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Oncology Newsfeed

  • 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


  • FDA Approves New Treatment for Hairy Cell Leukemia

    On September 13, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxiti, AstraZeneca) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

    Read the full FDA press release here.

    Posted 9/13/2018


  • CMS Supports North Carolina and South Carolina Ahead of Hurricane Florence

    The Centers for Medicare & Medicaid Services (CMS) have announced efforts underway to support North Carolina and South Carolina in response to Hurricane Florence. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Florence. CMS has waived certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; created special enrollment opportunities for individuals to access healthcare immediately; and taken steps to ensure dialysis patients obtain critical services.

    •  Waivers for Hospitals and other Healthcare Facilities: CMS has temporarily waived or modified certain Medicare, Medicaid, and CHIP requirements. CMS issued a number of blanket waivers, listed on the website below, and the CMS Regional Offices have granted other provider-specific requests for specific types of hospitals and other facilities in North Carolina and South Carolina. These waivers work to provide continued access to care for beneficiaries. For more information on the waivers CMS granted, visit www.cms.gov/emergency.
    • Special Enrollment Opportunities for Hurricane Victims:  CMS has made available special enrollment periods for all Medicare beneficiaries and certain individuals seeking health plans offered through the Federal Health Insurance Exchange. This gives people impacted by the hurricane the opportunity to change their Medicare health and prescription drug plans and gain access to health coverage on the Exchange immediately if eligible for the special enrollment period. For more information on these special enrollment periods, visit:
          - https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/8-9-natural-disaster-SEP.pdf
          - https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Past-Emergencies/Hurricanes-and-tropical-storms.html
    • Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. For more information and to access the toolkit, visit https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/index.html.
    • Dialysis Care: CMS is helping patients obtain access to critical services. The Kidney Community Emergency Response (KCER) program has been activated ahead of the storm and is working with the End Stage Renal Disease Network of the South Atlantic, ESRD NW 6, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. The ESRD NW toll-free hotline is 800-524-7139 and the KCER hotline is 866-901-3773. Additional information is available on the KCER website www.kcercoalition.com.
    • Medical equipment and supplies replacements: CMS temporarily suspended certain requirements necessary for Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access necessary medical equipment and supplies. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.
    • Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in North Carolina and South Carolina, but will continue to investigate allegations of immediate threat to patient health and safety.
    • Ensuring Access to Care in Medicare Advantage and Part D.  During a public health emergency, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

    For more information, visit www.cms.gov/emergency.

    Posted 9/13/2018