CMS denies Caldolor separate Medicare reimbursement under NOPAIN Act for CY2025

CUMBERLAND PHARMACEUTICALS INC

CMS excluded Caldolor from NOPAIN Act separate payment list announced Nov 1, 2024 for CY2025.
CMS concluded Caldolor does not qualify because FDA indication lacks mention of post-operative use.
Company submitted comments in July 2023 and July 2024 arguing Caldolor meets statutory requirements.
Company says majority of Caldolor use is surgical and FDA approval based on post-surgical pain studies.
Cumberland is evaluating options; calls CMS determination inconsistent with NOPAIN Act intent.

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