies addressed in the proposed rule, read our article: “New Tech Scrutiny and Support in Latest Medicare Inpatient Proposal.”
MDR Watch
Europe readies for the May 26 Medical Device Regulation go-live:
