The American Society of Clinical Oncology (ASCO) recently received clarification from the United States Pharmacopeia (USP) around the newly revised USP General Chapter <797> Pharmaceutical Compounding Standards – Sterile Preparations and USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings, which become official December 1, 2019 and may not apply to most U.S. oncology practices that administer and prepare oncological agents. However, as rules and regulations vary across states, practices should contact their respective state pharmacy board, medical board, regulatory agency, and/or accrediting organization to determine how the standards may apply to their specific situation.
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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Throughout 2019, legislation to address surprise billing—when patients receive unanticipated medical bills for services from out-of-network providers received at in-network facilities—has become a growing focus on Capitol Hill.
In early July 2019, 14 out of the 16 members of the House GOP Doctors Caucus sent a letter to Department of Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma requesting that their agencies reconsider a policy allowing Medicare Advantage plans to use step therapy.
On November 14, the Fundación ECO para la Excelencia y la Calidad de la Oncología (ECO) will host a one-day Quality Training Program (QTP) workshop at the Hotel Riu Plaza España in Madrid, Spain. Registration for the workshop is now open.
Twenty practices in three countries elevated their standard of care and achieved ASCO's Quality Oncology Practice Initiative (QOPI®) Certification in the second quarter of this year.
President Trump recently signed an executive order, “Improving Price and Quality Transparency in American Health Care to Put Patients First,” aiming to provide patients with more transparent information about the price and quality of health care services so that patients can make better-informed decisions about their care.
On July 10, organizations representing patients, providers, medical researchers, survivors, and their families joined together to call on Congress to improve access to clinical trials for patients with life-threatening diseases. The coalition, which is made up of 86 supporting organizations, is urging Congress to pass the bipartisan CLINICAL TREATMENT Act (H.R. 913), which would guarantee coverage of the routine care costs of clinical trial participation for Medicaid enrollees with a life-threatening condition.
On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Applications are now being accepted for the 2020-2021 cycle of ASCO’s Health Policy Leadership Development program. The Health Policy Leadership Development Program is a one-year program that gives ASCO members the opportunity to develop expertise in health policy, advocacy, and grassroots activity while learning valuable leadership skills.
“We applaud the National Academies of Sciences, Engineering, and Medicine for its recommendations on cancer control in the United States. The report examines the oncology community’s efforts over the past 10 years and lays out a comprehensive path for addressing the complex issues facing the entire cancer care continuum, from government agencies to the individual physician.
On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule to update and streamline the prior authorization process under Medicare Part D. The proposal aims to improve access to prescription medications for Part D beneficiaries and alleviate administrative burden for providers. Under the proposal, clinicians would be able to complete prior authorizations for Part D prescriptions online and through a more streamlined process. ASCO supports efforts to improve the prior authorization process for patients and providers, including electronic prior authorizations.
ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the 2020 Hospital Inpatient Prospective Payment System (IPPS) proposed rule. ASCO’s comments focus on appropriate coverage and reimbursement for Chimeric Antigen Receptor T-Cell Therapy (CAR-T) therapies, the need to address disparities between rural and urban hospitals, and implementation of meaningful quality measures to improve cancer care for patients and providers.
ASCO is seeking 10 oncology practices in rural or urban centers in the U.S. that primarily treat underserved populations to participate in its Quality Oncology Practice Initiative (QOPI®) and Quality Training Program (QTP) offerings for a three-year period, with training and funding support provided.
A recent American Medical Association (AMA) report on opioids highlights how provider mandates—on training, prior authorizations—have not had a significant impact on curtailing the opioid epidemic. According to the Opioid Task Force 2019 Progress Report, prescription opioid-related mortality may be leveling off, however deaths from heroin and illicitly manufactured fentanyl and fentanyl analogs are at an all-time high. Instead, the report calls on policymakers to address the opioid epidemic with policies to promote evidence-based treatment.