On July 9, 2021, the Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.).
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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In addition to the Association for Clinical Oncology’s (ASCO) advocacy at the federal level in Washington, DC, ASCO is also at work in state capitals advocating for improved patient access to high-quality, equitable cancer care at the state level. Cancer policy advancements at the state level have recently occured in Arizona, Pennsylvania, and Oregon.
The Department of Health and Human Services (HHS), the Department of Labor, the Department of the Treasury, and the Office of Personnel Management released an interim final rule with comment period (IFR), Requirements Related to Surprise Billing; Part I. This rule is the first of a series that will implement provisions of the No Surprises Act (NSA) signed into law as part of the 2021 COVID-19 relief bill.
On June 30, 2021, the Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services in response to two cancer-related provisions in the 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) proposed rule. ASCO’s comments include responses to CMS’ Requests for Information (RFIs) on the transition to digital quality measures and health equity.
Delegates from the Association for Clinical Oncology (ASCO) participated in a Special Meeting of the American Medical Association’s (AMA) House of Delegates (HOD), where the HOD voted to approve two ASCO-backed resolutions.
In a joint position statement, ASCO and Friends of Cancer Research say individuals with cancer or a history of cancer should be eligible for clinical trials—including COVID-19 vaccine trials—unless there is safety justification for exclusion.
The U.S. Department of Health and Human Services (HHS) released revised reporting requirements for recipients of Provider Relief Fund (PRF) payments. Updates include expanding the amount of time providers will have to report information, efforts to reduce burdens on smaller providers, and extending key deadlines for expending PRF payments for recipients who received payments after June 30, 2020.
A new ASCO guideline update recommends offering 1 year of adjuvant olaparib to patients with high-risk early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer and germline BRCA mutations after completion of (neo)adjuvant chemotherapy and local treatment, including radiation.
On June 16, 2021, the Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
The COVID-19 pandemic has profoundly interrupted delivery of key preventive services, resulting in many adolescents missing routine human papillomavirus (HPV) vaccine doses. In response, the American Society of Clinical Oncology (ASCO) and nearly 80 National Cancer Institute (NCI)-designated cancer centers and other organizations issued a joint statement urging the nation’s health care systems, physicians, parents and children, and young adults to get HPV vaccination back on track.
The American Society of Clinical Oncology (ASCO) issued a new position statement outlining the issues that telemedicine cross-state licensure presents for the cancer care community, in addition to ASCO’s recommendations to continue the practice during the COVID-19 pandemic and beyond.
American Society of Clinical Oncology (ASCO) members who are practicing oncologists may have received emails inviting them to participate in the American Medical Association’s (AMA) Specialty Society Relative Value Scale (RVS) Update Committee (RUC) survey.
On Friday, May 28, President Biden released his full Fiscal Year (FY) 2022 budget request, which expands on the ‘skinny’ budget released in early April 2021. The full budget request includes an increase in funding for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and would fully fund the 21st Century Cures Act and the Beau Biden Cancer Moonshot Initiative. While the budget request is non-binding, it does signal the President’s priorities to Congress, stakeholders, and the general public.
On May 28, 2021, the Food and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.