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Oncology Newsfeed

  • FDA Approves NGS Test to Detect MRD in ALL and Myeloma

    On September 28, 2018, the U.S. Food and Drug Administration announced that the agency is permitting marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.

    MRD is a general measure of the amount of cancer in the body (tumor burden), specifically the number of cancer cells that remain in a person’s bone marrow, either during or after treatment. Measuring MRD provides a tool to detect very low levels of tumor burden. MRD is useful to evaluate in patients who have responded to therapy when their tumor burden is below what can be detected with standard methods. The detection of MRD is associated with recurrence of the disease in those patients.

    Read details in the FDA announcement.

    Posted 10/1/18

  • FDA Approves Cemiplimab-rwlc for Cutaneous Squamous Cell Carcinoma

    On September 28, the U.S. Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Sanofi) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

    Read the full FDA press release here.

    Posted 10/1/18

  • FDA Approves Dacomitinib for Metastatic NSCLC

    On September 27, the Food and Drug Administration approved dacomitinib tablets (Vizimpro, Pfizer Inc.) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

    Read the full FDA press release here.

    Posted 9/28/18

  • House Approves Legislation Banning Pharmacist “Gag Clauses”

    On Tuesday, September 25, 2018, the U.S. House passed by voice vote two Senate bills that ban so-called "gag clauses" which prevent pharmacists from informing consumers when it would cost less to pay out-of-pocket for prescriptions drugs instead of using their health insurance.

    On Monday, the U.S. Senate passed two pieces of legislation that would prohibit such "gag clauses." The Patient Right to Know Drug Prices Act, S. 2554, impacts private health plans including those in the ACA marketplace, and the Know the Lowest Price Act of 2018, S. 2553, covers Medicare Advantage and Part D plans. 

    Having cleared the House, the legislation next moves to the White House for President Trump's signature.

    Posted 9/25/18

  • FDA Approves Duvelisib for CLL/SLL, FL

    On September 24, the U.S. Food and Drug Administration (FDA) approved duvelisib (Copiktra) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. Duvelisib also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.

    Read the FDA press release here.

    Posted 9/25/2018

  • ACCC Submits Comments to Proposed 2019 OPPS Rule

    On September 24, 2018, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed CY 2019 Outpatient Prospective Payment System (OPPS) rule.

    In its comments, ACCC recommends that CMS:

    • Not finalize its proposal to reduce reimbursement to Wholesale Acquisition Cost (WAC) plus 3 percent for new drugs and biologicals that do not yet have adequate Average Sales Price (ASP) data;

    • Not finalize its proposal to reduce payment for separately payable drugs purchased under the 340B program at nonexcepted hospital off-campus provided-based departments;

    • Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for certain clinic visits furnished at excepted off-campus provider-based departments;

    • Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for service-line expansions at excepted off-campus provider-based departments;

    • Clarify how hospital should bill for furnishing certain outpatient services related to CAR T-cell therapies and ensure that hospitals are paid appropriately for furnishing these therapies; and

    • Ensure that any model based on Competitive Acquisition Program (CAP) authority is voluntary for all participants, preserves patient access to treatment and provider flexibility, and promotes cost-efficiency through more effective distribution and delivery of drugs and biological rather than utilization management tools.
    Read full comment letter here.

    Posted 9/24/18


  • Pfizer Announces Relief for Cancer Patients Affected by Hurricane Florence

    Pfizer Oncology has announced emergency relief protocols to ensure that patients who receive their Pfizer Oncology medicines through the Pfizer Patient Assistance Program and are impacted by Hurricane Florence have continued access to their medications.

    In addition to these emergency protocols, Pfizer has also activated a comprehensive and coordinated plan at the company-wide level to provide further disaster support.

    Read more here.

    Posted 9/24/18

  • Hogan Lovells to Host Webinar on Legal Considerations of Telehealth

    On October 3, Hogan Lovells will host a complimentary webinar to discuss recent and proposed changes in the coverage of telehealth services, potential future developments, and key legal issues to consider. Topics will include:   
    • Recent and proposed expansion of Medicare coverage of telehealth services
    • State law considerations in providing telehealth
    • Fraud and abuse issues in telehealth
    • Innovations, future trends, and the evolution of what’s considered “telehealth”
    Click here to register for this complimentary webinar.

    Posted 9/20/18

  • CMS Issues CY 2019 Proposed Rule Aimed at Efficiency, Transparency, Clinician Burden

    On September 17, the Centers for Medicare & Medicaid Services (CMS) released the Medicare & Medicaid; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction proposed rule for calendar year 2019. This proposed rule was released to build upon the administration’s ‘Patients Over Paperwork’ and ‘Cut the Red Tape’ initiatives. The deadline for submitting comments on the proposed rule is 60 days from the rule's release into the US Federal Register.

    ACCC is currently analyzing the rule and will provide an update to members soon.

    View the proposed CY 2019 rule.

    Posted 9/17/2018

  • House of Representatives Passes Transparency Reforms to Medicare LCDs

    On September 12, the House of Representatives passed the Local Coverage Determination (LCD) Clarification Act, which aims to improve accountability and transparency in the process Medicare contractors use to make local coverage decisions. Key provisions in the bill include:
    • Open and recorded Medicare Administrative Contractor (MAC) Carrier Advisory Committee meetings
    • Upfront disclosure of evidence MACs consider when drafting an LCD, as well as the rationale they are relying on to deny coverage.
    • Additional options for challenging an LCD
    • Annual reports to Congress on the number of LCD appeals and actions taken in lieu of the creation of an ombudsman.
    Read the College of American Pathologists (CAP) press release here.

    Posted 9/13/2018