The American Society of Clinical Oncology (ASCO)’s new policy statement highlights the need for formalized efforts to address health-related social needs and outlines ways to address social determinants of health in cancer care.
ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action.
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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.
On February 16, 2024, the Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
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.
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.
The American Society of Clinical Oncology’s (ASCO) Serving the Underserved Task Force shared survey results that provide insight on oncology professionals’ experiences and strategies to support their work caring for underserved populations.
The Centers for Medicare & Medicaid Services (CMS) has finalized prior authorization policy updates within Medicare Advantage (MA), Medicaid Managed Care and Fee for Service, Children’s Health Insurance Plans (CHIP) Managed Care and Fee for Service, and Qualified Health Plans (QHPs) on the Federally Facilitated Exchanges (FFEs). These changes come in response to the Association for Clinical Oncology (ASCO) and other stakeholder concerns that prior authorization processes limit beneficiary access to care in Medicare Advantage.
The Alliance for Childhood Cancer held its 14th annual Action Days Feb.13-14, 2024, in Washington. ASCO is a proud member of the Alliance, a cohort of national patient advocacy groups, professional medical organizations, and scientific organizations dedicated to advancing research and policies to prevent cancer. During this year's Action Days, more than 200 advocates representing 34 states took part in 150 meetings on Capitol Hill.
Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer & Executive Vice President of the Association for Clinical Oncology (ASCO), will testify before the full House Committee on Ways and Means on the crisis of ongoing cancer drug shortages. Dr. Gralow will share ASCO members’ firsthand experiences managing clinical care in the face of severe shortages. She will also urge Congress to take action to help mitigate the problem.
CMS has released guidance on the billing requirements for G2211 to ensure that coding and billing staff know when to bill the code, the necessary documentation requirements, and the associated patient coinsurance and deductibles.
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.
Congress passed a continuing resolution (CR) on January 18, 2024, that extends FY 2023 federal funding levels until March 8, 2024, for all Department of Health and Human Services agencies.
The Centers for Medicare & Medicaid Services (CMS) issued its rule requiring federal health plans—including Medicare Advantage plans, Medicaid plans, and Qualified Health Plans (QHP) on Federally Facilitated Exchanges (FFEs)— to establish an electronic prior authorization process that will be integrated into providers’ workflows.
The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to two proposed rules: the 2025 Medicare Advantage and Part D proposed rule and the 2025 Notice of Benefit and Payment Parameters proposed rule. ASCO’s comments support provisions that address utilization management and health equity, which have the potential to improve access to care for the cancer community.
In a response to the Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking proposed rule, the Association for Clinical Oncology (ASCO) urges the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) not to implement the disincentives as proposed. ASCO also asks CMS for further clarification on the enforcement process, and the Association supports establishing a meaningful opportunity for appeals.