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Oncology Newsfeed

  • FDA Approves Opdivo Plus Yervoy Combo For HCC Patients Previously Treated with Sorafenib

    On March 11, 2020, Bristol Myers-Squibb announced that the U.S. Food and Drug Adminstration (FDA) has approved Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo + Yervoy cohort of the Phase 1/2 CheckMate-040 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Read the corporate announcement

    Posted 3/11/2020

  • HHS Issues Final Interoperability and Patient Access Rule

    On Monday, March 9, the U.S. Department of Health and Human Services (HHS) issued The Interoperability and Patient Access final rule (CMS-9115-F) from CMS and the Office of the National Coordinator for Health IT (ONC). 

    The rule finalizes new policies aimed at giving patients access to their health information, using CMS's authority to regulate Medicare Advantage (MA), Medicaid, CHIP, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). Currently these data are held by health insurers, hospitals, and vendors of electronic health records (EHRs).

    New policies include:

    • Patient Access API (applicable Jan.1, 2021)
    • Provider Directory API (applicable Jan.1, 2021)
    • Payer-to-Payer Data Exchange (applicable Jan.1, 2022)
    • Improving the Dually Eligible Experience by Increasing the Frequency of Federal-State Data Exchanges (applicable April 1, 2022)
    • Public Reporting and Information Blocking (applicable late 2020)
    • Digital Contact Information (applicable late 2020)
    • Admission, Discharge, and Transfer Event Notifications (applicable fall 2020)
    Read CMS fact sheet.

    Posted 3/10/2020

  • USPSTF New Guideline Calls for HCV Screening for Adults Aged 18 to 79

    The U.S. Preventive Services Task Force (USPSTF) has published new screening recommends for hepatitis C virus (HCV) infection. The recommendation statement calls for HCV screening in adults 18 to 79 years of age. The new screening guidance was published March 2 in the Journal of the American Medical Association (JAMA).

    Access the full JAMA article.
    View USPSTF recommendtion statement.

    Posted 3/3/2020

  • FDA Approves Sarclisa® for Relapsed Refractory Multiple Myeloma

    On March, 2, 2020, the U.S. Food and Drug Administration (FDA) approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.

    Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.

    Sarclisa has Orphan Drug Designation status from the FDA.

    Read corporate press release.

    Posted 3/2/2020

  • Lung Cancer Screening Rates Still Low, CDC Reports

    A report published by the Centers for Disease Control and Prevention (CDC) on Feb. 28, examines the prevalence of lung cancer screening by state for 10 states using Behavioral Risk Factor Surveillance System (BRFSS) data. The study found that overall for the 10 states,12.7% adults aged 55–80 years met the U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening.* Of adults meeting USPSTF criteria, 12.5% reported they had received a CT scan to check for lung cancer in the last 12 months. 

    The study is published in the February 28, Morbidity and Mortality Weekly Report. 2020;69(8);201.

    Access the report here.

    *The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.

  • CAP Opens Comment Period for MMR/MSI Testing Draft Recommendations

    The College of American Pathologists (CAP), the American Society of Clinical Oncology (ASCO), the Association for Molecular Pathology, and Fight Colorectal Cancer are collaborating to develop clinical guidelines for testing DNA mismatch repair (MMR) and microsatellite instability (MSI) status in patients with a range of cancers.

    The groups have opened the public comment period for the guideline “MMR and MSI Testing in Patients Being Considered for Checkpoint Inhibitor Therapy.” Find details, including background information, recommended resources to review before providing comments, and overarching questions for consideration here

    All stakeholders—including pathologists who refer and perform molecular testing, oncologists, laboratory personnel, and allied health professionals—are encouraged to provide feedback on the draft recommendations to ensure the final recommendations are clinically practical. The comment period runs from February 19 to March 13, 2020.

    Posted 2/24/2020

  • ACCC Joins Coalition Letter Urging Inclusion of H.R. 913 in Healthcare Extenders Package

    The Association of Community Cancer Centers (ACCC) joined in a wide coalition letter to congressional leadership urging that Congress include the bipartisan Clinical Treatment Act (H.R. 913) in the Healthcare Extenders Package that is likely to pass this spring.  

    Passage of the Clinical Treatment Act would guarantee that routine care costs of clinical trial participation would be covered for Medicaid beneficiaries with a life-threatening condition. Currently, Medicaid is not federally required to cover these clinical trial associated costs. 

    Because these costs only encompass non-experimental costs of treating patients (e.g., doctor's visits and lab work) on clinical trials, the Clinical Treatment Act would not significantly affect overall cost to Medicaid programs.

    Read coalition letter.

    Posted 2/19/20

  • CMS Issues Proposed Changes to Medicare Advantage & Part D

    On Feb. 5, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule and Advance Notice Part II.  

    The CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P) would:

    • require Part D plans to offer real-time drug price comparison tools to beneficiaries starting Jan. 1, 2022, to allow consumers to shop for lower-cost alternative therapies under their prescription drug benefit plan. 

    • allow a second, “preferred” specialty tier in Part D with a lower cost sharing amount.

    • require Part D plans to disclose the measures they use to evaluate pharmacy performance in their network agreements. This would allow CMS to track and report publicly how plans are measuring and applying pharmacy performance measures.
    In the Advance Notice, the agency asks for comments on potentially developing measures of generic and biosimilar utilization in Medicare Part D as part of a plan’s star rating.

    Access a fact sheet on the CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P).
    Download the proposed rule.

    Access a fact sheet on the 2021 Medicare Advantage and Part D Advance Notice Part II.

    Download Medicare Advantage and Part D Advance Notice Part II.

    Posted 2/6/2020

  • CMS to Host MIPS Value Pathway Webinar

    The Centers for Medicare & Medicaid Services (CMS) is hosting a webinar on Wednesday, February 12 at 2:30 pm ET to provide an overview of the MIPS Value Pathways (MVPs) participation framework thats outlined in the 2020 Quality Payment Program Final Rule. CMS is committed to co-developing the MIPS Value Pathways with stakeholders and the public, and will be using this webinar to answer questions from organizations interested in providing input on MVPs.

    The webinar will:

    • Recap the MIPS Value Pathways framework
    • Discuss the goals of the MVPs and benefits for clinicians
    • Obtain feedback and answer questions as time allows

    Register Here

    MIPS Value Pathways Webinar
    Wednesday, February 12, 2020
    2:30 – 3:30 pm ET

    NOTE: This webinar will only cover existing information about the MIPS Value Pathways, as found within the 2020 Final Rule,
    MVPs webpage, and accompanying materials such as the MVPs fact sheet and illustrative diagrams. No new information about the MVPs will be presented during the webinar.

    Posted 2/3/2020

  • FDA Expands Coverage of Diagnostic Testing Using NGS

    On Jan. 27, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded coverage of FDA-approved laboratory diagnostic tests that use next generation sequencing (NGS) for patients with germline, or inherited, ovarian or breast cancer. CMS also gave the Medicare Administrative Contractors (MACs) the ability to determine coverage of NGS laboratory tests for other inherited cancers.

    Read CMS Decision Memo for NGS for Medicare Beneficiaries with Advanced Cancer (CAG-00450R).

    Read CMS announcement.

    Posted 1/28/2020