Change Healthcare, a healthcare technology company that is a business unit of Optum and owned by UnitedHealth Group, fell victim to a cyberattack on February 21, 2024. Regular updates on the situation are available for impacted customers on Optum’s website. The American Society of Clinical Oncology (ASCO) is assessing the oncology-specific impact of the attack and will keep its members up to date.
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.
To sign up for advocacy alerts, log in to ASCO.org with your member or guest account, and visit the subscription center available under your account profile.
April 30, 2024
April 29, 2024
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.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication.
April 26, 2024
On April 26, 2024, the Food and Drug Administration issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
These guidances are a continuation of an effort initiated in 2017 in collaboration with the American Society of Clinical Oncology and Friends of Cancer Research to broaden eligibility criteria in cancer trials. The new guidances provide FDAs current thinking on several critical eligibility categories.
April 25, 2024
The American Society of Clinical Oncology and the College of American Pathologists are calling on manufacturers of diagnostics and therapeutics to adopt therapeutic group labeling to improve access to effective modern therapies for patients.
April 24, 2024
The Federal Trade Commission (FTC) issued a final rule on April 23 that prohibits employers from enforcing noncompete agreements against workers.
April 23, 2024
On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for this indication for adults in 2018.
April 23, 2024
On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
April 23, 2024
On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
April 19, 2024
Volunteers from the Association for Clinical Oncology (ASCO) were on Capitol Hill on April 17 for the 2024 ASCO Advocacy Summit where they met with lawmakers to discuss critical issues in cancer care and research. During the event, more than 170 advocates from 48 states, Washington, D.C., and Puerto Rico met with more than 200 congressional offices. The Advocacy Summit was accompanied by a broader Week of Action, during which ASCO advocates from across the country sent almost 1,000 messages to Members of Congress through the ACT Network.
April 18, 2024
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
April 17, 2024
Cancer doctors from across the U.S. are lending their voices to a new advocacy campaign to end drug shortages. Led by the Association for Clinical Oncology (ASCO), nearly 500 oncology professionals have signed an open letter to Congress and the administration highlighting the severe impact of drug shortages on cancer care and urging swift action from lawmakers.
April 12, 2024
On April 10, 2024, the Centers for Medicare & Medicaid Services issued the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) proposed rule. The rule would update Medicare fee-for-service payment rates and policies for inpatient hospitals and LTCHs for FY 2025. Initial highlights of the proposal are included here.
April 9, 2024
The Centers for Medicare & Medicaid Services released the 2025 Notice of Benefit and Payment Parameters final rule and the 2025 Medicare Advantage and Part D final rule. The Association for Clinical Oncology (ASCO) submitted comments on the proposed versions of both rules. Summaries of the final rules, highlighting provisions ASCO commented on, are included here.
April 9, 2024
The Association for Clinical Oncology (ASCO) is holding its annual Advocacy Summit Week of Action from April 15-19, during which ASCO members are encouraged to connect with their Members of Congress about policies and legislation that impact cancer care and research. Participants may visit the ACT Network to contact their lawmakers and urge them to take action on priority issues.
April 9, 2024
State governments are increasingly considering legislation to streamline prior authorizations processes, which Association for Clinical Oncology (ASCO) members say delay patient care, adversely affect cancer care outcomes, and divert providers from patient care. States have regulatory authority over fully insured health benefit plans (group and individual plans) and health benefit plans administered by the state itself (Medicaid and state employee benefit plans). This means that state governments can impact plan design through either legislation or regulatory action, and during the past decade, a majority of states have been working to leverage that impact to reform prior authorization.
Pages |