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With respect to the newness criterion at 419.66(b)(1), the SCOUT MD TM Surgical Guidance System received FDA Breakthrough Device designation effective February 1, 2023

Update to the Extraordinary Circumstances Exception (ECE) Policy for the Hospital OQR, REHQR, and ASCQR Programs In the CY 2026 OPPS/ASC proposed rule (90 FR 33756 through 33757), we proposed to update the current Hospital OQR, REHQR, and ASCQR Program ECE policies codified at 42 CFR 419.46(e)