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  • FDA Approves Pemigatinib for Certain Unresectable Advanced Cholangiocarcinomas

    On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

    The FDA also approved the FoundationOne® CDX (Foundation Medicine, Inc.)  as a companion diagnostic for patient selection.

    Read FDA announcement.

    Posted 4/20/2020



  • FDA Approves Tucatinib in Combination for Advanced HER2-Positive Breast Cancer

    On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.

    Read FDA announcement.


    Posted 4/17/2020


  • White House Guidance Suggests Phased-In Approach for Easing COVID-19 Restrictions

    On Thursday, April 16, the White House released guidance for a phased-in approach for easing social distancing and stay-at-home restrictions instituted in response to the novel coronavirus-19. In a call with state governors on Thursday, President Trump said that each state can determine its own plan for reopening, and that the White House three-phase plan titled, "Guidelines: Opening Up America Again," was intended to serve as general guidance and was not a mandate.

    Some state governors are starting to lay out forward-looking scenarios. However, state governors remain concerned about relaxing stay-at-home restrictions too early, before there is the capacity to clearly identify who is sick and where.


    Posted 4/17/2020


  • BMS Expands Patient Support Programs for Newly Uninsured Patients in the U.S.

    Bristol Myers Squibb (BMS) is expanding its patient support programs to help unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. Patients will be able to immediately access their medicines through one single point of entry and all BMS-branded medicines will be free (see list). The program will be in effect for six months, after which, patients who are currently enrolled may continue on the program until they have insurance.

    Read the press release.


    4/17/2020


  • FDA Approves Eltrombopag 25-mg Powder for Suspension Package Size

    Novartis Pharmaceuticals Corporation has announced that the US Food and Drug Administration approved Promacta® (eltrombopag) 25-mg powder for suspension package size on March 23, 2020.

    Read corporate announcement.


    4/17/2020


  • COVID-19 Program on Vidscrip Platform

    Video Platform for COVID-19 Patient Communications is now available, sponsored by AstraZeneca.

    In an effort to support healthcare professionals during this unprecedented time and provide an efficient way, to address the overwhelming influx of calls and emails from patients with questions and concerns about COVID-19, AstraZeneca is sponsoring a healthcare technology company called Vidscrip, through June 30, 2020, or until such time as the COVID-19 virus is no longer a US public health emergency.

    This program enables healthcare professionals to use their own computer to record short videos that answer questions to common COVID-19 questions and then share those videos with their patients through their web page, or through direct links to their patient’s phone via a personalized email or text message.

    For more information visit www.vidscrip.com/COVID19 or text “COVIDAZUS” to 73771.


    4/16/2020


  • Trastuzumab-dttb, Biosimilar of Herceptin, Launches on U.S. Market

    On April 15, Merck announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials, according to the company press release. 

    Read company announcement.

    4/15/2020 



  • IMFINZI® ES-SCLC National Broadcast

    Tuesday, April 21
    7:30 PM ET or 9:30 PM ET

    This national broadcast program includes a 45-minute presentation followed by a Q & A session. Preregistration is required. Click here for details. 

    4/14/2020


  • CMS Issues Guidance on Payer COVID-19 Coverage

    On April 11, the Centers for Medicare & Medicaid Services (CMS) released guidance for implementation of the requirement for group health plans and group and individual health insurance to cover both COVID-19 diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.

    The guidance also ensures that COVID-19 antibody testing will be covered. When a COVID-19 antibody test becomes widely available, it could become a key element in fighting the pandemic.

    Access the guidance

    4/13/2020



  • ASCO Launches COVID-19 Registry

    The American Society of Clinical Oncology (ASCO) has announced the launch of the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry) to help the cancer community learn about the pattern of symptoms and severity of COVID-19 among patients with cancer. The registry will also aim to gain insight into how COVID-19 infections impact the delivery of cancer care and patient outcomes. The registry will collect both baseline and follow-up data throughout the pandemic and into 2021.

    Learn more.

    Posted 4/13/2020


  • HHS Starts Distribution of $30 Billion in Provider Relief Funds

    The bipartisan CARES Act, signed into law March 27, provides for $100 billion in relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response. On April 10, the U.S. Department of Health and Human Services (HHS) announced the immediate start to distribution of $30 billion in relief funds to providers. HHS states that eligible providers will begin receiving payment via direct deposit starting April 10, 2020. 

    Full details including who is eligible, how payment distributions are determined, what to do if you are an eligible provider, and 
    more here.

    Posted 4/10/2020

     
     


  • CMS Adds New COVID-19 Workforce Flexibility Waivers

    On April 9, the Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules so that hospitals, clinics, and other healthcare facilities can boost their frontline medical staffs during the novel Coronavirus (COVID-19) pandemic.

    These changes affect doctors, nurses, and other clinicians nationwide, and focus on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30.

    Access CMS fact sheet on detailing Blanket Waivers for Healthcare Providers (includes information on the new waivers and those announced previously).

    Posted 4/10/2020



  • No Change to Open Payments Dispute Timeline, CMS Says

    The Centers for Medicare & Medicaid Services (CMS) plans to stay on schedule for publicizing Open Payments data by the end of June, despite the COVID-19 crisis. Thus, if stakeholders want to review information on payments from drug and device manufacturers and group purchasing organizations to certain providers before publication, they must do so before May 15. 

    Source: InsideHealthPolicy 4/8/2020

    Posted 4/10/2020


  • FDA Approves Braftovi in Combo with Cetuximab for mCRC with BRAF V600E Mutation

    On April 8, 2020, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy.

    Read FDA announcements.

    Posted 4/9/2020


  • CMS Issues Updated Infection Control Guidance for Inpatient & Outpatient Care

    On April 8, the Centers for Medicare & Medicaid Services (CMS) announced the agency has issued a series of updated guidance documents focused on infection control to prevent the spread of the 2019 Novel Coronavirus (COVID-19) in a variety of inpatient and outpatient care settings. The updates aim to help clinicians in a variety of healthcare setting prevent and mitigate spread of the novel coronavirus. 

    CMS states that the guidance, based on Centers for Disease Control and Prevention (CDC) guidelines, will help ensure infection control in a wide range of areas, according to the agency, including:  of patient triage, screening and treatment, the use of alternate testing and treatment sites and telehealth, drive-through screenings, limiting visitations, cleaning and disinfection guidelines, staffing, and more.

    Read CMS press release.

    For hospitals, psychiatric hospitals and Critical Access Hospitals (CAHs), the revised guidance, for example, provides expanded recommendations on screening and visitation restrictions, discharge to subsequent care locations for patients with COVID-19, recommendations related to staff screening and testing, and return-to-work policies.

    In addition, for hospitals and CAHs, the revised guidance on the Emergency Medical Labor and Treatment Act (EMTALA) includes a detailed discussion of: patient triage, appropriate medical screening and treatment; the use of alternate testing sites; telehealth; and appropriate medical screening examinations performed at alternate screening locations, which are not subject to EMTALA, as long as the national emergency remains in force.

    Find latest CMS updates (dated 4/8/20) to guidance documents on infection control here (listed under Clinical & technical guidance.)

    Posted 4/8/2020



  • HHS Announces Upcoming Funding to Provide $186 Million for COVID-19 Response

    On Monday, April 6, the U.S. Department of Health and Human Services (HHS) announced upcoming action by the Centers for Disease Control and Prevention (CDC) to provide $186,000,000 in funding for additional resources to state and local jurisdictions in support of the nation’s response to the 2019 novel coronavirus (COVID-19). An HHS press release states that the CDC will use the funding to: 
    • Supplement an existing cooperative agreement to a number of states and local  identified as having the highest number of reported COVID-19 cases (“hot zones”) and jurisdictions with accelerating or rapidly accelerating COVID-19 cases.
    • Supplement an existing cooperative agreement to state jurisdictions through the Emerging Infections Program (EIP) to enhance surveillance capabilities.

    CDC will use existing networks to reach out to state and local jurisdictions to access this initial funding.

    To view the list of CDC funding actions to jurisdictions, click here.

    Read HHS press release here.

    Posted 4/6/2020



  • Novartis Announces New C-Code for Adakveo®, Effective April 1

    Novartis has announced that, effective April 1, 2020, the Centers for Medicare & Medicaid Services (CMS) has issued a product-specific C-code, C9053 for 100 mg/10 mL (10 mg/mL) solution in a single-dose vial of ADAKVEO® (crizanlizumab-tmca) for IV infusion. The code can be reported in box 44 on the CMS-1450 (UB-04) claim form for the hospital outpatient department.

    C-codes are used primarily to report services under the Outpatient Prospective Payment System (OPPS), but may also be recognized by other private and public payer types. Please check with each payer for specific requirements.

    Important billing and coding information:

    ADAKVEO is supplied as a 100 mg/10 mL (10 mg/mL) single dose vial. See below for coding details:

    Unique C-Code for ADAKVEO

    Description

    Units per 10 mL (10 mg/mL) single-dose vial

    C9053

    Injection, ADAKVEO, 1 mg

    100


    Please make sure to include C9053 on appropriate claims submission forms for ADAKVEO administered April 1 and later. If you have questions or need further clarification, please contact your Reimbursement Manager or ADAKVEO Support at PANO at 1-800-282-7630.

    Posted 3/24/2020



  • FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer

    On March 27, 2020, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

    Read FDA announcement.

    Posted 3/30/2020


  • CMS Expands Accelerated & Advance Payment Program for Medicare Providers & Suppliers

    On March 28, the Centers for Medicare & Medicaid Services (CMS) announced it is expanding the Accelerated and Advance Payment Program for all Medicare providers throughout the country during the COVID-19 public health emergency. The payments can be requested by hospitals, doctors, durable medical equipment suppliers, and other Medicare Part A and Part B providers and suppliers.

    To qualify for accelerated or advance payments, the provider or supplier must:

    • Have billed Medicare for claims within 180 days immediately prior to the date of signature on the provider’s/ supplier’s request form,
    • Not be in bankruptcy,
    • Not be under active medical review or program integrity investigation, and
    • Not have any outstanding delinquent Medicare overpayments.

    Medicare will start accepting and processing the Accelerated/Advance Payment Requests immediately. CMS anticipates that the payments will be issued within seven days of the provider’s request. Access CMS fact sheet for more information.

    Posted 3/29/2020



  • President Trump Signs CARES Act

    On March 27, President Trump signed the $2 trillion coronavirus emergency aid bill, known as the CARES Act, into law.

    The legislation includes relief for state and local governments, businesses (large and small), hospitals, and individuals affected by the coronavirus emergency. This is the third coronavirus aid package from Congress this month.

    Posted 3/27/2020