Coding and Reimbursement Updates
This Month’s E-Reiumbursement Newsletter from Bobbi Buell for October 29, 2025. In this edition: TrumpRx, New CPT Codes, Modifier 25 and More…
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Oncologists are getting hit with yet another one-two payment punch under a new national downcoding policy from Cigna.
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E-Reimbursement SPECIAL EDITION–Medicare Physician Fee Schedule Final Rule 2026
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Details are not yet available (and have not been officially posted), but the Continuing Resolution (“CR”) signed by President Trump yesterday will continue telehealth as it was, allowing patients to receive care at home. That’s the good news. The bad news is that it will only be restored until January 30th through this bill. If you have been holding telehealth claims, stay tuned.
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State and National Legislative & Regulatory Issues
On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule (PFS) final rule for 2026. The rule finalizes physician reimbursement and policy reforms under the PFS as well as changes to reporting requirements and policy updates for the Quality Payment Program.
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Last week, after agreeing to a deal to end the federal government shutdown, Congress passed a continuing resolution that would reopen the government, at least through January 30, 2026. Within the continuing resolution package was an extension of the Medicare telehealth waivers, which had previously expired on October 1, 2025 (NOTE: The package contained several divisions, however the link provided in this newsletter only goes to the section containing the telehealth items). In the passed legislation, the telehealth waivers that had expired will now be extended through January 30, 2026.
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FDA Approvals
KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection 165 mg/ 2,000 units per mL is indicated for use in adult patients across most solid tumor indications for KEYTRUDA® (pembrolizumab) Injection 100 mg—whether alone or in combination with other therapies.
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The Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).
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The U.S. Food and Drug Administration (FDA) has issued multiple safety updates affecting oncology drugs, including new labeling requirements for postapproval safety issues, Risk Evaluation and Mitigation Strategy (REMS) program changes, boxed warnings for CAR-T and chemotherapy agents, and mandatory genetic testing requirements to prevent fatal toxicities.
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The Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
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The Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
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The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.
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The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.
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The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.
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