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Oncology Newsfeed

  • 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


  • ACCC Submits Comments to CMS on FY2019 IPPS Proposed Rule

    On June 25, 2018, the Association of Community Cancer Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the fiscal year (FY) 2019 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule. In comments to the agency:

    • ACCC asked that CMS adopt a stepwise strategy on reimbursement for CAR T therapies and adopt a temporary pass-through until enough cost data can be collected to establish an adequate MS-DRG for CAR T.
    • ACCC supported CMS' move to loosen hospital-within-a-hospital rules that unnecessarily impede flexibility for PPS-exempt hospitals.
    • ACCC also supported CMS' move to eliminate measures from the PPS-Exempt Cancer Hospital Quality Reporting Program (PCHQR) that unnecessarily increase burdens on hospitals.
    Read the full ACCC comment letter here.

    Posted 6/29/2018


  • CMS Advances Demonstration to Waive MIPS Requirements for Clinicians in Certain At-Risk Medicare Advantage Plans

    On June 29, the Centers for Medicare & Medicaid Services (CMS) announced that they would be advancing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, which would waive Merit-Based Incentive Payment System (MIPS) requirements for clinicians who participate sufficiently in certain Medicare Advantage plans that involve taking on risk. CMS seeks public comment on the information collection burdens associated with the demonstration, which is under consideration for formal approval.

    Read the full CMS press release here.

    Posted 6/29/2018


  • FDA Approves Encorafenib/Binimetinib Combo for Advanced Melanoma with BRAF Mutation

    On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

    Read FDA announcement.

    Posted June 27, 2018


  • FDA Restricts Use of Keytruda and Tecentriq for Urothelial Cancer

    On June 20, 2018, the FDA announced that it was restricting the use of Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

    This restriction results from decreased survival associated with the use of Keytruda or Tecentriq as monotherapy compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

    Read the full FDA announcement here.

    Posted 6/21/2018


  • ACCC Submits Comments to CMS on NCA for CAR T Therapy

    On June 15, 2018, the Association of Community Cancer Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's opening of a National Coverage Analysis (NCA) for CAR T therapies for cancer. Currently, two CAR T-cell therapies are approved the U.S. Food and Drug Administration, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel).  In comments its to the agency , ACCC urged that CMS:

    • Adopt a national coverage policy ensuring full Medicare coverage of CAR T therapies for their FDA-approved indications in all settings of care permitted by their labeling and REMS.
    • Allow Medicare Administrative Contractors (MACs) to cover FDA-approved CAR T therapies for indications listed in national compendia or supported by certain literature.
    • Clarify that the FDA-approved indications for CAR T therapies are covered by Medicare during the NCA process and complete that process as soon as possible to maintain uninterrupted patient access to these therapies.

    Additionally, ACCC expressed concern that the outcome of the NCA process may be stifling to innovation of CAR T therapies in the pipeline.

    Read ACCC Comment Letter

    Posted 6/20/2018



  • FDA Approves Bevacizumab in Combination with Chemotherapy for Ovarian Cancer

    On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.

    Read the full FDA announcement here.

    Posted 6/13/18


  • FDA Approves Pembrolizumab for Advanced Cervical Cancer

    On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

    Read the full FDA press release here.

    Posted 6/13/2018