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 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. 

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.

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.

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.

As of January 1, 2024, oncology practitioners can bill and receive Medicare payment for connecting patients to navigation services. The Centers for Medicare & Medicaid Services adopted two billing codes for Principle Illness Navigation services: G0023 for the initial 60 minutes per patient per month, and G0024 to capture each additional 30 minutes per patient per month. The American Society of Clinical Oncology has received many inquiries about coding and billing for these new services and has made resources available for the oncology community.

State legislative sessions are beginning across the country. While ASCO anticipates lighter legislative agendas at the state level in2024, given the upcoming elections in November, the Association will continue to work with the state affiliates and our coalition partners to educate lawmakers on the issues impacting cancer care.