On August 20, the American Society of Clinical Oncology (the Society), and its affiliate organization the Association for Clinical Oncology (the Association), will host ASCO Practice Leadership: 2021 MPFS & OPPS Rules, a free webinar that will review the 2021 Medicare Physician Fee Schedule (MPFS) and Hospital Outpatient Prospective Payment System (OPPS) proposed rules.
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 5, 2020, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
The Centers for Medicare & Medicaid Services released its 2021 Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment System proposed rules. The administration also released an accompanying Executive Order focusing on telehealth and rural healthcare.
On August 3, President Trump signed an Executive Order on Improving Rural Health and Telehealth Access aimed at increasing access to healthcare services in rural areas. The Centers for Medicare & Medicaid Services also released the Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment System proposed rules for 2021.
The U.S. Department of Health and Human Services (HHS) posted the General and Targeted Distribution Post-Payment Notice of Reporting Requirements on the Provider Relief Fund (PRF), which aims to inform those who have received one or more payments from the PRF of the upcoming timeline for future reporting requirements.
On July 31, 2020, the Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements proposed rule. The proposal—which aims to reduce prescription-related fraud, misuse, and abuse—contains an important exemption for beneficiaries undergoing cancer treatment from additional opioid DUR requirements.
The Association for Clinical Oncology (ASCO) recently submitted comments to the National Cancer Institute (NCI) in response to its Request for Information (RFI): Seeking Stakeholder Input on Scientific Gaps and Research Needs Related to Delivery of Cancer-related Care via Telehealth. The RFI aims to elicit stakeholder feedback and allow NCI to assess the current state of telehealth in the United States and its role in oncology in the context of the COVID-19 pandemic.
On July 30, 2020, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
On January 1, 2021, significant changes to the office and outpatient Evaluation and Management services Current Procedural Terminology (CPT ®) codes (99202-99215) will go into effect. Practices, physicians, and staff must prepare in advance for these changes to ensure a successful transition and avoid any disruption in reimbursement, but it can be difficult to know where to begin. To help the oncology community during this transition, American Society of Clinical Oncology has prepared a set of tools, and continues to develop educational materials, that explain the coming changes.
The American Society of Clinical Oncology (ASCO) released a position statement that raises concerns about home infusion of anticancer therapy and Centers for Medicare & Medicaid Services (CMS) regulations regarding the practice.
On July 23, the U.S. Department of Health and Human Services (HHS) Secretary Alex Azar released a renewal of determination to extend the current COVID-19 Public Health Emergency (PHE) by up to another 90 days. The renewal is effective July 25.
On July 24, 2020, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL.
Today President Trump signed four executive orders (EOs) aimed at addressing the high cost of prescription drugs. The EOs, as described by the White House, would: (1) address the price of insulin by requiring federally qualified health centers to pass along any available discounts to patients, (2) allow for importation of certain drugs from other countries, (3) pass manufacturer discounts on Part D drugs to patients at the pharmacy, bypassing pharmacy benefit managers, and finally (4) implement a “favored nations” policy to allow Medicare to purchase Part B drugs at the lower prices paid by foreign countries. The fourth EO will go into effect in 30 days unless drug companies lower their prices first.
COVID-19 data collection efforts by the American Society of Clinical Oncology (ASCO) were featured in three separate abstracts during the Association for Cancer Research (AACR) Virtual Meeting: COVID-19 and Cancer this week. Two of the abstracts highlighted COVID-19 data from PracticeNET, and one abstract that was selected for an oral presentation reported on the ASCO Survey on COVID-19 in Oncology (ASCO) Registry.