ARTICLE SUMMARY:
In this week’s Pathways Picks: CMS plans to reverse bonus payment fast track for Breakthrough Devices, and advances novel payment models in orthopedics and digital health; FDA is slow on TEMPO responses while exempting AI exemption petition; UK ups AI sandbox investments; and more regulatory updates from FDA and the EU.
Top Picks: New Medicare Directions
CMS proposes reversal on NTAPs, advances novel pay models:
End to streamlined bonus-pay path? FDA-designated Breakthrough Devices would no longer enjoy a fast track to Medicare inpatient new technology add-on payments (NTAPs) and outpatient pass-through payments under an April 10 proposal from CMS. If finalized, the change would require companies to demonstrate “substantial clinical improvement” for their Breakthrough Device over existing care, and it would likely lead to a massive drop-off in new awards from the bonus payment programs, which have grown in recent years. For more details on the proposal and historical context, see in Market Pathways: “CMS Eyes End to Streamlined Path For New Technology Payments.”
