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The compound has never been the subject of a completed Phase III human clinical trial

Consistent with the Executive Order and to better attain the goals we have articulated in previous HPT rulemakingrequiring hospitals to make meaningful price information available to consumers, employers, policymakers, and others to support a more competitive, innovative, affordable, and higher quality healthcare systemin the CY 2026 OPPS/ASC proposed rule, CMS proposed several updates to the regulations at 45 CFR part 180

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