The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
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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The Department of Health and Human Services (HHS) issued two final rules aimed at improving the interoperability of electronic health records and defining information blocking. The first rule comes from HHS’ Office of the National Coordinator for Health Information Technology (ONC), and the second rule comes from the Centers for Medicare & Medicaid Services (CMS).
The Association for Clinical Oncology (ASCO) recently submitted comments in response to Part II of the Centers for Medicare & Medicaid Services’ (CMS) calendar year 2021 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies. The advance notice proposes updates and changes to the methodologies used to pay Medicare Advantage plans, Programs of All-Inclusive Care for the Elderly organizations, and Part D sponsors.
The Association for Clinical Oncology (ASCO) recently held a briefing on Capitol Hill to inform policymakers and other stakeholders about the need for the bipartisan CLINICAL TREATMENT Act (H.R. 913), which would guarantee coverage of the routine care costs for Medicaid enrollees with life-threatening conditions participating in clinical trials.
The American Society of Clinical Oncology will host a webinar for ASCO members regarding the Society’s response to and resources for COVID-19.
The American Society of Clinical Oncology (ASCO) has developed a summary of updates from states and private payers in response to COVID-19. The summary includes information on coverage for laboratory tests, provider visits, telehealth, and other related care, along with changes to prior authorization requirements, network restrictions, and prescription refills, among other updates.
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the email from the FDA will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety.
“We commend the U.S. Food and Drug Administration (FDA) for releasing draft guidance to encourage inclusion of older adults in clinical trials of drugs for the treatment of cancer. We thank Richard Pazdur, MD, director of the FDA Oncology Center of Excellence, for his leadership on this important issue.
On March 6, 2020, President Trump signed into law the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. This $8.3 billion package provides funding for the country’s response to coronavirus, including amongst its many provisions an emergency telehealth waiver, vaccine development, support for state and local governments, and assistance for affected small businesses.
Highlights from the bill include:
Emergency Telehealth Waiver ($500 million estimated cost)
On March 6, 2020, President Trump signed into law the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. On January 31, 2020, Health and Human Services (HHS) Secretary Azar declared a public health emergency effective January 27, 2020, affording the Centers for Medicare & Medicaid Services (CMS) the flexibility to quickly support Medicare beneficiaries.
WHAT: Clinical trials often provide patients with life-threatening conditions the best - perhaps only - treatment option for their condition. However, unlike Medicare and private and commercial payers, Medicaid is not federally required to cover routine care costs (like physician visits and laboratory studies) for patients on clinical trials. Without the guarantee of coverage, many Medicaid beneficiaries do not have the latest technological and scientific advancements as a treatment option.
March 4 is International HPV Awareness Day, which aims to promote education about the human papillomavirus (HPV), raise awareness about prevention methods, and encourage governments and individuals to take advantage of the HPV vaccine and screening for cancer—goals that ASCO supports.
The Association for Clinical Oncology (ASCO) recently joined more than a dozen other health groups in sending a letter to leaders of the Senate Committee on Health, Education, Labor, and Pensions (HELP) to convey their support of S.2723—The Mitigating Emergency Drug Shortages (MEDS) Act—which would help reduce drug shortages by addressing vulnerabilities in the drug supply chain. The letter urges the committee to quickly advance this important piece of legislation.
In a letter to the Centers for Medicare & Medicaid Services (CMS), the Association for Clinical Oncology (ASCO) expressed concerns regarding two provisions in the 2021 Affordable Care Act (ACA) Notice of Benefit and Payment Parameters proposed rule. This proposal, if implemented, would update the regulatory and financial standards applied to ACA Exchanges.