Oncology News & Updates

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.

Learn More

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.

Learn More

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.

Learn More

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

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

National Guideline Updates

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

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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!

Learn More

Corporate Member Highlights

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

Learn More

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

Learn More

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).

Learn More

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.

Learn More

Coding and Reimbursement Updates

E-Reimbursement Newsletter: Volume 35, Issue 8, September 2025 –  Ready for the Shutdown–Telehealth, OPPS Q4, Prior Auth/WISeR

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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

Learn More

Coding and Reimbursement Updates

Learn More

Northern California Clinical Trials

UCSF Helen Diller Family Comprehensive Cancer Center

Learn More

ELEGANT Clinical Trial Overview

Learn More

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.

Learn More

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).

Learn More

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.

Learn More

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

Learn More

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

Learn More

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).

Learn More

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

Learn More

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).

Learn More

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.

Learn More

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).

Learn More

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.

Learn More

FDA LINK

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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^®).

Learn More

Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here:

Learn More

Other

Noridian Medicare Jurisdiction E Part B

Learn More

California Medical Association Practices Resources (CPR):

Learn More

FDA Approvals

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

Learn More

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.

Learn More

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.

Learn More

National Guideline Updates

View the NCCN eBulletin Here

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

ASCO in Action

Expanded Oncology Summer Internship Program Targets Increased Workforce Diversity.

Learn More

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

Learn More

Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here

Learn More

Other

View the AACR Cancer Disparities Progress Report 2024 Congressional Briefing

Learn More

View the AACR Cancer Disparities Progress Report 2024

Learn More

View the May 2024 ASH Practice Update

Learn More

FDA Approvals

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

Learn More

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

Learn More

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.

Learn More

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.]).

Learn More

National Guideline Updates

Check out the NCCN Calendar of Events:

Learn More

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.

Learn More

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

Learn More

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

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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

Learn More

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.

Learn More

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.

Learn More

Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here

Learn More

Other

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

Learn More

View Noridian Medicare Jurisdiction E Part B Updates.

Learn More

FDA Approvals

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

Learn More

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

Learn More

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

Learn More

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

Learn More

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

Learn More

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.

Learn More

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

Learn More

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

Learn More

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.

Learn More

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

Learn More

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.

Learn More

ASCO News

View ASCO Daily News Here:

Learn More

Practices, Providers Face Uncertainty Following Change Healthcare Ransomware Attack.

Learn More

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

Learn More

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

Learn More

Congress to Finalize Cancer Research Funding Levels for FY 2024.

Learn More

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

Learn More

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

Learn More

CMA News

View California Medical Association Newswire here:

Learn More

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

Learn More

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

Learn More

Biden Administration announces advanced payments for physicians affected by cyberattack.

Learn More

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

Learn More

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

Learn More

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

Learn More

CMS releases updated fee schedule conversion factor.

Learn More

CMS & Noridian Updates

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

Learn More

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

Learn More

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

Learn More

Read MLNC Newsletter here:

Learn More

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

Learn More

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

Learn More

Coding and Reimbursement Updates

View E-Reimbursement Newsletter Here:

Learn More

View Breaking News Optum/Change Outage Update Here:

Learn More

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.

Learn More

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

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

Coding and Reimbursement Updates

View the February E-Reimbursement Newsletter.

Learn More

Other

View the ASCO in Action February newsletter.

Learn More

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.

Learn More

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

Learn More

FDA Approvals

On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.

Learn More

On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.

Learn More

The FDA has granted full approval to KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, and expanded the indication to: treatment of adult patients with locally advanced or metastatic urothelial cancer. The combination initially received accelerated approval in April 2023 for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

Learn More

The FDA has approved WELIREG® (belzutifan) 40-mg tablets for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Learn More

Coding and Reimbursement Updates

View the January E-Reimbursement Newsletter.

Learn More

CMS & Noridian Updates

CMS has finalized the Interoperability and Prior Authorization “e-PA” Rule requiring MA plans to establish electronic PA systems. Starting in 2026 MA plans must send PA decisions within 72 hours for expedited requests and 7 days for standard requests, detail a specific reason for denying a PA appeal, and report PA metrics as part of new transparency and reporting requirements. This rule impacts MA, Medicaid, CHIP, Medicare, and ERISA plans. This rule does not require HHS to establish a list of items/services eligible for real-time decisions as in Seniors’ Act.

Learn More

Governor Gavin Newsom and the State of California received federal approval from the Centers for Medicare & Medicaid Services (CMS) of its MCO tax federal waiver application. Effective January 1, 2024, rates for primary care (including nurse practitioners and physician assistants), maternity care (including OB/GYNs and doulas), and non-specialty mental health services will be increased to at least 87.5 percent of Medicare rates.

Learn More

National Guideline Updates

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas. These NCCN Guidelines® are currently available as Version 1.2024.

Learn More

Other

View the ASCO in Action January newsletter.

Learn More

Register for Bristol Myers Squibb’s, “A Treatment Option for Patients with Unresectable or Metastatic Melanoma regardless of BRAF status & Metastatic NSCLC Regardless of PD-L1 Expression” on Wednesday, February 28, 2024 at 6:30 PM – PST.

Learn More