Precision medicine treatments (otherwise known as targeted therapies) have the potential to improve outcomes for patients with advanced cancer. Over the last 5 years, 20% of the U.S. Food and Drug Administration’s (FDA) drug approvals have been for precision medicine treatments. With so many treatments coming onto the market, it can be challenging for oncologists to navigate the options available to identify the right treatment for each patient.
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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Applications are now open for oncology practices in 11 specific U.S. urban centers with high proportions of African-American patients with breast cancer to participate in ASCO’s Quality Oncology Practice Initiative (QOPI®), QOPI® Certification, and Quality Training Program (QTP). Susan G. Komen® is providing training and funding support.
The Centers for Medicare & Medicaid Services (CMS) recently announced a new voluntary pilot program that will give select providers access to Medicare claims data staring in January 2020. The “Data at the Point of Care” (DPC) pilot, which is part of the MyHealthEData Administration-wide initiative led by the White House Office of American Innovation, will allow participating providers to fill in information gaps by providing access to structured and complete claims data, including previous patient diagnoses, past procedures, and medication lists. Medicare beneficiaries give permission for this data to be shared in their early sign-up for Medicare and can always opt-out of their claims data being shared.
On August 2, 2019, the Food and Drug Administration approved pexidartinib (TURALIO™, Daiichi Sankyo) capsules for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT.
On July 30, 2019, the Food and Drug Administration approved darolutamide (NUBEQA®, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer.
ASCO submitted comments to a Senate Finance Committee markup on the “The Prescription Drug Pricing Reduction Act (PDPRA),” a package of proposals aimed at addressing the high cost of prescription drugs.
ASCO has released an ethical framework for researchers on incorporating research biopsies in cancer clinical trials. The framework, published in a statement in the Journal of Clinical Oncology, provides guidance on when to include optional and mandatory biopsies based on both participant risk and scientific utility.
On July 29, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for reimbursement under the Hospital Outpatient Prospective Payment System (HOPPS) in 2020. ASCO is still analyzing the proposal and will provide more information to members as soon as possible. Based on a preliminary analysis, key provisions in the proposed rule include:
Annual HOPPS Update
In state legislatures across the United States this year, ASCO and state societies partnered to advocate for health policies to improve the cancer care delivery system and ensure patients and survivors have access to high-quality care.
In a comment letter to Acting Food and Drug Administration (FDA) Commissioner Norman E. “Ned” Sharpless, MD, ASCO expressed concerns that a proposed modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) could adversely affect patients with cancer-related pain.
On July 29, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2020 Medicare Physician Fee Schedule (MPFS) and other changes to Medicare Part B payment policies, including proposals related to the Quality Payment Program (QPP), online ahead of publication in the Federal Register on August 14.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recently expanded its HPV vaccination age range recommendations. These expansions include catch-up vaccinations for persons through age 26 who are not adequately vaccinated, and recommended vaccination based on shared clinical decision making for individuals ages 27 through 45 years who are not adequately vaccinated.
The first practice outside of the U.S. to achieve Quality Oncology Practice Initiative (QOPI®) Certification, Contemporary Oncology Team of Athens, Greece, is now the first to be re-certified.