Oncology News & Updates

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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FDA Approvals

The Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.

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The Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

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The Food and Drug Administration (FDA) has required this safety notice as part of the COPIKTRA REMS (Risk Evaluation
and Mitigation Strategy) to inform about updates to the Prescribing Information in July 2024.

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US FDA adds label warning to J&J’s and Legend Biotech’s cancer therapy.

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The Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

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State and National Legislative & Regulatory Issues

The Board of Pharmacy’s compounding regulations are now effective. The approved regulations clearly exempt physicians, which is something CMA advocated for throughout the process. This rulemaking package was of interest to multiple specialties.

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CMS has instructed all Medicare Administrative Contractors (MACs) to continue temporarily holding claims with dates of service on or after October 1, 2025, for services impacted by the expired Medicare legislative payment provisions under the Full-Year Continuing Appropriations and Extensions Act, 2025.

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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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National Guideline Updates

NCCN Guidelines Navigator for Breast Cancer Genetic Testing and Treatment Debuts During Breast Cancer Awareness Month.

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ASCO News and Updates

In a study reported in JCO Oncology Practice, Kirkwood et al identified recent changes in and characteristics of the hematologist/medical oncologist (oncologist) workforce in the United States, with the data revealing gaps in coverage according to age and other patient demographics.

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ASCO Members: How is the Government Shutdown Impacting You?
The Association for Clinical Oncology (ASCO) is urgently collecting stories on how the government shutdown is impacting our members’ ability to provide patient care and conduct research.

Please share examples concerning delays to critical services or the interruption of cancer trials and research activities.

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ASCO Edge – Essential Practice Management Education for Oncology Professionals
The American Society of Clinical Oncology (ASCO) ASCO Edge initiative, an online oncology practice and operations management educational series developed by oncology professionals for oncology professionals. ASCO Edge content is a member-only benefit that provides members with education and the tools to effectively manage the business side of  their practices. Through modules covering topics from employment law to leadership and succession planning, members will gain the foundational understanding and advanced insights needed to effectively manage practice operations and continue to deliver exceptional patient care. Please share this with your membership and encourage them to get started today.

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ACT Now! Tell Congress to Make Telehealth Flexibilities Permanent
Medicare telehealth flexibilities expired on September 30. It’s crucial that Congress hears from you today about the importance of continued access to telehealth services for patients with cancer.

Due to Congress’s lack of action, pre-pandemic telehealth restrictions are back in place, meaning that patients have to be in a designated rural area and go to an approved site, rather than their own homes, to receive telehealth care.

For patients with cancer, telehealth provides essential access to care for those who need it most, and we must tell Congress to make the previous telehealth flexibilities permanent by supporting the CONNECT for Health Act (H.R. 4206/ S. 1261). Please ask your members to urge your lawmakers to restore our patients’ access to telehealth!

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Corporate Member Highlights

From Be One Medicines: BRUKINSA tablets will be available in late October 2025.

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The American Cancer Society and Pfizer have launched a three-year initiative, “Change the Odds,” aimed at improving health outcomes in medically underrepresentedcommunities across the United States by increasing awareness of and access to: Cancer Screenings, Patient Support & Navigation and Clinical Trials

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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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FDA Approvals

Jazz Pharmaceuticals Announces U.S. FDA Approval of ModeysoTM (dordaviprone, Jazz Pharmaceuticals)  as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma.

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Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.

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DATROWAY® (datopotamab deruxtecan-dlnk, Daiichi Sankyo) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFRmutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinumbased chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial

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Coding and Reimbursement Updates

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Northern California Clinical Trials

UCSF Helen Diller Family Comprehensive Cancer Center

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ELEGANT Clinical Trial Overview

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FDA Approvals

LYNOZYFIC is now approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

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Pfizer Oncology is pleased to share that on July 11, 2025, the FDA approved a less frequent dosing option for certain responding patients being treated with ELREXFIO® (elranatamab-bcmm).  ELREXFIO is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

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Astellas Pharma US, Inc. is pleased to announce the U.S. Food and Drug Administration (FDA) approval of a 300 mg vial size (NDC: 0469-4425-30) for VYLOY Ò
(zolbetuximab-clzb) in addition to its current 100 mg vial size (NDC: 0469-3425-10).

For more information, please visit VyloyHCP.com.

Please click here for the full Prescribing Information.

For important state pricing disclosure information, click here.

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U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels

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Coding and Reimbursement Updates

Bobbi Buell’s E-Reimbursement newsletter for July is now available online. It includes an update on The Proposed Medicare Part B Rules 2026, OPPS Proposal for 2026

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FDA Approvals

On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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On June 13, 2024, the Food and Drug Administration granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company).

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On June 14, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

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On June 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

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On June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc., a Bristol Myers Squibb company) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).

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On June 26, 2024, 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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FDA LINK

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National Guideline Updates

The National Comprehensive Cancer Network (NCCN) is seeking community oncology practices to participate in the Health Equity Report Card Pilot Project in Community Oncology settings.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates^®) for Endometrial Carcinoma and Uterine Sarcoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Uterine Neoplasms v2.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates^®) for Non-Small Cell Lung Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Non-Small Cell Lung Cancer v6.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates^®) for Myeloproliferative Neoplasms to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Myeloproliferative Neoplasms v1.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates^®) for Classic Follicular Lymphoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for B-Cell Lymphomas v2.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Thyroid Carcinoma. These NCCN Guidelines^® are currently available as Version 3.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for Small Cell Lung Cancer. These NCCN Guidelines^®are currently available as Version 3.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene Fusions. These NCCN Guidelines^® are currently available as Version 2.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®), the NCCN Radiation Therapy Compendium^™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC^™) for Acute Lymphoblastic Leukemia. These NCCN Guidelines^® are currently available as Version 1.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for Non-Small Cell Lung Cancer. These NCCN Guidelines^® are currently available as Version 7.2024.

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The NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for Non-Small Cell Lung Cancer v6.2024 has been updated and published based on the most recent changes from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®).

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here:

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Other

Noridian Medicare Jurisdiction E Part B

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California Medical Association Practices Resources (CPR):

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FDA Approvals

On May 5, 2024, (FDA) Oncology Center of Excellence (OCE) launched the Project 5 in 5 crowdsourcing initiative.

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On May 16, 2024, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

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On May 29, 2024, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older.

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National Guideline Updates

View the NCCN eBulletin Here

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia. These NCCN Guidelines® are currently available as Version 3.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer. These NCCN Guidelines® are currently available as Version 3.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Gastric Cancer. These NCCN Guidelines®are currently available as Version 2.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the NCCN Drugs & Biologics Compendium (NCCN Compendium®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Pediatric Hodgkin Lymphoma. These NCCN Guidelines® are currently available as Version 1.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. These NCCN Guidelines® are currently available as Version 4.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Appendiceal Adenocarcinoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer v2.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Head and Neck Cancers to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers v4.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Melanoma: Cutaneous to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Cutaneous v2.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer v2.2024.

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ASCO in Action

Expanded Oncology Summer Internship Program Targets Increased Workforce Diversity.

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Medicare Fee Schedule Updates Enable Reimbursement for Patient Navigation, Learn More in Free Webinar.

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here

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Other

View the AACR Cancer Disparities Progress Report 2024 Congressional Briefing

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View the AACR Cancer Disparities Progress Report 2024

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View the May 2024 ASH Practice Update

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FDA Approvals

On April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.).

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On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.)

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On April 26, 2024, the Food and Drug Administration issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.

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On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]).

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National Guideline Updates

Check out the NCCN Calendar of Events:

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Esophageal and Esophagogastric Junction Cancers.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hairy Cell Leukemia

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Biliary Tract Cancers to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Biliary Tract Cancers v1.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma v3.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Non-Small Cell Lung Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v5.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Rectal Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer v1.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for T- Cell Lymphomas to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for T-Cell Lymphomas v3.2024

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for T-cell Large Granular Lymphocytic Leukemia and T-Cell Prolymphocytic Leukemia to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for T-Cell Lymphomas V.3.2024.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Multiple Myeloma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma v3.2024.

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here

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Other

On April 10, 2024 Takeda Announces EXKIVITY (mobocertinib) Is No Longer Commercially Available in U.S. Market.

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View Noridian Medicare Jurisdiction E Part B Updates.

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FDA Approvals

On March 7, 2024, the Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with Obinutuzumab.

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On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy.

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Pfizer Oncology is proud to announce the FDA approval of a new pediatric indication for BESPONSA® (inotuzumab ozogamicin).

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On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products.

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On March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]).

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National Guideline Updates

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Bladder Cancer.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer Screening and Diagnosis.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Distress Management.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the NCCN Drugs & Biologics Compendium (NCCN Compendium®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Gastric Cancer.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Breast Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer v2.2024

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Head and Neck Cancers to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers v3.2024.

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ASCO News

View ASCO Daily News Here:

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Practices, Providers Face Uncertainty Following Change Healthcare Ransomware Attack.

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Cancer Care Providers Applaud Final Rule to Strengthen Health Insurance Standards.

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New ASCO Guideline Recommendations Answer Key Questions About Vaccinating Adults with Cancer.

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Congress to Finalize Cancer Research Funding Levels for FY 2024.

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2024 Medicare Provider Conversion Factor Updated to Reflect Federal Spending Legislation.

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New ASCO Policy Statement Calls for Global Equity in Cancer Clinical Trials.

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CMA News

View California Medical Association Newswire here:

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Please share your feedback on Change Healthcare cyberattack: Deadline extended to April 3.

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Reminder: Optum offering temporary funding assistance for providers affected by cyberattack.

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Biden Administration announces advanced payments for physicians affected by cyberattack.

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New York Times video on prior authorization spotlights CMA physicians and California patients.

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CMS reopens MIPS Extreme/Uncontrollable Circumstances exception application due to cyberattack.

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Final federal spending bills allow half of 3.37% Medicare cut to remain in effect.

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CMS releases updated fee schedule conversion factor.

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CMS & Noridian Updates

Billing and Coding: MolDX: Proteomics Testing (A59641) – R2 – Effective January 31, 2024.

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MolDX: NRAS Genetic Testing (L36335) – R7 – Effective July 27, 2023.

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Optum, the parent company for Change Healthcare, has worked with Noridian to transition providers enrolled in Change Healthcare connections to the Optum iEDI Clearinghouse.

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Read MLNC Newsletter here:

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View CMS Medicare Learning Network (MLN) Matters (MM) New Waived Tests:

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View CMS Medicare Learning Network (MLN) Matters (MM) Stay of Enrollment:

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Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here:

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View Breaking News Optum/Change Outage Update Here:

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Other

Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer. KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.

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FDA Approvals

On December 5, 2023, the US Food and Drug Administration (FDA) approved FABHALTA® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).1,2

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On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.

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On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

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On February 16, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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Treatment for Adult Patients With Locally Advanced or Metastatic Urothelial Cancer KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

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National Guideline Updates

NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Non-Small Cell Lung Cancer to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v1.2024.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), the NCCN Radiation Therapy Compendium™, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Acute Myeloid Leukemia. These NCCN Guidelines® are currently available as Version 1.2024.

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Coding and Reimbursement Updates

View the February E-Reimbursement Newsletter.

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Other

View the ASCO in Action February newsletter.

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ImmunoGen, Inc. is now part of AbbVie, Inc. The acquisition of ImmunoGen is a transformative move for AbbVie and advances the AbbVie mission to make a remarkable impact on patients’ lives and enhance our value as a long-term partner to those who share our vision for solving serious health issues.

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On behalf of Merck, read more about the update regarding TICE® BCG BCG LIVE (for intravesical use) (“TICE BCG”).

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