The U.S. House of Representatives voted to pass the Food and Drug Administration (FDA) Reauthorization Act, which governs FDA’s authority to collect user fees from the industry it regulates in order to fund core FDA programs.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
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On July 11, 2017, the U.S. Food and Drug Administration approved blinatumomab (BLINCYTO®, Amgen Inc.) for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.
The FDA recently announced it will undertake a new Medical Innovation Development Plan to facilitate the development of innovative drugs and lower health care costs.
ASCO submitted a comment letter to FDA about proposed modifications to the “FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids,” which outlines optional training for health care providers who prescribe Extended Release (ER) and Long-Acting (LA) opioids.
ASCO and Friends of Cancer Research (Friends) held a meeting on June 30 with key stakeholders across the cancer research community to identify concrete approaches to broaden eligibility criteria for cancer clinical trials.
In an effort to help the oncology community understand the specific provisions of healthcare reform legislation, ASCO has developed a side-by-side comparison of the Affordable Care Act (ACA) with the two bills currently moving through Congress that aim to repeal and at least partly replace the law. ASCO filtered its comparison through the lens of the society’s principles for healthcare reform.
On July 7, 2017, the U.S. Food and Drug Administration approved L-glutamine oral powder (Endari™, Emmaus Medical, Inc.) for oral administration to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years and older.
A new article in the Journal of Oncology Practice (JOP) studies the impact of communication on care at the end of life. The findings show that completing a values assessment and partaking in advanced care planning can lead to advance directives and less aggressive care at the end of life.
On June 29, 2017, the U.S. Food and Drug Administration granted marketing approval to the PraxisTM Extended RAS Panel (Illumina, Inc.), a next generation sequencing (NGS) test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer (mCRC). The test is used to aid in the identification of patients who may be eligible for treatment with panitumumab (VECTIBIX®, Amgen, Inc.).
The next installment of ASCO’s webinar series on the Quality Payment Program (QPP) will take place Monday, July 10 at 4:00 p.m. ET. The webinar, entitled Quality Payment Program: Optimizing your MIPS Score, will help participants optimize their Merit-Based Incentive Payment System (MIPS) score in order to receive the full reimbursement they are entitled to for services provided under Medicare Part B.
CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO, has announced that Ascension has signed an agreement to participate in the CancerLinQ® platform. Ascension, the largest nonprofit health system in the United States, includes oncology care facilities throughout the country that can benefit from CancerLinQ’s growing quality network.
ASCO recently joined a group of nearly 20 advocacy organizations in endorsing a set of guiding principles for any efforts to change the process by which patients access unapproved therapies outside of a clinical trial—known as expanded access.
ASCO is pleased to announce that its Quality Oncology Practice Initiative (QOPI®) Qualified Clinical Data Registry (QCDR) will be available for the Centers for Medicare and Medicaid Services (CMS) Merit-Based Incentive Payment System (MIPS) reporting starting July 1, 2017. By using the QOPI® QCDR for MIPS reporting, practices will be able to report on one measure for one patient in 2017 to avoid any cuts to Medicare reimbursements in 2019.
ASCO’s delegates participated in the American Medical Association’s (AMA) annual House of Delegates (HOD) meeting to advocate on behalf of oncologists and patients with cancer on issues including utilization management, MACRA implementation, access to health insurance, and opioids.
On June 23, 2017, the U.S. Food and Drug Administration approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE