The American Society of Clinical Oncology and the Association for Clinical Oncology (collectively ASCO) are closely monitoring the current, acute shortages of cisplatin and carboplatin in the United States. ASCO has developed guidance for clinicians and recommendations to policymakers to help mitigate the current shortages and prevent similar situations in the future. ASCO is also keeping its members up-to-date as supplies of both drugs become available and encourages providers to report shortages and contact their lawmakers about the situation.
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 May 19, 2023, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
Dr. Brian Persing, a medical oncologist and hematologist in Mobile, Alabama and member of the Association of Clinical Oncology (ASCO), the world’s leading professional organization representing nearly 45,000 oncology professionals, will testify before the House Appropriations Subcommittee on Labor Health and Human Services and Education today in support of increased federal funding for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC) Division of Cancer Prevention and Control. He will also advocate for robust funding of the Advanced Research Projects Agency for Health (ARPA-H).
Today President Joe Biden announced his intent to nominate Monica M. Bertagnolli, MD, FACS, FASCO, to be the next Director of the National Institutes of Health (NIH).
On January 30, 2023, the Biden Administration announced the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023. The PHE enabled flexibilities that helped providers treat patients during the pandemic. With the PHE ending, many of these flexibilities are being phased out. The American Society of Clinical Oncology (ASCO) summarized the known end dates of some major flexibilities of interest to oncologists.
On May 9, 2023, the Drug Enforcement Administration (DEA) filed a temporary rule extending the full set of telemedicine flexibilities for prescribing controlled substances, established by the COVD-19 Public Health Emergency (PHE), through November 11, 2023. It also provides an additional one-year “grace period” through November 11, 2024, for telemedicine relationships that are, or will be, established on or before November 11, 2023.
Members of the Association for Clinical Oncology converged on Capitol Hill on May 2 for the 2023 ASCO Advocacy Summit where they met face-to-face with lawmakers to discuss critical issues in cancer care and research. The summit was part of a broader Week of Action where advocates from across the country were encouraged to send nearly a thousand letters to Members of Congress through the ACT Network urging them to act on key policy priorities.
More than 150 members of the Association of Clinical Oncology (ASCO), the leading professional organization for oncology professionals, will meet with Members of Congress on Tuesday urging them to make cancer care a top priority.
“Lawmakers have a profound effect on cancer patients and their doctors. From funding the research that leads to new groundbreaking treatments, to ensuring those treatments are covered by insurance and accessible and affordable to patients; lawmakers play a pivotal role,” said ASCO Board Chair Lori J. Pierce, MD, FASTRO, FASCO.
The Food and Drug Administration expects additional releases of cisplatin from Accord Healthcare in the upcoming days. Providers and others can check on Accord supplies through their usual channels and can also contact the company directly at 866-941-7875, Option 2. The American Society of Clinical Oncology will keep its members informed as supply becomes available.
The Association for Clinical Oncology, and nearly 120 other national physician specialty societies and state medical associations, commend a bipartisan group of physician members of Congress who recently introduced the Strengthening Medicare for Patients and Providers Act (H.R. 2474) in the U.S. House of Representatives. The bill would allow Medicare physicians to receive inflationary reimbursement updates, based on the Medicare Economic Index, similar to those other health care providers receive.
The Centers for Medicare & Medicaid Services (CMS) will continue to allow clinicians, groups, and virtual groups in the Merit-based Incentive Payment System (MIPS) use the Extreme and Uncontrollable Circumstances exemption application to request reweighting of one or more MIPS performance categories for the 2023 performance year due to the COVID-19 public health emergency (PHE). CMS expects to release the application in spring 2023. MIPS participants wishing to have one or more performance categories reweighted in the 2023 performance year due to the COVID-19 PHE must complete an application.
On April 17, the Centers for Medicare & Medicaid Services (CMS) released the 2024 Patient Protection and Affordable Care Act Notice of Benefit and Payment Parameters final rule. The agency finalized policies designed to expand access to coverage, advance health equity, and make health insurance plans more affordable including:
On April 19, 2023, the Food and Drug Administration approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater.
Today members of the U.S. House of Representatives unveiled a proposed legislative deal to reduce federal spending in exchange for raising the nation’s debt ceiling. The proposal includes significant funding cuts to federal agencies, which would include resources for the National Institutes of Health (NIH) and National Cancer Institute (NCI). It also proposes adding work requirements for Medicaid enrollment.
A statement from Dr. Julie Gralow, Chief Medical Officer and Executive Vice President, Association of Clinical Oncology follows:
On April 17, 2023, the Food and Drug Administration approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) for use in adult and pediatric patients (12 years and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.