The Association for Clinical Oncology (ASCO) welcomes the U.S. Food and Drug Administration’s (FDA) efforts to increase the number of clinical trial participants from rural areas and underrepresented racial and ethnic populations and supports many of the recommendations included in the agency’s draft guidance regarding the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and devices.
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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On August 1, 2023, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long‑Term Care Hospital (LTCH) Prospective Payment System (PPS) final rule. In addition to updating Medicare payment rates and policies for inpatient hospitals in FY 2024, the rule aims to advance health equity and support underserved communities.
On August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015.
Prior to leaving Washington, D.C., to spend the August recess in their states and districts, members of Congress engaged in a flurry of July activity on issues the Association for Clinical Oncology (ASCO) is tracking closely.
On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
The American Medical Association (AMA) will conduct a Practice Information Survey, to collect data on practice expenses and hours spent on patient care. The data will be shared with the Centers for Medicare & Medicaid Services and directly impact Medicare physician reimbursement. The survey is being distributed to a very limited number of practices and physicians, making every response crucial to providing CMS with valid data, so please take the survey if you receive it.
The Senate Appropriations Committee on July 27 passed the Labor, Health and Human Services, Education, and Related Agencies FY 2024 spending bill, which includes $47.8 billion in funding for the National Institutes of Health (NIH), $7.38 billion for the National Cancer Institute (NCI) and $1.5 billion for the Advanced Research Projects Agency on Health (ARPA-H).
A statement from Everett E. Vokes, MD, FASCO, Chair of the Board, Association for Clinical Oncology, follows:
On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test.
The American Society of Clinical Oncology has released new tools to help cancer care providers assess and manage age-associated vulnerabilities in older patients undergoing systemic cancer treatment. These tools include a guideline update and new videos on performing a geriatric assessment and using the results to inform patient care.
The Association for Clinical Oncology (ASCO) responded to a bicameral Request for Information (RFI) on the underlying factors driving drug shortages. The Association’s comments highlighted the impact of the shortages on patient care and pointed to economic failures and supply chain vulnerabilities that have led to shortages of critical oncology drugs for more than a decade.
On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2024 Medicare Physician Fee Schedule (PFS) and updates to the Quality Payment Program (QPP). The agency also released the 2024 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule.
On July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule to reimburse hospitals that were underpaid under the 340B drug pricing program since 2018.
The Department of Health and Human Services (HHS), Department of Labor and the Treasury Department issued a proposed rule regulating the availability of short-term limited duration insurance (STLDI) plans. The rule would restrict the availability of these plans to no more than four months.
ASCO is continuing to collaborate with State Affiliates and outside stakeholders to raise awareness and facilitate implementation of the CLINICAL TREATMENT Act, which requires all states and territories to cover and reimburse routine costs of care for treating a Medicaid enrollee who is participating in a qualifying clinical trial.
The Association for Clinical Oncology (ASCO) continues to advocate for increased access to cancer care and improved health equity for Medicaid beneficiaries and Deferred Action for Childhood Arrivals recipients. In three recent comment letters, ASCO applauded proposals to improve access to high-quality, equitable cancer care and made important recommendations regarding the agency’s plans to expand health care coverage to more people.
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