Last Call: CMS Comments Due June 9 on Proposed Breakthrough Device NTAP Changes

The deadline to submit comments on CMS's Proposed Rule to repeal the FDA Breakthrough Device Designation (BDD) alternative pathway for New Technology Add-on Payment (NTAP) eligibility is Tuesday, June 9, 2026, at 5:00 p.m. EDT.

As discussed in our previous alert, the proposal could have significant implications for companies developing, commercializing, or investing in breakthrough medical technologies.

Gardner Law is submitting comments opposing the proposed repeal. Our concern is straightforward: eliminating the pathway could make it more difficult for hospitals to adopt breakthrough technologies during the critical early commercialization period, delay patient access, disrupt companies that have relied on the pathway, and weaken the U.S. medtech innovation ecosystem.

FDA strategy, evidence generation, reimbursement, patient access, and commercialization are closely interconnected. Companies that may be affected by this proposal should consider whether submitting comments would help ensure CMS understands the practical impact of the proposed change.

Individual company perspectives, real-world examples, and patient access considerations can be valuable additions to the administrative record.

If your organization is considering submitting comments and would like assistance, please contact the Gardner Law team before the June 9 deadline.