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Oncology Newsfeed

  • Moderna Announces EUA Request to FDA for COVID-19 Vaccine Candidate

    On November 30, 2020, Moderna announced that it has submitted an emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate mRNA-1273. Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17. 

     

    The company shared that the primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 based on 196 cases confirms the high efficacy observed at the first interim analysis. The point estimate performed indicates a vaccine efficacy of 94.1 percent. Efficacy was consistent across age, race, ethnicity, and gender demographics.

     

    Moderna anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an EUA is granted.

    Read Moderna's press release. You can find out more on Moderna's COVID-19 vaccine candidate from the Wall Street Journal, New York Times, and Bloomberg.

    Posted 12/1/2020



  • CMS Announces Resources + Office Hours for RO Model Participants

    The Centers for Medicare & Medicaid Services (CMS) has released resources and reminders to help those participating in the Radiation Oncology (RO) Model. These resources include help with accessing and navigating the Radiation Oncology Administrative Portal (ROAP).

    Upcoming Changes to the ROAP:

    • Access to multiple RO Model IDs
    • Low volume opt-out
    • Ability to edit your profile information.

    If you haven't already done so, CMS encourages you to register for ROAP as soon as possible. To register for ROAP, you will need your Model ID, Taxpayer Identification Number (TIN) for physician group practices and freestanding radiation therapy centers or CMS Certification Number (CCN) for Hospital Outpatient Departments, first name, last name, and email address of the designated primary contact in the appropriate fields.

    If you do not know your Model ID, please contact the CMS Helpdesk (1.888.734.6433, option 5). Hospital Outpatient Departments should email or call with their CMS Certification Number (CCN), so it can provide the correct Model ID; physician group practices and freestanding radiation therapy centers should call the Helpdesk with their practice’s Taxpayer Identification Number (TIN) to retrieve the correct Model ID.

    ROAP Office Hours
    RO participants can call into standing office hours that have been set up for troubleshooting ROAP login issues. Office hour dates and times include:

    • Tuesday, December 1 at 12:00 PM EST
    • Thursday, December 3 at 12:00 PM EST

    More dates are to be determined after Dec. 3, 2020. To join an office hour, join the Zoom meeting by following the link or by entering the Meeting ID (160 189 1276) and password (881584) on Zoom.

    For additional information about the RO Model, please visit its website. Or read the ROAP User Manual and ROAP FAQs.

    Posted 12/1/2020

     



  • CMS Issues Most Favored Nation Drug Pricing Model

    On Nov. 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released the Most Favored Nation (MFN) Model Interim Final Rule with Comment Period (IFC). The Model begins on Jan. 1, 2021, and will operate for seven years.

    The Model is mandatory for all Medicare physicians, non-physician practitioners, supplier groups (such as group practices), hospital outpatient departments (including 340B-covered entities), ambulatory surgical centers, and other providers and suppliers that receive separate Medicare Part B fee-for-service payment for the Model’s included drugs.   

    Participants may be granted a financial hardship exemption from the Model; however, these exemptions will be granted at the sole discretion of the agency.  Cancer hospitals, children’s hospitals, critical access hospitals, rural health clinics, federally qualified health centers and Indian Health Service facilities will not participate. CMS will also exclude from the Model hospitals participating in CMS Innovation Center models in which payment for outpatient services is made under a fully capitated or global budget basis, such as the Maryland Total Cost of Care Model. CMS will not exclude entities participating in the Oncology Care Model (OCM) but will adjust reconciliation calculations to avoid paying performance-based payments based on the MFN Model’s drug payment changes. 

    Included Drugs

    The first year of the demonstration includes 50 Part B drugs that encompass a high percentage of Medicare Part B drug spending. Each year, CMS will re-assess the list and new Part B drugs may be added to include drugs that move into the top 50 drugs based on updated annual Part B spending, after applying certain exclusions. CMS will only remove drugs from the list under limited circumstances. 

    Certain categories of drugs are excluded from the MFN Model’s drug list, including: 

    • Vaccines, 

    • Radiopharmaceuticals, 

    • Oral anti-cancer, anti-emetic, and immunosuppressive drugs, 

    • Compounded drugs, 

    • Intravenous immune globulin products, 

    • Drugs billed under HCPCS codes to which any generic drugs are assigned, and 

    • Drugs subject to an EUA or approved for treating COVID-19, and drugs billed under “not otherwise classified” codes. 

    Comment period on the Model ends 60 days after publication in the Federal Register.

     

    More information is available on the Model's website here. 

    Posted 11/24/2020



  • FDA Issues EUA for Casirivamab + Imdevimab Antibodies to Treat COVID-19

    On November 21, 2020, the U.S. Food and Drug Administration (FDA) announced its second emergency use authorization (EUA) for monoclonal antibodies to treat COVID-19. Under the EUA, casirivamab and imdevimab must be administered together by intravenous use for the treatment of mild to moderate COVID-19 in adults and pediatric patients who:

    • Are 12-years-old or older

    • Weigh at least 40 kilograms (about 88 pounds)

    • Have positive results of direct SARS-CoV-2 viral testing

    • Are at risk for progressing to severe COVID-19*.

    *This includes those who are 65 years of age or older or who have certain chronic medical conditions.

    When administered together in patients with COVID-19 via clinical trial, casirivamab and imdevimab reduced COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. A benefit has not been shown in patients hospitalized due to COVID-19. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.

    Read the FDA announcement.

    Posted 11/23/2020



  • Pfizer + BioNTech Announce EUA Request to FDA for COVID-19 Vaccine

    On November 20, 2020, Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for BNT162b2, the companies’ COVID-19 mRNA vaccine candidate. If approved, some Americans could receive the vaccine as early as mid-December. 


    Through an accelerated clinical trial process, the potential vaccine demonstrated a 95 percent efficacy rate with no serious safety concerns to date. The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion by the end of 2021. 


    The companies have also initiated rolling submissions with regulatory agencies around the world. Upon authorization, the companies state that they will be ready to distribute the vaccine within hours. 


    Read Pfizer's announcement. Find out more about Pfizer and BioNTech’s COVID-19 vaccine candidate from AP News, New York Times, and Washington Post. 


    Posted 11/20/2020



  • FDA Issues EAU for Monoclonal Antibody to Treat COVID-19

    On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody therapy, for the treatment of mild to moderate COVID-19 in adult and pediatric patients who:

    • Have positive results of direct SARS-CoV-2 viral testing
    • Are 12-years-old or older
    • Weigh at least 40 kilograms (about 88 pounds)
    • Are at high risk for progressing to severe COVID-19 and/or hospitalization.

    Bamlanivimab has shown through clinical trials to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment, compared to placebo. As part of the EUA, efficacy of the agent continues to be evaluated and several quality measures have been imposed to protect patients. 

    Read the FDA announcement. 

    Posted 11/20/2020



  • CMS Announces Quality Payment Program COVID-19 Exception Application

    The Centers for Medicare & Medicaid Services (CMS) recognizes that not all practices have been impacted by COVID-19 to the same extent. For the 2020 performance year, CMS will be using its extreme and uncontrollable circumstances policy to allow merit-based incentive payment system (MIPS) eligible clinicians, groups, and virtual groups to submit an application requesting reweighting of one or more of their MIPS performance categories to zero percent due to the COVID-19 public health emergency.

    If you have any concerns about the effect of the COVID-19 pandemic on your practice's 2020 performance data, including cost measures, submit an Extreme and Uncontrollable Circumstances application and be sure to cite COVID-19 as the reason for your application. Applications are due December 31, 2020.

    If an application is approved, you can still receive scores for the quality, improvement activities and Promoting Interoperability performance categories if you submit data. If the cost performance category is included in your approved application, you will not be scored on cost measures even if other data are submitted. Once an application has been submitted, you will be notified by email if your request is approved or denied. If approved, the exception will be added to your eligibility profile on the QPP Participation Status Tool but may not appear until the submission window opens in 2021.

    Read the 2020 Exceptions Applications fact sheet. For more information, visit the promoting interoperability hardship exception andextreme and uncontrollable circumstances exceptionwebpages.

    For Alternate Payment Model (APM) Entities: CMS has proposed to allow APM entities to submit an application to reweight MIPS performance categories as a result of extreme and uncontrollable circumstances, such as the public health emergency resulting from the COVID-19 pandemic. Applications are due December 31, 2020. Learn more in the 2021 Quality Payment Program Proposed Rule Overview Fact Sheet.

    Posted 11/16/2020



  • FDA Approves Pembrolizumab + Chemotherapy for TNBC

    On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Keytruda® (pembrolizumab) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.

    Read the FDA announcement.

    Read the Merck press release.

    Posted 11/16/2020


  • CMS Reminder to Update Billing Information to Receive APM Incentive Payments

    The Centers for Medicare & Medicaid Services (CMS) Quality Payment Program website includes 2020 Alternative Payment Model (APM) incentive payment details. To access information on the incentive amount and organization paid, clinicians and surrogates can log in to the QPP website using their HARP credentials. In order to receive payments, certain clinicians will need to verify their Medicare billing information by November 13, 2020.

    Eligible clinicians who were qualifying APM participants have already begun receiving their 2020 APM incentive payments last month based on their 2018 performance. If you are a clinician and have already received your payment, you do not need to update anything.

    CMS also posted a new 2020 APM Incentive Payment Fact Sheet to explain:

    • Who is eligible to receive an APM incentive payment in 2020?

    • How CMS determines your 2020 APM incentive payment.

    • Frequently asked questions and answers.

    For any questions, contact the CMS Quality Payment Program at QPP@cms.hhs.gov or 1.866.288.8292. To receive assistance more quickly, consider calling during non-peak hours—before 10 a.m. and after 2 p.m. ET.
    Posted 11/11/20



  • CMS Announces 2021 Federal Health Insuance Exchange Open Enrollment Period

    The Centers for Medicare & Medicaid Services (CMS) announced that the open enrollment period for the federal health insurance exchange will officially begin on Sunday, November 1 and run through Tuesday, December 15, 2020. Coverage will begin as soon as January 1, 2021.

    Consumers can log in to HealthCare.gov and CuidadodeSalud.gov, or they can call 1-800-318-2596 to fill out an application and enroll in a 2021 exchange health plan. 

    Please note: Current enrollees who don’t update their application and enroll in a plan by the deadline on December 15, 2020 will be automatically enrolled in the same plan, or another plan with the same insurance company intended to be as similar as possible. If that’s not available, they will generally be enrolled in another plan with a different insurance company.

    Consumers who miss the deadline to re-enroll in a plan of their choice during open enrollment will also not be able to make any plan changes until the next coverage year, unless they qualify for certain special enrollment periods.

    Read the CMS fact sheet for more information.

    Posted 11/02/2020