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Oncology Newsfeed

  • 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


  • ACCC In the Press at ASCO 2018

    At the 2018 ASCO Annual Meeting, we had the opportunity to connect with many ACCC members and engage a wide audience! Oncology Business Review, OncLive, and ASCO Post sat down with a number of ACCC advocates and leaders to discuss pressing issues in cancer care. 

    ACCC Treasurer Randall A. Oyer, MD, with an update on the ACCC Immuno-Oncology Institute: 


    ACCC Immuno-Oncology Institute Executive Committee Member Ivo Abraham, PhD, RN, speaks about value in cancer care: 

    ACCC Past President Jennie R. Crews, MD, MMM, FACP, describes how care coordination in immunotherapy is engaging new providers with the cancer care team:


    Dr. Abraham shares his perspective on hurdles to adoption of biosimilars in oncology:

    Watch more from Dr. Abraham on:

    Key features of a biosimilar - via OBR

    Biosimilars approved and nearing approval for oncology - via OBR

    Biosimilar pricing and reimbursement - via OBR

    Dr. McBride Discusses financial toxicity in oncology with OncLive:



    Lee S. Schwartzberg, MD, FACP, discusses how the ACCC Immuno-Oncology Institute is evolving to support integration of IO in the community through new working groups, resources for cross-specialty care coordination, and team education for this rapidly expanding field. - ASCO Post




    Dr. Zibelman discusses managing immune-related adverse events with OncLive:

     


    Posted 6/13/2018


  • FDA Approves Venetoclax for CLL, Small Lymphocytic Lymphoma

    On June 8, 2018, the Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

    Read the full FDA announcement here.

    Posted 6/11/2018



  • DOJ & Trump Administration Will Not Defend ACA’s Pre-Existing Coverage

    The Trump administration's U.S. Department of Justice (DOJ) on June 7, stated it will not defend the Affordable Care Act from litigation spearheaded by 20 conservative Republican-led states that aims to invalidate the ACA.  Rather than defend the law, the DOJ has asked a Texas court to overturn the ban on denying insurance coverage to those with pre-existing conditions. The Texas lawsuit, filed in February, argues that the recent congressional action to eliminate the individual mandate should result in other key provisions of the ACA being overturned.

    Essentially, the 20 GOP-led states are reviving the 2010 lawsuit argument over the constitutionality of the ACA.

    According to news reports, Attorney General Jeff Sessions explained the decision in letters to House Speaker Paul Ryan (R-WI) and Minority Leader Nancy Pelosi (D-CA), indicating that Congress’ action repealing the individual mandate means that ACA provisions banning insurers from denying coverage or charging more to those with pre-existing health conditions are now invalidated.

    While the ACA remains the law and there is no immediate threat to pre-existing coverage protection, legal experts are noting that it is extremely far from precedent that a sitting administration would not argue the constitutionality of a sitting law.

    Sources:     InsideHealthPolicy, Politico, Bloomberg BNA, New York Times

    Posted 6/8/2018