H.R. 4441 — Patient Access to Innovative New Technologies Act of 2025

This section amends section 1886(d)(5)(K) of the Social Security Act to authorize conditional new technology add-on payments (NTAP) under Medicare's inpatient prospective payment system for breakthrough devices (i.e., those designated by FDA under section 515B of the Federal Food, Drug, and Cosmetic Act for expedited development and priority review and subsequently approved, cleared, or authorized for that indication) that receive FDA approval after the deadline in 42 CFR 412.87(f)(2) but before July 1 of the fiscal year for which NTAP was sought. (As background, NTAP provides temporary additional Medicare payments to hospitals for new, costly technologies not yet reflected in diagnosis-related group rates.) The provision applies to discharges beginning in the first quarter after FDA approval, requires budget-neutral implementation, takes effect upon enactment, and applies to devices approved, cleared, or authorized on or after July 1, 2023.