FDA Approvals
The Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck).
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The Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
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Coding and Reimbursement Updates
E-Reimbursement Newsletter: Volume 35, Issue 8, September 2025 – Ready for the Shutdown–Telehealth, OPPS Q4, Prior Auth/WISeR
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Effective Oct. 1, oncology practices will have a wide range of new International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM) coding options, thanks to the 2026 code set that will take effect then.
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