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Oncology Newsfeed

  • FDA Issues Emergency Use Authorization for Remdesivir for Severe COVID-19

    On May 1, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.

    The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

    Read the full FDA announcement.

    Posted 5/1/2020


  • CMS Issues Sweeping Regulatory Waivers & Changes to Further Expand Telehealth Options

    On April 30, the Centers for Medicare & Medicaid Services (CMS) issued another round of sweeping regulatory waivers and rule changes aimed at further increasing access to telehealth for Medicare beneficiaries in response to the COVID-19 public health emergency. Among the announced changes, CMS is:

    • Expanding the types of providers able to provide services via telehealth to Medicare beneficiaries to include physical therapists, occupational therapists, and speech language pathologists.
    • Allowing hospitals to bill for telehealth services provided by hospital-based practitioners in Medicare outpatient settings (including when patients are at home when the home is serving as a temporary provider-based department of the hospital). The agency states that this might include counseling, educational, and therapy services.
    • Expanding the types of services reimbursable under Medicare for audio-only telehealth visits to include behavioral health and patient education services, and increasing reimbursement (retroactively to March 1) for audio-only telehealth visits. 
    • Waiving the video requirement for telehealth E/M services. These are now added to the list of audio-only telehealth services that are reimbursable visits.
    • Expediting the process for adding new services to the list of those Medicare services that can be provided by telehealth.
    • Permitting rural health clinics and federally qualified health clinics to provide telehealth as a distant site, thus enabling Medicare beneficiaries to receive care from home.
    Read the CMS announcement for full details.

    Posted 5/1/2020

     



  • FDA Approves Daratumumab and Hyaluronidase-fihj for Multiple Myeloma

    On May 1, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.

    Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received:

    • in combination with bortezomib, melphalan and prednisone  in newly diagnosed patients who are ineligible for autologous stem cell transplant,
    • in combination with lenalidomide and dexamethasone  in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy,
    • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy,
    • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
    Read FDA announcement.

    Posted 5/1/2020


  • FDA Approves Niraparib for Frontine Maintenance of Advanced Ovarian Cancer

    On April 29, 2020, the U.S. Food and Drug Administration approved niraparib (Zejula, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

    Read the FDA announcement.

    Posted 4/29/2020


  • CMS Re-evaluating Accelerated Payment Program; Halting Advance Payment Program

    On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. 

    CMS states that significant additional funding will continue to be available to hospitals and other healthcare providers through other programs such as the Coronavirus Aid, Relief, and Economic Security (CARES) Act (PL 116-136) and the Paycheck Protection Program and Health Care Enhancement Act (PL 116-139) for healthcare providers. The U.S. Department of Health and Human Services (HHS) is distributing these funds through the Provider Relief Fund, and these payments do not need to be repaid.

    View CMS' updated fact sheet on the Accelerated Payment Program and Advance Payment Program here.

    Posted 4/27/2020


  • President Trump Signs $484 Billion Coronavirus Relief Package

    On Friday, April 24, President Trump signed into law a $484 billion coronavirus relief package. Congress passed the legislation earlier this week. Included in the emergency funding is $75 billion for hospitals and $25 billion for coronavirus testing.

    Read a summary of the Paycheck Protection and Health Care Enhancement Act (courtesy of the American Medical Association).

    Posted 4/24/2020



  • House Passes Coronavirus Rescue Funding Package Totaling Nearly $500 Billion

    On Thursday, April 23, the U.S. House of Representatives passed the coronavirus rescue package totaling nearly $500 billion by a vote of 388-5-1. Four conservative Republicans broke with the GOP leadership to vote against the bill, referencing the impact on the federal deficit. The Senate passed the legislation unanimously by voice vote earlier this week. 

    The legislation would bring an immediate $321 billion in funding for the Paycheck Protection Program, the small business rescue fund that was depleted last week. The rescue package would also provide $75 billion in emergency relief for hospitals, $25 billion to ramp up coronavirus testing, and an additional $60 billion in economic disaster loans for small businesses.

    The bill now goes to President Trump, who is expected the sign the legislation into law.

    Posted 4/23/2020



  • CMS Launches COVID-19 Workforce Virtual Toolkit

    On April 22, the Centers for Medicare & Medicaid Services (CMS) released a new toolkit to help state and local healthcare decision-makers in managing healthcare workforce challenges in response to the COVID-19 emergency. The online toolkit, developed by the Healthcare Resilience Task Force, includes a full suite of available resources to aid in response based on state and local needs. 

    Access the COVID-19 Workforce Virtual Tookit.

    Posted 4/22/2020


  • FDA Approves Sacituzumab Govitecan-hziy in Previously-Treated Metastatic Triple Negative Breast Cancer

    On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy™) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

    Read FDA announcement.

    Read corporate press release.

    Posted 4/22/2020


  • ONC, CMS to Exercise Enforcement Discretion for Interoperability Requirements

    The Office of the National Coordinator for Health Information Technology (ONC) announced April 21 that due to the COVID-19 public health emergency, ONC will exercise its discretion in enforcing all new requirements that have compliance dates and time frames until three months after each initial compliance date or timeline identified in the ONC Cures Act Final Rule. Learn more.

    Cures Final Act Rule Enforcement Discretion Dates & Timeframes.

    CMS press release.
    CMS announcement.

    Posted 4/22/2020