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Oncology Newsfeed

  • FDA Approves Ivosidenib for R/R AML

    On July 20, the Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. It is the first FDA-approved therapy for patients with R/R AML and an IDH1 mutation.

    Read the Agios corporate press release here.

    Posted 7/20/18


  • FDA Approves Ribociclib in Combination for Advanced, Metastatic Breast Cancer

    On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

    The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

    Read the full FDA press release here.

    Posted 7/18/18


  • ACCC Submits Comments to Administration's Drug Pricing Blueprint

    On July 16, the Association of Community Cancer Centers (ACCC) submitted comments to the Request for Information (RFI) included in the administration's Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. The plan was released in May. 

    In its comments, ACCC expresses support for the overarching goal to "bend the cost curve by improving care, providing the right care at the right time, reducing over-treatment and under-treatment, and reducing hospital admissions and readmissions." However, ACCC cautions that "any policy solution to rein in drug costs must preserve patients' access to—and ability to afford—quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer providers."

    In brief, ACCC comments on the following concerns:

    • If HHS goes forward with revitalization of the Competitive Acquisition Program (CAP), there must be sufficient modifications to the program to preserve patient access to drugs, maintain provider flexibility, and permit providers to choose whether to participate based on whether participation in CAP will help them best serve their patients' needs, and not in response to punitive reimbursement cuts.
    • HHS should not impose Medicare Part D utilization management requirements on Medicare Part B drugs or move these drugs into Medicare Part D as doing so would reduce patient access and could increase costs to the Medicare program and patients. In addition, HHS should clarify how these changes would work in practice.
    • HHS should ensure that payment rates reflect the true costs of providing care at a particular site of service.
    • HHS should ensure that any proposals related to modifying the 340B Drug Pricing Program encourage all oncology providers to treat underserved patient populations.
    Read the ACCC Comment letter for a full discussion of these issues.

    Posted 7/16/2018

     



  • FDA Approves Enzalutamide for Castration-resistant Prostate Cancer

    On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).

    This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC.

    Read FDA announcement.

    Posted 7/16/2018



  • CMS Issues Proposed CY2019 Physician Fee Schedule & QPP Rule

    On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) released the CY 2019 Medicare Physician Fee Schedule (PFS) proposed rule. Included are proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare PFS on or after January 1, 2019.

    The agency's proposals for Year 3 of the Quality Payment Program (QPP) are incorporated under the CY2019 PFS proposed rule.

    Comments on the proposed rule are due by September 10, 2018.

    ACCC is currently analyzing the proposed rule and will provide an in-depth analysis for membership. 

    Read the CMS fact sheet on the 2019 PFS proposed rule.
    Read the CMS fact sheet on proposed QPP changes.


    CMS to Host Webinar on Proposed Rule for Year 3 QPP

    On Tuesday, July 17 from 1:00 - 2:30 PM ET, CMS will host a webinar on the proposed rule for Year 3 (2019) of the Quality Payment Program. CMS subject matter experts will:

    • Provide an overview of the proposed rule for Year 3 of the Quality Payment Program
    • Highlight key differences between Year 2 and proposed Year 3 requirements
    • Discuss the comment submission process
    • Provide additional resources

    Register here.

    Posted 7/12/2018



  • FDA Approves Nivolumab Plus Ipilimumab for Metastatic Colorectal Cancer

    On July 11, the Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb) plus Yervoy (ipilimumab, Bristol-Myers Squibb) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

    Read the full Bristol-Myers Squibb press release here.

    Posted 7/11/2018


  • ACS Launches Series to Outline 21st-Century Blueprint for Cancer Control

    In an effort to refocus nationwide efforts in oncology care, the American Cancer Society (ACS) has begun to outline its vision for cancer control in the 21st century through a series of articles. The first article in this series, published July 1, addresses trends in cancer mortality and disparities in cancer outcomes. ACS found that one area of critical disparity in cancer outcomes was socioeconomic status, indicated by educational attainment. Future articles in the series will focus on areas such as prevention, screening and early detection, cancer care and treatment, and research.

    Read the full ACS press release here.

    Posted 7/10/2018


  • NCI, VA Come to Agreement to Improve Veterans' Access to Cancer Clinical Trials

    On July 10, the National Cancer Institute (NCI) and the Department of Veterans Affairs (VA) announced the launch of the NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE). NAVIGATE will be launching at 12 VA facilities across the country. As part of the agreement, NCI will provide infrastructure funding support needed for VA facilities to participate in NCI-sponsored clinical trials, and VA will manage organizational and operational activities within its national healthcare system to establish a network to focus on NCI trial goals.

    Read the full NIH press release here.

    Posted 7/10/2018


  • GAO Reports Calls for More Oversight of 340B Contract Pharmacies

    In a report released on June 28, the Government Accountability Office (GAO) calls for improvement in federal oversight of compliance at 340B contract pharmacies. From 2010 to 2017, the number of pharmacies with which 340B covered entities have contracted increased from about 1,300 to almost 20,000. The 340B Drug Pricing Program is administered by the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS).

    The GAO report describes: 
    1) financial arrangements selected covered entities have with contract pharmacies;
    2)  the extent that selected covered entities provide discounts on 340B drugs dispensed by contract pharmacies to low-income, uninsured patients; and
    3)  HRSA's efforts to ensure compliance with 340B Program requirements at contract pharmacies. 

    Among the report's seven recommendations for improving oversight are that HRSA audits assess for duplicate discounts in Medicaid managed care, and that HRSA require information on how entities determined the scope of noncompliance and evidence of corrective action before closing audits. 

    Read GAO recommendations.
    Read full report.

    Posted July 3, 2018


  • CMS Posts MIPS Final Scores, Performance Feedback for Review

    On July 2, 2018, CMS announced that participants in the Merit-based Incentive Payment System (MIPS) in 2017 could review their MIPS final score and performance feedback on the Quality Payment Program website. The payment adjustment received in 2019 is based on this final score. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished under the Medicare Physician Fee Schedule in 2019.

    MIPS eligible clinicians or groups (along with their designated support staff or authorized third-party intermediary), including those who are subject to the APM scoring standard, may request for CMS to review their performance feedback and final score through a process called targeted review. 

    If you believe an error has been made in your MIPS payment adjustment calculation, you can request a targeted review until September 30, 2018. The following are examples of circumstances in which you may wish to request a targeted review:

    • Errors or data quality issues on the measures and activities you submitted
    • Eligibility issues (e.g., you fall below the low-volume threshold and should not have received a payment adjustment)
    • Being erroneously excluded from the APM participation list and not being scored under APM scoring standard
    • Not being automatically reweighted even though you qualify for automatic reweighting due to the 2017 extreme and uncontrollable circumstances policy

    You can access your MIPS final score and performance feedback and request a targeted review by:

    • Going to the Quality Payment Program website
    • Logging in using your Enterprise Identity Management (EIDM) credentials; these are the same EIDM credentials that allowed you to submit your MIPS data. Please refer to the EIDM User Guide for additional details.

    CMS has posted new resources on CMS.gov to help eligible clinicians and groups understand their Merit-based Incentive Payment System (MIPS) final score, performance feedback, and payment adjustment, as well as the targeted review process. The new resources include:

    For more information, visit the Quality Payment Program Resource Library on CMS.gov to review new and existing Quality Payment Program resources, or contact the Quality Payment Program at QPP@cms.hhs.gov or 1-866-288-8292 (TTY: 1-877-715-6222).

    Posted 7/2/2018