The US Food and Drug Administration (FDA) recently finalized four new final Guidance for Industry documents for cancer clinical trial eligibility criteria that describe ways that clinical trials can safely include patients who have historically been excluded. The guidance documents complement ongoing work by ASCO and Friends of Cancer Research (Friends) to eliminate overly restrictive eligibility criteria that can exclude patients from trials without scientific or participant safety justification. Clinical trials provide patients with cancer access to promising investigational therapies – which are sometimes the only treatment option available – and advance clinical care by producing safety and efficacy data about new therapies.
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 U.S. Department of Health and Human Services (HHS) is hosting Telemedicine Hack, a free 10-week learning community aimed at accelerating telemedicine implementation for ambulatory providers, and the American Medical Association (AMA) launched its Telehealth Impact Physician Survey as part of an effort to ensure appropriate telemedicine implementation during COVID-19.
The Association of Clinical Oncology congratulates the eighteen practices that prioritized the quality of care they provide by achieving the Quality Oncology Practice Initiative (QOPI®) Certification in the second quarter of 2020.
The Association for Clinical Oncology signed on to a letter from the American Medical Association and statements from the Council of Medical Specialty Societies and the American College of Physicians’ Council of Subspecialty Societies expressing concerns about the Trump Administration’s executive order suspending immigration on certain professional visas to the United States (U.S.). The groups state that such restrictions on health care professionals could hinder efforts to address the COVID-19 pandemic in the U.S. and urge the Administration to make health care professionals, researchers, and dependent family members exempt from the proclamation.
The Association for Clinical Oncology (ASCO) recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the FY 2021 Hospital Inpatient Prospective Payment System proposed rule.
Following the completion of the 2020 Merit-based Incentive Payment System (MIPS) reporting year, the American Society of Clinical Oncology (ASCO) will no longer offer MIPS reporting through the QOPI® Reporting Registry, ASCO’s Qualified Clinical Data Registry (QCDR).
The American Society of Clinical Oncology (ASCO) and the U.S. Food and Drug Administration (FDA) will be holding the 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop, which will be fully virtual. The goal of the workshop is to provide a detailed discussion for creating regulatory-grade patient-reported data on tolerability.
The National Cancer Institute (NCI) announced an opportunity for current NCI-funded Principal Investigators whose postdoctoral fellows have temporarily lost stipend support from a non-profit funder because of the COVID-19 pandemic to apply for a funding supplement to cover the fellow’s salary and applicable facilities and administrative costs for the time and effort devoted to the NCI-funded grant.
On July 7, 2020, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS).
The Centers for Medicare & Medicaid Services (CMS) published the Open Payments Program Year 2019 data, along with newly submitted and updated payment records from previous program years.
On June 23, 2020, The U.S. District Court for the District of Columbia upheld a Trump administration policy requiring hospitals and health insurers to publish their negotiated rates for health services. The policy, which aims to increase transparency in U.S. healthcare system, is scheduled to go into effect on January 1, 2021.
The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (CMS-5531-IFC) interim final rule. The rule clarifies earlier changes to Medicare reimbursement that promote the use of telehealth services during the COVID-19 pandemic and establishes reimbursement for audio-only evaluation and management (E&M) services at the same rate as telehealth and in-person E&M services.
On May 19, ASCO released the ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic, and it is now available in Arabic, Chinese (simplified), French, Japanese, Portuguese (Brazilian), Russian, and Spanish (Latin America).
On June 30, 2020, the Food and Drug Administration approved avelumab (BAVENCIO®, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
The Centers for Medicare & Medicaid Services (CMS) announced flexibilities for clinicians participating in the 2020 Quality Payment Program (QPP) Merit-based Incentive Payment System (MIPS) who have been impacted by the COVID-19 Public Health Emergency (PHE). Affected clinicians may submit an Extreme & Uncontrollable Circumstances Application to reweight any MIPS performance categories or may apply for the MIPS Promoting Interoperability Performance Category Hardship Exception.