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Oncology Newsfeed

  • NCCN Updates Genetic Testing Guidelines for Assessing Breast, Ovarian, and Pancreatic Cancer Risk

    On Dec. 4, 2019, the National Comprehensive Cancer Network (NCCN) announced publication of updated genetic risk assessment recommendations for breast, ovarian and pancreatic cancers. Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic Version 1.2020 include new and expanded sections on risk assessment and management related to these cancer types, but retains a conservative approach toward testing practices where evidence is still lacking. 

    Read NCCN press release.

    Posted 12/6/2019


  • FDA Approves Atezolizumab + Chemotherapy for Metastatic Non-Squamous NSCLC

    On Dec. 3, 2019, the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

    Read the corporate announcement.

    Read FDA announcement.

    Posted 12/04/2019; updated 12/06/2019


  • ACCC Dec. 5 Webinar on CY2020 Medicare Final Payment Rules

    On Thursday, Dec. 5 the Association of Community Cancer Centers (ACCC) will host a members-only webinar on the Centers for Medicare & Medicaid Services (CMS) CY2020 Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) final rules.

    ACCC's summaries of the CY 2020 OPPS final rule  MPFS final rule are available here [login required].

    Webinar 
    CMS CY2020 OPPS & PFS Final Rules: What You Need to Know
    Thursday, December 5, 2019
    2:00 – 3:00 PM EST

    REGISTER HERE. [Login required]

    Posted 11/27/2019



  • FDA Approves Reblozyl for Anemia in Adults with Beta Thalassemia

    On Nov. 8, 2019, the U.S. Food and Drug Administration (FDA) granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

    REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

    Beta thalassemia, also called “Cooley’s anemia,” is an inherited blood disorder that reduces the production of hemoglobin, an iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots.

    Read the FDA announcement.

    Posted 11/25/2019



  • FDA Approves New Treatment Option for CLL Under International Collaboration

    Nov. 21, 2019, the U.S. Food and Drug Administration (FDA) -  as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada - granted supplemental approval to acalabrutinib (Calquence ) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

    Read FDA announcement.

    Read AstraZeneca corporate press release.

    Posted 11/21/2019
    Re-posted 11/26/2019


  • CMS Plans Dec. 3 Call on Hospital Price Transparency Final Rule

    The Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network is holding a call on the final Hospital Price Transparency Final Rule on Dec. 3, from 1:30 - 3:30 PM EST.

    Register here.

    During this call, learn about provisions in the final rule effective Jan.1, 2021, including:

    • Requirements for making public all standard charges for all items and services in a machine-readable format
    • Requirements for displaying shoppable services in a consumer-friendly manner
    • Monitoring and enforcement

    A question and answer session follows the presentation. CMS encourages participants  to review the fact sheet and final rule prior to the call.

    Posted: 11/21/2019



  • CMS Issues Rules on Price Transparency for Hospitals and Health Insurance Issuers

    On Nov. 15, the Centers for Medicare & Medicaid Services (CMS) issued two rules that aim to increase price transparency and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The agency finalized the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public rule, and issued the Transparency in Coverage Proposed Rule. Both rules (final and proposed) require that pricing information be made publicly available.

    The final "Price Transparency Requirements for Hospitals to Make Standard Charges Public" rule will require hospitals to make their standard charges public in two ways starting in January 1, 2021:

    • Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
    • Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common "shoppable services" in a consumer-friendly way and update the information at least annually.

    CMS fact sheet on final rule.
    Access final rule.

    CMS states that the proposed "Transparency in Coverage" rule is issued in response to an Executive Order dated June 24, 2019. The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury are collectively issuing the proposed rule. As written, the rule would require that most employer-based group health plan and health insurance issuers provide up-front disclosure of price and cost-sharing information to participants, beneficiaries, and enrollees. 

    If finalized, the "Transparency in Coverage" proposed rule would require health plans to:

    • Provide consumers with real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request. This would allow consumers to shop and compare costs between specific providers before receiving care.

    Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry.  

    Access a CMS fact sheet on the proposed rule.
    Access the proposed rule.

    More details are available in the HHS press release.

    Posted 11/15/2019


  • FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma

    On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

    FDA granted this application priority review and zanubrutinib received orphan product and breakthrough therapy designations for treatment of MCL. 

    Read FDA announcement.

    Posted 11/15/2019


  • ACP Issues New Guidance for Colorectal Cancer Screening

    On November 5, the American College of Physicians (ACP) published a new evidence-based guidance statement that supports colorectal cancer screening for average-risk adults between ages 50 and 75 who do not have symptoms. The new guidance was published in the Annals of Internal Medicine.


    The frequency of screening depends upon the screening approach selected, according to a statement from ACP, which suggests any of the following screening strategies:

    • Fecal immunochemical test (FIT) or high sensitivity guaiac-based fecal occult blood test (gFOBT) every two years
    • Colonoscopy every 10 years
    • Flexible sigmoidoscopy every 10 years plus FIT every two years

    Read the ACP press release.

    Posted 11/06/2019



  • FDA Office of Hematology Oncology Products, Now Called Office of Oncologic Diseases

    On November 5, the U.S. Food and Drug Administration (FDA) announced that the FDA's office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019.

    The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been reorganized and renamed the Office of Oncologic Diseases (OOD).

    Richard Pazdur, M.D., who joined the FDA in 1999 as director for the Division of Drug Oncology Products and became the OHOP Director in 2005, is the acting director of OOD.

    Read FDA press release.

    Posted 11/06/2019