The Department of Health and Human Services Office for Civil Rights and the Centers for Medicare & Medicaid Services issued a final rule under Section 1557 of the Affordable Care Act (ACA) advancing protections against discrimination in health care. This long-awaited regulation restores the full scope of ACA’s section 1557 non-discrimination protections on the basis of sex, gender identity, or pregnancy status, after the scope of the protections had been limited by the previous administration.
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.
May 7, 2024
May 7, 2024
On May 2, the Centers for Medicare & Medicaid Services finalized a rule expanding access to health care coverage for Deferred Action for Childhood Arrivals (DACA) recipients. Beginning November 1, 2024, DACA recipients will be eligible to enroll in a Qualified Health Plan through the Affordable Care Act Health Insurance Marketplace, or for coverage through a Basic Health Program.
May 7, 2024
The Centers for Medicare & Medicaid Services issued a series of final rules aimed at standardizing several aspects of the Medicaid program. Additionally, the Department of Health and Human Services Health Resources and Services Administration issued the long-awaited 340B Administrative Dispute Resolution final rule. Key points from the four rules are listed.
May 6, 2024
The Food and Drug Administration (FDA) released a final rule April 29 that regulates laboratory-developed tests the same as other in vitro diagnostic tests. This was a response to concerns about the potential for inaccuracies and/or performance gaps in these tests compared to FDA-authorized tests.
May 6, 2024
The American Society of Clinical Oncology (ASCO) announced four additional medical schools have been selected to participate in the Society’s Oncology Summer Internship (OSI) Program.
May 3, 2024
A REMS Letter for Professional Societies has been released to address the potential risk for severe hypocalcemia in patients with advanced kidney disease following Prolia administration.
April 30, 2024
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.
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.
Pages |