On December 1, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the 2021 Medicare Physician Fee Schedule (PFS) and other changes to Medicare Part B reimbursement, including updates to the Quality Payment Program (QPP). On December 2, CMS released its Hospital Outpatient Prospective Payment System (OPPS) final rule for 2021. Details on the impact of the rules on cancer care are included.
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 December 1, 2020, the Food and Drug Administration approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
A newly published original report in JCO Clinical Cancer Informatics examines Medicare data to discern how the COVID-19 pandemic is affecting the timeliness and continuity of cancer screening and treatment for seniors.
On November 25, 2020, the Food and Drug Administration granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.
The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services recently released two final rules aimed at modifying and clarifying existing regulations on physician self-referrals and safeguards against inappropriate incentives in federal health care plans.
From November 13- 17, Association for Clinical Oncology (ASCO) delegates participated in the American Medical Association’s (AMA) House of Delegates (HOD) Meeting, which was held virtually due to the ongoing COVID-19 public health emergency. AMA HOD is the principal policy-making body of AMA. It meets twice a year to discuss pressing issues and establish association policies.
During the meeting, delegates approved two ASCO-backed resolutions to improve cancer care:
The Association for Clinical Oncology (ASCO) opposes the Most Favored Nation (MFN) Model for Medicare Part B drug reimbursement, which outlines a structured, nationwide, mandatory demonstration that will be phased in over four years, with full implementation for the final three years of the seven-year model. This plan effectively overrides a statutory provision under the guise of a demonstration project by imposing a new reimbursement model on cancer care absent any evidence that it can lower costs without negative consequences for Medicare beneficiaries.
The Centers for Medicare & Medicaid Services today released the Most Favored Nation (MFN) Model Interim Final Rule with Comment Period (IFC). The MFN Model would be mandatory, last for seven years, and initially affect 50 drugs reimbursed under Medicare Part B. The Administration has floated this concept multiple times and the Association for Clinical Oncology (ASCO) has vigorously objected each time. ASCO continues to oppose any imposition of a mandatory demonstration model on oncology practices and is deeply concerned about this model’s potential impact on patients and providers.
The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:
The Centers for Medicare & Medicaid Services (CMS) released its Home Health Prospective Payment System final rule for 2021. The final rule reflects comments the Association for Clinical Oncology (ASCO) submitted on the proposed rule in support of increased access to telemedicine in home healthcare and concerns over home infusion of chemotherapy.
The Association for Clinical Oncology submitted comments on two rules from the Centers for Medicare & Medicaid Services. The Medicare Coverage for Innovative Devices and Definition of Reasonable and Necessary proposed rule would establish a new Medicare coverage pathway for innovative new medical devices and create regulatory standards for making “reasonable and necessary” determinations for Medicare Part A and Part B items and services. The interim final rule, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, extends the COVID-19 registry Merit-Based Incentive Payment System Improvement Activity through the end of 2021.
The American Society of Clinical Oncology (ASCO) is conducting a national survey to better understand the barriers and facilitators to the collection of sexual orientation and gender identity (SOGI) data within oncology practice and research in order to help identify gaps in data collection and care that need to be addressed to improve outcomes for patients.
The Centers for Medicare & Medicaid Services (CMS) finalized needed reimbursement increases to outpatient evaluation and management (E&M) services starting in January 2021. By law, however, the Medicare Physician Fee Schedule (PFS) must remain budget neutral, so some services will experience a decrease in reimbursement to offset the increase to outpatient E&M services. The Association for Clinical Oncology strongly supports the coming changes to outpatient E&M codes and believes the best solution to protect resources for patients with cancer is to waive budget neutrality.
The American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry (ASCO Registry) recently launched a new, interactive data dashboard, which summarizes the demographic and cancer information of patients included in the ASCO Registry.
On October 26 and November 6, 2020, the Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens.