On July 14, 2022, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).
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 Centers for Medicare & Medicaid Services (CMS) has published 2022 Alternative Payment Model (APM) Incentive Payment details on the Quality Payment Program (QPP) website. Clinicians can access the information by logging in to the QPP website using their HARP credentials. In an effort to ensure correct payments and information are available during the 2022 payment year, CMS verifies eligible clinicians’ APM participation and the APM Incentive Payment calculation.
On July 7, 2022, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2023 Medicare Physician Fee Schedule (PFS) and updates to the Quality Payment Program (QPP). The Association for Clinical Oncology (ASCO) continues to analyze the full proposal, but based on a preliminary analysis, key provisions for the cancer care community are included here.
The Centers for Medicare & Medicare Services (CMS) has opened the Final Score Preview period for the Merit-based Incentive Payment System (MIPS) 2021 performance year. The preview period is a new phase of MIPS that provides clinicians the opportunity to preview their final score prior to the release of 2023 payment adjustment information.
On December 10, 2021, President Biden signed the “Protecting Medicare and American Farmers from Sequester Cuts Act,” which phased in the Medicare sequester cuts that had been paused during the COVID-19 Public Health Emergency (PHE), starting April 1, 2022. From April 1, through June 30, 2022, the cut is 1%. The cut will return to 2% on July 1, 2022.
On June 27, 2022, the Centers for Medicare & Medicaid Services (CMS), through its Center for Medicare & Medicaid Innovation (CMMI), announced a new, voluntary oncology payment model, the Enhancing Oncology Model (EOM).
ASCO is committed to the delivery of medically appropriate, equitable, evidence-based cancer care. For patients of child-bearing age, a cancer diagnosis raises medical considerations around pregnancy and fertility preservation. Every patient should have the ability to pursue, in partnership with their oncologist, all treatment options that offer the best chance of a successful outcome for their cancer.
On June 24, 2022, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma.
“The Association for Clinical Oncology (ASCO) applauds the Food and Drug Administration’s (FDA) decision to remove Juul products from the market in the United States (U.S.). This is an important step in preventing another generation from becoming addicted to nicotine—regardless of how it is delivered.”
On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for patients with wild-type BRAF solid tumors.
The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the fiscal year (FY) 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long‑Term Care Hospital (LTCH) Prospective Payment System (PPS) proposed rule. ASCO’s Comments address CAR-T reimbursement and respond to several Requests for Information (RFI) on social determinants of health data collection, measuring healthcare disparities across CMS’s quality programs, climate change, and advancing digital quality.
The Supreme Court released a unanimous decision in American Hospital Association et al. v. Becerra, Secretary of Health and Human Services, et al. in favor of the American Hospital Association (AHA) and its objection to reduced reimbursement rates for Medicare Part B drugs purchased through the 340B drug pricing program.
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 U.S. House of Representatives passed its comprehensive legislation to reauthorize the Food and Drug Administration (FDA) user fee agreements, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). ASCO is pleased that several of the Association’s priorities were included in the final House-passed bill.
From June 10-15, delegates from the Association for Clinical Oncology (ASCO) participated in the 2022 Annual Meeting of the American Medical Association’s (AMA) House of Delegates (HOD). The AMA HOD is the principal policy-making body of AMA and meets twice a year to discuss pressing issues and establish association policies. This year, the meeting returned to an in-person format in Chicago.
The AMA HOD voted to approve two ASCO-backed resolutions during the meeting: