ARTICLE SUMMARY:
In this week’s Pathways Picks: Continued upswing for Medicare New Technology Add-On Payments; AI device payment bill introduced; De Novo bottleneck breaks; FDA taps Hill user fee veteran as policy chief; China updates classification rules; South Africa enacts ISO 13485 requirement; EU notified bodies weigh in on AI Act; and more.
US Picks
Reimbursement updates, FDA policy chief, RFK’s FDA visit, and deregulation:
Another Record NTAP haul is coming. CMS is primed to award New Technology Add-on Payments to a record number of medical devices for the third year running. The Medicare agency identified 15 devices that are virtually assured to qualify for the bonus reimbursement starting October 1 in its FY 2026 hospital inpatient payment proposed rule published April 1. CMS identified another two devices that are likely to qualify but need to provide additional information about cost calculations and another nine that will receive the payment if they secure FDA authorization by May 1. If 26 devices are awarded NTAPs when CMS issues its final rule in the summer, it would more than double the previous record for new NTAPs, set last year, awarded since the program launched in 2001. All of these are FDA Breakthrough Devices seeking the add-on payments via a special route that doesn’t require manufacturers to prove “substantial clinical improvement.” An additional three non-Breakthrough devices are pursuing FY 2026 NTAPs via the traditional route, but they have more to prove regarding clinical impact. Under the NTAP program, hospitals receive an extra, targeted reimbursement to cover the costs of new technologies for two to three years while CMS works out the proper long-term payment policy for the products. It can serve as a useful market on-ramp for new devices, but historically, in industry’s view, CMS has been overly cautious in how it awards the payments. The agency also disclosed plans in the FY 2026 proposed rule to continue add-on payments for 14 devices started receiving NTAPs in prior years.
